Tezspire 210 mg/1.91 mL (110 mg/mL) subcutaneous pen injector

Generic name:
Tezepelumab - injection

Pronunciation
(TEZ-e-PEL-ue-mab)

Brand name(s)
Tezspire

This medication is used with other medications to control and prevent symptoms of severe asthma (such as wheezing and shortness of breath). Controlling symptoms of asthma helps you maintain your normal activities and decreases time lost from work or school. Tezepelumab belongs to a class of medications known as monoclonal antibodies. It helps reduce swelling (inflammation) of the airways in the lungs to make breathing easier.

This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks or breathing problems. If an asthma attack occurs, use your quick-relief inhaler as prescribed.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using tezepelumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once every 4 weeks. The injection is given in the upper arm, thigh, or abdomen.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Take the medication out of the refrigerator at least 60 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave, place it in hot water, or leave it in direct sunlight). Do not shake the medication. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, bruised, red, hard, or damaged. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

If you are regularly using a corticosteroid medication, you should not stop using it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. If you suddenly stop using the corticosteroid medication, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may slowly lower the dose of your corticosteroid medication after you begin using tezepelumab. Tell your doctor or pharmacist right away if you have withdrawal.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

Pain, redness, or swelling at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using tezepelumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• infection due to a parasite (helminth)

Tell your health care professional that you are using tezepelumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If your dose is given by a health care professional and you miss a dose, ask your doctor right away for a new dosing schedule. If you are using this medication at home and miss a dose, use it as soon as you remember. Use your next dose on the regular day. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze. Keep the medication in the original carton to protect from light. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, do not put it back in the refrigerator and discard after 30 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.