What is Nucala® (Mepolizumab)?

Nucala® is a biologic medication. Its generic name is mepolizumab. It belongs to a drug class known as monoclonal antibodies.

Nucala is approved by the U.S. Food and Drug Administration (FDA) to treat the following conditions:

• severe eosinophilic asthma
• chronic rhinosinusitis with nasal polyps (CRSwNP)
• eosinophilic granulomatosis with polyangiitis (EGPA)
• hypereosinophilic syndrome (a rare blood disorder that can affect the heart and lungs)

Nucala is given as an injection into the skin. Patients have the option of taking Xolair in a doctor’s office or clinic or self-administering it at home using an injectable pen.

Nucala is designed to stop inflammation in the airways before it can start. The medication prevents and reduces symptoms in the lungs and airways.

What is Nucala used for?

Nucala is indicated for people who have severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome.

Nucala indications

Nucala is indicated to treat the following allergic conditions:

• Adults and children ages 6 years and older who have severe asthma with an eosinophilic phenotype.
• Adults 18 years of age and older with severe CRSwNP that is not adequately controlled.
• Adults 18 years of age and older who have EGPA.
• Adults and children ages 12 years and older who have hypereosinophilic syndrome for ≥6 months without a known secondary cause.

Nucala is not an emergency medication for sudden breathing problems. It is a maintenance or long-term control medication. Nucala is not intended for rapid relief of acute asthma attacks or sudden breathing difficulties.

How does Nucala work?

Nucala works by targeting and blocking a protein called interleukin-5 (IL-5). IL-5 binds to cell surface receptors involved in the production and activation of eosinophils (a type of white blood cell). Nucala prevents IL-5 from binding and interacting with the receptors. This reduces the number of eosinophils that can cause inflammation in the lungs and airways.

Nucala is an add-on maintenance treatment, meaning that it can be taken along with other prescribed medications. For example, Nucala can be taken along with daily inhaled corticosteroids or long-acting beta2-agonists (LABA) that help control asthma. This drug combination can also help improve respiratory function.

If you’re prescribed Nucala, work together with your doctor on a treatment plan. Follow it closely, as the specific combination of medications you’re prescribed may vary based on the severity of your condition. Regular appointments and communication with your doctor can ensure your treatment plan is effective.

Nucala dosing

The Nucala dosage may vary depending on your condition.

• Severe asthma in adults and children ages 12 and older: Nucala is given once every 4 weeks. The dosage is 100 mg.
• Severe asthma in children ages 6 to 11 years of age: Nucala is given once every 4 weeks. The dosage is 40 mg.
• CRSwNP in adults: Nucala is given once every 4 weeks. The dosage is 100 mg.
• EGPA in adults: Nucala is given once every 4 weeks. The dosage is 300 mg, admininstered as three 100 mg injections.
• Hypereosinophilic syndrome in adults and children ages 12 and older: Nucala is given once every 4 weeks. The dosage is 300 mg, administered as three 100 mg injections.

Nucala injection

Nucala is typically administered as a subcutaneous injection under the skin in the upper arm, thigh or stomach. The medication is delivered in the tissue layer between the skin and the muscle.

Avoid injecting the biologic into the same site each time. This can cause sensitivity, pain and scarring.

You can choose to receive the medication at your doctor’s office or self-administer at home with a Nucala auto-injector. Your doctor can provide training on how to administer the auto-injector.

Nucala self-administration

The Nucala auto-injector is a pre-filled syringe that you can self-administer at home. Many people taking Nucala at home feel the pen offers greater convenience and a sense of empowerment. They can take the injection when they want, on their own schedule.

People taking Nucala at home should follow the prescribed dosing regimen. If you choose to self-administer with the Nucala pen, it’s important to follow the specific instructions for taking the medication.

Ask your doctor for training on how to correctly administer the auto-injector. Make sure you know the injection site and proper technique. Talk with your doctor regularly to ensure you are injecting it safely and effectively.

Nucala ingredients

Active ingredient: Mepolizumab.

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

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

Nucala side effects

Nucala can cause adverse effects ranging from mild to severe. The most common side effects of Nucala are:

• Headache
• Back pain
• Fatigue
• Injection site reactions

More serious adverse reactions may include:

• Swelling of your face, mouth, and tongue
• Breathing problems
• Fainting, dizziness, feeling lightheaded (low blood pressure)
• Skin rash or hives
• Stomach pain or discomfort
• Joint pain
• Vomiting

Nucala may lower your immune system’s ability to fight off herpes zoster infections, also called shingles. Your doctor may recommend getting a shingles vaccine before starting Nucala. This will decrease your chances of getting shingles.

Some people may experience an allergic reaction soon after the Nucala injection. Tell your healthcare provider or get emergency help right away if the allergic reaction is severe. This is anaphylaxis, a potentially life-threatening condition. Symptoms of anaphylaxis may include:

• hives on the skin
• swelling of your face, mouth and/or tongue
• breathing problems
• nausea, abdominal cramps or vomiting
• low blood pressure
• fainting, dizziness, feeling lightheaded

If you take Nucala at home, you will need a prescription for epinephrine. Epinephrine is the first-line treatment for anaphylaxis. Take it at the first sign of symptoms.

Before using Nucala, tell your healthcare provider about all of your medical conditions. Provide a list of any other medications you’re taking that could cause drug interactions. Do not stop taking other medications unless instructed to do so by your healthcare provider.

How much does Nucala cost?

Biologics are expensive medications due to their complex production process. Nucala’s list price is $3,688.83 per 100 mg for people without health insurance. Most people will not pay the list price. The actual cost will vary based on your insurance coverage.

Check your health insurance plan to see if you’re covered for Nucala. The Nucala Copay Program helps most eligible, commercially insured patients pay as little as $0 in out-of-pocket costs. You must fill out an enrollment form to qualify. Eligibility is reassessed each year. The maximum amount available under the copay program for most people is $9,450 per year. The maximum amount for people who are in a high-deductible health insurance plan is $15,000 per year.

If you’re approved for the Copay Program, you will receive an email from Nucala with instructions on how to save on out-of-pocket costs, tailored for you and your needs.

Nucala also offers a unique Gateway to Nucala program to help people to better understand insurance company policies for covering Nucala. The program helps you get an estimate on what your out-of-pocket cost may be. It is not a guarantee of coverage.

You can also enroll in the MyNucala Patient Support Program for guidance, tools and resources on affording Nucala. GSK, who manufactures Nucala, offers copay assistance programs as well.

Nucala is covered under Medicare Part B if it is administered in a doctor’s office or clinic. It is also covered under some Part D plans. People who are on Medicare Part B pay 20% of the cost while Medicare covers the rest. You should anticipate paying a deductible, or co-insurance cost.

People who are on Medicare Part D can apply for Medicare Extra Help (also known as Low-Income Subsidy or “LIS”), a patient support program that helps people pay for drug costs. People eligible for Extra Help typically pay between $0 and $9 for their prescriptions.

Nucala is also covered under some Medicaid programs, but the costs may vary depending on the state.

Charitable organizations such as The Assistance Fund, Inc., Patient Advocate Foundation and The HealthWell Foundation are dedicated to offering financial support to patients with specific medical conditions, irrespective of their chosen treatment. People with commercial or public insurance, including those under Medicare and Medicaid, can reach out directly to these foundations for financial assistance.