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Prescribing Information
TEZSPIRE®

Tezspire

tezepelumab

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Highlights of Prescribing Information

<?xml version="1.0" encoding="UTF-8"?><title>These highlights do not include all the information needed to use TEZSPIRE safely and effectively. See full prescribing information for TEZSPIRE.<br/>TEZSPIRE<sup>®</sup> (tezepelumab-ekko) injection, for subcutaneous use<br/>Initial U.S. Approval: 2021</title>

SPL product data elements section
RECENT MAJOR CHANGES SECTION
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
13 NONCLINICAL TOXICOLOGY
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
SPL PATIENT PACKAGE INSERT SECTION
INSTRUCTIONS FOR USE SECTION
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

SPL product data elements section

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<?xml version="1.0" encoding="UTF-8"?><section ID="ID_A1AD8AEC-7A7B-4532-90EF-9A31AE71BA2A"> <id root="016ed935-beef-4de1-b7ae-80844d1de8a2"/> <code code="43683-2" codeSystem="2.16.840.1.113883.6.1" displayName="RECENT MAJOR CHANGES SECTION"/> <effectiveTime value="20251017"/> <excerpt> <highlight> <text> <paragraph/> <paragraph>Indications and Usage (<linkHtml href="#ID_e8e6b63a-0c98-42c1-9563-1abede185ee0">1.2</linkHtml>) 10/2025</paragraph> </text> </highlight> </excerpt> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_33cf0c4d-6e0a-4b82-ac7d-ca0f77121fe3"> <id root="9d8ef16d-ad4c-4db4-ab43-93c2dcfaf870"/> <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/> <title>1 INDICATIONS AND USAGE </title> <effectiveTime value="20251017"/> <excerpt> <highlight> <text> <paragraph>TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: </paragraph> <list listType="unordered"> <item> <caption>•</caption>for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. (<linkHtml href="#ID_67be522c-18b2-4d1a-be07-bed257190a58">1.1</linkHtml>)</item> <item> <caption> </caption> <content styleCode="underline">Limitations of Use:</content> </item> <item> <caption> </caption>Not for relief of acute bronchospasm or status asthmaticus. (<linkHtml href="#ID_67be522c-18b2-4d1a-be07-bed257190a58">1.1</linkHtml>)</item> <item> <caption>•</caption>for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (<linkHtml href="#ID_e8e6b63a-0c98-42c1-9563-1abede185ee0">1.2</linkHtml>)</item> </list> </text> </highlight> </excerpt> <component> <section ID="ID_67be522c-18b2-4d1a-be07-bed257190a58"> <id root="f73e314f-91b9-4c1b-9325-9f421f0e8e9c"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>1.1 Asthma </title> <text> <paragraph>TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.</paragraph> <paragraph> <content styleCode="underline">Limitations of Use:</content> </paragraph> <paragraph>TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.</paragraph> </text> <effectiveTime value="20251017"/> </section> </component> <component> <section ID="ID_e8e6b63a-0c98-42c1-9563-1abede185ee0"> <id root="6c822ca0-e656-4647-9065-582ca3c78fb8"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>1.2 Chronic Rhinosinusitis with Nasal Polyps </title> <text> <paragraph> <content styleCode="xmChange">TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).</content> </paragraph> </text> <effectiveTime value="20251017"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_26188470-bcec-4adb-a4c1-1ec7b8b74e09"> <id root="9aa301f6-f4ce-45ad-9c29-080ac8c3cb05"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & ADMINISTRATION SECTION"/> <title>2 DOSAGE AND ADMINISTRATION </title> <effectiveTime value="20251017"/> <excerpt> <highlight> <text> <paragraph>Recommended dosage is 210 mg administered once every 4 weeks. (<linkHtml href="#ID_cf9eeebc-3a26-461a-8de8-98561dd3052b">2.1</linkHtml>)</paragraph> <list listType="unordered"> <item> <caption>•</caption>Administer by subcutaneous injection. (<linkHtml href="#ID_cf9eeebc-3a26-461a-8de8-98561dd3052b">2.1</linkHtml>)</item> <item> <caption>•</caption>See full prescribing information for preparation and administration instructions. (<linkHtml href="#ID_4f4af2aa-3e01-48e7-9f3d-eb20c9842ab4">2.2</linkHtml>)</item> </list> </text> </highlight> </excerpt> <component> <section ID="ID_cf9eeebc-3a26-461a-8de8-98561dd3052b"> <id root="cf9eeebc-3a26-461a-8de8-98561dd3052b"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>2.1 Recommended Dosage </title> <text> <paragraph>The recommended dosage of TEZSPIRE is 210 mg administered subcutaneously once every 4 weeks.</paragraph> <paragraph> <content styleCode="underline">Missed Dose Information</content> </paragraph> <paragraph>If a dose is missed, administer the dose as soon as possible. Thereafter, the patient can continue (resume) dosing on the usual day of administration. If the next dose is already due, then administer as planned.</paragraph> </text> <effectiveTime value="20211217"/> </section> </component> <component> <section ID="ID_4f4af2aa-3e01-48e7-9f3d-eb20c9842ab4"> <id root="0b8bf392-8c7f-49b3-ade8-0fb4b5107b83"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>2.2 Preparation and Administration Instructions </title> <text> <paragraph>TEZSPIRE vial and pre‑filled syringe are intended for administration by a healthcare provider.</paragraph> <paragraph>TEZSPIRE pre-filled pen can be administered by patients/caregivers or healthcare providers. Patients/caregivers may administer TEZSPIRE pre-filled pen after proper training in subcutaneous injection technique and after the healthcare provider determines it is appropriate.</paragraph> <paragraph>Each vial, pre-filled syringe and pre‑filled pen contain a single dose of TEZSPIRE.</paragraph> <list listType="unordered"> <item> <caption>•</caption>Prior to administration, remove TEZSPIRE from the refrigerator and allow it to reach room temperature. This generally takes 60 minutes. Do not expose to heat and do not shake. Do not use if the security seal on the carton has been broken. Do not put back in the refrigerator once TEZSPIRE has reached room temperature.</item> <item> <caption>•</caption>Visually inspect TEZSPIRE for particulate matter and discoloration prior to administration. TEZSPIRE is a clear to opalescent, colorless to light yellow solution. Do not use TEZSPIRE if liquid is cloudy, discolored, or if it contains large particles or foreign particulate matter. Do not use if the vial, pre-filled syringe or pre‑filled pen has been dropped or damaged or if the expiration date has passed.</item> <item> <caption>•</caption>Inject TEZSPIRE 210 mg (contents of one vial, one pre-filled syringe or one pre-filled pen as described below) subcutaneously into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. If a healthcare provider or caregiver administers the injection, the upper arm can also be used. A patient should not self-inject in the upper arm. TEZSPIRE should not be injected into areas where the skin is tender, bruised, erythematous, or hardened. It is recommended to rotate the injection site with each injection.</item> </list> <paragraph> <content styleCode="underline">Administration Instructions for Single-Dose Pre-filled Syringe</content> </paragraph> <paragraph>Refer to Figure 1 to identify the pre-filled syringe components for use in the administration steps.</paragraph> <paragraph>Do not remove the needle cover until Step 2 of these instructions when you are ready to inject TEZSPIRE. Do not touch the needle guard activation clips to prevent premature activation of the needle safety guard.</paragraph> <paragraph> <content styleCode="bold">Figure 1 TEZSPIRE Pre-filled Syringe Components</content> </paragraph> <renderMultiMedia ID="id250011061" referencedObject="d0f2514a-6adf-42f7-96b1-a070617d641d"/> <table styleCode="Noautorules" width="100%"> <col width="7%"/> <col width="27%"/> <col width="66%"/> <tbody> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>1.</item> </list> </td> <td colspan="2" valign="top"> <paragraph>Grasp the syringe body to remove the pre-filled syringe from its carton. Do not grab the pre-filled syringe by the plunger.</paragraph> <paragraph>The pre-filled syringe may contain small air bubbles; this is normal. Do not expel the air bubbles prior to administration.</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>2.</item> </list> </td> <td valign="top"> <renderMultiMedia ID="id-838156739" referencedObject="ID_820b042c-39fe-4543-8547-d7c09def9084"/> </td> <td valign="top"> <paragraph>Do not remove the needle cover until ready to inject. Hold the syringe body and remove the needle cover by pulling straight off. Do not hold the plunger or plunger head while removing the needle cover. You may see a drop of liquid at the end of the needle. This is normal.</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>3.</item> </list> </td> <td valign="top"> <renderMultiMedia ID="id2055725580" referencedObject="e01e97af-9245-4e14-9960-7b9c2df515e3"/> </td> <td valign="top"> <paragraph>Gently pinch the skin and administer subcutaneously at approximately 45° angle into the recommended injection site (i.e., upper arm, thigh, or abdomen).</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>4.</item> </list> </td> <td valign="top"> <renderMultiMedia ID="id959072033" referencedObject="c5be2b3c-4fb3-425a-b67d-ff2818d2c979"/> </td> <td valign="top"> <paragraph>Inject all of the medication by pushing in the plunger all the way until the plunger head is completely between the needle guard activation clips. This is necessary to activate the needle guard.</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>5.</item> </list> </td> <td valign="top"> <renderMultiMedia ID="id35474572" referencedObject="ID_590d5899-7131-436d-b4ec-7098cb79d3f8"/> </td> <td valign="top"> <paragraph>After injection, maintain pressure on the plunger head and remove the needle from the skin. Release pressure on the plunger head to allow the needle guard to cover the needle. Do not re-cap the pre-filled syringe.</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>6.</item> </list> </td> <td colspan="2" valign="top"> <paragraph>Discard the used syringe into a sharps container.</paragraph> </td> </tr> </tbody> </table> <paragraph> <content styleCode="underline">Administration Instructions for Single-Dose Pre-filled Pen</content> </paragraph> <paragraph>These administration instructions are intended for healthcare providers use only. Patients and caregivers should refer to the TEZSPIRE pre-filled pen ‘Instructions for Use’ for more detailed instructions on the preparation and administration of TEZSPIRE pre-filled pen <content styleCode="italics">[See Instructions for Use]</content>.</paragraph> <paragraph>Patients/caregivers may inject after proper training in subcutaneous injection technique according to the ‘Instructions for Use’, and after the healthcare provider determines it is appropriate.</paragraph> <paragraph>Refer to Figure 2 to identify the pre-filled pen components for use in the administration steps.</paragraph> <paragraph>Do not remove the cap until you are ready to inject TEZSPIRE.</paragraph> <paragraph> <content styleCode="bold">Figure 2 TEZSPIRE Pre-filled Pen Components</content> </paragraph> <renderMultiMedia ID="id-789670934" referencedObject="C35B1727-A023-4369-960B-070C2C50A89F"/> <table styleCode="Noautorules" width="100%"> <col width="7%"/> <col width="24%"/> <col width="2%"/> <col width="67%"/> <tbody> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>1.</item> </list> </td> <td colspan="3" valign="top"> <paragraph>Grab the middle of the pre-filled pen body to remove the pre-filled pen from its carton.<br/> </paragraph> <paragraph>The pre-filled pen may contain small air bubbles; this is normal. Do not expel the air bubbles prior to administration.</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>2.</item> </list> </td> <td valign="top"> <renderMultiMedia ID="id-939684261" referencedObject="ID_34170091-2d57-4ab2-a294-f8fbca11184f"/> </td> <td colspan="2" valign="top"> <paragraph>Do not remove the cap until ready to inject. Hold the pre-filled pen body with 1 hand and carefully pull the cap straight off with your other hand. Do not touch the needle or push the orange needle guard with your finger. Do not put the cap back on the pre-filled pen. You could cause the injection to happen too soon or damage the needle.</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>3.</item> </list> </td> <td colspan="3" valign="top"> <paragraph>Gently pinch the skin at the injection site or give the injection without pinching the skin.<br/> </paragraph> <paragraph>Inject TEZSPIRE by following the steps into the recommended injection site (i.e., upper arm, thigh, or abdomen).<br/> </paragraph> <paragraph>When injecting, you will hear the first click that tells you the injection has started. Press and hold the pre-filled pen for 15 seconds until you hear the second click. Do not change the position of the pre-filled pen after the injection has started.</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>4.</item> </list> </td> <td colspan="2" valign="top"> <renderMultiMedia ID="id1215238951" referencedObject="ID_285deebf-1c60-4f1a-ba25-05a1a9ffccbc"/> </td> <td valign="top"> <paragraph>Position the pre-filled pen. Place the orange needle guard flat against the skin (90‑degree angle). Make sure you can see the viewing window.</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>5.</item> </list> </td> <td colspan="2" valign="top"> <renderMultiMedia ID="id446128707" referencedObject="ID_04acfd66-01fc-4814-a0f7-8b6d54d07e67"/> </td> <td valign="top"> <paragraph>Press down firmly until you cannot see the orange needle guard. You will hear the first ‘click’, this tells you the injection has started. The orange plunger will move down in the viewing window during the injection.</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>6.</item> </list> </td> <td colspan="2" valign="top"> <renderMultiMedia ID="id1580639753" referencedObject="F0D9F737-74FC-480E-A35F-7AEECAB4FC14"/> </td> <td valign="top"> <paragraph>Hold down firmly for about 15 seconds. You will hear a second ‘click’, this tells you the injection has finished. The orange plunger will fill the viewing window.</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>7.</item> </list> </td> <td colspan="2" valign="top"> <renderMultiMedia ID="id-1623839356" referencedObject="ID_2fee0221-ddba-4f8c-bd5b-a651dba87c27"/> </td> <td valign="top"> <paragraph>After you have completed the injection, lift the pre-filled pen straight up. The orange needle guard will slide down and lock into place over the needle.</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <list listType="ordered"> <item> <caption> </caption>8.</item> </list> </td> <td colspan="3" valign="top"> <paragraph>Discard the used pre-filled pen into a sharps container.</paragraph> </td> </tr> </tbody> </table> </text> <effectiveTime value="20251017"/> <component> <observationMedia ID="d0f2514a-6adf-42f7-96b1-a070617d641d"> <text>Figure_1</text> <value mediaType="image/jpeg"> <reference value="figure1_needle.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_820b042c-39fe-4543-8547-d7c09def9084"> <text>Number_3_picture</text> <value mediaType="image/jpeg"> <reference value="number3picture.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="e01e97af-9245-4e14-9960-7b9c2df515e3"> <text>number4picture</text> <value mediaType="image/jpeg"> <reference value="number4picture.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="c5be2b3c-4fb3-425a-b67d-ff2818d2c979"> <text>number5picture</text> <value mediaType="image/jpeg"> <reference value="number5picture.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_590d5899-7131-436d-b4ec-7098cb79d3f8"> <text>number6picture</text> <value mediaType="image/jpeg"> <reference value="number6picture.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="C35B1727-A023-4369-960B-070C2C50A89F"> <text>figure_2_pre-filled_pen_components</text> <value mediaType="image/jpeg"> <reference value="figure_2_pre-filled_pen_components.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_34170091-2d57-4ab2-a294-f8fbca11184f"> <text>figure_2-image-2</text> <value mediaType="image/jpeg"> <reference value="figure2_image2.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_285deebf-1c60-4f1a-ba25-05a1a9ffccbc"> <text>figure2_image-4</text> <value mediaType="image/jpeg"> <reference value="figure2_image4.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_04acfd66-01fc-4814-a0f7-8b6d54d07e67"> <text>figure_2_image_5</text> <value mediaType="image/jpeg"> <reference value="figure_2_image_5.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="F0D9F737-74FC-480E-A35F-7AEECAB4FC14"> <text>figure_2_image_6</text> <value mediaType="image/jpeg"> <reference value="figure_2_image_6.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_2fee0221-ddba-4f8c-bd5b-a651dba87c27"> <text>figure_2_image_7</text> <value mediaType="image/jpeg"> <reference value="figure_2_image_7.jpg"/> </value> </observationMedia> </component> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_4a674674-ecc2-4749-b7c3-35374ec48fc0"> <id root="f832ff4d-a690-4336-ab9f-a029c61238c3"/> <code code="43678-2" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE FORMS & STRENGTHS SECTION"/> <title>3 DOSAGE FORMS AND STRENGTHS </title> <text> <paragraph>Injection: a clear to opalescent, colorless to light yellow solution available as:</paragraph> <list listType="unordered"> <item> <caption>•</caption>210 mg/1.91 mL (110 mg/mL) solution in a single-dose glass vial.</item> <item> <caption>•</caption>210 mg/1.91 mL (110 mg/mL) solution in a single-dose pre-filled syringe.</item> <item> <caption>•</caption>210 mg/1.91 mL (110 mg/mL) solution in a single‑dose pre‑filled pen.</item> </list> </text> <effectiveTime value="20230526"/> <excerpt> <highlight> <text> <paragraph>Injection:</paragraph> <list listType="unordered"> <item> <caption>•</caption>210 mg/1.91 mL (110 mg/mL) solution in a single-dose glass vial. (<linkHtml href="#ID_4a674674-ecc2-4749-b7c3-35374ec48fc0">3</linkHtml>)</item> <item> <caption>•</caption>210 mg/1.91 mL (110 mg/mL) solution in a single-dose pre-filled syringe. (<linkHtml href="#ID_4a674674-ecc2-4749-b7c3-35374ec48fc0">3</linkHtml>)</item> <item> <caption>•</caption>210 mg/1.91 mL (110 mg/mL) solution in a single‑dose pre‑filled pen. (<linkHtml href="#ID_4a674674-ecc2-4749-b7c3-35374ec48fc0">3</linkHtml>)</item> </list> </text> </highlight> </excerpt> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_e03c4879-2993-49ff-9e4a-b15396538f88"> <id root="49999b73-0f3f-4861-813f-b6c3c06c0f6b"/> <code code="34070-3" codeSystem="2.16.840.1.113883.6.1" displayName="CONTRAINDICATIONS SECTION"/> <title>4 CONTRAINDICATIONS </title> <text> <paragraph>TEZSPIRE is contraindicated in patients who have known hypersensitivity to tezepelumab-ekko or any of its excipients <content styleCode="italics">[see <linkHtml href="#ID_ac54d6b8-f757-4012-809c-1858f2ba58f3">Warnings and Precautions (5.1)</linkHtml>]</content>.</paragraph> </text> <effectiveTime value="20251017"/> <excerpt> <highlight> <text> <paragraph>Known hypersensitivity to tezepelumab-ekko or excipients. (<linkHtml href="#ID_e03c4879-2993-49ff-9e4a-b15396538f88">4</linkHtml>)</paragraph> </text> </highlight> </excerpt> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_b89fd492-7b7e-4c8d-9361-799abc0c97e2"> <id root="5eee23fa-e12b-4471-91e3-ca346c802f2c"/> <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/> <title>5 WARNINGS AND PRECAUTIONS </title> <effectiveTime value="20251017"/> <excerpt> <highlight> <text> <list listType="unordered"> <item> <caption>•</caption>Hypersensitivity Reactions: Hypersensitivity reactions have been observed in the clinical trials (e.g., rash, allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. Initiate appropriate treatment as clinically indicated in the event of a hypersensitivity reaction. (<linkHtml href="#ID_ac54d6b8-f757-4012-809c-1858f2ba58f3">5.1</linkHtml>)</item> <item> <caption>•</caption>Risk Associated with Abrupt Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Decrease corticosteroids gradually, if appropriate. (<linkHtml href="#ID_72a3e58e-0595-420f-9b51-8a955ebb50d0">5.3</linkHtml>)</item> <item> <caption>•</caption>Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until the parasitic infection resolves. (<linkHtml href="#ID_531509cd-1a1f-4f2e-a80d-d0587cb96281">5.4</linkHtml>)</item> <item> <caption>•</caption>Vaccination: Avoid use of live attenuated vaccines. (<linkHtml href="#ID_57ee624f-4910-4215-93ed-34348b7d1ed0">5.5</linkHtml>)</item> </list> </text> </highlight> </excerpt> <component> <section ID="ID_ac54d6b8-f757-4012-809c-1858f2ba58f3"> <id root="7ec7ce39-fa1c-41dc-919b-3017043e04cf"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>5.1 Hypersensitivity Reactions </title> <text> <paragraph>Hypersensitivity reactions were observed in the clinical trials (e.g., rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have also been reported <content styleCode="italics">[see <linkHtml href="#ID_e03c4879-2993-49ff-9e4a-b15396538f88">Contraindications (4)</linkHtml> and </content> <content styleCode="italics"> <linkHtml href="#ID_27f23df6-4300-40ee-8412-7e280947839d">Adverse Reactions (6.2)</linkHtml> </content> <content styleCode="italics">]</content>. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.</paragraph> </text> <effectiveTime value="20251017"/> </section> </component> <component> <section ID="ID_96a71437-55f9-40f9-b550-2d3a1f0c616c"> <id root="96a71437-55f9-40f9-b550-2d3a1f0c616c"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>5.2 Acute Asthma Symptoms or Deteriorating Disease </title> <text> <paragraph>TEZSPIRE should not be used to treat acute asthma symptoms or acute exacerbations. Do not use TEZSPIRE to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with TEZSPIRE.</paragraph> </text> <effectiveTime value="20211217"/> </section> </component> <component> <section ID="ID_72a3e58e-0595-420f-9b51-8a955ebb50d0"> <id root="72a3e58e-0595-420f-9b51-8a955ebb50d0"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>5.3 Risk Associated with Abrupt Reduction of Corticosteroid Dosage </title> <text> <paragraph>Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.</paragraph> </text> <effectiveTime value="20211217"/> </section> </component> <component> <section ID="ID_531509cd-1a1f-4f2e-a80d-d0587cb96281"> <id root="9043bf6f-a8af-4595-8948-ad4e509524cc"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>5.4 Parasitic (Helminth) Infection </title> <text> <paragraph>Thymic stromal lymphopoietin (TSLP) may be involved in the immunological response to some helminth infections. Patients with known helminth infections were excluded from participation in clinical trials. It is unknown if TEZSPIRE will influence a patient’s response against helminth infections.</paragraph> <paragraph>Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving treatment with TEZSPIRE and do not respond to anti-helminth treatment, discontinue treatment with TEZSPIRE until infection resolves.</paragraph> </text> <effectiveTime value="20251017"/> </section> </component> <component> <section ID="ID_57ee624f-4910-4215-93ed-34348b7d1ed0"> <id root="57ee624f-4910-4215-93ed-34348b7d1ed0"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>5.5 Live Attenuated Vaccines </title> <text> <paragraph>The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.</paragraph> </text> <effectiveTime value="20211217"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_427a2318-86d2-4194-aee2-5c74d98a42ea"> <id root="4f5f7378-439c-4057-a167-e2418bea0344"/> <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/> <title>6 ADVERSE REACTIONS </title> <text> <paragraph>The following clinically significant adverse reactions are described elsewhere in the labeling:</paragraph> <list listType="unordered"> <item> <caption>•</caption>Hypersensitivity Reactions <content styleCode="italics">[see <linkHtml href="#ID_ac54d6b8-f757-4012-809c-1858f2ba58f3">Warnings and Precautions (5.1)</linkHtml>]</content> </item> </list> </text> <effectiveTime value="20251017"/> <excerpt> <highlight> <text> <paragraph>Most common adverse reactions (incidence ≥ 3%) are:</paragraph> <list listType="unordered"> <item> <caption>•</caption>Asthma: pharyngitis, arthralgia, and back pain. (<linkHtml href="#ID_d8912730-d3f1-4353-ab41-db70fe9746b5">6.1</linkHtml>)</item> <item> <caption>•</caption>Chronic rhinosinusitis with nasal polyps: nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction and arthralgia. (<linkHtml href="#ID_d8912730-d3f1-4353-ab41-db70fe9746b5">6.1</linkHtml>)</item> </list> <paragraph> <content styleCode="bold">To report SUSPECTED ADVERSE REACTIONS, contact </content> <content styleCode="bold">AstraZeneca at 1-800-236-9933</content> <content styleCode="bold"> or FDA at 1-800-FDA-1088 or <linkHtml href="http://www.fda.gov/medwatch">www.fda.gov/medwatch.</linkHtml> </content> </paragraph> </text> </highlight> </excerpt> <component> <section ID="ID_d8912730-d3f1-4353-ab41-db70fe9746b5"> <id root="9327b487-afc1-4bb1-be98-f05c27df7f51"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>6.1 Clinical Trials Experience </title> <text> <paragraph>Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.</paragraph> <paragraph> <content styleCode="underline">Adverse Reactions in Adult and Pediatric Patients 12 Years of Age and Older with Asthma</content> </paragraph> <paragraph>The safety of TEZSPIRE in asthma was based on the pooled safety population from PATHWAY and NAVIGATOR, which consists of 665 adult and pediatric patients 12 years of age and older with severe asthma who received at least one dose of TEZSPIRE 210 mg subcutaneously once every 4 weeks. The two placebo-controlled clinical trials were of 52 weeks duration. In addition, a similar safety profile was seen in a trial that enrolled 150 adult patients with severe asthma who required treatment with daily oral corticosteroids <content styleCode="italics">[see </content> <content styleCode="italics"> <linkHtml href="#ID_b7d372ab-0403-4e4a-8a7a-6d12314d824a">Clinical Studies (14.1)</linkHtml> </content> <content styleCode="italics">]</content>.</paragraph> <paragraph>Adverse reactions that occurred at an incidence greater than or equal to 3% and more common than in the placebo group from the pooled safety population (PATHWAY and NAVIGATOR) are shown in Table 1.</paragraph> <table styleCode="Noautorules" width="100%"> <caption>Table 1 Adverse Reactions with TEZSPIRE with Incidence Greater than or Equal to 3% and More Common than Placebo in Patients with Severe Asthma in the Pooled Safety Population (PATHWAY and NAVIGATOR)</caption> <col width="33%"/> <col width="33%"/> <col width="33%"/> <tbody> <tr> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Adverse Reaction</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">TEZSPIRE</content> </paragraph> <paragraph> <content styleCode="bold">N=665</content> </paragraph> <paragraph> <content styleCode="bold">%</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <paragraph> <content styleCode="bold">N=669</content> </paragraph> <paragraph> <content styleCode="bold">%</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Pharyngitis<footnote ID="_Ref88574078">Pharyngitis (including Pharyngitis, Pharyngitis bacterial, Pharyngitis streptococcal and Viral pharyngitis)</footnote> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>3</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Arthralgia</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>3</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>Back pain</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"> <paragraph>3</paragraph> </td> </tr> </tbody> </table> <paragraph> <content styleCode="underline">Specific Adverse Reactions</content> </paragraph> <paragraph> <content styleCode="italics">Cardiovascular Events</content> </paragraph> <paragraph>In a randomized, double-blind, long term extension trial, patients 12 years and older with severe asthma from trials NAVIGATOR and the additional trial <content styleCode="italics">[see <linkHtml href="#ID_b7d372ab-0403-4e4a-8a7a-6d12314d824a">Clinical Studies (14.1)</linkHtml>]</content> received TEZSPIRE 210 mg subcutaneously every 4 weeks or placebo for up to 104 weeks. In the trial, the incidence rates (IR) per 100 patient-years (PY) for serious cardiac adverse events in patients treated with TEZSPIRE or placebo were 1.08 and 0.21, respectively, with an incidence rate difference (IRD) of 0.88 (95% CI: 0.24, 1.53). The types of serious cardiac adverse events were heterogeneous. In the trial, the IR per 100 PY for adjudicated major adverse cardiovascular events (MACE, defined as cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated with TEZSPIRE or placebo were 0.60 and 0.42, respectively, with an IRD of 0.18 (95% CI: -0.51, 0.75). </paragraph> <paragraph> <content styleCode="italics">Injection Site Reactions</content> </paragraph> <paragraph>In the pooled safety population (PATHWAY and NAVIGATOR), in which TEZSPIRE or placebo was administered using the vial by a healthcare provider, injection site reactions (e.g., injection site erythema, injection site swelling, injection site pain) occurred at a rate of 3.3% in patients treated with TEZSPIRE compared with 2.7% in patients treated with placebo.</paragraph> <paragraph>In an open-label trial of 216 patients with asthma in which TEZSPIRE was administered by healthcare providers and patients or caregivers using either the pre-filled pen or pre-filled syringe, injection site reactions (e.g., injection site erythema, injection site swelling, injection site pain) were observed in 5.7% patients using the pre-filled pen and 0% using the pre-filled syringe. However, the trial was not designed to compare injection site reactions between patients who received TEZSPIRE by the pre-filled pen versus pre-filled syringe.</paragraph> <paragraph> <content styleCode="underline">Adverse Reactions in Adult Patients with Chronic Rhinosinusitis with Nasal Polyps</content> </paragraph> <paragraph>The safety of TEZSPIRE in CRSwNP was based on WAYPOINT, a randomized, double-blind, parallel group, multicenter, placebo-controlled trial of 52 weeks duration, which consisted of 203 adult patients aged 18 years and older on standard of care treatment for CRSwNP who received at least one dose of TEZSPIRE 210 mg subcutaneously once every 4 weeks <content styleCode="italics">[see <linkHtml href="#ID_3087cfcf-d875-47aa-bcf9-9587f2d3a84c">Clinical Studies (14.2)</linkHtml>]</content>. </paragraph> <paragraph>Adverse reactions that occurred at an incidence greater than or equal to 3% and more common than in the placebo group from the safety population (WAYPOINT) are shown in Table 2.</paragraph> <table styleCode="Noautorules" width="100%"> <caption>Table 2 Adverse Reactions with TEZSPIRE with Incidence Greater than or Equal to 3% and More Common than Placebo in Patients with CRSwNP (WAYPOINT)</caption> <col width="33%"/> <col width="33%"/> <col width="33%"/> <tbody> <tr> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Adverse Reaction</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">TEZSPIRE</content> </paragraph> <paragraph> <content styleCode="bold">N=203</content> </paragraph> <paragraph> <content styleCode="bold">%</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Placebo<br/>N=205</content> </paragraph> <paragraph> <content styleCode="bold">%</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Nasopharyngitis</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>18</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>10</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Upper respiratory tract infection<footnote ID="_Ref212120009">Upper respiratory tract infection (including Upper respiratory tract infection and Viral upper respiratory tract infection)</footnote> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>12</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>8</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Epistaxis</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>3</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Pharyngitis<footnote ID="_Ref212120070">Pharyngitis (including Pharyngitis, Pharyngitis bacterial, Pharyngitis streptococcal and Viral pharyngitis)</footnote> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>1</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Back pain</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Influenza</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>1</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Injection site reaction<footnote ID="_Ref212120082">Injection site reaction (e.g., Injection site erythema, Injection site swelling and Injection site pain)</footnote> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>Arthralgia</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>2</paragraph> </td> </tr> </tbody> </table> </text> <effectiveTime value="20251017"/> </section> </component> <component> <section ID="ID_27f23df6-4300-40ee-8412-7e280947839d"> <id root="f5214bf9-66c1-418b-9e3f-930256424b65"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>6.2 Postmarketing Experience </title> <text> <paragraph>The following adverse reactions have been identified during post-approval use of TEZSPIRE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.</paragraph> <paragraph> <content styleCode="italics">Hypersensitivity reactions</content>: anaphylaxis</paragraph> </text> <effectiveTime value="20251017"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_269746ec-a6c6-41ca-ba3a-b61e17d638f9"> <id root="269746ec-a6c6-41ca-ba3a-b61e17d638f9"/> <code code="34073-7" codeSystem="2.16.840.1.113883.6.1" displayName="DRUG INTERACTIONS SECTION"/> <title>7 DRUG INTERACTIONS </title> <text> <paragraph>No formal drug interaction studies have been performed with TEZSPIRE.</paragraph> </text> <effectiveTime value="20211217"/> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_0cc839d1-1924-4247-b97b-8ffdf4e5639b"> <id root="0f17d132-5045-4dd5-a1a9-826f2789ac94"/> <code code="43684-0" codeSystem="2.16.840.1.113883.6.1" displayName="USE IN SPECIFIC POPULATIONS SECTION"/> <title>8 USE IN SPECIFIC POPULATIONS </title> <effectiveTime value="20251017"/> <component> <section ID="ID_9dd9300e-5827-4dd9-974e-659e39176b25"> <id root="776d586c-5f14-4c8f-9a48-88204105da35"/> <code code="42228-7" codeSystem="2.16.840.1.113883.6.1" displayName="PREGNANCY SECTION"/> <title>8.1 Pregnancy </title> <text> <paragraph> <content styleCode="underline">Risk Summary</content> </paragraph> <paragraph>There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. In an enhanced pre- and post-natal development (ePPND) study conducted in cynomolgus monkeys, placental transport of tezepelumab-ekko was observed but there was no evidence of fetal harm following intravenous administration of tezepelumab-ekko throughout pregnancy at doses that produced maternal exposures up to 168 times the exposure at the maximum recommended human dose (MRHD) of 210 mg administered subcutaneously <content styleCode="italics">(see Data)</content>.</paragraph> <paragraph>The estimated background risk of major birth defects and miscarriages for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.</paragraph> <paragraph> <content styleCode="underline">Clinical Considerations</content> </paragraph> <paragraph> <content styleCode="italics">Disease-associated maternal and/or embryo/fetal risk:</content> </paragraph> <paragraph>In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.</paragraph> <paragraph> <content styleCode="underline">Data</content> </paragraph> <paragraph> <content styleCode="italics">Animal Data</content> </paragraph> <paragraph>In the ePPND study, pregnant cynomolgus monkeys received tezepelumab-ekko from GD20 to GD22 (dependent on pregnancy determination), at the beginning of organogenesis, and once every 7 days until the end of gestation at doses that produced exposures up to 168 times that achieved with the MRHD (on an AUC basis with maternal intravenous doses up to 300 mg/kg/week). There were no tezepelumab-ekko related adverse effects on maternal health, pregnancy outcome, embryo-fetal development, or neonatal growth and development up to 6.5 months of age. Tezepelumab-ekko crossed the placenta in cynomolgus monkeys and tezepelumab-ekko serum concentrations were 0.5- to 6.7-fold higher in infants relative to maternal animals.</paragraph> </text> <effectiveTime value="20230526"/> </section> </component> <component> <section ID="ID_75210918-E184-4126-A0B5-3E53DDE96FF5"> <id root="49f2b4c7-cff4-4d92-8de4-c902afba02ac"/> <code code="77290-5" codeSystem="2.16.840.1.113883.6.1" displayName="LACTATION SECTION"/> <title>8.2 Lactation </title> <text> <paragraph> <content styleCode="underline">Risk Summary</content> </paragraph> <paragraph>There is no information regarding the presence of tezepelumab-ekko in human milk, its effects on the breastfed infant, or its effects on milk production. However, tezepelumab-ekko is a human monoclonal antibody immunoglobulin G2λ (IgG2λ), and immunoglobulin G (IgG) is present in human milk in small amounts. Tezepelumab‑ekko was present in the milk of cynomolgus monkeys postpartum following dosing during pregnancy <content styleCode="italics">(see Data)</content>. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TEZSPIRE and any potential adverse effects on the breastfed infant from TEZSPIRE or from the underlying maternal condition.</paragraph> <paragraph> <content styleCode="underline">Data</content> </paragraph> <paragraph> <content styleCode="italics">Animal Data</content> </paragraph> <paragraph>In a prenatal and postnatal development study in cynomolgus monkeys, tezepelumab-ekko concentrations in milk were up to 0.5% of the maternal serum concentrations after intravenous administration of tezepelumab-ekko up to 300 mg/kg/week (168 times the exposures based on AUC achieved at MRHD). The concentration of tezepelumab-ekko in animal milk does not necessarily predict the concentration of drug in human milk.</paragraph> </text> <effectiveTime value="20230526"/> </section> </component> <component> <section ID="ID_2DEB3D5F-5278-4C57-B002-2D97EFD9A696"> <id root="d8f6c454-1d75-4323-b575-1d285a192036"/> <code code="34081-0" codeSystem="2.16.840.1.113883.6.1" displayName="PEDIATRIC USE SECTION"/> <title>8.4 Pediatric Use </title> <text> <paragraph> <content styleCode="underline">Asthma</content> </paragraph> <paragraph>The safety and effectiveness of TEZSPIRE for the add-on maintenance treatment of severe asthma have been established in pediatric patients aged 12 years and older <content styleCode="italics">[see <linkHtml href="#ID_d8912730-d3f1-4353-ab41-db70fe9746b5">Adverse Reactions (6.1)</linkHtml> and </content> <content styleCode="italics"> <linkHtml href="#ID_b7d372ab-0403-4e4a-8a7a-6d12314d824a">Clinical Studies (14.1)]</linkHtml> </content>. Use of TEZSPIRE for this indication is supported by evidence from a total of 82 pediatric patients aged 12 to 17 years enrolled in NAVIGATOR and received treatment with TEZSPIRE 210 mg subcutaneously every 4 weeks (n=41) or placebo (n=41). Compared with placebo, improvements in annualized asthma exacerbation (rate ratio 0.70; 95% CI 0.34, 1.46) and FEV1 (LS mean change versus placebo 0.17 L; 95% CI -0.01, 0.35) were observed in pediatric patients treated with TEZSPIRE. The safety profile and pharmacodynamic responses in pediatric patients were generally similar to the overall study population.</paragraph> <paragraph>The safety and effectiveness of TEZSPIRE have not been established in patients younger than 12 years of age with asthma.</paragraph> <paragraph> <content styleCode="underline">CRSwNP</content> </paragraph> <paragraph>The safety and effectiveness of TEZSPIRE for the add-on maintenance treatment of inadequately controlled CRSwNP have been established in pediatric patients aged 12 years and older. Use of TEZSPIRE for this indication is supported by evidence from the adequate and well-controlled study of TEZSPIRE in adults (WAYPOINT) <content styleCode="italics">[see <linkHtml href="#ID_3087cfcf-d875-47aa-bcf9-9587f2d3a84c">Clinical Studies (14.2)</linkHtml>]</content> with the following additional data:</paragraph> <list listType="unordered"> <item> <caption>•</caption>Pharmacokinetic (PK) data from adult and pediatric patients aged 12 years and older with severe asthma and adult patients with CRSwNP <content styleCode="italics">[see <linkHtml href="#ID_A8E0278F-22FB-4C64-B5D4-D006F1EE0F70">Clinical Pharmacology (12.3)</linkHtml>]</content>.</item> <item> <caption>•</caption>Safety data in pediatric patients aged 12 years and older with severe asthma <content styleCode="italics">[see <linkHtml href="#ID_d8912730-d3f1-4353-ab41-db70fe9746b5">Adverse Reactions (6.1)</linkHtml>]</content>.</item> </list> <paragraph>The safety and effectiveness of TEZSPIRE have not been established in patients younger than 12 years of age with CRSwNP.</paragraph> </text> <effectiveTime value="20251017"/> </section> </component> <component> <section ID="ID_0CBDF8A2-26FB-4A46-A10F-97D20EA3590B"> <id root="9f700076-01d2-4c02-9553-8446d6230787"/> <code code="34082-8" codeSystem="2.16.840.1.113883.6.1" displayName="GERIATRIC USE SECTION"/> <title>8.5 Geriatric Use </title> <text> <paragraph> <content styleCode="underline">Asthma</content> </paragraph> <paragraph>Of the 665 patients with asthma treated with TEZSPIRE in clinical trials (PATHWAY and NAVIGATOR) for severe asthma, 119 patients (18%) were 65 years or older. No overall differences in safety or effectiveness of TEZSPIRE have been observed between patients 65 years of age and older and younger patients <content styleCode="italics">[see <linkHtml href="#_6.1_Clinical_Trials">Adverse Reactions (6.1)</linkHtml> and </content> <content styleCode="italics"> <linkHtml href="#ID_b7d372ab-0403-4e4a-8a7a-6d12314d824a">Clinical Studies (14.1)</linkHtml> </content> <content styleCode="italics">]</content>.</paragraph> <paragraph> <content styleCode="underline">CRSwNP</content> </paragraph> <paragraph>Of the 203 patients with CRSwNP treated with TEZSPIRE in a clinical trial (WAYPOINT) for CRSwNP, 29 patients (14%) were 65 years or older. No overall differences in safety or effectiveness of TEZSPIRE have been observed between patients 65 years of age and older and younger adult patients <content styleCode="italics">[see <linkHtml href="#ID_d8912730-d3f1-4353-ab41-db70fe9746b5">Adverse Reactions (6.1)</linkHtml> and <linkHtml href="#ID_3087cfcf-d875-47aa-bcf9-9587f2d3a84c">Clinical Studies (14.2)</linkHtml>]</content>.</paragraph> </text> <effectiveTime value="20251017"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_768c38dc-6a44-49b7-ab8e-e36b67e556c3"> <id root="d5b1ac68-e298-4462-b92b-779a7c51b0e3"/> <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/> <title>11 DESCRIPTION </title> <text> <paragraph>Tezepelumab-ekko, a thymic stromal lymphopoietin (TSLP) blocker, is a human monoclonal antibody immunoglobulin G2λ (IgG2λ) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Tezepelumab-ekko has a molecular weight of approximately 147 kDa.</paragraph> <paragraph>TEZSPIRE (tezepelumab-ekko) injection is a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-dose vial, single-dose pre-filled syringe or single‑dose pre‑filled pen.</paragraph> <paragraph>Each single-dose vial, pre-filled syringe or pre‑filled pen delivers 1.91 mL containing 210 mg tezepelumab-ekko, glacial acetic acid (2.8 mg), L-proline (48 mg), polysorbate 80 (0.19 mg), sodium hydroxide, and water for injection. The pH is 5.2.</paragraph> </text> <effectiveTime value="20230526"/> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_c2832033-ae4a-4fa8-9d69-81d106cc6eaf"> <id root="150693e6-e77a-47e2-831d-40acf5f32c46"/> <code code="34090-1" codeSystem="2.16.840.1.113883.6.1" displayName="CLINICAL PHARMACOLOGY SECTION"/> <title>12 CLINICAL PHARMACOLOGY </title> <effectiveTime value="20251017"/> <component> <section ID="ID_dbe961f3-5e3c-442d-83cb-ba72c87c9d77"> <id root="b0fa7426-497c-4712-9c38-f7d44222371d"/> <code code="43679-0" codeSystem="2.16.840.1.113883.6.1" displayName="MECHANISM OF ACTION SECTION"/> <title>12.1 Mechanism of Action </title> <text> <paragraph>Tezepelumab-ekko is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody IgG2λ that binds to human TSLP with a dissociation constant of 15.8 pM and blocks its interaction with the heterodimeric TSLP receptor. TSLP is a cytokine mainly derived from epithelial cells and occupies an upstream position in inflammatory cascades.</paragraph> <paragraph>Airway and mucosal inflammation are important components of the pathogenesis of asthma and CRSwNP. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes, ILC2 cells) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in airway and mucosal inflammation. Increased levels of TSLP mRNA and protein are found in the airways of patients with asthma as well as in nasal polyp tissue. Blocking TSLP with tezepelumab-ekko reduces biomarkers and cytokines associated with inflammation including blood eosinophils, airway submucosal eosinophils, IgE, FeNO, IL-5, and IL-13; however, the mechanism of tezepelumab-ekko action in asthma and CRSwNP has not been definitively established.</paragraph> </text> <effectiveTime value="20251017"/> </section> </component> <component> <section ID="ID_DD60477F-0F86-4B2F-AEE6-A972D78284A9"> <id root="8f46ec84-3256-4377-ba36-080492a9beab"/> <code code="43681-6" codeSystem="2.16.840.1.113883.6.1" displayName="PHARMACODYNAMICS SECTION"/> <title>12.2 Pharmacodynamics </title> <text> <paragraph>In NAVIGATOR, administration of TEZSPIRE 210 mg subcutaneously every 4 weeks (n=528) reduced blood eosinophils counts, FeNO, IL-5 concentration and IL-13 concentration from baseline compared with placebo (n=531) with an onset of effect 2 weeks after initiation of treatment and sustained reduction on treatment to 52 weeks. TEZSPIRE caused a slow but progressive reduction in serum total IgE concentration throughout 52 weeks of treatment. Similar effects were seen in PATHWAY.</paragraph> <paragraph>In WAYPOINT, administration of TEZSPIRE 210 mg subcutaneously every 4 weeks (n=203) resulted in reductions from baseline of blood eosinophils, FeNO (in participants with co-morbid asthma [about 60% of patients]) and serum IgE as compared to placebo (n=205). Blood eosinophils were reduced beginning at Week 4, the first observed timepoint, with reductions maintained through Week 52. Reductions in FeNO and serum IgE were observed during the treatment period at Weeks 24 and 52.</paragraph> </text> <effectiveTime value="20251017"/> </section> </component> <component> <section ID="ID_A8E0278F-22FB-4C64-B5D4-D006F1EE0F70"> <id root="623cf133-8012-4e4e-9f55-556db061e0f0"/> <code code="43682-4" codeSystem="2.16.840.1.113883.6.1" displayName="PHARMACOKINETICS SECTION"/> <title>12.3 Pharmacokinetics </title> <text> <paragraph>The pharmacokinetics of tezepelumab-ekko is similar in patients with asthma and CRSwNP. </paragraph> <paragraph>The pharmacokinetics of tezepelumab-ekko were dose-proportional following administration of a single subcutaneous dose over a dose range from 0.01 to 2 times the recommended dose. With an every 4 weeks dosing regimen, tezepelumab-ekko achieves steady-state after 12 weeks and the accumulation ratio for C<sub>trough</sub> is 1.86-fold.</paragraph> <paragraph> <content styleCode="underline">Absorption</content> </paragraph> <paragraph>Following subcutaneous administration, the maximum serum concentration was reached in approximately 3 to 10 days. Based on population pharmacokinetic analysis, the estimated absolute bioavailability was approximately 77%. There was no clinically relevant difference in bioavailability when administered to different injection sites (abdomen, thigh, or upper arm).</paragraph> <paragraph> <content styleCode="underline">Distribution</content> </paragraph> <paragraph>Based on population pharmacokinetic analysis, central and peripheral volume of distribution of tezepelumab-ekko were 3.9 L and 2.2 L, respectively, for a 70 kg individual.</paragraph> <paragraph> <content styleCode="underline">Elimination</content> </paragraph> <paragraph>As a human monoclonal antibody, tezepelumab-ekko is eliminated by intracellular catabolism and there is no evidence of target-mediated clearance within the studied dose range. Based on population pharmacokinetic analysis, the estimated clearance for tezepelumab-ekko was 0.17 L/d for a 70 kg individual. The elimination half-life was approximately 26 days.</paragraph> <paragraph> <content styleCode="italics">Metabolism</content> </paragraph> <paragraph>Tezepelumab-ekko is a human monoclonal antibody (IgG2λ) that is degraded by proteolytic enzymes widely distributed in the body and not metabolized by hepatic enzymes.</paragraph> <paragraph> <content styleCode="underline">Specific Populations</content> </paragraph> <paragraph> <content styleCode="italics">Age, Sex, Race</content> </paragraph> <paragraph>Based on population pharmacokinetic analysis, age (12 to 80 years), sex and race (White, Black, Asian, Other) had no clinically meaningful effects on the pharmacokinetics of tezepelumab-ekko.</paragraph> <paragraph> <content styleCode="italics">Body Weight</content> </paragraph> <paragraph>Based on population pharmacokinetic analysis, higher body weight was associated with lower exposure. However, the effect of body weight on exposure had no meaningful impact on efficacy or safety and does not require dose adjustment.</paragraph> <paragraph> <content styleCode="italics">Pediatric Patients</content> </paragraph> <paragraph>CRSwNP</paragraph> <paragraph>Clinical studies have not been conducted in pediatric patients aged 12 years and older with CRSwNP. Tezepelumab-ekko exposures are expected to be comparable between adults and pediatric patients aged 12 years and older at the recommended subcutaneous dosage (210 mg every 4 weeks) for CRSwNP.</paragraph> <paragraph> <content styleCode="italics">Patients with Renal impairment</content> </paragraph> <paragraph>No formal clinical studies have been conducted to investigate the effect of renal impairment on tezepelumab-ekko. The population pharmacokinetic analysis included 320 (23%) subjects with mild renal impairment and 38 (3%) subjects with moderate renal impairment. Tezepelumab-ekko clearance was similar in patients with mild renal impairment (estimated creatinine clearance 60 to 89 mL/min), moderate renal impairment (estimated creatinine clearance 30 to 59 mL/min) and those with normal renal function (estimated creatinine clearance ≥ 90 mL/min). Tezepelumab-ekko has not been studied in patients with severe renal impairment (estimated creatinine clearance < 30 mL/min).</paragraph> <paragraph> <content styleCode="italics">Patients with Hepatic impairment</content> </paragraph> <paragraph>No formal clinical studies have been conducted to investigate the effect of hepatic impairment on tezepelumab-ekko. Since tezepelumab-ekko is degraded by proteolytic enzymes widely distributed in the body and not metabolized by hepatic-specific enzymes, change in hepatic function is not expected to influence tezepelumab-ekko clearance.</paragraph> <paragraph> <content styleCode="underline">Drug Interaction Studies</content> </paragraph> <paragraph>No formal drug interaction studies have been conducted with tezepelumab-ekko. Based on the population pharmacokinetic analysis, commonly co-administered asthma medications (leukotriene receptor antagonist, theophylline/aminophylline, oral and inhaled corticosteroid) had no clinically meaningful effect on tezepelumab-ekko clearance.</paragraph> </text> <effectiveTime value="20251017"/> </section> </component> <component> <section ID="ID_5d74b11f-8550-46f6-8fa4-4c04471c602d"> <id root="386ea767-eb7b-4f0b-aef1-ee8f50ffc39b"/> <code code="88830-5" codeSystem="2.16.840.1.113883.6.1" displayName="IMMUNOGENICITY"/> <title>12.6 Immunogenicity </title> <text> <paragraph>The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of tezepelumab-ekko or of other tezepelumab products.</paragraph> <paragraph>In patients with asthma (NAVIGATOR and an additional trial), anti-drug antibodies (ADA) were detected at any time in 29 (5%) out of 601 patients who received TEZSPIRE at the recommended dosing regimen during the 48 to 52‑week study period. Of these 29 patients, 11 patients (2% of patients treated with TEZSPIRE) developed treatment-emergent antibodies and 1 patient (<1% of patients treated with TEZSPIRE) developed neutralizing antibodies. ADA titers were generally low and often transient. No evidence of ADA impact on pharmacokinetics, pharmacodynamics, efficacy, or safety was observed.</paragraph> <paragraph>In patients with CRSwNP (WAYPOINT), a treatment-emergent ADA response developed in 5 (3%) out of 164 patients treated with TEZSPIRE at the recommended dosage regimen during the 52-week treatment period. Neutralizing antibodies were detected in 1 of the ADA positive patients. While there was no observed impact of ADA on pharmacokinetics, pharmacodynamics, efficacy, or safety, there were insufficient numbers of patients with treatment‑emergent ADA to make a formal assessment in CRSwNP. </paragraph> </text> <effectiveTime value="20251017"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_383f16cb-259d-41a7-8e7c-b0078c49427a"> <id root="383f16cb-259d-41a7-8e7c-b0078c49427a"/> <code code="43680-8" codeSystem="2.16.840.1.113883.6.1" displayName="NONCLINICAL TOXICOLOGY SECTION"/> <title>13 NONCLINICAL TOXICOLOGY </title> <effectiveTime value="20211217"/> <component> <section ID="ID_695defd6-a265-4e7c-b484-a5ebdd668e04"> <id root="695defd6-a265-4e7c-b484-a5ebdd668e04"/> <code code="34083-6" codeSystem="2.16.840.1.113883.6.1" displayName="CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION"/> <title>13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility </title> <text> <paragraph>Animal studies have not been conducted to evaluate the carcinogenic potential of tezepelumab-ekko. The malignancy risk in humans from an antibody that blocks TSLP ligand, such as tezepelumab-ekko, is currently unknown.</paragraph> <paragraph>Male and female fertility was unaffected based upon no observed adverse histopathological findings in the reproductive organs and no changes in menstrual cycle or semen analysis in sexually mature cynomolgus monkeys that received tezepelumab-ekko for 26 weeks at subcutaneous doses up to 300 mg/kg/week (approximately 134 times the MRHD on an AUC basis).</paragraph> </text> <effectiveTime value="20211217"/> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_b9f5346e-4202-4d08-9d05-e895a4ce0b87"> <id root="999023d8-adc1-4ae5-b251-91cb6447ccc1"/> <code code="34092-7" codeSystem="2.16.840.1.113883.6.1" displayName="CLINICAL STUDIES SECTION"/> <title>14 CLINICAL STUDIES </title> <effectiveTime value="20251017"/> <component> <section ID="ID_b7d372ab-0403-4e4a-8a7a-6d12314d824a"> <id root="fc0bbea0-6e19-4722-9240-8251e0780181"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>14.1 Clinical Studies in Patients with Asthma </title> <text> <paragraph>The efficacy of TEZSPIRE for add-on maintenance treatment of severe asthma was evaluated in two randomized, double-blind, parallel group, placebo-controlled clinical trials (PATHWAY [NCT02054130] and NAVIGATOR [NCT03347279]) of 52 weeks duration. The two trials enrolled a total of 1,609 patients 12 years of age and older with severe asthma.</paragraph> <paragraph>PATHWAY was a 52-week dose-ranging exacerbation trial that enrolled 550 adult patients with severe asthma who received treatment with tezepelumab-ekko 70 mg subcutaneously every 4 weeks, TEZSPIRE 210 mg subcutaneously every 4 weeks, tezepelumab-ekko 280 mg subcutaneously every 2 weeks, or placebo subcutaneously. Patients were required to have a history of 2 or more asthma exacerbations requiring oral or injectable corticosteroid treatment or 1 asthma exacerbation resulting in hospitalization in the past 12 months.</paragraph> <paragraph>NAVIGATOR was a 52-week exacerbation trial that enrolled 1,061 patients (adult and pediatric patients 12 years of age and older) with severe asthma who received treatment with TEZSPIRE 210 mg subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Patients were required to have a history of 2 or more asthma exacerbations requiring oral or injectable corticosteroid treatment or resulting in hospitalization in the past 12 months.</paragraph> <paragraph>In both PATHWAY and NAVIGATOR, patients were required to have an Asthma Control Questionnaire 6 (ACQ-6) score of 1.5 or more at screening and reduced lung function at baseline [pre-bronchodilator forced expiratory volume in 1 second (FEV1) below 80% predicted in adults, and below 90% predicted in adolescents]. Patients were required to have been on regular treatment with medium or high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller, with or without oral corticosteroids (OCS). Patients continued background asthma therapy throughout the duration of the trials. In both trials, patients were enrolled without requiring a minimum baseline level of blood eosinophils or FeNO.</paragraph> <paragraph>The demographics and baseline characteristics of PATHWAY and NAVIGATOR are provided in Table 3 below.</paragraph> <paragraph> <content styleCode="bold">Table 3 Demographics and Baseline Characteristics of Patients in PATHWAY and NAVIGATOR</content> </paragraph> <table width="100%"> <col width="41%"/> <col width="30%"/> <col width="30%"/> <thead> <tr> <th align="left" styleCode="Rrule Botrule Lrule Toprule " valign="top"/> <th align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <content styleCode="bold">PATHWAY</content> <br/> <content styleCode="bold">N=550</content> </th> <th align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <content styleCode="bold">NAVIGATOR</content> <br/> <content styleCode="bold">N=1,059</content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean age (year) (SD) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>52 (12)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>50 (16)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Female (%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>66</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>64</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>White (%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>92</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>62</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Black or African American (%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>6</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Asian (%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>28</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Hispanic or Latino (%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>15</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Never smoked (%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>81</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>80</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>High-dose ICS use (%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>49</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>75</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>OCS use (%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>9</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean number of exacerbations in previous year (SD)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>2.4 (1.2)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>2.8 (1.4)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean duration of asthma (years) (SD)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>17 (12)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>22 (16)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean baseline % predicted FEV<sub>1 </sub>(SD)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>60 (13)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>63 (18)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean post-bronchodilator FEV<sub>1</sub> reversibility (%) (SD)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>23 (20)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>15 (15)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean baseline blood EOS count (cells/µL) (SD)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>371 (353)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>340 (403)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Positive serum specific IgE to any perennial allergen (%)<footnote ID="_Ref212112783">In the FEIA panel</footnote> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>46</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>64</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>Mean FeNO (ppb) (SD) </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"> <paragraph>35 (39)</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"> <paragraph>44 (41)</paragraph> </td> </tr> </tbody> </table> <paragraph>EOS, Eosinophils; FEIA, Fluorescent enzyme immunoassay; FeNO, Fractional exhaled nitric oxide; FEV<sub>1</sub>, Forced expiratory volume in one second; ICS, Inhaled corticosteroid, IgE, Immunoglobulin E; OCS, Oral corticosteroid; ppb, Parts per billion; SD, Standard deviation</paragraph> <paragraph>The results summarized below are for the recommended TEZSPIRE 210 mg subcutaneously every 4 weeks dosing regimen.</paragraph> <paragraph> <content styleCode="underline">Exacerbations</content> </paragraph> <paragraph>The primary endpoint for PATHWAY and NAVIGATOR was the rate of clinically significant asthma exacerbations measured over 52 weeks. Clinically significant asthma exacerbations were defined as worsening of asthma requiring the use of or increase in oral or injectable corticosteroids for at least 3 days, or a single depo-injection of corticosteroids, and/or emergency department visits requiring use of oral or injectable corticosteroids and/or hospitalization.</paragraph> <paragraph>In both PATHWAY and NAVIGATOR, patients receiving TEZSPIRE had significant reductions in the annualized rate of asthma exacerbations compared to placebo. There were also fewer exacerbations requiring emergency room visits and/or hospitalization in patients treated with TEZSPIRE compared with placebo (Table 4).</paragraph> <paragraph> <content styleCode="bold">Table 4 Rate of Clinically Significant Exacerbations Over 52 Weeks in PATHWAY and NAVIGATOR</content> </paragraph> <table width="100%"> <col width="14%"/> <col width="35%"/> <col width="24%"/> <col width="27%"/> <thead> <tr> <th align="center" rowspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"> <content styleCode="bold">Trial</content> </th> <th align="center" rowspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"> <content styleCode="bold">Treatment</content> </th> <th align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"> <content styleCode="bold">Exacerbations per year</content> </th> </tr> <tr> <th align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <content styleCode="bold">Rate</content> </th> <th align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <content styleCode="bold">Rate Ratio (95% CI)</content> </th> </tr> </thead> <tbody> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph> <content styleCode="bold">Annualized Asthma Exacerbation Rate</content> </paragraph> </td> </tr> <tr> <td rowspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>PATHWAY</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>TEZSPIRE (N=137)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.20</paragraph> </td> <td align="center" rowspan="2" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.29 (0.16, 0.51)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>Placebo (N=138)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.72</paragraph> </td> </tr> <tr> <td rowspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>NAVIGATOR</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>TEZSPIRE (N=528)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.93</paragraph> </td> <td align="center" rowspan="2" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.44 (0.37, 0.53)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>Placebo (N=531)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>2.10</paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph> <content styleCode="bold">Exacerbations requiring emergency room visit/hospitalization</content> </paragraph> </td> </tr> <tr> <td rowspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>PATHWAY</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>TEZSPIRE (N=137)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.03</paragraph> </td> <td align="center" rowspan="2" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.15 (0.04, 0.58)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>Placebo (N=138)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.18</paragraph> </td> </tr> <tr> <td rowspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>NAVIGATOR</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>TEZSPIRE (N=528)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.06</paragraph> </td> <td align="center" rowspan="2" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.21 (0.12, 0.37)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>Placebo (N=531)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.28</paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph> <content styleCode="bold">Exacerbations requiring hospitalization</content> </paragraph> </td> </tr> <tr> <td rowspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>PATHWAY</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>TEZSPIRE (N=137)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.02</paragraph> </td> <td align="center" rowspan="2" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.14 (0.03, 0.71)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>Placebo (N=138)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.14</paragraph> </td> </tr> <tr> <td rowspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>NAVIGATOR</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>TEZSPIRE (N=528)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.03</paragraph> </td> <td align="center" rowspan="2" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.15 (0.07, 0.22)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>Placebo (N=531)</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"> <paragraph>0.19</paragraph> </td> </tr> </tbody> </table> <paragraph>In NAVIGATOR, patients receiving TEZSPIRE experienced fewer exacerbations than those receiving placebo regardless of baseline levels of blood eosinophils or FeNO (Figure 3). Similar results were seen in PATHWAY.</paragraph> <paragraph> <content styleCode="bold">Figure 3 Annualized Asthma Exacerbation Rate Ratio Over 52 Weeks Across Different Baseline Biomarkers in NAVIGATOR</content> </paragraph> <renderMultiMedia ID="id-751814355" referencedObject="ID_7b976b0f-997f-47b6-b9b4-3b7a583a6a18"/> <paragraph>The time to first exacerbation was longer for the patients receiving TEZSPIRE compared with placebo in NAVIGATOR (Figure 4). Similar findings were seen in PATHWAY.</paragraph> <paragraph> <content styleCode="bold">Figure 4 Kaplan-Meier Cumulative Incidence Curves for Time to First Exacerbation in NAVIGATOR</content> </paragraph> <renderMultiMedia ID="id-859039289" referencedObject="ID_4e41221e-db63-4b9c-8895-6c18762abed7"/> <paragraph> <content styleCode="underline">Lung Function</content> </paragraph> <paragraph>Change from baseline in FEV<sub>1</sub> was assessed as a secondary endpoint in PATHWAY and NAVIGATOR. Compared with placebo, TEZSPIRE provided clinically meaningful improvements in the mean change from baseline in FEV<sub>1</sub> in both trials (Table 5).</paragraph> <table width="100%"> <caption>Table 5 Mean Change from Baseline in Pre-Bronchodilator FEV1 at End of Trial in PATHWAY and NAVIGATOR<footnote ID="_Ref212132914">Week 52 in PATHWAY, Week 52 in NAVIGATOR</footnote> </caption> <col width="14%"/> <col width="30%"/> <col width="30%"/> <col width="26%"/> <tbody> <tr> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Trial</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Treatment</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">LS Mean Change from Baseline (L)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Difference from Placebo</content> </paragraph> <paragraph> <content styleCode="bold">(95% CI)</content> </paragraph> </td> </tr> <tr> <td align="center" rowspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>PATHWAY</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>TEZSPIRE (N=133)<footnote ID="_Ref212132989">Number of patients contributing to the full analysis (FA) with at least 1 change from baseline value</footnote> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>0.08</paragraph> </td> <td align="center" rowspan="2" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.13 (0.03, 0.23)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>Placebo (N=138)<footnoteRef IDREF="_Ref212132989"/> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>-0.06</paragraph> </td> </tr> <tr> <td align="center" rowspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>NAVIGATOR</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>TEZSPIRE (N=527)<footnoteRef IDREF="_Ref212132989"/> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>0.23</paragraph> </td> <td align="center" rowspan="2" styleCode="Rrule Lrule Toprule Botrule " valign="middle"> <paragraph>0.13 (0.08, 0.18)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>Placebo (N=531)<footnoteRef IDREF="_Ref212132989"/> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>0.10</paragraph> </td> </tr> </tbody> </table> <paragraph>In NAVIGATOR, improvement in FEV<sub>1 </sub>was seen as early as 2 weeks after initiation of treatment and was sustained through week 52 (Figure 5).</paragraph> <paragraph> <content styleCode="bold">Figure 5 Mean Change (95% CI) from Baseline in Pre-Bronchodilator FEV1 (L) in NAVIGATOR</content> </paragraph> <renderMultiMedia ID="id836954631" referencedObject="EFE3D86E-53C0-4078-91F5-73066D64DDD3"/> <paragraph> <content styleCode="underline">Patient Reported Outcomes</content> </paragraph> <paragraph>Changes from baseline in Asthma Control Questionnaire 6 (ACQ-6) and Standardized Asthma Quality of Life Questionnaire for ages 12 and older [AQLQ(S)+12] were also assessed as secondary endpoints in PATHWAY and NAVIGATOR. In both trials, more patients treated with TEZSPIRE compared to placebo had a clinically meaningful improvement in ACQ-6 and AQLQ(S)+12. Clinically meaningful improvement (responder rate) for both measures was defined as improvement in score of 0.5 or more at end of trial. In NAVIGATOR, the ACQ-6 responder rate for TEZSPIRE was 86% compared with 77% for placebo (OR=1.99; 95% CI 1.43, 2.76) and the AQLQ(S)+12 responder rate for TEZSPIRE was 78% compared with 72% for placebo (OR=1.36; 95% CI 1.02, 1.82). Similar findings were seen in PATHWAY.</paragraph> <paragraph> <content styleCode="underline">Additional Trial</content> </paragraph> <paragraph>In a randomized, double-blind, parallel group, placebo-controlled clinical trial, the effect of TEZSPIRE (210 mg subcutaneously every 4 weeks) on reducing the use of maintenance OCS was evaluated. The trial enrolled 150 adult patients with severe asthma who required treatment with daily OCS (7.5 mg to 30 mg per day) in addition to regular use of high-dose ICS and a long-acting beta-agonist with or without additional controller(s). The primary endpoint was categorized percent reduction from baseline of the final OCS dose at Week 48 (≥90% reduction, ≥75% to <90% reduction, ≥50% to <75% reduction, >0% to <50% reduction, and no change or any increase in OCS), while maintaining asthma control. TEZSPIRE did not demonstrate a statistically significant reduction in maintenance OCS dose compared with placebo (cumulative OR=1.28; 95% CI 0.69, 2.35).</paragraph> </text> <effectiveTime value="20251017"/> <component> <observationMedia ID="ID_7b976b0f-997f-47b6-b9b4-3b7a583a6a18"> <text>figure_2</text> <value mediaType="image/jpeg"> <reference value="image-01.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_4e41221e-db63-4b9c-8895-6c18762abed7"> <text>figure_3</text> <value mediaType="image/jpeg"> <reference value="image-02.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="EFE3D86E-53C0-4078-91F5-73066D64DDD3"> <text>figure_4</text> <value mediaType="image/jpeg"> <reference value="image-03.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="ID_3087cfcf-d875-47aa-bcf9-9587f2d3a84c"> <id root="bc3394c4-9212-45d3-be14-93c87b3984e7"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title>14.2 Clinical Studies in Patients with Chronic Rhinosinusitis with Nasal Polyps </title> <text> <paragraph>The efficacy of TEZSPIRE for add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) was evaluated in a randomized, double-blind, parallel group, multicenter, placebo-controlled trial (WAYPOINT [NCT04851964]) of 52 weeks treatment duration conducted in 408 patients aged 18 years and older on standard of care treatment for CRSwNP. This study included patients with symptomatic CRSwNP despite treatment with nasal corticosteroids, and who had systemic corticosteroids within the past 12 months and/or any history of sino-nasal surgery, or with contraindications and/or intolerance to either. </paragraph> <paragraph>Patients received TEZSPIRE 210 mg or placebo subcutaneously every 4 weeks for 52 weeks in addition to nasal corticosteroid treatment for CRSwNP.</paragraph> <paragraph>The demographics and baseline characteristics of patients enrolled in WAYPOINT are provided in Table 6.</paragraph> <table styleCode="Noautorules" width="100%"> <caption>Table 6 Demographics and Baseline Characteristics of Adult Patients in WAYPOINT</caption> <col width="50%"/> <col width="50%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"/> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">WAYPOINT</content> </paragraph> <paragraph> <content styleCode="bold">N=408</content> <footnote ID="_Ref212132116">Number of patients (N) =407 for mean total NPS; N=406 for mean bi-weekly NCS and mean bi-weekly loss of smell; N=404 for mean LMK sinus CT total score and mean blood eosinophils; N=389 for mean total IgE.</footnote> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean age (years) (SD)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>50 (14)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Male (%) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>65</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean CRSwNP duration (years) (SD)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>13 (10)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Patients with ≥1 prior surgery (%) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>71</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Patients with systemic corticosteroid use for CRSwNP in the previous year (%)</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>58</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean total NPS<footnote ID="_Ref212120489">Higher scores indicate greater disease severity or symptom severity.</footnote> (SD), range 0-8 </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>6.1 (1.2)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean bi-weekly NCS<footnoteRef IDREF="_Ref212120489"/> (SD), range 0-3 </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>2.6 (0.5)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean LMK sinus CT total score<footnoteRef IDREF="_Ref212120489"/> (SD), range 0-24 </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>19 (4)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean bi-weekly loss of smell<footnoteRef IDREF="_Ref212120489"/> (SD), range 0-3 </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>2.9 (0.4)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean blood eosinophils (cells/µL) (SD) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>358 (238)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Mean total IgE IU/mL (SD) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>176 (285)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Asthma<footnote ID="_Ref212120503">Includes patients with asthma or AERD or NSAID-ERD. All but 3 patients with AERD or NSAID-ERD included in this subgroup also had a diagnosis of asthma reported.</footnote> (%) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>61</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>NSAID-ERD/AERD (%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>17</paragraph> </td> </tr> </tbody> </table> <paragraph>AERD, Aspirin exacerbated respiratory disease; CRSwNP, Chronic rhinosinusitis with nasal polyps; CT, Computed tomography; IgE, Immunoglobulin E; IU, International units; LMK, Lund-Mackay; NCS, Nasal congestion score; NPS, Nasal polyp score; NSAID‑ERD, Nonsteroidal anti-inflammatory drug exacerbated respiratory disease; SD, Standard deviation</paragraph> <paragraph>The co-primary efficacy endpoints were change from baseline in total nasal polyp score (NPS) evaluated by nasal endoscopy at Week 52 as graded by independent blinded assessors, and change from baseline in bi-weekly mean nasal congestion score (NCS) evaluated at Week 52. For total NPS, polyps on each side of the nose were graded on a categorical scale (0=no polyps, 1=small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2=polyps reaching below the lower border of the middle turbinate, 3=polyps reaching the lower border of the inferior turbinate or a middle meatal polyp with a score of 2 with any additional polyp medial to the middle turbinate, 4=large polyps causing complete or near complete obstruction of the inferior nasal cavity [i.e. touching the floor of the nose]) for a total score of 0 to 8. Nasal congestion was rated daily by the patients on a 0 to 3 categorical severity scale (0=none, 1=mild, 2=moderate, 3=severe).</paragraph> <paragraph>Statistically significant efficacy was observed in WAYPOINT for the co-primary endpoints of improvement in total NPS and in bi-weekly mean NCS at Week 52 (Table 7).</paragraph> <table width="100%"> <caption>Table 7 Results of Change from Baseline in Total Nasal Polyp Score and Bi-weekly Mean Nasal Congestion Score at Week 52 in Adults with CRSwNP (WAYPOINT)</caption> <col width="11%"/> <col width="15%"/> <col width="16%"/> <col width="15%"/> <col width="16%"/> <col width="26%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"/> <td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">TEZSPIRE</content> </paragraph> <paragraph> <content styleCode="bold">210 mg Q4W</content> </paragraph> <paragraph> <content styleCode="bold">(N=203)</content> </paragraph> </td> <td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <paragraph> <content styleCode="bold">(N=205)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">LS mean difference vs. placebo</content> </paragraph> <paragraph> <content styleCode="bold">(95% CI)</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Scores</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>Baseline mean</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>LS mean change</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>Baseline mean</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>LS mean change</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>NPS</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>6.1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>-2.47</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>6.1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>-0.47</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>-2.01</paragraph> <paragraph>(-2.33, -1.68)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>NCS</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>2.59</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>-1.76</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>2.55</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>-0.81</paragraph> </td> <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph>-0.95</paragraph> <paragraph>(-1.12, -0.78)</paragraph> </td> </tr> <tr> <td colspan="6" styleCode="Toprule " valign="top"> <paragraph>LS mean change, Least squared mean change from baseline; reduction in score indicates improvement; NCS, Nasal congestion score; NPS, Nasal polyp score</paragraph> </td> </tr> </tbody> </table> <paragraph>Figure 6 demonstrates the time course of improvement in the mean change from baseline in NPS.</paragraph> <paragraph> <content styleCode="bold">Figure 6 LS Mean Change from Baseline in Total Nasal Polyp Score up to Week 52 in Adults (WAYPOINT)</content> </paragraph> <renderMultiMedia ID="id2146081907" referencedObject="ID_7db973cd-130e-4877-9dd8-4f3b9353c5e9"/> <paragraph>Figure 7 demonstrates the time course of improvement in the bi-weekly mean change from baseline in NCS.</paragraph> <paragraph> <content styleCode="bold">Figure 7 LS Mean Change from Baseline in Bi-weekly Mean Nasal Congestion Score up to Week 52 in Adults (WAYPOINT)</content> </paragraph> <renderMultiMedia ID="id-875692015" referencedObject="ID_572067df-2a7d-4883-afa8-179ea54316d2"/> <paragraph>Key secondary endpoints at Week 52 included time to surgery decision and/or systemic corticosteroid use for nasal polyps, change from baseline in loss of smell, and change from baseline in Lund-Mackay (LMK) sinus CT scan score. </paragraph> <paragraph>TEZSPIRE significantly reduced the proportion of patients with need for sino-nasal surgery or systemic corticosteroids by 92% compared to placebo over 52 weeks (Hazard Ratio: 0.08; 95% CI: 0.03, 0.17) (Figure 8).</paragraph> <paragraph> <content styleCode="bold">Figure 8 Kaplan Meier Curve for Time to First Systemic Corticosteroid Use and/or Sino-Nasal Surgery Decision Over 52 Weeks in Adults (WAYPOINT)</content> </paragraph> <renderMultiMedia ID="id-2118595632" referencedObject="ID_0edb80a6-df79-417e-8b15-a4fafb4e0eec"/> <paragraph>TEZSPIRE significantly reduced the proportion of patients requiring sino-nasal surgery by 98% compared to placebo over 52 weeks (Hazard Ratio: 0.02; 95% CI: 0.00, 0.09) and significantly reduced the proportion of patients requiring systemic corticosteroids for CRSwNP by 88% compared to placebo over 52 weeks (Hazard Ratio: 0.12; 95% CI: 0.04, 0.27). </paragraph> <paragraph>The loss of smell score was based on a subject’s daily rating of the severity of their worst difficulty with sense of smell over the past 24 hours on a 0 to 3 scale (0=none, 1=mild, 2=moderate, 3=severe). The loss of smell score was calculated every 2 weeks as the bi-weekly mean. TEZSPIRE significantly improved the loss of smell compared to placebo. The LS mean difference for loss of smell at Week 52 in the TEZSPIRE group versus placebo was -1.01 [95% CI: -1.18, -0.83]. </paragraph> <paragraph>The LMK sinus CT scan score evaluated the opacification of each sinus at baseline and Week 52 using a 0 to 2 scale (0=no abnormality; 1=partial opacification, 2=total opacification) deriving a maximum score of 12 per side and a total maximum score of 24 (higher scores indicate more opacification). A significant decrease in the LMK sinus CT scan score was observed. The LS mean difference for LMK sinus CT scan score at Week 52 in the TEZSPIRE group versus placebo was -5.76 [95% CI: -6.45, -5.07].</paragraph> </text> <effectiveTime value="20251017"/> <component> <observationMedia ID="ID_7db973cd-130e-4877-9dd8-4f3b9353c5e9"> <text>Figure_6</text> <value mediaType="image/jpeg"> <reference value="Figure_6.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_572067df-2a7d-4883-afa8-179ea54316d2"> <text>Figure_7</text> <value mediaType="image/jpeg"> <reference value="Figure_7.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_0edb80a6-df79-417e-8b15-a4fafb4e0eec"> <text>Figure_8</text> <value mediaType="image/jpeg"> <reference value="Figure_8.jpg"/> </value> </observationMedia> </component> </section> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_0ca9ca30-ba93-4034-b55a-015635ef392c"> <id root="75d8c394-9f45-4e57-b897-e40688e80970"/> <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/> <title>16 HOW SUPPLIED/STORAGE AND HANDLING </title> <text> <paragraph> <content styleCode="underline">How Supplied</content> </paragraph> <paragraph>TEZSPIRE (tezepelumab-ekko) injection is a sterile, preservative-free, clear to opalescent, colorless to light yellow solution supplied as a single-dose vial, single-dose pre-filled syringe with a fixed 27-gauge ½ inch needle with a needle cover or single-dose pre-filled pen with a fixed 27-gauge ½ inch needle with a needle cover. The vial, pre-filled syringe and pre-filled pen, including the needle cover and stopper, are not made with natural rubber latex.</paragraph> <paragraph>TEZSPIRE is available as:</paragraph> <list listType="unordered"> <item> <caption>•</caption>Single-Dose Vial: Carton contains one 210 mg/1.91 mL (110 mg/mL) glass vial (NDC 55513‑100‑01)</item> <item> <caption>•</caption>Single-Dose Pre-filled Syringe: Carton contains one 210 mg/1.91 mL (110 mg/mL) pre-filled syringe (NDC 55513‑112‑01)</item> <item> <caption>•</caption>Single-Dose Pre-filled Pen: Carton contains one 210 mg/1.91 mL (110 mg/mL) pre-filled pen (NDC 55513-123‑01)</item> </list> <paragraph> <content styleCode="underline">Storage and Handling</content> </paragraph> <paragraph>Store refrigerated between 36°F to 46°F (2°C to 8°C). If necessary, TEZSPIRE may be kept at room temperature between 68°F to 77˚F (20°C to 25°C) for a maximum of 30 days. Do not put back in the refrigerator once TEZSPIRE has reached room temperature. After removal from the refrigerator, TEZSPIRE must be used within 30 days or discarded.</paragraph> <paragraph>Store TEZSPIRE in original carton to protect from light until time of use.</paragraph> <paragraph>Do not freeze. Do not shake. Do not expose to heat.</paragraph> </text> <effectiveTime value="20230526"/> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_26d770e3-7a50-4977-bf82-127b5f0d36a6"> <id root="39a8f7b3-8d70-4cb2-b020-1ec4cc77e033"/> <code code="34076-0" codeSystem="2.16.840.1.113883.6.1" displayName="INFORMATION FOR PATIENTS SECTION"/> <title>17 PATIENT COUNSELING INFORMATION </title> <text> <paragraph>Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).</paragraph> <paragraph> <content styleCode="underline">Hypersensitivity Reactions</content> </paragraph> <paragraph>Inform patients that hypersensitivity reactions (e.g., anaphylaxis, rash and allergic conjunctivitis) can occur following administration of TEZSPIRE <content styleCode="italics">[<linkHtml href="#ID_e03c4879-2993-49ff-9e4a-b15396538f88">see Contraindications (4)</linkHtml> and <linkHtml href="#ID_427a2318-86d2-4194-aee2-5c74d98a42ea">Adverse Reactions (6)</linkHtml>]</content>. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). Instruct patients to contact their healthcare provider if they experience symptoms of an allergic reaction <content styleCode="italics">[see </content> <content styleCode="italics"> <linkHtml href="#ID_ac54d6b8-f757-4012-809c-1858f2ba58f3">Warnings and Precautions (5.1)</linkHtml> </content> <content styleCode="italics">]</content>.</paragraph> <paragraph> <content styleCode="underline">Not for Acute Symptoms or Deteriorating Disease</content> </paragraph> <paragraph>Inform patients that TEZSPIRE does not treat acute asthma symptoms or acute exacerbations. Inform patients to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with <content styleCode="italics">TEZSPIRE [see <linkHtml href="#ID_96a71437-55f9-40f9-b550-2d3a1f0c616c">Warnings and Precautions (5.2)</linkHtml>]</content>.</paragraph> <paragraph> <content styleCode="underline">Risk Associated with Abrupt Reduction of Corticosteroid Dosage</content> </paragraph> <paragraph>Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a healthcare provider. Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy<content styleCode="italics"> [see <linkHtml href="#ID_72a3e58e-0595-420f-9b51-8a955ebb50d0">Warnings and Precautions (5.3)</linkHtml>]</content>.</paragraph> <paragraph> <content styleCode="underline">Administration of Vaccines</content> </paragraph> <paragraph>Instruct patients to inform the healthcare provider that they are taking TEZSPIRE prior to a potential vaccination <content styleCode="italics">[see <linkHtml href="#ID_57ee624f-4910-4215-93ed-34348b7d1ed0">Warnings and Precautions (5.5)</linkHtml>]</content>.</paragraph> <paragraph> <content styleCode="underline">Proper Storage and Disposal</content> </paragraph> <paragraph>Advise patients to refrigerate TEZSPIRE at 36°F to 46°F (2°C to 8°C). TEZSPIRE may be kept at room temperature between 68°F to 77˚F (20°C to 25°C) for a maximum of 30 days <content styleCode="italics">[see <linkHtml href="#ID_0ca9ca30-ba93-4034-b55a-015635ef392c">How Supplied/Storage and Handling (16)</linkHtml>]</content>. Inform patients and caregivers of the need for proper disposal of the pre-filled pen after use, including the use of a sharps disposal container.</paragraph> <paragraph>Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-15185</paragraph> <paragraph>US License No. 2059</paragraph> <paragraph>At: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799</paragraph> <paragraph>Marketed by: Amgen Inc. and AstraZeneca AB</paragraph> <paragraph>©AstraZeneca and Amgen 2025</paragraph> <paragraph>TEZSPIRE is a trademark of Amgen Inc. and AstraZeneca.</paragraph> </text> <effectiveTime value="20251017"/> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_596e1748-1c1c-4f68-8f7b-0ad069bba76b"> <id root="235d3c75-3c1d-4ce2-b6eb-bab64a5bcfc9"/> <code code="42230-3" codeSystem="2.16.840.1.113883.6.1" displayName="SPL PATIENT PACKAGE INSERT SECTION"/> <text> <paragraph/> <table width="100%"> <col width="27%"/> <col width="22%"/> <col width="3%"/> <col width="47%"/> <tbody> <tr> <td align="center" colspan="4" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">PATIENT INFORMATION</content> </paragraph> <paragraph> <content styleCode="bold">TEZSPIRE<sup>®</sup> (TEZ-SPY-ER)</content> </paragraph> <paragraph> <content styleCode="bold">(tezepelumab-ekko)</content> </paragraph> <paragraph> <content styleCode="bold">injection, for subcutaneous use</content> </paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">What is TEZSPIRE?</content> </paragraph> <paragraph>TEZSPIRE is a prescription medicine used: </paragraph> <list listType="unordered"> <item> <caption>•</caption>with other asthma medicines for the maintenance treatment of severe asthma in people 12 years of age and older whose asthma is not controlled with their current asthma medicine.</item> <item> <caption>•</caption>with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in people 12 years of age and older whose CRSwNP is not controlled with their current CRSwNP medicine.</item> </list> <paragraph>TEZSPIRE helps: </paragraph> <list listType="unordered"> <item> <caption>•</caption>prevent severe asthma attacks (exacerbations) and can improve your breathing.</item> <item> <caption>•</caption>reduce the size of your polyps, improve symptoms i.e. nasal congestion and loss of smell, and reduce the need for oral corticosteroids and surgery for your nasal polyps.</item> </list> <paragraph>TEZSPIRE is not used to treat sudden breathing problems. Tell your healthcare provider if your asthma does not get better or if it gets worse after you start treatment with TEZSPIRE.</paragraph> <paragraph>It is not known if TEZSPIRE is safe and effective in children under 12 years of age for the treatment of asthma.</paragraph> <paragraph>It is not known if TEZSPIRE is safe and effective in children under 12 years of age for the treatment of CRSwNP.</paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Do not use TEZSPIRE if you</content>:</paragraph> <list listType="unordered"> <item> <caption>•</caption>are allergic to tezepelumab‑ekko or any of the ingredients in TEZSPIRE. See the end of this Patient Information leaflet for a complete list of ingredients in TEZSPIRE.</item> </list> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Before using TEZSPIRE, tell your healthcare provider about all of your medical conditions, including if you:</content> </paragraph> <list listType="unordered"> <item> <caption>•</caption>have ever had a severe allergic reaction (hypersensitivity). </item> <item> <caption>•</caption>have a parasitic (helminth) infection.</item> <item> <caption>•</caption>have recently received or are scheduled to receive any live attenuated vaccinations. People who receive TEZSPIRE should not receive live attenuated vaccines.</item> <item> <caption>•</caption>are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if TEZSPIRE may harm your unborn baby.</item> <item> <caption>•</caption>are breastfeeding or plan to breastfeed. It is not known if TEZSPIRE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use TEZSPIRE.</item> </list> <paragraph> <content styleCode="bold">Tell your healthcare provider about all the medicines you take</content>, including prescription and over-the-counter medicines, vitamins, and herbal supplements.</paragraph> <paragraph> <content styleCode="bold">Do not </content>change or stop your other medicines, including corticosteroid medicines or other asthma medicines unless your healthcare provider tells you to. This may cause other symptoms that were controlled by those medicines to come back.</paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">How should I use TEZSPIRE?</content> </paragraph> <list listType="unordered"> <item> <caption>•</caption> <content styleCode="bold">See the detailed Instructions for Use that comes with TEZSPIRE pre-filled pen for information on how to prepare and inject TEZSPIRE.</content> </item> <item> <caption>•</caption>Use TEZSPIRE exactly as prescribed by your healthcare provider.</item> <item> <caption>•</caption>TEZSPIRE is injected under your skin (subcutaneously) 1 time every 4 weeks.</item> <item> <caption>•</caption>TEZSPIRE comes in a single-dose vial, in a single-dose pre-filled syringe, and in a single-dose pre-filled pen.</item> <item> <caption>•</caption>Your healthcare provider can inject you with TEZSPIRE in a healthcare setting.</item> <item> <caption>•</caption>If your healthcare provider decides that you or a caregiver can give the injections of TEZSPIRE, you or your caregiver should receive training on the right way to prepare and inject the TEZSPIRE single dose pre-filled pen.</item> <item> <caption>•</caption> <content styleCode="bold">Do not</content> try to inject TEZSPIRE until you or your caregiver have been shown the right way by your healthcare provider.</item> <item> <caption>•</caption>If you miss a dose, inject a dose as soon as possible. After that, you can continue to use TEZSPIRE on your usual injection day. If you did not notice that you missed a dose until it is time for your next scheduled dose, skip the missed dose and inject the next scheduled dose as planned. <content styleCode="bold">Do not</content> inject more than one dose in a day. If you have questions about when to inject TEZSPIRE, contact your healthcare provider.</item> </list> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">What are the possible side effects of TEZSPIRE?</content> </paragraph> <paragraph> <content styleCode="bold">TEZSPIRE may cause serious side effects, including:</content> </paragraph> <list listType="unordered"> <item> <caption>•</caption> <content styleCode="bold">allergic (hypersensitivity) reactions, including anaphylaxis. </content>Serious allergic reactions can happen after you get your TEZSPIRE injection. Allergic reactions can sometimes happen hours or days after you get a dose of TEZSPIRE. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of allergic reaction:</item> </list> </td> </tr> <tr> <td colspan="2" styleCode="Lrule " valign="top"> <list listType="unordered"> <item> <caption>∘</caption>rash</item> <item> <caption>∘</caption>hives</item> <item> <caption>∘</caption>swelling of your face, mouth, and tongue</item> </list> </td> <td colspan="2" styleCode="Rrule " valign="top"> <list listType="unordered"> <item> <caption>∘</caption>breathing problems</item> <item> <caption>∘</caption>red, itchy, swollen, or inflamed eyes</item> <item> <caption>∘</caption>fainting, dizziness, feeling lightheaded</item> </list> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">The most common side effects of TEZSPIRE include:</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule " valign="top"> <list listType="unordered"> <item> <caption>•</caption>sore throat (pharyngitis)</item> <item> <caption>•</caption>common cold symptoms (nasopharyngitis)</item> <item> <caption>•</caption>flu</item> </list> </td> <td colspan="2" valign="top"> <list listType="unordered"> <item> <caption>•</caption>joint pain (arthralgia)</item> <item> <caption>•</caption>upper respiratory tract infections</item> <item> <caption>•</caption>injection site reactions</item> </list> </td> <td styleCode="Rrule " valign="top"> <list listType="unordered"> <item> <caption>•</caption>back pain</item> <item> <caption>•</caption>nose bleeds</item> </list> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>These are not all of the possible side effects of TEZSPIRE.</paragraph> <paragraph>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800-FDA-1088.</paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">General information about the safe and effective use of TEZSPIRE</content> </paragraph> <paragraph>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TEZSPIRE for a condition for which it was not prescribed. Do not give TEZSPIRE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TEZSPIRE that is written for health professionals.</paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">What are the ingredients in TEZSPIRE?</content> </paragraph> <paragraph> <content styleCode="bold">Active ingredient</content>: tezepelumab-ekko.</paragraph> <paragraph> <content styleCode="bold">Inactive ingredients</content>: glacial acetic acid, L-proline, polysorbate 80, sodium hydroxide, and water for injection.</paragraph> </td> </tr> <tr> <td colspan="4" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Manufactured by:</paragraph> <paragraph>AstraZeneca AB, Södertälje, Sweden SE-15185</paragraph> <paragraph>US License No. 2059</paragraph> <paragraph>At: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799</paragraph> <paragraph>Marketed by: Amgen Inc. and AstraZeneca AB</paragraph> <paragraph>©AstraZeneca and Amgen 2025</paragraph> <paragraph>TEZSPIRE is a trademark of Amgen Inc. and AstraZeneca.</paragraph> <paragraph>For more information, go to <linkHtml href="https://www.TEZSPIRE.com">https://www.TEZSPIRE.com</linkHtml> or call 1-800-236-9933. </paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph>This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: October 2025</paragraph> </td> </tr> </tbody> </table> </text> <effectiveTime value="20251017"/> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_e65eedcf-33f2-41cf-8fc7-1f363d937906"> <id root="b67bca44-31da-4ce2-8efb-bd1774e440ca"/> <code code="59845-8" codeSystem="2.16.840.1.113883.6.1" displayName="INSTRUCTIONS FOR USE SECTION"/> <text> <paragraph/> <table width="100%"> <col width="51%"/> <col width="11%"/> <col width="38%"/> <tbody> <tr> <td align="center" colspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">INSTRUCTIONS FOR USE</content> </paragraph> <paragraph> <content styleCode="bold">TEZSPIRE<sup>®</sup> (TEZ-SPY-ER)</content> </paragraph> <paragraph> <content styleCode="bold">(tezepelumab-ekko)</content> </paragraph> <paragraph> <content styleCode="bold">injection, for subcutaneous use</content> </paragraph> <paragraph> <content styleCode="bold">Single-dose Pre-filled pen</content> </paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <paragraph>This Instructions for Use contains information on how to inject TEZSPIRE.</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Before using your TEZSPIRE pre-filled pen, your healthcare provider should show you or your caregiver how to use it the right way.</paragraph> <paragraph> <content styleCode="bold">Read this Instructions for Use before you start using your TEZSPIRE pre-filled pen and each time you get a refill.</content> There may be new information. This information should not replace talking to your healthcare provider about your medical condition and your treatment.</paragraph> <paragraph>If you or your caregiver have any questions, talk to your healthcare provider.</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">Important information you need to know before injecting TEZSPIRE</content> </paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">Store TEZSPIRE in a refrigerator between 36°F to 46°F (2°C to 8°C) in its original carton until you are ready to use it.</content> </paragraph> <paragraph>TEZSPIRE may be kept at room temperature between 68°F to 77˚F (20°C to 25°C) for a maximum of 30 days.</paragraph> <paragraph>Store TEZSPIRE in the original carton to protect it from light.</paragraph> <paragraph>When TEZSPIRE has reached room temperature, <content styleCode="bold">do not</content> put it back in the refrigerator.</paragraph> <paragraph>Throw away (dispose of) TEZSPIRE that has been stored at room temperature for more than 30 days.</paragraph> </td> </tr> <tr> <td styleCode="Lrule " valign="top"> <paragraph> <content styleCode="bold">Do not</content> use your TEZSPIRE pre-filled pen if:</paragraph> <list listType="unordered"> <item> <caption>•</caption>it has been frozen</item> <item> <caption>•</caption>it has been dropped or damaged</item> <item> <caption>•</caption>the security seal on the carton has been broken</item> <item> <caption>•</caption>the expiration date (EXP) has passed</item> </list> </td> <td colspan="2" styleCode="Rrule " valign="top"> <paragraph> <content styleCode="bold">Do not:</content> </paragraph> <list listType="unordered"> <item> <caption>•</caption>freeze your pre-filled pen or expose it to heat</item> <item> <caption>•</caption>shake your pre-filled pen</item> <item> <caption>•</caption>share, or use your pre-filled pen more than 1 time</item> </list> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>If any of the above happens, throw away the pre-filled pen in a puncture-resistant (sharps) container and use a new TEZSPIRE pre-filled pen.</paragraph> <paragraph>Each TEZSPIRE pre-filled pen contains 1 dose of TEZSPIRE that can only be used 1 time.</paragraph> <paragraph>TEZSPIRE is given only as an injection under the skin (subcutaneous).</paragraph> <paragraph> <content styleCode="bold">Keep the TEZSPIRE pre-filled pen and all medicines out of the sight and reach of children.</content> </paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">Your TEZSPIRE pre-filled pen</content> </paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">Do not</content> remove the cap until Step 6 of these instructions when you are ready to inject TEZSPIRE.</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule Botrule " valign="top"> <renderMultiMedia ID="id297347948" referencedObject="ID_6017f071-d310-4d70-96c0-55681f82053e"/> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">Preparing to inject TEZSPIRE</content> </paragraph> <paragraph> <content styleCode="bold">Step 1 – Gather supplies</content> </paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <list listType="unordered"> <item> <caption> </caption> <list listType="unordered"> <item> <caption>•</caption>1 TEZSPIRE pre-filled pen from the refrigerator</item> <item> <caption>•</caption>1 alcohol wipe</item> <item> <caption>•</caption>1 cotton ball or gauze</item> <item> <caption>•</caption>1 small bandage (optional)</item> <item> <caption>•</caption>1 puncture-resistant (sharps) disposal container. See Step 10 for instructions on how to throw away (dispose of) the used TEZSPIRE pre-filled pen safely.</item> </list> </item> </list> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule Botrule " valign="top"> <renderMultiMedia ID="id281547640" referencedObject="ID_631b9d22-8f88-4390-90b5-0aca0caea20b"/> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Step 2 – Prepare to use your TEZSPIRE pre-filled pen</content> </paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Lrule " valign="top"> <paragraph> <content styleCode="bold">Let TEZSPIRE come to room temperature between 68°F to 77˚F (20°C to 25°C</content>) <content styleCode="bold">for about 60 minutes before giving the injection.</content> </paragraph> <paragraph>Keep the pre-filled pen in its original carton to protect it from light.</paragraph> <paragraph> <content styleCode="bold">Do not</content> warm the pre-filled pen in any other way. For example, <content styleCode="bold">do not</content> warm it in a microwave or hot water, in direct sunlight, or near other heat sources.</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <renderMultiMedia ID="id589901780" referencedObject="ID_34a05d99-508e-44f4-91e9-11bddab64800"/> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Do not</content> put TEZSPIRE back in the refrigerator after it has reached room temperature. Throw away (dispose of) TEZSPIRE that has been stored at room temperature for more than 30 days.</paragraph> <paragraph> <content styleCode="bold">Do not</content> remove the cap until Step 6.</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">Step 3 – Remove and check the pre-filled pen</content> </paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Lrule Botrule " valign="top"> <paragraph>Grab the middle of the pre-filled pen body to remove the pre-filled pen from its carton.</paragraph> <paragraph> <content styleCode="bold">Check the pre-filled pen for damage. Do not</content> use the pre-filled pen if the pre-filled pen is damaged.</paragraph> <paragraph> <content styleCode="bold">Check the expiration date</content> on the pre-filled pen. <content styleCode="bold">Do not</content> use the pre-filled pen if the expiration date has passed.</paragraph> <paragraph> <content styleCode="bold">Look at the liquid through the viewing window.</content> The liquid should be clear and colorless to light yellow.</paragraph> <paragraph> <content styleCode="bold">Do not</content> inject TEZSPIRE if the liquid is cloudy, discolored, or contains large particles.</paragraph> <paragraph>You may see small air bubbles in the liquid. This is normal. You do not need to do anything about it.</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <renderMultiMedia ID="id521367596" referencedObject="ID_470048b5-8c46-4d03-b6a4-e62ad5cf479f"/> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">Injecting TEZSPIRE</content> </paragraph> <paragraph> <content styleCode="bold">Step 4 – Choose an injection site</content> </paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Lrule Botrule " valign="top"> <paragraph>If you are giving yourself the injection, the <content styleCode="bold">recommended injection site</content> is the front of your thigh or the lower part of your stomach (abdomen). <content styleCode="bold">Do not</content> inject yourself in the arm.</paragraph> <paragraph>A caregiver may inject you in the upper arm, thigh, or abdomen.</paragraph> <paragraph>For each injection, choose a different site that is at least 1 inch (3 cm) away from where you last injected.</paragraph> <paragraph> <content styleCode="bold">Do not</content> inject:</paragraph> <list listType="unordered"> <item> <caption>•</caption>into the 2‑inch (5 cm) area around your belly button</item> <item> <caption>•</caption>where the skin is tender, bruised, scaly or hard</item> <item> <caption>•</caption>into scars or damaged skin</item> <item> <caption>•</caption>through clothing</item> </list> </td> <td styleCode="Rrule Botrule " valign="top"> <list listType="unordered"> <item> <caption> </caption> <renderMultiMedia ID="id-1328361100" referencedObject="ID_25048d21-8f1d-49fc-badd-3e93fe275ba9"/> </item> </list> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">Step 5 – Wash your hands and clean the injection site</content> </paragraph> <paragraph>Wash your hands well with soap and water.</paragraph> <paragraph>Clean the injection site with an alcohol wipe in a circular motion. Let it air dry.</paragraph> <paragraph> <content styleCode="bold">Do not</content> touch the cleaned area before injecting.</paragraph> <paragraph> <content styleCode="bold">Do not</content> fan or blow on the cleaned area.</paragraph> </td> </tr> <tr> <td align="center" colspan="3" styleCode="Rrule Lrule Botrule " valign="middle"> <renderMultiMedia ID="id-1286571246" referencedObject="C7DBA438-9BD3-44E3-B441-0B9E290849B6"/> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">Step 6 – Pull off the cap</content> </paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Do not</content> remove the cap until you are ready to inject.</paragraph> <paragraph>Hold the pre-filled pen body with 1 hand, and carefully pull the cap straight off with your other hand.</paragraph> <paragraph>Put the cap to the side and throw it away later.</paragraph> <paragraph>The orange needle guard is now exposed. The orange needle guard is there to prevent you from touching the needle.</paragraph> <paragraph> <content styleCode="bold">Do not</content> touch the needle or push on the orange needle guard with your finger.</paragraph> <paragraph> <content styleCode="bold">Do not</content> put the cap back on the pre-filled pen. You could cause the injection to happen too soon or damage the needle.</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <renderMultiMedia ID="id-1160854550" referencedObject="B15D8E62-BE33-463C-8399-49FB347137B0"/> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">Step 7 – Inject TEZSPIRE</content> </paragraph> </td> </tr> <tr> <td colspan="2" rowspan="2" styleCode="Lrule " valign="top"> <paragraph>Follow your healthcare provider’s instruction on how to inject. You can either gently pinch the skin at the injection site or give the injection without pinching the skin.</paragraph> <paragraph>Inject TEZSPIRE by following the steps in figures <content styleCode="bold">a, b, c</content> and <content styleCode="bold">d</content>.</paragraph> <paragraph>When injecting, you will hear the first click that tells you the injection has started. Press and hold the pre-filled pen for 15 seconds until you hear the <content styleCode="bold">second click</content>.</paragraph> <paragraph> <content styleCode="bold">Do not</content> change the position of the pre-filled pen after the injection has started.</paragraph> </td> <td styleCode="Rrule " valign="top"> <renderMultiMedia ID="id1156569458" referencedObject="ID_3f796aa1-1956-4ad3-83c0-07472df8b0f5"/> </td> </tr> <tr> <td styleCode="Rrule " valign="top"> <paragraph> <content styleCode="bold">Position the pre-filled pen.</content> </paragraph> <list listType="unordered"> <item> <caption>•</caption>Place the orange needle guard flat against your skin (90-degree angle).</item> <item> <caption>•</caption>Make sure you can see the viewing window.</item> </list> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule Botrule " valign="top"> <renderMultiMedia ID="id1308208820" referencedObject="B1256702-28E7-4501-9BDE-BD445600A84B"/> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Step 8 – Check the viewing window</content> </paragraph> <paragraph>Check the viewing window to make sure all the medicine has been injected.</paragraph> <paragraph>If the orange plunger rod does not fill the viewing window, you may not have received the full dose.</paragraph> <paragraph>If this happens or if you have any other concerns, contact your healthcare provider.</paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Lrule Botrule " valign="top"> <renderMultiMedia ID="id-1821419710" referencedObject="ID_7020c5e9-aef5-4f62-a55d-186046e31275"/> </td> <td styleCode="Rrule Botrule " valign="top"> <renderMultiMedia ID="id-952863059" referencedObject="B694038D-0F74-4F7F-A77D-EE9F0404D407"/> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule Toprule Botrule " valign="top"> <paragraph> <content styleCode="bold">Step 9 – Check the injection site</content> </paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Lrule Toprule Botrule " valign="top"> <paragraph>There may be a small amount of blood or liquid where you injected. This is normal.</paragraph> <paragraph>Gently hold pressure over your skin with a cotton ball or gauze until the bleeding stops.</paragraph> <paragraph> <content styleCode="bold">Do not</content> rub the injection site. If needed, cover the injection site with a small bandage.</paragraph> </td> <td styleCode="Rrule Toprule Botrule " valign="top"> <renderMultiMedia ID="id619028823" referencedObject="ID_9ad34197-1ec4-4d0a-a2c1-3ae0e9e566d4"/> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule " valign="top"> <paragraph> <content styleCode="bold">Disposing of TEZSPIRE</content> </paragraph> <paragraph> <content styleCode="bold">Step 10 – Dispose of the used pre-filled pen safely</content> </paragraph> </td> </tr> <tr> <td colspan="2" styleCode="Lrule Botrule " valign="top"> <paragraph>Each pre-filled pen contains a single dose of TEZSPIRE and <content styleCode="bold">cannot be used again</content>. <content styleCode="bold">Do not</content> put the cap back on the pre-filled pen.</paragraph> <paragraph>Put your used pre-filled pen and cap in a <content styleCode="bold">sharps disposal container</content> right away after use. Put other used supplies in your household trash.</paragraph> <paragraph> <content styleCode="bold">Do not</content> throw away the pre-filled pen in your household trash.</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <renderMultiMedia ID="id-424498652" referencedObject="ID_6b77b018-497a-471b-a043-331b18da04f0"/> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Throw away (Disposal) guidelines</content> </paragraph> <paragraph>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:</paragraph> <list listType="unordered"> <item> <caption> </caption> <list listType="unordered"> <item> <caption>•</caption>made of a heavy-duty plastic,</item> <item> <caption>•</caption>can be closed with a tight-fitting puncture-resistant lid, without sharps being able to come out,</item> <item> <caption>•</caption>upright and stable during use,</item> <item> <caption>•</caption>leak-resistant, and</item> <item> <caption>•</caption>properly labeled to warn of hazardous waste inside the container.</item> </list> </item> </list> <paragraph>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the area that you live in, go to the FDA’s website at: <linkHtml href="https://www.fda.gov/medical-devices/consumer-products/safely-using-sharps-needles-and-syringes-home-work-and-travel">http://www.fda.gov/safesharpsdisposal</linkHtml>.</paragraph> <paragraph> <content styleCode="bold">Do not</content> dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</paragraph> <paragraph> <content styleCode="bold">Do not</content> recycle your used sharps disposal container.</paragraph> <paragraph>Manufactured by:</paragraph> <paragraph>AstraZeneca AB, Södertälje, Sweden SE-15185</paragraph> <paragraph>US License No. 2059</paragraph> <paragraph>At: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799</paragraph> <paragraph>Marketed by: Amgen Inc. and AstraZeneca AB</paragraph> <paragraph>©AstraZeneca and Amgen 2025</paragraph> <paragraph>TEZSPIRE is a trademark of Amgen Inc. and AstraZeneca.</paragraph> <paragraph>For more information, go to <linkHtml href="https://www.TEZSPIRE.com">https://www.TEZSPIRE.com</linkHtml> or call 1-800-236-9933.</paragraph> </td> </tr> <tr> <td colspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: October 2025</paragraph> </td> </tr> </tbody> </table> </text> <effectiveTime value="20251017"/> <component> <observationMedia ID="ID_6017f071-d310-4d70-96c0-55681f82053e"> <text>Tezspire-prefille-pen</text> <value mediaType="image/jpeg"> <reference value="Tezspire-prefille-pen.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_631b9d22-8f88-4390-90b5-0aca0caea20b"> <text>Step_1</text> <value mediaType="image/jpeg"> <reference value="Step_1.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_34a05d99-508e-44f4-91e9-11bddab64800"> <text>Step_2</text> <value mediaType="image/jpeg"> <reference value="step_2-ok.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_470048b5-8c46-4d03-b6a4-e62ad5cf479f"> <text>step_3</text> <value mediaType="image/jpeg"> <reference value="step_3.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_25048d21-8f1d-49fc-badd-3e93fe275ba9"> <text>step_4_injection_site</text> <value mediaType="image/jpeg"> <reference value="step_4_injection_site.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="C7DBA438-9BD3-44E3-B441-0B9E290849B6"> <text>step_5</text> <value mediaType="image/jpeg"> <reference value="step_5.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="B15D8E62-BE33-463C-8399-49FB347137B0"> <text>step_6</text> <value mediaType="image/jpeg"> <reference value="step_6.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_3f796aa1-1956-4ad3-83c0-07472df8b0f5"> <text>step_7</text> <value mediaType="image/jpeg"> <reference value="step_7.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="B1256702-28E7-4501-9BDE-BD445600A84B"> <text>step_7-b-c-d</text> <value mediaType="image/jpeg"> <reference value="step_7-b-c-d.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_7020c5e9-aef5-4f62-a55d-186046e31275"> <text>step_8_with _text</text> <value mediaType="image/jpeg"> <reference value="step_8_with _text.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="B694038D-0F74-4F7F-A77D-EE9F0404D407"> <text>step_8</text> <value mediaType="image/jpeg"> <reference value="step_8.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_9ad34197-1ec4-4d0a-a2c1-3ae0e9e566d4"> <text>step_9</text> <value mediaType="image/jpeg"> <reference value="step_9.jpg"/> </value> </observationMedia> </component> <component> <observationMedia ID="ID_6b77b018-497a-471b-a043-331b18da04f0"> <text>step_10</text> <value mediaType="image/jpeg"> <reference value="step_10.jpg"/> </value> </observationMedia> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_f5e6c9f6-65af-4fcf-b1d1-bfdc852f1a46"> <id root="3d556088-ae66-4e7a-8665-679c9a933691"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <title>PACKAGE/LABEL PRINCIPAL DISPLAY PANEL </title> <text> <paragraph>NDC 55513-100-01 Rx only</paragraph> <paragraph>TEZSPIRE<sup>TM</sup> </paragraph> <paragraph>(tezepelumab-ekko)</paragraph> <paragraph>Injection</paragraph> <paragraph>210 mg/1.91 mL (110 mg/mL)</paragraph> <paragraph>For Subcutaneous Injection Only</paragraph> <paragraph>1 singe-dose vial. Discard unused portion.</paragraph> <paragraph>AMGEN<sup>®</sup> AstraZeneca</paragraph> <renderMultiMedia ID="id-751496505" referencedObject="a6072a8b-e10f-47b7-a67f-d7b6ce8f4fba"/> </text> <effectiveTime value="20230526"/> <component> <observationMedia ID="a6072a8b-e10f-47b7-a67f-d7b6ce8f4fba"> <text>vial_label_single-dose</text> <value mediaType="image/jpeg"> <reference value="vial_label_single-dose.jpg"/> </value> </observationMedia> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_0E88C582-DFAC-4E21-8F1F-41F75067E242"> <id root="aad8a799-ff72-4c13-ae37-561f4730f846"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <title>PACKAGE/LABEL PRINCIPAL DISPLAY PANEL </title> <text> <paragraph>NDC 55513-112-01</paragraph> <paragraph>TEZSPIRE<sup>TM</sup> (tezepelumab-ekko) Injection</paragraph> <paragraph>210 mg/1.91 mL (110 mg/mL)</paragraph> <paragraph>Rx Only</paragraph> <paragraph>For Subcutaneous Injection Only</paragraph> <paragraph>Store the pre-filled syringe refrigerated at 36° F to 46° F</paragraph> <paragraph>(2° C to 8° C) in original carton to protect from light.</paragraph> <paragraph>DO NOT SHAKE, FREEEZE, OR EXPOSE TO HEAT.</paragraph> <paragraph>1 Singe-dose pre-filled syringe. Discard unused portion</paragraph> <paragraph>AMGEN<sup>®</sup> AstraZeneca</paragraph> <renderMultiMedia ID="id-896044688" referencedObject="ID_2bc45c92-b10a-4c0e-8cc3-55912ffda6d7"/> </text> <effectiveTime value="20230526"/> <component> <observationMedia ID="ID_2bc45c92-b10a-4c0e-8cc3-55912ffda6d7"> <text>carton-apfs-sales</text> <value mediaType="image/jpeg"> <reference value="carton_subcutaneous_injection_ndc_55513-112-01.jpg"/> </value> </observationMedia> </component> </section>

<?xml version="1.0" encoding="UTF-8"?><section ID="ID_5A24AA43-60EC-4AFA-ABEB-3E0E1892C4EE"> <id root="f9593645-3850-475d-9047-387570fab7a3"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <title>PACKAGE/LABEL PRINCIPAL DISPLAY PANEL </title> <text> <paragraph>NDC 55513-123-01 Rx only</paragraph> <paragraph>TEZSPIRE<sup>®</sup> </paragraph> <paragraph>(tezepelumab-ekko)</paragraph> <paragraph>Injection</paragraph> <paragraph>210 mg/1.91 mL (110 mg/mL)</paragraph> <paragraph>For Subcutaneous Injection Only</paragraph> <paragraph>Store the pre-filled pen refrigerated at 36°F to 46°F</paragraph> <paragraph>(2°C to 8°C) in original carton to protect from light.</paragraph> <paragraph>DO NOT SHAKE FREEZE OR EXPOSE TO HEAT.</paragraph> <paragraph>1 Single-dose pre-filled pen.</paragraph> <paragraph>Discard unused portion.</paragraph> <paragraph>ATTENTION: Follow enclosed “Instructions for Use”</paragraph> <paragraph>to prepare and deliver your dose.</paragraph> <paragraph>AMGEN<sup>®</sup> AstraZeneca</paragraph> <renderMultiMedia ID="id-1336060800" referencedObject="ID_40337f83-ae6f-461f-84f6-6b0f9b155c71"/> </text> <effectiveTime value="20230526"/> <component> <observationMedia ID="ID_40337f83-ae6f-461f-84f6-6b0f9b155c71"> <text>carton_201mg_1.91ml_single-dose_pre-filled_pen</text> <value mediaType="image/jpeg"> <reference value="carton_label_single-dose_pre-filled_pen.jpg"/> </value> </observationMedia> </component> </section>

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