Frequently asked questions

Find answers to common questions about NUCALA

Need more information? Along with the help of your doctor, our nurses are here to talk to you about NUCALA. 844-4-NUCALA (844-468-2252).

  • What is NUCALA?

    NUCALA is a prescription medicine for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). 

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  • What is eosinophilic granulomatosis with polyangiitis?

    EGPA (eosinophilic granulomatosis with polyangiitis, formerly known as Churg-Strauss syndrome) is a rare chronic condition that leads to inflammation of the blood vessels (known as vasculitis). The main characteristics of EGPA are development of asthma as an adult, allergic rhinitis (hay fever), growths in the nose, and an increase in eosinophils (a type of white blood cell, pronounced as ee-uh-sin-uh-fils).

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  • How do I pronounce “eosinophilic granulomatosis with polyangiitis”?

    Eosinophilic [ee-uh-sin-uh-fil-ik] granulomatosis [gran-yuh-loh-muh-toh-sis] with polyangiitis [pol-e-an-je-i-tis].

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  • Is NUCALA a steroid?

    NUCALA is not a steroid; it's a biologic. Unlike drugs that are made chemically, a biologic is isolated from living cells.

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  • What are the benefits of NUCALA for EGPA?

    In a 1-year clinical study, patients receiving NUCALA had:

    • Longer time in complete remission*
    • Fewer relapses†
    • Lower dose of oral steroids (like prednisone)

     

    Results may vary.

     

    * “Complete remission” was defined as no active vasculitis and a prednisone or prednisolone dose less than or equal to 4 mg per day.

    † “Relapse” was defined as worsening symptoms that required increased steroid dose, and/or increase in dose or start of immunosuppressants, and/or hospitalization.

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  • Who should not use NUCALA?

    You should not use NUCALA if you are allergic to mepolizumab or any of the ingredients in NUCALA.

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  • What are the most common side effects of 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). These are not all of the possible side effects of NUCALA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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  • How does NUCALA work?

    NUCALA reduces the number of eosinophils in the blood. Eosinophils are a type of white blood cell that is a normal part of the body's immune system. Too many eosinophils may lead to inflammation. It is not fully understood how NUCALA works.

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  • What are eosinophils?

    Eosinophils are white blood cells that are a normal part of your immune system. When there are too many of them in your blood or tissues, they can worsen inflammation in your body.

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  • How does my doctor know my eosinophil level?

    Your doctor will test your blood—typically through a complete blood count, or CBC, with differential—that will show the level of eosinophils in your blood.

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  • What lab work do I need before starting NUCALA?

    Your doctor will determine if lab work is needed before or during your treatment with NUCALA.

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  • What should I expect when I receive my injections of NUCALA?

    NUCALA for EGPA is given as 3 separate 100-mg injections administered at the same time in an office visit or at home every 4 weeks. You, your caregiver, or your healthcare provider will inject NUCALA just under your skin (subcutaneously) into your thigh or abdomen. Your caregiver or your healthcare provider may also inject in your upper arm. It is recommended that the individual 100-mg injections be administered at least 5 cm (approximately 2 inches) apart if more than 1 injection is administered at the same site. If you receive your injection at your doctor’s office, you may be asked to stay in the office so your doctor can monitor you for any allergic reactions, including anaphylaxis. Then you'll be able to leave, though sometimes serious allergic reactions can occur hours or days after you get your dose.

     

    If administering at home, your doctor will provide information on how to monitor for allergic reactions, including anaphylaxis, that can occur after a NUCALA injection, sometimes hours or days after you get your dose.

     

    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; fainting, dizziness, feeling lightheaded (low blood pressure); hives; breathing problems; or rash.

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  • Can I stop taking my other EGPA medicines while on NUCALA?

    Do not stop taking your other medicines unless instructed to do so by your doctor. Please consult with your doctor prior to making any changes to your medicines.

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  • I’m already taking other medicines. Can I also be on NUCALA?

    NUCALA is a prescription medicine that may be used with other medicines for the treatment of EGPA. You should talk to your doctor about all the medicines you are taking.

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  • Will NUCALA reduce my oral steroid use?

    On average, patients with EGPA taking NUCALA had lower doses of oral steroids by the end of the study. Almost half of patients taking NUCALA had their oral steroids reduced to 4 mg or less per day, compared to less than 10% of patients not taking NUCALA. Nearly 1 in 5 patients who were taking NUCALA were able to completely stop oral steroid use compared to 3% of patients not taking NUCALA.

    Results may vary.

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  • If I achieve remission with NUCALA, how long will it last?

    Some patients who were able to achieve remission* in the first 6 months were able to stay in remission during the remainder of the 1-year clinical study.

    Results may vary.

     

    * “Complete remission” was defined as no active vasculitis and a prednisone or prednisolone dose less than or equal to 4 mg per day.

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  • How or where can I get NUCALA?

    Ask your doctor if NUCALA is right for you. NUCALA is available by prescription only. It can be administered at home or by a doctor at your doctor's office or at a treatment center. Your doctor can help you figure out where you can get NUCALA.

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  • When can I expect to feel better?

    Everyone is different. NUCALA works over time. Once you start NUCALA, do not stop taking or decrease the dose of any of your other EGPA medicines unless you're instructed to do so by your doctor. Talk to your doctor about any concerns you may have with receiving NUCALA.

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  • What if I miss a dose (300 mg, administered as 3 separate 100-mg injections)?

    If you take NUCALA at your doctor’s office and miss an injection appointment for any reason, talk to your doctor about getting back on track as soon as possible. If you take NUCALA at home and miss a dose, you or your caregiver should inject a dose (300 mg, administered as 3 separate 100-mg injections) of NUCALA as soon as you remember. Then, continue (resume) your injection on your regular dosing schedule. If you do not notice that you have missed a dose until it is time for your next scheduled dose, then just inject the next scheduled dose as planned. If you are not sure what to do, ask your doctor, pharmacist, or nurse.

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  • I was prescribed NUCALA before, and my dose is increasing. What should I expect?

    NUCALA for EGPA is given as 3 separate, 100-mg injections at the same time every 4 weeks. 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; fainting, dizziness, feeling lightheaded (low blood pressure); hives; breathing problems; or rash. Talk to your doctors about any questions you may have.

     

    • If you receive your injections in your doctor’s office, you may be asked to stay in the office so your doctor can monitor you for any allergic reactions, including anaphylaxis. Then you'll be able to leave, though sometimes serious allergic reactions can occur hours or days after.
    • If you take NUCALA at home, your doctor will provide information on how to monitor for allergic reactions, including anaphylaxis, that can occur after a NUCALA injection, sometimes hours or days after you get your dose.

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At-home administration

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  • Whom do I contact if I need help with my injection?

    Your doctor will be able to help you with any more questions you might have.

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  • What do I do if I miss a dose?

    You or your caregiver should inject a dose (300 mg, administered as 3 separate 100-mg injections) of NUCALA as soon as you remember. Then, continue (resume) your injection on your regular dosing schedule. If you do not notice that you have missed a dose until it is time for your next scheduled dose, then just inject the next scheduled dose as planned. If you are not sure what to do, ask your doctor, pharmacist, or nurse.

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  • How do I store my Autoinjector/prefilled syringe?

    Store in the refrigerator between 36°F to 46°F (2°C to 8°C). Keep in the original carton until time of use to protect from light. Do not freeze. Do not shake. Keep away from heat. If necessary, an unopened carton can be stored outside the refrigerator at up to 86°F (30°C) for up to 7 days. Safely throw away the Autoinjectors/prefilled syringes if the unopened carton is left out of the refrigerator for more than 7 days.

     

    Autoinjectors/prefilled syringes must be used within 8 hours after you take them out of the carton. Safely throw away if not used within 8 hours.

    Keep NUCALA and all medicines out of the reach of children.

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  • What if I’m going on a trip or vacation and need to take my NUCALA with me?

    Store in the refrigerator between 36°F to 46°F (2°C to 8°C). Keep in the original carton until time of use to protect from light. Do not freeze. Do not shake. Keep away from heat. If necessary, an unopened carton can be stored outside the refrigerator at up to 86°F (30°C) for up to 7 days. Safely throw away the Autoinjectors/prefilled syringes if the unopened carton is left out of the refrigerator for more than 7 days.

     

    Autoinjectors/prefilled syringes must be used within 8 hours after you take them out of the carton. Safely throw away if not used within 8 hours.

    Keep NUCALA and all medicines out of the reach of children.

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  • What should I do if a security seal on the carton is broken?

    Do not use the Autoinjector/prefilled syringe. Contact GSK at 1-888-825-5249.

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Autoinjector

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Prefilled syringe

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Clinical study results

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  • Was the clinical trial completed only by GlaxoSmithKline?

    No. The study was completed with the National Institutes of Health (NIH) across several academic centers.

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  • What were the details of the clinical trial?

    A total of 136 patients with EGPA were evaluated in a randomized, placebo-controlled, multicenter, 1-year trial. Patients received 300 mg of NUCALA (as three 100-mg injections) or placebo injected subcutaneously (under the skin) once every 4 weeks. Starting at Week 4, patients' oral corticosteroids could be reduced by their doctor if appropriate.

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  • Who were the patients enrolled in the clinical trial?

    All patients enrolled were aged 18 years or older; 59% were female, and 92% were white. All had received a diagnosis of EGPA (relapsing or refractory) at least 6 months before. They had been taking daily oral steroids (a stable dose of at least 7.5 mg of prednisone or prednisolone) for at least 4 weeks before their first study visit. They may or may not have been taking immunosuppressants when enrolled in the study.

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  • What is the BVAS?

    Known as the Birmingham Vasculitis Activity Score (BVAS), this scoring tool rates disease activity in patients with vasculitis and is primarily used in clinical studies. The BVAS scores are grouped by 9 organ systems, and assessments are made based off the responses from these systems.

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  • Could the researchers adjust the patients’ oral steroid dose during the clinical trial with NUCALA?

    Yes. Starting at Week 4, doctors could reduce the patients' oral corticosteroids as appropriate.

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  • How long did it take for patients in the clinical trial to see results?

    The clinical trial was not designed to measure when NUCALA started to work. It was designed to determine the effect of NUCALA on disease activity and oral steroid dose at a certain point in time. NUCALA plus other medicines may help reduce EGPA disease activity more than other medicines alone.

     

    More patients receiving NUCALA who were able to achieve remission in the first 6 months were able to stay in remission during the remainder of the 1-year clinical study. In the clinical trial for NUCALA, "remission" was defined as no active vasculitis and a prednisone or prednisolone dose less than or equal to 4 mg per day.

     

    Some patients were able to have their oral steroid dose reduced as early as 4 weeks after beginning treatment with NUCALA.

     

    Results may vary.

     

    It's a good idea to keep a daily journal about how you're feeling during treatment with NUCALA. Use your notes to keep your doctor informed of any changes you're feeling.

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Insurance & Gateway to NUCALA

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  • What is Gateway to NUCALA?

    Gateway to NUCALA representatives can assist you in these ways:

    • answer questions about insurance coverage for NUCALA
    • help share information about out-of-pocket costs for NUCALA
    • explain GSK’s programs that may help you afford NUCALA

     

    Information from Gateway is not a guarantee of coverage; be sure to verify the information provided with your health plan.

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  • How do I contact Gateway to NUCALA?

    You can reach a Gateway to NUCALA representative directly by calling 844-4-NUCALA (844-468-2252) toll-free, Monday-Friday, 8AM to 8PM ET.

     

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  • How much does NUCALA cost?

    Costs vary. If you have insurance, each insurance policy is different. Your insurance generally pays part of the costs and you pay the remaining part out of pocket — this is typically referred to as your co-payment or co-insurance.

     

    To understand your out-of-pocket costs for NUCALA, contact your insurance company or Gateway to NUCALA.

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  • What is the NUCALA Copay Program?

    Even with insurance coverage, it may be difficult to cover your co-payments. The NUCALA Copay Program helps eligible commercially insured patients with their eligible out-of-pocket costs for NUCALA up to $9,450 annually. Visit www.GSKCopayPrograms.com for complete Program Eligibility Terms and Conditions.

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  • How do I enroll in the NUCALA Copay Program?

    There are 2 ways to apply* for the NUCALA Copay Program:

     

     

    If you are approved for the NUCALA Copay Program, you’ll receive an approval email with specific instructions on how to save on the out-of-pocket cost for your NUCALA, tailored just for you.

     

    *Eligibility restrictions and program maximums apply. Visit www.GSKCopayPrograms.com for complete Program Terms and Conditions.

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  • What is the Services Request form?

    This form gives the Gateway to NUCALA representatives permission to have your health insurance and financial information in order to investigate your insurance benefits and the potential savings programs for which you may qualify. The Services Request form (English version or use the Spanish version) must be completed by your doctor and you.

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  • What is a benefits investigation?

    If you authorize it, a Gateway to NUCALA representative will contact your health insurance provider to confirm how NUCALA is covered under your current plan. Once the representative has completed their investigation, you will receive a summary of insurance benefits based on the information our representative has received.

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  • How long does it take to complete the benefits investigation process?

    Depending on the process with your insurance plan, a benefits investigation may take approximately 4 to 6 days. Once your benefits have been determined, you will receive a benefits summary letter by mail. You may also receive a phone call from a representative from Gateway to NUCALA and/or the specialty pharmacy that is filling your prescription. It's important to answer or return these calls so there's no delay in starting your treatment.

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  • I received a call from a pharmacy asking for more information. What should I do?

    If your doctor orders NUCALA from a specialty pharmacy, the pharmacy may call you to review your insurance coverage and explain your out-of-pocket costs. It's important to answer or return these calls so there's no delay in starting your treatment. To protect your privacy, the pharmacy may not mention NUCALA when leaving a message.

     

    Since the specialty pharmacy ships NUCALA to you or your doctor, they may ask for your credit card information to pay those costs not covered by your insurance plan. If you have concerns about paying your out-of-pocket costs, contact Gateway to NUCALA for information about support programs for which you may be eligible. Ask your doctor if NUCALA is right for you.

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