EGPA

Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare autoimmune disorder that often results in inflammation of blood vessels and a high number of white blood cells known as eosinophils (e-o-SIN-o-phils). Inflammation and damage to your blood vessels related to EGPA can restrict the amount of blood that reaches tissues and organs throughout your body. This can cause different effects throughout the body and irreversible damage if left untreated.

Everyone has eosinophils. They are white blood cells and a normal part of your immune system. If you have EGPA, that means your eosinophil count is high. A high number of eosinophils in your blood can lead to inflammation throughout your body to various tissues and organs.

While there are many symptoms of EGPA, a few of the most common include:

  • Wheezing, coughing, shortness of breath, chest tightness
  • Difficulty with smell, nasal congestion, frequent sinus infections
  • Numbness and tingling in the feet and hands
  • Rashes, fever, fatigue, pain, and weight loss

Symptoms can vary in patients. For some people, too many eosinophils can also cause airway inflammation that leads to asthma attacks. This type of asthma is known as eosinophilic asthma, which helps to explain why people with EGPA often have asthma.

If you are experiencing any of the asthma symptoms above, reach out to your doctor to discuss your conditions.

You may be referred to a specialist for EGPA, which could include rheumatologists, allergists, pulmonologists, or any other specialist your doctor recommends.

About FASENRA

Tell your doctor if you:

  • are taking oral or inhaled corticosteroid medicines
  • have a parasitic (helminth) infection
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed
  • are taking prescription and over-the-counter medicines, vitamins, or herbal supplements

Do not stop taking your other EGPA medicines unless instructed to do so by your doctor.

FASENRA may cause serious side effects, including:

  • allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your FASENRA injection. Allergic reactions can sometimes happen hours or days after you get your injection. 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 lightheaded (low blood pressure)
    • rash
    • hives

The most common side effects of FASENRA include: headache and sore throat. These are not all the possible side effects of FASENRA.

The safety information above does not replace discussions with your healthcare provider about your medical condition or treatment. Please read Patient Information and Prescribing Information for FASENRA.

Before using FASENRA, tell your healthcare provider about all of your medical conditions, including if you:

  • are taking oral or inhaled corticosteroid medicines. Do not stop taking your corticosteroid medicines unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine to come back
  • have a parasitic (helminth) infection
  • are pregnant or plan to become pregnant. It is not known if FASENRA will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with FASENRA.
  • are breastfeeding or plan to breastfeed. It is not known if FASENRA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use FASENRA.
  • are taking prescription and over-the-counter medicines, vitamins, or herbal supplements

Do not stop taking your other medicines unless instructed to do so by your healthcare provider.

FASENRA is a prescription medicine approved to help treat people 18 years and older with EGPA. It's a biologic treatment given by injection once every 4 weeks.

The mechanism of action of FASENRA in EGPA is not fully understood.

For EGPA, FASENRA may be able to help you:

Achieve remission*

Lower oral steroid use

Your results may vary. Do not stop taking your other EGPA medicines unless your healthcare provider tells you to.

*Remission was defined as no active vasculitis and daily oral steroid use was 4mg or less.

Based on the design of the study, results are descriptive only.

The FASENRA prefilled syringe is an injection administered under the skin (subcutaneously) by a healthcare provider.

The FASENRA Pen is an injection administered under the skin (subcutaneously) by the patient, caregiver, or healthcare provider. Do not try to inject the FASENRA Pen until you have been trained by your healthcare provider.

FASENRA is designed to target and remove eosinophils, which play a role in EGPA. The mechanism of action of FASENRA in EGPA is not fully understood.

Do not use FASENRA if you are allergic to benralizumab or any of the ingredients in FASENRA. Click here for full Important Safety Information.

FASENRA is 1 injection every 4 weeks.

Each FASENRA dose is very important, so if you miss a dose of FASENRA, call your healthcare provider. Stay on track with your treatment and help reduce your chances of forgetting a dose. Click here to sign up for dose reminders or a dose calendar.

FASENRA Support

Many factors determine how much you will pay for FASENRA. You could pay as little as $0. The FASENRA Savings Program is for commercially insured patients to cover patient out-of-pocket costs for FASENRA and its administration, up to $13,000 per calendar year.

If you need help paying for FASENRA, AstraZeneca may be able to help. You can get more information on FASENRA affordability programs by calling 1-833-360-HELP (4357).

FASENRA 360 provides a range of support services if you are on FASENRA, including reimbursement support, affordability programs if you are eligible, nursing support for FASENRA questions including injection training and support for FASENRA Pen,* and ongoing education. Call 1-833-360-HELP (4357) Monday–Friday, 8 AM to 6 PM ET.

*Information from our nurses does not replace the advice or training from your physician or other healthcare providers. Nurses cannot provide diagnosis or treatment advice to callers.

Self-Injection

If you are having any problems with your FASENRA Pen, call FASENRA 360 at 1-833-360-HELP (4357) for assistance. Also, let your doctor know.

If you think that your FASENRA Pen is damaged, call FASENRA 360 at 1-833-360-HELP (4357) for assistance. Also, let your doctor know.

Store FASENRA in a refrigerator between 36°F to 46°F (2°C to 8°C) in its original carton until you are ready to use it. FASENRA may be kept at room temperature between 68°F to 77°F (20°C to 25°C) for a maximum of 14 days. Once removed from the refrigerator and brought to room temperature, FASENRA must be used within 14 days or thrown away (disposed of).

Yes, a trained caregiver or healthcare provider can administer your FASENRA injection for you.

Your doctor is the best source of information for your health and how to self-administer. If you would like additional information on how to inject your FASENRA Pen, you can call FASENRA 360 at 1-833-360-HELP (4357).

Click here to read the full Instructions for Use about how to self-administer your FASENRA Pen. Or, you can also watch a step-by-step Instructional video here. Both will show you how to self-administer your FASENRA Pen.

Each FASENRA Pen contains 1 dose of FASENRA that is for one-time use only. Once you have completed the injection process, immediately dispose of the Pen in an FDA-cleared Sharps Disposal Container. Do not throw away the Pen in your household trash. Throw away the cap and other used supplies in your trash.

AstraZeneca is committed to keeping FASENRA Pens out of landfills. We can send you a Sharps Disposal Container to safely dispose of your FASENRA Pens. Simply drop the Pen inside the Sharps Disposal Container right after use. Log the date on the container to track your treatments. After your 10th dose, repackage the container in the box it came in and ship with the USPS pre-paid label. When your full Sharps Disposal Container is received, we will mail you a new one. To obtain a Sharps Disposal Container, call FASENRA 360 at 1-833-360-HELP (4357). Your Specialty Pharmacy may also have options available.

Your Specialty Pharmacy can provide alcohol wipes and cotton balls or gauze. FASENRA 360 can also provide a Sharps Disposal Container so you can properly dispose of your used FASENRA Pen.

Always talk with your healthcare provider before traveling. If you have questions, check the latest TSA guidelines at www.tsa.gov before flying to make sure you’re aware of the most up-to-date information. FASENRA 360 can provide an Insulated Travel Bag to help you travel with your medication. Please call FASENRA 360 at 1-833-360-HELP (4357) for more information.

If you think you may be having an allergic reaction, seek medical attention immediately. Such reactions may happen within hours or days after the injection. FASENRA can potentially cause serious allergic reactions. You must look out for signs of these reactions (such as hives, rash, breathing problems, fainting, dizziness, feeling lightheaded and/or swelling of your face, tongue, or mouth) while you are taking FASENRA. It is important that you talk to your doctor about how to recognize early symptoms of serious allergic reactions and how to manage these reactions if they occur.

You may report side effects related to AstraZeneca products.

IMPORTANT SAFETY INFORMATION

Do not use FASENRA if you are allergic to benralizumab or any of the ingredients in FASENRA. Do not use to treat sudden breathing problems.

 

FASENRA may cause serious side effects, including:

  • allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your FASENRA injection. Allergic reactions can sometimes happen hours or days after you get your injection. 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 lightheaded (low blood pressure)
    • rash
    • hives

Before using FASENRA, tell your healthcare provider about all of your medical conditions, including if you:

  • are taking oral or inhaled corticosteroid medicines. Do not stop taking your corticosteroid medicines unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine to come back
  • have a parasitic (helminth) infection
  • are pregnant or plan to become pregnant. It is not known if FASENRA will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with FASENRA
  • are breastfeeding or plan to breastfeed. It is not known if FASENRA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use FASENRA
  • are taking prescription and over-the-counter medicines, vitamins, or herbal supplements.

Do not stop taking your other medicines unless instructed to do so by your healthcare provider. Tell your healthcare provider if your condition does not get better or if it gets worse after you start treatment with FASENRA.

The most common side effects of FASENRA:

  • adults and children 6 years and older with asthma include headache and sore throat
  • adults with EGPA include headache
  • adults and children 12 years and older with HES include headache, allergic reactions, and flu-like symptoms

These are not all the possible side effects of FASENRA.

APPROVED USE

FASENRA is a prescription medicine used:

  • with other asthma medicines for the maintenance treatment of asthma in adults and children 6 years and older whose asthma is not controlled with their current asthma medicines. FASENRA is not used to treat sudden breathing problems.
  • to treat adults with eosinophilic granulomatosis with polyangiitis (EGPA).
  • to treat adults and children 12 years and older with hypereosinophilic syndrome (HES).