WARNINGS
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.
USES
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.
TEZSPIRE helps prevent severe asthma attacks (exacerbations) and can improve your breathing.
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.
HOW TO USE
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 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
breathing problems
hives
red, itchy, swollen, or inflamed eyes
swelling of your face, mouth, and tongue o fainting, dizziness, feeling lightheaded
The most common side effects of TEZSPIRE include:
sore throat (pharyngitis)
joint pain (arthralgia)
back pain
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.
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.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
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.
STORAGE
Store refrigerated between 36-degrees F to 46-degrees F (2-degrees C to 8-degreesC). If necessary, TEZSPIRE may be kept at room temperature between 68-degrees F to 77-degrees F (20-degrees C to 25-degrees 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.
Store TEZSPIRE in original carton to protect from light until time of use.
Do not freeze. Do not shake. Do not expose to heat.
NOTES
Medication Guide: revision date 02/2023
Prescribing Information: revision date 05/2023
Please call your healthcare provider for more information.
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 corticosteroid medicines or other asthma medicines unless your healthcare provider tells you to.
