NUCALA Risks & Side Effects

Please review this safety information

Below you can learn about the risks and side effects of NUCALA. This, however, is not all the safety information and does not replace talking to your healthcare provider about your medical condition or treatment. Please see the full Prescribing Information and Patient Information for NUCALA for more information, or ask your healthcare provider.

Who should not use NUCALA?

It is not known if NUCALA for CRSwNP is safe and effective in children and adolescents under 18 years of age.

Do not use NUCALA if you are allergic to mepolizumab or any of the ingredients in NUCALA (see “What are the ingredients in NUCALA?” below).

Before receiving NUCALA, tell your healthcare provider about all of your medical conditions, including if you:

• have a parasitic (helminth) infection.
• are taking oral or inhaled corticosteroid medicines. Do not stop taking your corticosteroid medicines, unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine to come back.
• are pregnant or plan to become pregnant. It is not known if NUCALA may harm your unborn baby.
• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use NUCALA and breastfeed. You should not do both without talking with your healthcare provider first.
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Do not stop taking your other medicines unless instructed to do so by your healthcare provider.

What are the possible side effects of NUCALA?

NUCALA can cause serious side effects, including:

• Allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your NUCALA injection. Allergic reactions can sometimes happen hours or days after you get a dose of NUCALA. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:
  • swelling of your face, mouth, and tongue
  • breathing problems
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • rash
  • hives
• Herpes zoster infections that can cause shingles have happened in people who received NUCALA.

The most common side effects of NUCALA include: headache, injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and tiredness (fatigue). Mouth/throat pain and joint pain have been reported with CRSwNP.

 

These are not all the possible side effects of NUCALA. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report negative side effects to GSK at gsk.public.reportum.com or 1-888-825-5249.

What are the ingredients in NUCALA?

Active ingredient: mepolizumab.

Inactive ingredients (vials): polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.

Inactive ingredients (prefilled syringes and Autoinjectors): citric acid monohydrate, EDTA disodium dihydrate, polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.