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Frequently asked
questions
about NUCALA
and Severe Asthma

Select a Topic

ABOUT NUCALA

What is NUCALA?

NUCALA is an add-on, prescription maintenance treatment for patients aged 12 years and older with severe asthma, eosinophilic type. NUCALA is not used to treat other eosinophilic conditions or sudden breathing problems.

NUCALA is a biologic. Unlike drugs that are made chemically, NUCALA is isolated from living cells. It was developed to target a type of white blood cell called eosinophils [ee-uh-sin-uh-fils] that can contribute to inflammation in the lungs.

What are the benefits of NUCALA?

Adding injections of NUCALA once every four weeks to current asthma medications can:

  • Prevent severe asthma attacks. Studies have proven that NUCALA significantly reduced the occurrence of severe asthma attacks by more than half.
  • Reduce ER visits and/or hospitalizations and the disruptions they cause.
  • Reduce the use of oral steroids. NUCALA is NOT a steroid, and when added to your asthma medication, it helps to reduce your use of steroids like prednisone.

    Your results may vary.

Studies also showed that NUCALA helped*:

  • Improve asthma control and reduce symptoms.
  • Improve daily life. In a study, people with severe asthma stated they had a better health-related quality of life after taking NUCALA.

    * Results are limited based on the design of clinical trials; your experience may be different from these studies.
What are eosinophils?

Eosinophils [ee-uh-sin-uh-fils] are white blood cells that are a normal part of your immune system. When there are too many of them in your blood, they can worsen inflammation in your lungs. That can put you at greater risk for severe asthma attacks, also known as exacerbations.

Why do I need to add NUCALA to all of my other asthma medications?

If your asthma is still uncontrolled even with your current high-dose daily medicines, you may not be treating one of the underlying causes of your kind of asthma: eosinophils. NUCALA is designed to target eosinophils. If your doctor determines that eosinophils are contributing to your severe asthma, adding NUCALA to your current medications significantly reduces asthma attacks and your use of oral corticosteroids.

Your results may vary.

How can a blood test show if NUCALA can help me?

Your doctor can give you a simple blood test — the Complete Blood Count, or CBC, with differential — that will show the level of eosinophils in your blood. In clinical studies, this eosinophil count helped identify patients whose asthma is more likely to respond to treatment with NUCALA.

How does NUCALA work?

NUCALA reduces the number of eosinophils in the blood. Eosinophils [ee-uh-sin-uh-fils] are a type of white blood cell that are a normal part of the body's immune system. Too many eosinophils may lead to inflammation in the lungs that can cause severe asthma attacks. The mechanism of action of NUCALA is not fully understood.

Reducing inflammation can lead to fewer severe asthma attacks, but you still may have some attacks. Many factors can contribute to severe asthma, which is why it's important to continue to take your current asthma medications as instructed by your healthcare provider. If you don't feel improvement right away, remember, your body may take time to reduce the inflammation.

What should I expect when I receive my injection of NUCALA?

NUCALA is an injection you receive at your asthma specialist's office once a month (every four weeks). Your healthcare provider will inject NUCALA just under your skin (subcutaneously) into your upper arm, thigh, or abdomen. 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.

Can I stop taking my other asthma medications while on NUCALA?

No. NUCALA was designed to work with your current asthma medications to reduce your asthma attacks. Don't make any changes in your medications without first consulting your asthma specialist.

What are the side effects of NUCALA?

NUCALA can cause serious side effects, including:

  • allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your injection of NUCALA. Allergic reactions can sometimes happen hours or days after you get a dose of NUCALA. 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
    • breathing problems
    • fainting, dizziness, feeling light-headed (low blood pressure)
    • rash
    • hives
  • Herpes zoster infections that can cause shingles have happened in people who receive 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).

What information should I share with my doctor before taking NUCALA?

Before receiving NUCALA, tell your healthcare provider about all of your medical conditions, including if you:

  • have not had chickenpox (varicella) or the chickenpox vaccine.
  • are taking oral or inhaled corticosteroid medicines. Do not stop taking your other asthma medicines, including your corticosteroid medicines, unless instructed by your healthcare provider because this may cause other symptoms to come back.
  • have a parasitic (helminth) infection.
  • are pregnant or plan to become pregnant. It is not known if NUCALA may harm your unborn baby.
    • A pregnancy registry for women who receive NUCALA while pregnant collects information about the health of you and your baby. You can talk to your healthcare provider about how to take part in this registry or you can get more information and register by calling 1-877-311-8972 or visit www.mothertobaby.org/asthma.
  • are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use NUCALA and breastfeed. You should not do both without talking with your healthcare provider first.
  • are taking prescription and over-the-counter medicines, vitamins, and herbal supplements.
Can I take NUCALA if I'm pregnant or breastfeeding?

Tell your healthcare provider about all of your health conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if NUCALA may harm your unborn baby.
    • A pregnancy registry for women who receive NUCALA while pregnant collects information about the health of you and your baby. You can talk to your healthcare provider about how to take part in this registry or you can get more information and register by calling 1-877-311-8972 or visit www.mothertobaby.org/asthma.
  • are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use NUCALA and breastfeed. You should not do both without talking with your healthcare provider first.

SEVERE ASTHMA

What is severe asthma?

Your asthma may be considered severe if you take daily high-dose asthma medications and have a history of severe asthma attacks (also called exacerbations) that required oral steroids like prednisone. Those attacks may have been so severe that you needed to go to an ER or be hospitalized. Repeated asthma attacks also put you at greater risk of having future asthma attacks. That's why it's important for you to understand your asthma and work with your specialist to develop an asthma management plan. Read more

INSURANCE COVERAGE AND CO-PAY ASSISTANCE

What is the Gateway to NUCALA?

Gateway to NUCALA is staffed with experts who can:

  • answer questions about your insurance plan's coverage of NUCALA
  • help you understand your out-of-pocket cost for NUCALA
  • explain GSK's programs that may help you afford NUCALA

Gateway to NUCALA
Monday–Friday, 8AM to 8PM ET
1-844-4-NUCALA (1-844-468-2252) toll-free

How much does NUCALA cost?

Costs vary.
Each insurance policy is different. Costs depend on your individual plan. 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 cost for NUCALA, contact your insurance company or Gateway to NUCALA. Gateway to NUCALA is a patient support service that can research your estimated cost for NUCALA under your insurance policy. To start the process, call:

Gateway to NUCALA
Monday–Friday, 8AM to 8PM ET
1-844-4-NUCALA (1-844-468-2252) toll-free

There are some common terms that are helpful to understand. Words like:

  • Deductible: a fixed amount you pay up front before the insurance company pays.
  • Co-payment (co-pay) and co-insurance are cost-sharing arrangements.
    • Co-payment: the specified flat amount you pay for a specific service.
    • Co-insurance: the percentage you pay for a specific service.
  • Out-of-pocket maximum: the maximum dollar amount that you will be required to pay annually.
  • Specialty pharmacy: one of several national pharmacies that handle the distribution of biologics and other specialized drugs.
  • Prior authorization: the process for health insurance companies to decide if they will cover a prescribed medication before it is delivered.
Will my health insurance or Medicare provide coverage for NUCALA?

While most insurance companies offer coverage for NUCALA, actual coverage can vary. To understand how your insurance covers NUCALA, you will need to contact your insurance company or Gateway to NUCALA for assistance. Gateway to NUCALA is a patient support service that can provide information as to whether your insurance plan covers NUCALA for you. To start the process, call:

Gateway to NUCALA
Monday–Friday, 8AM to 8PM ET
1-844-4-NUCALA (1-844-468-2252) toll-free

What is benefits investigation?

Upon proper authorization, our representatives contact your health insurance provider to confirm how NUCALA is covered under your current plan. Once this process is completed, you will be provided a summary of benefits based on the information our representative has received.

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

Depending on the process with your insurance plan, benefits investigation may take 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 the specialty pharmacy that is filling your prescription.

I just got a call from a pharmacy asking for more information. What should I do?

Your doctor can order NUCALA from a specialty pharmacy, so one of these specialty pharmacies 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 doctor's office, the pharmacy may ask for your credit card information to cover 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 you may be eligible to receive.

What is the Services Request form?

This form allows the release of your health insurance and financial information, in order to verify your insurance benefits and the potential savings programs for which you may qualify. You can also opt in to access informative e-mails, educational newsletters, and treatment support while taking NUCALA.

What is the $0 Co-pay Program?

The $0 Co-pay Program for NUCALA helps insured patients with their co-payment. For eligible patients, the program can help with co-payments of up to $9,000 per year. You will receive a letter within two weeks about your eligibility, so you can start using the program right away. The coverage does not include the cost of your doctor's visit or the administration of NUCALA.

To see if you are eligible, complete a Services Request form.

In addition to filling out the form completely, it is important that you fill out the $0 Co-pay Program section on the second page of the form.

Or you can call:
Gateway to NUCALA
Monday-Friday, 8AM to 8PM ET
1-844-4-NUCALA (1-844-468-2252) toll-free

What are the eligibility requirements for the Co-pay Program?

For eligible patients, the program can help with co-payments of up to $9,000 per year.

  • You are eligible if you have commercial insurance or are uninsured.
  • 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.

Please see Terms and Conditions for full program eligibility details.

How soon will I know if I qualify?

If you're eligible for the $0 Co-pay Program, you will receive a welcome letter within two weeks.

I received a $0 Co-pay Card, but I'm having difficulty using it. Whom can I call for help?

If you have any questions about using your card, please call Monday-Friday, 8AM to 8PM ET, at 1-844-4-NUCALA (1-844-468-2252) toll-free to speak with a customer representative from NUCALA.

Is there a Patient Assistance Program (PAP) for NUCALA and, if so, how do I qualify?

Yes. If you are uninsured and meet certain eligibility requirements, you may qualify for the Patient Assistance Program, which offers free medicines to eligible patients. Patients with Medicare Part D or other insurance can also qualify under certain circumstances.

To apply, complete the Services Request form, or call:
Gateway to NUCALA
Monday-Friday, 8AM to 8PM ET
1-844-4-NUCALA (1-844-468-2252) toll-free

What services are available to patients without insurance coverage?

For patients who are uninsured and meet certain eligibility requirements, we may be able to provide medication free of charge.

Call Gateway to NUCALA
Monday-Friday, 8AM to 8PM ET
1-844-4-NUCALA (1-844-468-2252) toll-free

ADDITIONAL ASSISTANCE

If I have additional questions on the topics above, whom can I call to help me?

Call Gateway to NUCALA
Monday–Friday, 8AM to 8PM ET
1-844-4-NUCALA (1-844-468-2252) toll-free

Important Safety Information

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

Important Safety Information

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

Do not use to treat sudden breathing problems.

NUCALA can cause serious side effects, including:

  • allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your injection of NUCALA. Allergic reactions can sometimes happen hours or days after you get a dose of NUCALA. 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
    • breathing problems
    • fainting, dizziness, feeling light-headed (low blood pressure)
    • rash
    • hives
  • Herpes zoster infections that can cause shingles have happened in people who received NUCALA.

Before receiving NUCALA, tell your healthcare provider about all of your medical conditions, including if you:

    • have not had chickenpox (varicella) or the chickenpox vaccine.
    • are taking oral or inhaled corticosteroid medicines. Do not stop taking your other asthma medicines, including your corticosteroid medicines, unless instructed by your healthcare provider because this may cause other symptoms to come back.
    • have a parasitic (helminth) infection.
    • are pregnant or plan to become pregnant. It is not known if NUCALA may harm your unborn baby.
      • A pregnancy registry for women who receive NUCALA while pregnant collects information about the health of you and your baby. You can talk to your healthcare provider about how to take part in this registry or you can get more information and register by calling 1-877-311-8972 or visit www.mothertobaby.org/asthma.
    • are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use NUCALA and breastfeed. You should not do both without talking with your healthcare provider first.
    • are taking prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • 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).

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.