Tezepelumab Injection

Brand Name(s): Tezspire®

WHY is this medicine prescribed?

Tezepelumab injection is used along with other medications to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 years and older whose asthma is not controlled with their current asthma medication. Tezepelumab injection is in a class of medications called monoclonal antibodies. It works by reducing a certain type of white blood cell to help decrease swelling and irritation of the airways to allow for easier breathing.

HOW should this medicine be used?

Tezepelumab injection comes as a solution (liquid) in single-dose, prefilled syringes, prefilled dosing pens, and vials to inject subcutaneously (just under the skin) into your upper arm, thigh, or abdomen. It is usually given once every 4 weeks. Your doctor will determine the length of your treatment based on your condition and how well you respond to the medication.

Tezepelumab may be given to you by a nurse or other healthcare provider, or you may be told to inject the medication by yourself at home using a prefilled dosing pen. If you will be injecting tezepelumab yourself, a healthcare provider will show you how to inject the medication. Carefully read the manufacturer's instructions for use that comes with the medication. These instructions describe how to inject a dose of tezepelumab injection using a dosing pen. Be sure to ask your pharmacist or doctor if you have any questions about how to inject this medication. Dispose of used dosing pens in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Do not decrease your dose of any other asthma medication or stop taking any other medication that has been prescribed by your doctor unless your doctor tells you to do so. Your doctor may want to decrease the doses of your other medications gradually.

Tezepelumab injection is not used to treat a sudden attack of asthma symptoms. Your doctor will prescribe a short-acting inhaler to use during attacks. Talk to your doctor about how to treat symptoms of a sudden asthma attack. If your asthma symptoms get worse or if you have asthma attacks more often, be sure to talk to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before receiving tezepelumab injection,

• tell your doctor and pharmacist if you are allergic to tezepelumab, any other medications, or any of the ingredients in tezepelumab injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, you are taking or plan to take.
• tell your doctor if you have a parasitic infection.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving tezepelumab, call your doctor.
• do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you forget to inject your dose, inject the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

If you miss an appointment to receive a dose of tezepelumab injection, call your doctor to reschedule the appointment.

What SIDE EFFECTS can this medicine cause?

Tezepelumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, redness, or swelling at the injection site
• sore throat
• joint pain
• back pain

• rash
• hives
• breathing problems
• swelling of the eyes, face, lips, tongue, or throat
• fainting, dizziness, feeling lightheaded
• red, itchy, swollen or inflamed eyes

Tezepelumab may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, away from light, closed, and out of reach of children. Store tezepelumab injection in the refrigerator. Do not freeze or shake tezepelumab, and do not expose the medication to high temperatures. If a refrigerator is not available, you can store tezepelumab injection at room temperature, away from heat and light, for up to 30 days. Tezepelumab injection should not be put back into the refrigerator after it has been stored at room temperature.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about tezepelumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

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