Nucala (Mepolizumab)
Mepolizumab is a monoclonal antibody that works by reducing levels of eosinophils (a type of white blood cell). High eosinophil levels can contribute to certain disorders.
Mepolizumab is used to help prevent flare-ups or reduce symptoms of high eosinophil levels (hypereosinophilic syndrome, or HES) in adults and children at least 12 years old.
Mepolizumab is used in adults to help control symptoms and reduce flares of a rare autoimmune disorder called eosinophilic granulomatosis with polyangiitis (EGPA).
Mepolizumab is also used together with other medicines to help control severe asthma in adults and children who are at least 6 years old. Mepolizumab is not a rescue medicine for asthma attacks.
Mepolizumab is used in adults with other medicines to help control symptoms of chronic rhinosinusitis with nasal polyposis (long term sinus inflammation) that is not controlled by inhaled steroid medicine. Mepolizumab is also used to help prevent surgery for nasal polyposis.
The autoinjector is for use in people 12 years of age and older. The prefilled syringe is for use in children at least 6 years of age and older.
Mepolizumab may also be used for purposes not listed in this medication guide.
uses
What is Nucala (Mepolizumab) used for?
- Asthma -- Maintenance
- Hypereosinophilic Syndrome
- Sinusitis
- Wegener's Granulomatosis
- Nasal Polyps
- Rhinitis
warnings
What is the most important information I should know about Nucala (Mepolizumab)?
You should not use mepolizumab if you are allergic to it.
Tell your doctor if you have ever had:
- an oral or inhaled steroid medicine;
- herpes zoster (also called shingles); or
- infection caused by helminthic parasites.
You may be given a zoster (shingles) vaccine before you start using mepolizumab.
It is not known if mepolizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Nucala (Mepolizumab)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- symptoms of herpes zoster (shingles)--skin sores or blisters, itching, tingling, burning pain, rash on your face or torso.
Common side effects may include:
- headache;
- feeling tired;
- mouth or throat pain;
- back pain, joint pain; or
- pain, swelling, redness, burning, or itching where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Nucala (Mepolizumab) if I’m pregnant or breastfeeding?
It is not known if mepolizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Nucala (Mepolizumab)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Nucala (Mepolizumab)?
Use Nucala (Mepolizumab) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Your doctor will perform tests to make sure mepolizumab is the right treatment for you.
Mepolizumab is injected under the skin once every 4 weeks. A healthcare provider may give you this injection or may teach you how to properly use this medicine by yourself.
Mepolizumab is not a fast-acting rescue medicine for asthma attacks. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working.
- Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand how to use an injection.
- Inject mepolizumab under the skin into your thigh or abdomen. A caregiver can also give the injection in the upper arm.
- When using this medicine for EGPA or HES, make sure to inject each dose at least 5 cm (about 2 inches) away from the previous injection site.
- Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.
- Do not inject within 2 inches of your navel (belly button), or areas where the skin is hard, red, tender, or bruised. Do not inject into the same place two times in a row.
Remove the autoinjector or prefilled syringe out of the refrigerator and let it reach room temperature for 30 minutes before using it.
Do not warm the medicine with hot water, sunlight, or a microwave.
If you also use an oral or inhaled steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.
Call your doctor if your symptoms do not improve, or if they get worse.
Throw away a vial (bottle), prefilled syringe, or autoinjector after one use, even if there is still medicine left inside. Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
Store the vial (bottle) in its original container at room temperature. Protect from light and do not freeze.
Store the prefilled syringe or autoinjector in the original container in a refrigerator. Do not freeze or shake the medicine. After removing the medicine from its container, you must use the syringe or autoinjector within 8 hours.
You may store the unopened prefilled syringe or autoinjector at room temperature for up to 7 days. Throw away a syringe or autoinjector left out of the refrigerator for more than 7 days.
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.