Important Safety Information
NUCALA (mepolizumab) is a prescription infusion medication for patients six years of age or older with severe eosinophilic asthma. Do not use NUCALA if you are allergic to mepolizumab.
Tell your doctor about your medical history and all medications you’re currently taking — whether they’re prescription, over-the-counter, herbal supplements, or vitamins. The inactive ingredients of NUCALA are polysorbate 80, sodium phosphate dibasic heptahydrate, sucrose, citric monohydrate, EDTA disodium dihydrate, polysorbate 80, and sodium phosphate dibasic heptahydrate. Do not take NUCALA if you are allergic to any of its ingredients.
What is the most important information I should know about NUCALA?
Do not use NUCALA to treat sudden breathing problems, and do not stop taking other asthma medications unless instructed by your doctor. Also, tell your medical provider if you have a parasitic (helminth) infection — as NUCALA reduces white blood cell count. This could make it difficult for your immune system to fight infections caused by parasites.
It is unknown if NUCALA would harm your unborn baby. Therefore, prior to starting treatment, talk to your doctor if you’re pregnant, there’s a possibility you’re pregnant, or you’re planning on getting pregnant. There is a pregnancy registry for women who are undergoing NUCALA infusion treatment to collect information about you and your baby. To take part in the registry — or for more information — call 1-877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/.
Side Effects of NUCALA
As with any prescription medication, NUCALA carries a risk of side effects. Serious allergic reactions may occur hours or days after an infusion treatment. Tell your doctor immediately if you experience any symptoms of an allergic reaction, including:
- Breathing difficulties
- Swelling of your face, mouth, and/or tongue
- Low blood pressure
- Feeling light-headed
In addition to serious allergic reactions — including anaphylaxis — patients on NUCALA may have a higher risk of developing Herpes zoster infections that can cause shingles. Other common side effects of NUCALA include:
- Back pain
- Swelling, itching, or redness at the site where the IV was inserted
Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.
Dosage instructions vary depending on the patient’s age. For severe asthma in patients 12 years of age or older: 100 mg once every four weeks. For patients six years of age to 11 years of age: 40 mg once every four weeks. EGPA 300 mg as three separate 100 mg injections should be done once every four weeks. NUCALA is not indicated for acute bronchospasm or status asthmaticus.
Monitor patients after the infusion treatment to watch out for allergic reactions, including anaphylaxis. Should they occur, future treatments may be adjusted or stopped altogether.
Please refer to the full prescribing information.