Nucala (mepolizumab) is a prescription medication used to treat several conditions caused by having too many eosinophils in the body, including severe asthma.
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Nucala is a member of a family of medications called monoclonal antibodies (mAbs). Monoclonal antibodies are lab-created proteins that modify your immune response to help treat inflammatory conditions, such as asthma or chronic rhinosinusitis.
What Is Nucala Used To Treat?
The FDA has approved Nucala injection for:
- Maintenance treatment of severe asthma. Nucala can be used as an add-on to other asthma maintenance treatments in adults and children aged 6 years and older with severe asthma who are still having symptoms. Nucala isn’t used as a rescue medication to treat an asthma attack.
- Maintenance treatment of chronic rhinosinusitis with nasal polyps. Nucala can be used as an add-on to other chronic rhinosinusitis maintenance treatments in adults who aren’t responding to intranasal corticosteroids. Nucala helps relieve nasal congestion, nasal discharge, throat mucus, and smell loss. In addition, it helps reduce your nasal polyps’ size, oral corticosteroid use, and the need for surgery to remove polyps.
- Treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in adults. People with EGPA have a history of asthma, high levels of immune cells called eosinophils, and blood vessel swelling.
- Hypereosinophilic syndrome (HES) in adults and children aged 12 years and older.
How Does Nucala Work?
The mechanism of action in asthma has yet to be fully understood. Nonetheless, Nucala blocks the production of proteins in the immune system (called interleukins). This lowers the production and survival of eosinophils (a type of white blood cell), which results in decreased inflammation.
What Is The Dose of Nucala?
- For severe asthma in adults and chronic rhinosinusitis with nasal polyps: 100 mg subcutaneously (SC) every 4 weeks.
- For severe asthma in children 6 to 11 years: 40 mg SC every 4 weeks.
- For eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES): 300 mg SC every 4 weeks (three separate 100-mg injections given one right after the other, into the upper arm, thigh, or stomach area).
How Is Nucala Supplied and Used?
The following preparations and strengths are available:
- Single-dose prefilled syringe. Each 0.4-ml syringe contains 40 mg of mepolizumab.
- Single-dose prefilled autoinjector. Each 1-ml autoinjector contains 100 mg of mepolizumab.
- Powder in a single-dose vial. Before administration, your provider will mix the powder with sterile water. Each vial contains 100 mg of mepolizumab.
Nucala is given as a subcutaneous injection, which is an injection under the skin into the fat tissue between your skin and muscle. Never inject it into your muscle or vein. If you’re giving yourself multiple injections for EGPA or HES, make sure to give the injections at least 2 inches apart.
Your provider will inject the first few injections. You may self-inject Nucala after receiving proper training on how to correctly administer the SC injection from your provider or other healthcare professional.
Proper use, storage, and disposal
- This medication is injected under the skin of your thigh, abdomen, or the outer region of your upper arm.
- Rotate the injection sites each time you administer your dose.
- If your dose is higher than 100 mg, you’ll need to give yourself multiple injections. Make sure to leave at least 2 inches between each injection site.
- Avoid injecting into bruised, red, or painful sites and areas with scars or stretch marks.
- Store in a refrigerator (36°F to 46°F) in the original carton to protect it from light. When you’re ready to give yourself the medication, take it out of the carton in the refrigerator and lay it on a flat surface to warm up. This will take about 30 minutes. Don’t try to warm up the medication any other way. You may store an unopened carton outside the refrigerator at up to 86°F for a maximum of 7 days.
- Use the Nucala prefilled autoinjector within 8 hours after you take it out of the carton. If unused within 8 hours, throw it away safely.
- Always check the medication solution to make sure it’s clear or a pale yellow to pale brown color before using it. If it’s cloudy, discolored, or has particles (solid parts), don’t use it. Contact your provider or pharmacist about giving you a replacement.
- Don’t remove the needle cap until you’re ready to inject the medication because you’ll need to inject the medication within 5 minutes after removing the needle cap.
- Don’t save any leftover medication after you use it because the medication doesn’t contain any preservatives or anything to prevent it from being contaminated.
- Place the used syringe in an FDA-cleared sharps disposal container immediately after use. Avoid reusing them or throwing them in a regular trash can.
- Click here to learn more about sharps disposal in your state.
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What Should You Know Before Taking Nucala?
Before receiving your first dose, inform your provider if you have:
- A parasitic infection caused by worms.
- Not been vaccinated for shingles infection.
- A history of severe allergic reaction to this medication, other substances in the formulation, or other similar drugs.
Nucala Side Effects
Common side effects
Common side effects- Headache
- Injection site reaction
- Back pain
- Joint pain
- Pain in your mouth, tongue, tonsils, or throat
- Fatigue
They are typically temporary and go away on their own within a few days. However, talk to your provider or pharmacist if any side effect worsens or persists.
Mild side effects
- Fatigue
- Back pain
- Flu
- Upper abdominal pain
- Urinary tract infection (UTI)
- Itchiness
- Muscle spasms
- Eczema
- Headache
- Injection site reaction
- Mild allergic reaction
- Pain in your mouth, tongue, tonsils, or throat
- Fever
- Dry nose
- Skin rash
- Diarrhea
Serious side effects
Call your doctor immediately or seek emergency care if you have:
- Wheezing or difficulty breathing
- Shortness of breath
- Cough
- Chest tightness
- Flushing
- Hives
- Rash
- Swollen face, mouth, and tongue
- Difficulty swallowing
- Fainting or dizziness
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Use in Pregnancy and Lactation
There is insufficient human data on drug-associated risk. Monoclonal antibodies can cross the placental barrier. Thus, there may be a risk to the fetus; however, the extent of the risk is unknown.
One study in monkeys found no evidence of fetal harm in doses up to 9 times the maximum recommended human dose.
Your provider may prescribe Nucala only if the benefits outweigh the risks. If you’re pregnant and taking Nucala, it’s recommended that you contact MotherToBaby, a pregnancy registry that monitors you and your baby’s health, by calling 1-877-311-8972 or by visiting their website.
Nucala is a large protein likely to be present in breast milk in very small amounts. Thus, there appears to be an insignificant risk to the breastfed infant. However, animal studies have detected the medication in breast milk. Since the risk can’t be completely ruled out, make sure to tell your provider if you’re breastfeeding before starting Nucala.
How Much Does Nucala Cost?
Cost can vary depending on your insurance plan, location, and pharmacy. Contact your insurance provider to find out if your plan covers this medication or if you need prior authorization.
Contact us to get information about coverage, cost, and financial assistance.
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Dr. Robert Chad Hakim, PharmD, was born and raised in Northridge, CA. He received his pharmacy degree from the University of Wisconsin-Madison School of Pharmacy. The most rewarding part of his job is taking initiative to advance clinical programs that maximize impact on patient care. He has a board certification in critical care (BCCCP), and his areas of expertise are critical care, drug information, general medicine, and cardiology. In his free time, he enjoys traveling.