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Frequently Asked Questions about NUCALA

 

HAVE MORE QUESTIONS ABOUT NUCALA?

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

     

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  • 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).

     

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  • 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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  • 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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  • 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.

     

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

     

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  • 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.

     

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  • 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.

     

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  • 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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  • 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.

     

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

     

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  • You will receive NUCALA for EGPA as 3 separate injections at the same office visit every 4 weeks. Your healthcare provider will inject NUCALA just under your skin (subcutaneously) into your upper arm, thigh, or abdomen. 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. Once you receive your injection, 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.

     

    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.

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  • 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.

     

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  • 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.

     

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  • 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.

     

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  • 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.

     

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  • Ask your healthcare provider if NUCALA is right for you. NUCALA is available by prescription only. It must be administered 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.

     

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  • 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.

     

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  • If you miss an injection appointment for any reason, talk to your healthcare provider about getting back on track as soon as possible.

     

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  • NUCALA for EGPA is given in 3 separate, 100-mg injections during the same office visit every 4 weeks. After your injections, your HCP will monitor you for allergic reactions, including anaphylaxis, as appropriate. Then you'll be able to leave. Serious allergic reactions can sometimes happen hours or days after you get a dose of NUCALA. Talk to your healthcare provider about any questions you may have.

     

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* "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.

INTERESTED IN THE CLINICAL STUDY RESULTS?

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

     

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  • 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.

     

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

     

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  • 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.

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NEED MORE DETAILS ON INSURANCE AND GATEWAY TO NUCALA?

  • Gateway to NUCALA representatives can assist you in these ways:

    • answer questions about your insurance plan's coverage of NUCALA
    • help you understand your out-of-pocket cost for NUCALA
    • explain GSK programs that may assist with your out-of-pocket costs for NUCALA, if you are eligible
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  • 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.

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  • 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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  • 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, so 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.

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

     

    1. Download the Services Request form and bring it to your healthcare provider's office.
    2. Complete the Services Request form available at your healthcare provider's office.
    3. Call the 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.

     

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  • 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. This form must be completed by your healthcare provider and you.

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  • 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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  • 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.

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  • 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 the healthcare provider's office, 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.

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Ask your healthcare provider if NUCALA is right for you.