Patient information: uses, side effects, how to take - Tezspire

What is TEZSPIRE?

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.
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.

TEZSPIRE helps:

prevent severe asthma attacks (exacerbations) and can improve your breathing.
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.

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.

It is not known if TEZSPIRE is safe and effective in children under 12 years of age for the treatment of asthma.

It is not known if TEZSPIRE is safe and effective in children under 12 years of age for the treatment of CRSwNP.

Do not use TEZSPIRE if you:

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.

Before using TEZSPIRE, tell your healthcare provider about all of your medical conditions, including if you:

have ever had a severe allergic reaction (hypersensitivity).
have a parasitic (helminth) infection.
have recently received or are scheduled to receive any live attenuated vaccinations. People who receive TEZSPIRE should not receive live attenuated vaccines.
are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if TEZSPIRE may harm your unborn baby.
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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Do not 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.

How should I use TEZSPIRE?

See the detailed Instructions for Use that comes with TEZSPIRE pre-filled pen for information on how to prepare and inject TEZSPIRE.
Use TEZSPIRE exactly as prescribed by your healthcare provider.
TEZSPIRE is injected under your skin (subcutaneously) 1 time every 4 weeks.
TEZSPIRE comes in a single-dose vial, in a single-dose pre-filled syringe, and in a single-dose pre-filled pen.
Your healthcare provider can inject you with TEZSPIRE in a healthcare setting.
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.
Do not try to inject TEZSPIRE until you or your caregiver have been shown the right way by your healthcare provider.
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. Do not inject more than one dose in a day. If you have questions about when to inject TEZSPIRE, contact your healthcare provider.

What are the possible side effects of TEZSPIRE?

TEZSPIRE may cause serious side effects, including:

allergic (hypersensitivity) reactions, including anaphylaxis. 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:

rash
hives
swelling of your face, mouth, and tongue

breathing problems
red, itchy, swollen, or inflamed eyes
fainting, dizziness, feeling lightheaded

The most common side effects of TEZSPIRE include:

sore throat (pharyngitis)
common cold symptoms (nasopharyngitis)
flu

joint pain (arthralgia)
upper respiratory tract infections
injection site reactions

back pain
nose bleeds

These are not all of the possible side effects of TEZSPIRE.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800-FDA-1088.

General information about the safe and effective use of TEZSPIRE

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.

What are the ingredients in TEZSPIRE?

Active ingredient: tezepelumab-ekko.

Inactive ingredients: glacial acetic acid, L-proline, polysorbate 80, sodium hydroxide, and water for injection.

Manufactured by:

AstraZeneca AB, Södertälje, Sweden SE-15185

US License No. 2059

At: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799

Marketed by: Amgen Inc. and AstraZeneca AB

TEZSPIRE is a trademark of Amgen Inc. and AstraZeneca.

For more information, go to https://www.TEZSPIRE.com or call 1-800-236-9933.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: October 2025

INSTRUCTIONS FOR USE TEZSPIRE^®(TEZ-SPY-ER) (tezepelumab-ekko) injection, for subcutaneous use Single-dose Pre-filled pen
This Instructions for Use contains information on how to inject TEZSPIRE.
Before using your TEZSPIRE pre-filled pen, your healthcare provider should show you or your caregiver how to use it the right way. Read this Instructions for Use before you start using your TEZSPIRE pre-filled pen and each time you get a refill. There may be new information. This information should not replace talking to your healthcare provider about your medical condition and your treatment. If you or your caregiver have any questions, talk to your healthcare provider.
Important information you need to know before injecting TEZSPIRE
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. TEZSPIRE may be kept at room temperature between 68°F to 77˚F (20°C to 25°C) for a maximum of 30 days. Store TEZSPIRE in the original carton to protect it from light. When TEZSPIRE has reached room temperature, do not put it back in the refrigerator. Throw away (dispose of) TEZSPIRE that has been stored at room temperature for more than 30 days.
Do not use your TEZSPIRE pre-filled pen if: it has been frozen it has been dropped or damaged the security seal on the carton has been broken the expiration date (EXP) has passed	Do not: freeze your pre-filled pen or expose it to heat shake your pre-filled pen share, or use your pre-filled pen more than 1 time
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. Each TEZSPIRE pre-filled pen contains 1 dose of TEZSPIRE that can only be used 1 time. TEZSPIRE is given only as an injection under the skin (subcutaneous). Keep the TEZSPIRE pre-filled pen and all medicines out of the sight and reach of children.
Your TEZSPIRE pre-filled pen
Do not remove the cap until Step 6 of these instructions when you are ready to inject TEZSPIRE.

Preparing to inject TEZSPIRE Step 1 – Gather supplies
1 TEZSPIRE pre-filled pen from the refrigerator 1 alcohol wipe 1 cotton ball or gauze 1 small bandage (optional) 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.

Step 2 – Prepare to use your TEZSPIRE pre-filled pen
Let TEZSPIRE come to room temperature between 68°F to 77˚F (20°C to 25°C) for about 60 minutes before giving the injection. Keep the pre-filled pen in its original carton to protect it from light. Do not warm the pre-filled pen in any other way. For example, do not warm it in a microwave or hot water, in direct sunlight, or near other heat sources.
Do not 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. Do not remove the cap until Step 6.
Step 3 – Remove and check the pre-filled pen
Grab the middle of the pre-filled pen body to remove the pre-filled pen from its carton. Check the pre-filled pen for damage. Do not use the pre-filled pen if the pre-filled pen is damaged. Check the expiration date on the pre-filled pen. Do not use the pre-filled pen if the expiration date has passed. Look at the liquid through the viewing window. The liquid should be clear and colorless to light yellow. Do not inject TEZSPIRE if the liquid is cloudy, discolored, or contains large particles. You may see small air bubbles in the liquid. This is normal. You do not need to do anything about it.
Injecting TEZSPIRE Step 4 – Choose an injection site
If you are giving yourself the injection, the recommended injection site is the front of your thigh or the lower part of your stomach (abdomen). Do not inject yourself in the arm. A caregiver may inject you in the upper arm, thigh, or abdomen. For each injection, choose a different site that is at least 1 inch (3 cm) away from where you last injected. Do not inject: into the 2‑inch (5 cm) area around your belly button where the skin is tender, bruised, scaly or hard into scars or damaged skin through clothing
Step 5 – Wash your hands and clean the injection site Wash your hands well with soap and water. Clean the injection site with an alcohol wipe in a circular motion. Let it air dry. Do not touch the cleaned area before injecting. Do not fan or blow on the cleaned area.

Step 6 – Pull off the cap
Do not remove the cap until you are ready to inject. Hold the pre-filled pen body with 1 hand, and carefully pull the cap straight off with your other hand. Put the cap to the side and throw it away later. The orange needle guard is now exposed. The orange needle guard is there to prevent you from touching the needle. Do not touch the needle or push on 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.
Step 7 – Inject TEZSPIRE
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. Inject TEZSPIRE by following the steps in figures a, b, c and d. 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.
		Position the pre-filled pen. Place the orange needle guard flat against your skin (90-degree angle). Make sure you can see the viewing window.

Step 8 – Check the viewing window Check the viewing window to make sure all the medicine has been injected. If the orange plunger rod does not fill the viewing window, you may not have received the full dose. If this happens or if you have any other concerns, contact your healthcare provider.

Step 9 – Check the injection site
There may be a small amount of blood or liquid where you injected. This is normal. Gently hold pressure over your skin with a cotton ball or gauze until the bleeding stops. Do not rub the injection site. If needed, cover the injection site with a small bandage.
Disposing of TEZSPIRE Step 10 – Dispose of the used pre-filled pen safely
Each pre-filled pen contains a single dose of TEZSPIRE and cannot be used again. Do not put the cap back on the pre-filled pen. Put your used pre-filled pen and cap in a sharps disposal container right away after use. Put other used supplies in your household trash. Do not throw away the pre-filled pen in your household trash.
Throw away (Disposal) guidelines If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. 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: http://www.fda.gov/safesharpsdisposal. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-15185 US License No. 2059 At: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799 Marketed by: Amgen Inc. and AstraZeneca AB ©AstraZeneca and Amgen 2025 TEZSPIRE is a trademark of Amgen Inc. and AstraZeneca. For more information, go to https://www.TEZSPIRE.com or call 1-800-236-9933.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: October 2025