Tezepelumab is used together with other medicines for the maintenance treatment of severe asthma in people 12 years and older and whose asthma is not controlled with their current medication.

Tezepelumab is not a fast-acting rescue medicine for asthma attacks or bronchospasms. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working.

Tezepelumab may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Tezepelumab is injected under the skin, usually once every 4 weeks. A healthcare provider will give you this injection.

You will be watched closely for a short time after each injection, to make sure you do not have an allergic reaction.

If you also use a steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

Usual Adult Dose for Asthma:

210 mg subcutaneously every 4 weeks

Comments:
-This drug is not indicated for the relief of acute bronchospasm or status asthmaticus.

Use: As add-on maintenance treatment for severe asthma.

Usual Pediatric Dose for Asthma:

12 years or older: 210 mg subcutaneously every 4 weeks

Comments:
-This drug is not indicated for the relief of acute bronchospasm or status asthmaticus.

Use: As add-on maintenance treatment for severe asthma in pediatric patients 12 years or older.

You should not be treated with tezepelumab if you are allergic to it.

Tell your doctor if you have ever had:

• a severe allergic reaction;

• a parasite (helminth) infection; or

• if you are scheduled to receive or have received a live vaccine recently.

Tell your doctor if you are pregnant, plan to get pregnant, or if you are breastfeeding or plan to breastfeed.

Call your doctor for instructions if you miss an appointment for your tezepelumab injection.

Since tezepelumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid receiving a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or after the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy, short of breath, or if you have swelling in your face.

Common side effects of tezepelumab may include:

• sore throat; or

• joint or back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect tezepelumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.