<?xml version="1.0" encoding="UTF-8"?><section ID="ID_1ff3533a-a53d-4e38-ae51-7caafcf29ef9">
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<code code="42230-3" codeSystem="2.16.840.1.113883.6.1" displayName="SPL PATIENT PACKAGE INSERT SECTION"/>
<text>
<paragraph/>
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<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>
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<paragraph>
<content styleCode="bold">What is TEZSPIRE?</content>
</paragraph>
<paragraph>TEZSPIRE is a prescription medicine used 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. </paragraph>
<paragraph>TEZSPIRE helps prevent severe asthma attacks (exacerbations) and can improve your breathing.</paragraph>
<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.</paragraph>
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<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>
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<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 corticosteroid medicines or other asthma medicines unless your healthcare provider tells you to. </paragraph>
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<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>Do not try to inject TEZSPIRE until you 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>
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<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>
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<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 styleCode="Rrule Lrule Toprule Botrule " 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>
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<paragraph>
<content styleCode="bold">The most common side effects of TEZSPIRE include:</content>
</paragraph>
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<list listType="unordered">
<item>
<caption>•</caption>sore throat (pharyngitis)</item>
</list>
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<list listType="unordered">
<item>
<caption>•</caption>joint pain (arthralgia)</item>
</list>
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<list listType="unordered">
<item>
<caption>•</caption>back pain</item>
</list>
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<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>
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<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>
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<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>
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<paragraph>Manufactured by:</paragraph>
<paragraph>AstraZeneca AB, Sodertalje, 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 2023</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>
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<paragraph>This Patient Information has been approved by the U.S. Food and Drug Administration. </paragraph>
<paragraph>Issued: 02/2023</paragraph>
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</text>
<effectiveTime value="20230526"/>
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<section ID="ID_e65eedcf-33f2-41cf-8fc7-1f363d937906">
<id root="886c85c3-5d57-4973-9ed1-064a35eb5e34"/>
<code code="59845-8" codeSystem="2.16.840.1.113883.6.1" displayName="INSTRUCTIONS FOR USE SECTION"/>
<text>
<paragraph/>
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<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>
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<paragraph>This Instructions for Use contains information on how to inject TEZSPIRE.</paragraph>
</td>
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<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>
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<paragraph>
<content styleCode="bold">Important information you need to know before injecting TEZSPIRE</content>
</paragraph>
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<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>
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<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>
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<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>
<paragraph>.</paragraph>
</td>
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<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>
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<paragraph>
<content styleCode="bold">Your TEZSPIRE pre-filled pen</content>
</paragraph>
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<paragraph>
<content styleCode="bold">Do not</content> remove the cap until Step 6 of these instructions when you are ready to inject TEZSPIRE.</paragraph>
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<paragraph>
<content styleCode="bold">Preparing to inject TEZSPIRE</content>
</paragraph>
<paragraph>
<content styleCode="bold">Step 1 – Gather supplies</content>
</paragraph>
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<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>
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<paragraph>
<content styleCode="bold">Step 2 – Prepare to use your TEZSPIRE pre-filled pen</content>
</paragraph>
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<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>
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<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>
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<paragraph>
<content styleCode="bold">Step 3 – Remove and check the pre-filled pen</content>
</paragraph>
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<paragraph>Grab the middle of the pre-filled pen body to remove the pre-filled pen from its tray.</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>
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<paragraph>
<content styleCode="bold">Injecting TEZSPIRE</content>
</paragraph>
<paragraph>
<content styleCode="bold">Step 4 – Choose an injection site</content>
</paragraph>
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<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>
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<caption> </caption>
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<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>
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<paragraph>
<content styleCode="bold">Step 6 – Pull off the cap</content>
</paragraph>
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<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>
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<paragraph>
<content styleCode="bold">Step 7 – Inject TEZSPIRE</content>
</paragraph>
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<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>
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<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>
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<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>
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<paragraph>
<content styleCode="bold">Step 9 – Check the injection site</content>
</paragraph>
</td>
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<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>
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<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="Rrule 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 Lrule Botrule " valign="top">
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<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>
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<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, Sodertalje, 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 2023</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. Issued: 02/2023</paragraph>
</td>
</tr>
</tbody>
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