You have questions.

Icon that says "we have answers"

Frequently Asked Questions about NUCALA

 

HAVE MORE QUESTIONS ABOUT NUCALA?

  • What is NUCALA?

    NUCALA is a prescription medicine used with other medicines for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). It is not known if NUCALA is safe and effective in children and adolescents with EGPA under 18 years of age.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • What is eosinophilic granulomatosis with polyangiitis?

    EGPA (eosinophilic granulomatosis with polyangiitis, formerly known as Churg-Strauss syndrome) is a rare chronic condition that causes 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).

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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].

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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)

    Your 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.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • Who should not use NUCALA?

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

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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 weakness (fatigue). These are not all 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.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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. The mechanism of action of NUCALA is not fully understood.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • How does my healthcare provider know my eosinophil level?

    Your healthcare provider will give you a simple blood test—the complete blood count, or CBC, with differential—that will show the level of eosinophils in your blood.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • What lab work do I need before starting NUCALA?

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

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • What should I expect when I receive my injections of NUCALA?

    NUCALA for EGPA is given as 3 separate 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 healthcare provider 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 you are 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 light-headed (low blood pressure); hives; breathing problems; or rash.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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 healthcare provider. Please consult with your HCP prior to making any changes to your medicines.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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 healthcare provider about all medicines you are taking.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • Will NUCALA reduce my oral steroid use?

    Some EGPA patients taking NUCALA had lower doses of oral steroid, on average, by the end of the study. Almost half of the patients had their oral steroids reduced to 4 mg or less per day. One in five patients who were taking NUCALA were able to completely stop oral steroid use. Your results may vary.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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. Your 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.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • How or where can I get NUCALA?

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

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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 healthcare provider. Talk to your healthcare provider about any concerns you may have with receiving NUCALA.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • What if I miss an injection?

    If you take NUCALA at your doctor’s office and miss an injection appointment for any reason, talk to your healthcare provider about getting back on track as soon as possible. If you take NUCALA at home and miss an injection, you or your caregiver should inject a dose (3 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.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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 healthcare provider 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 healthcare provider 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.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • Autoinjector or prefilled syringe: Who do I contact if I need help with my injection?

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

  • Autoinjector or prefilled syringe: What do I do if I miss a dose?

    You or your caregiver should inject a dose (3 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.

  • Autoinjector or prefilled syringe: How do I store my Autoinjector or 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 prefilled Autoinjector or prefilled syringe if the unopened carton is left out of the refrigerator for more than 7 days.

     

    Autoinjectors and prefilled syringes must be used within 8 hours after you take them out of the carton. Safely throw away the Autoinjector or prefilled syringe in an FDA-cleared sharps disposal container if not used within 8 hours.

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

  • Autoinjector or prefilled syringe: 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 prefilled Autoinjector if the unopened carton is left out of the refrigerator for more than 7 days. Autoinjectors 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.

  • Autoinjector or prefilled syringe: What should I do if a security seal on the carton is broken?

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

  • Autoinjector: What happens if the medicine looks cloudy, the expiration date has passed, or the Autoinjector looks damaged?

    Do not use the Autoinjector. Contact GSK for more information at 1-888-825-5249.

  • Autoinjector: Can I change (rotate) the injection site for the Autoinjector?

    You may change (rotate) the site (thigh, abdomen, or upper arm) or move the Autoinjector as long as you have not started pressing down. When the yellow needle guard is pressed, your injection will start right away.

  • Autoinjector: Why do I need to inject within 5 minutes of removing the clear needle cap?

    This prevents the medicine from drying in the needle. It could affect how much medicine you get.

  • Autoinjector: What happens if I remove the Autoinjector before the 2nd click, the stopper has stopped moving, or the inspection window is not filled with the yellow indicator?

    If this happens, you may not have received your full dose. Contact GSK for more information at 1-888-825-5249.

  • Autoinjector: Can I reuse my Autoinjector?

    Do not use any Autoinjector more than once. Throw away the Autoinjector in an FDA-cleared sharps disposal container after your injection.

  • Autoinjector: Can I share my Autoinjector?

    Do not share the Autoinjector with other people. You may give other people a serious infection, or you may get a serious infection from them.

  • Autoinjector: What should I do if my Autoinjector was dropped or looks damaged?

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

  • Autoinjector: The expiration date on my Autoinjector has passed. What should I do?

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

  • Prefilled syringe: What happens if the medicine looks cloudy, the expiration date has passed, or the prefilled syringe looks damaged?

    Do not use the prefilled syringe. Contact GSK for more information at 1-888-825-5249.

  • Prefilled syringe: Can I change (rotate) the injection site for the prefilled syringe?

    You may change (rotate) the site (thigh, abdomen, or upper arm) as long as you have not started injecting the medicine.

  • Prefilled syringe: Why do I need to inject within 5 minutes of removing the gray needle cap?

    This prevents the medicine from drying in the needle. It could affect how much medicine you get.

  • Prefilled syringe: What happens if the needle does not retract (pull up) into the needle guard?

    Right away and carefully put the syringe and needle cap in the FDA-cleared sharps disposal container and contact GSK for more information at 1-888-825-5249.

  • Prefilled syringe: Can I reuse my prefilled syringe?

    Do not use any prefilled syringe more than once. Throw away the prefilled syringe in an FDA-cleared sharps disposal container after your injection.

  • Prefilled syringe: Can I share my prefilled syringe?

    Do not share the prefilled syringe with other people. You may give other people a serious infection, or you may get a serious infection from them.

  • Prefilled syringe: What should I do if my prefilled syringe was dropped or looks damaged?

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

  • Prefilled syringe: The expiration date on my prefilled syringe has passed. What should I do?

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

INTERESTED IN THE CLINICAL STUDY RESULTS?

  • Was the clinical trial completed only by GlaxoSmithKline?

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

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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 healthcare provider if appropriate.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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.

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • Could the researchers adjust the patients' oral steroid dose during the clinical trial with NUCALA?

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

     

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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.

     

    Individual 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 healthcare provider informed of any changes you're feeling.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

NEED MORE DETAILS ON INSURANCE AND GATEWAY TO NUCALA?

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

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • How do I contact Gateway to NUCALA?

    You can reach a Gateway to NUCALA representative directly by calling 1-844-4-NUCALA (844-468-2252) toll-free, Monday-Friday, 8AM to 8PM ET.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • What is the $0 Co-pay Program?

    Even with insurance coverage, it may be difficult to cover your co-payments. That's why the $0 Co-pay Program for NUCALA helps eligible commercially insured patients with their co-payments. The $0 Co-pay Program helps eligible approved patients with their out-of-pocket costs for NUCALA up to $15,000 for 12 months. If approved, you could pay as little as $0 for NUCALA.

     

    To enroll, call Gateway to NUCALA, go to www.NUCALACopayProgram.com, or download and complete a Services Request form and bring it to your doctor's office.

     

    Once you apply, you will receive a letter within 2 weeks about your eligibility. If you are eligible, you can start using the program right away.

     

    Medicare-eligible patients and patients enrolled in government-funded programs are not eligible for the NUCALA Co-pay Program. You must submit an Enrollment Form or complete an eligibility check online at www.NUCALACopayProgram.com to determine your eligibility.

     

    See the Terms and Conditions for full program eligibility details. This is not insurance.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • How do I enroll in the $0 Co-pay Program?

    You can enroll in the $0 Co-pay Program in one of the following 4 ways:

     

    1. Download the Services Request form (English version or use the Spanish version) and bring it to your healthcare provider's office.
    2. Complete the Services Request form (English version or use the Spanish version) available at your healthcare provider's office.
    3. Call Gateway to NUCALA at 1-844-4- NUCALA  (1-844-468-2252).
    4. Enroll online at www.NUCALACopayProgram.com.

    You may be eligible if you have commercial insurance.

    You are not eligible if you have a state or federal government-funded medical or prescription drug plan, such as Medicare, Medicaid, or TRICARE, or have insurance with a non-participating commercial payer. Medicare-eligible patients, including all patients who are age 65 or older, are not eligible to participate in the Co-pay Program for NUCALA Please see Terms and Conditions for full program eligibility details.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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. Services Request form (English version or use the Spanish version) must be completed by your healthcare provider and you.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • What is 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.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • 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 four to six (4-6) 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.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
  • I received a call from a pharmacy asking for more information. What should I do?

    If your healthcare provider 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 healthcare provider if NUCALA is right for you.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

 

 

Ask your healthcare provider if NUCALA is right for you.