Safety information for TEZSPIRE

Do not use TEZSPIRE if you are allergic to tezepelumab-ekko or any of its ingredients.

Do not use to treat sudden breathing problems.

TEZSPIRE may cause serious side effects, including:

• allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after 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 help right away if you get any of the following symptoms of an allergic reaction:
  • rash
  • breathing problems
  • hives
  • red, itchy, swollen, or inflamed eyes
  • swelling of your face, mouth, and tongue
  • fainting, dizziness, feeling lightheaded

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

• have ever had a severe allergic reaction.
• have a parasitic (helminth) infection.
• have recently received or are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with TEZSPIRE.
• are pregnant or plan to become pregnant.
• 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.
• are taking prescription and over-the-counter medicines, vitamins, or herbal supplements.

Do not change or stop taking your other asthma medicines unless instructed to do so by your healthcare provider.

The most common side effects of TEZSPIRE include: Sore throat, joint and back pain, common cold symptoms, flu, upper respiratory tract infections, injection site reactions, and nose bleeds. These are not all the possible side effects.

Approved Use

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 including i.e. nasal congestion and loss of smell, and reduce the need for oral corticosteroids and surgery for your nasal polyps in CRSwNP.

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.