What Is Fasenra?

Fasenra (benralizumab) is an injectable prescription drug used with other drugs to prevent symptoms in adults and adolescents 12 years and older with eosinophilic asthma. Eosinophilic asthma is a rare, severe type of asthma caused by eosinophils, a type of white blood cell associated with inflammation. This medication is used in people whose asthma is not controlled with other treatments.

Fasenra is in a drug class called monoclonal antibodies. It works by reducing eosinophils, which contribute to asthma symptoms. This helps decrease swelling and irritation of the airways, making it easier to breathe.

Fasenra is available as a subcutaneous (under the skin) injection in two different products: a prefilled syringe, which a healthcare provider administers, and an auto-injector pen, which can be given by a caregiver or self-administered with appropriate training.

What Is Fasenra Used For?

The Food and Drug Administration (FDA) approved Fasenra to be used with other drugs for maintenance treatment (to prevent symptoms) of severe eosinophilic asthma in adults and adolescents ages 12 years and older.

In clinical studies, people who took Fasenra had fewer asthma attacks that required hospitalization (and/or an emergency room visit). They also were able to lower the dose of oral steroids.

Fasenra can not be used to treat other eosinophilic conditions or relieve acute asthma attacks or bronchospasm (narrowing of the airways).

How to Take Fasenra

If you are prescribed Fasenra and you or your caregiver will be administering it:

• Read the prescription label and the information leaflet that comes with your prescription.
• Consult your healthcare provider if you have any questions.
• Do not use Fasenra until you have been trained by your healthcare provider.
• Before you start treatment and during treatment with Fasenra, your healthcare provider will order blood work. 
• Use Fasenra and your other asthma medications as directed by your healthcare provider. Do not change doses or medications unless your healthcare provider tells you to. Tell your healthcare provider if any of your medicines seem to stop working.

Fasenra comes in two administration forms: a single-dose auto-injector and prefilled syringe. The prefilled syringe can only be administered by a healthcare provider. You may self-administer the single-dose auto-injector after your healthcare provider trains you.

To prepare and administer the single-dose auto-injector:

• Take the pen (each Fasenra pen contains one dose) out of the refrigerator and let it come to room temperature. This takes about 30 minutes. 
• Do not shake the pen at any time. 
• While waiting, gather alcohol wipes, a cotton ball or gauze, a bandage, and your sharps disposal container. 
• Wash your hands with soap and water. Clean your injection site with an alcohol wipe. If you are injecting yourself, the recommended site is the front of the thigh or the lower stomach. If a caregiver injects you, they can inject you in the upper arm, thigh, or stomach. Do not try to inject your own arm. Do not inject Fasenra within 2 inches of your belly button or into damaged skin. Rotate injection sites - with each injection, use a spot at least 1 inch away from the previous injection. 
• Pull the cap straight off without touching the needle guard or needle. 
• Hold the Fasenra pen at a 90-degree angle, flat against the site where you will be injecting. You can inject with or without pinching the skin around the injection site. 
• Press down firmly and hold. You will hear a click. This means the injection has begun. Hold the pen in place for 15 seconds without moving it. A second click indicates that the injection is finished. 
• Lift the pen straight up. The needle guard will lock into place. Apply gentle pressure to the area with gauze or a cotton ball until bleeding (if any) stops. Then, place a bandage over the injection site. Place the Fasenra pen in a sharps container right away. Never attempt to reuse a Fasenra pen. 

Ask your healthcare provider if you have any questions or concerns about Fasenra.

Storage

Store Fasenra in the refrigerator (between 36 degrees and 46 degrees Fahrenheit [F]) in its original packaging until you are ready to use it. You can keep Fasenra at room temperature (68 to 77 degrees F) for 14 days. Once at room temperature, Fasenra must be used within 14 days or thrown away.

Keep Fasenra out of reach and out of sight of children. Do not freeze the medication or expose it to heat. Do not use Fasenra if it has been frozen or passed the expiration date.

What Are the Side Effects of Fasenra?

Like other medications, Fasenra can cause side effects. Tell your healthcare provider about any side effects you experience while taking this medication.

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

The most common side effects of Fasenra are:

• Headache 
• Sore throat
• Fever
• Hypersensitivity reaction (see below)
• Injection site reaction

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Hypersensitivity reaction or anaphylaxis: Symptoms can include rash, hives, swelling around the lips, tongue, and face, and difficulty breathing, and require emergency medical attention. 

Long-Term Side Effects

Many people tolerate Fasenra well. However, long-term or delayed side effects are possible. Long-term side effects may include viral upper respiratory infection or bronchitis.

Some people who take Fasenra develop an antibody that blocks the drug. This can happen with any monoclonal antibody treatment and occurs in about 5% of people who use Fasenra. Even so, developing an antibody to the drug is not expected to reduce the benefits of treatment.

Dosage: How Much Fasenra Should I Take?

Modifications

Fasenra is available as a single-dose prefilled syringe, which a healthcare provider administers, or a single-dose auto-injector pen, which can be given by a caregiver or self-administered. You and your healthcare provider will determine which option is best for you.

If you are pregnant or plan to become pregnant, talk to your healthcare provider before taking Fasenra. If you take Fasenra and find out you are pregnant, contact your healthcare provider for medical advice. It is not known if Fasenra can harm an unborn baby. There is a pregnancy registry for women who use Fasenra during pregnancy. Your healthcare provider can give you more information about the registry if needed.

Talk to your healthcare provider if you are breastfeeding or planning to breastfeed. This medication may be excreted in breast milk.

Fasenra has not been studied in people with kidney or liver problems. Consult your healthcare provider before taking Fasenra to ensure it is safe for you.

Missed Dose

If you miss a dose of Fasenra, call your healthcare provider for instructions.

Overdose: What Happens If I Take Too Much Fasenra?

In clinical trials, no dose-related toxicities were reported in people receiving up to 200 milligrams (mg) of Fasenra. There is no specific treatment in the event of an overdose. However, if you take too much Fasenra, you may be treated for any adverse side effects and monitored by a healthcare provider as necessary.

Precautions

What Are Reasons I Shouldn’t Take Fasenra?

Fasenra is not appropriate for everyone. You should not take this medication if you are allergic to benralizumab or any of the inactive ingredients in Fasenra.

Fasenra also is contraindicated (meaning it should not be used) in acute asthma, acute bronchospasm, or status asthmaticus. Status asthmaticus is a life-threatening asthma exacerbation that does not respond to initial treatments. 

Fasenra may be prescribed with caution in some people, only if the healthcare provider determines it is safe. This includes people at risk for parasitic worm infection. 

What Other Medications May Interact With Fasenra?

No drug interaction studies have been conducted with Fasenra. It is not expected to have significant interactions with other drugs. However, caution is always advised when multiple drugs are taken together. Tell your healthcare provider about all of your medicines, including prescription and over-the-counter (OTC) medicines and vitamins or supplements.

What Medications Are Similar?

Fasenra is a monoclonal antibody prescribed in addition to other medications for severe eosinophilic asthma that has not responded to other treatments.

Other monoclonal antibodies used for asthma include:

• Cinqair (reslizumab) can be used in adults 18 years and older (in addition to other medications) with severe eosinophilic asthma.
• Dupixent (dupilumab) can be used in adults and children 6 years and older (in addition to other medications) who have moderate to severe eosinophilic asthma or who depend on oral steroid treatment.
• Nucala (mepolizumab) can be used in adults and children ages 6 years and older (in addition to other medications) with severe eosinophilic asthma.
• Xolair (omalizumab) can be used in adults and children 6 years and older with moderate to severe persistent asthma not controlled with inhaled steroids. People must have a positive skin test or react to a perennial (year-round) allergen.

People who take Fasenra typically take other medications for asthma as well, such as short-acting beta-agonists or long-acting beta-agonists (LABAs). Rescue inhalers are a common type of medication used for acute asthma exacerbations or before exercise in people with exercise-induced bronchospasm.

Examples of rescue inhalers include:

• ProAir HFA (albuterol)
• Proventil HFA (albuterol)
• Ventolin HFA (albuterol)
• Xopenex HFA (levalbuterol)

Long-acting beta-agonists, or LABAs, are available as single-ingredient products but should never be taken alone. LABAs should always be taken with an inhaled steroid, either as two individual products or as a combination product. Serevent (salmeterol) is an example of a LABA.

Some examples of inhaled steroids include:

• Alvesco (ciclesonide)
• Asmanex (mometasone)
• Flovent HFA (fluticasone)
• Pulmicort Flexhaler (budesonide)
• Qvar RediHaler (beclomethasone)

Some combination inhaled drugs contain both a steroid and a LABA. Examples include:

• Advair Diskus (fluticasone and salmeterol)
• Breo (fluticasone and vilanterol)
• Dulera (mometasone and formoterol)
• Symbicort (budesonide and formoterol)

Trelegy Ellipta, another asthma medication, contains three drugs: a steroid (fluticasone), an anticholinergic drug (umeclidinium), and a LABA (vilanterol). There are also a variety of other drugs that may be prescribed for asthma maintenance, for example, oral medications like Singulair (montelukast) or oral steroids such as prednisone.

This list is a list of drugs also prescribed for asthma. It is NOT a list of drugs recommended to take with Fasenra. Ask your pharmacist or a healthcare provider if you have questions.

How Can I Stay Healthy While Taking Fasenra?

Before taking Fasenra, discuss your medical history and all medications you take with your healthcare provider. Make sure to follow your healthcare provider’s instructions for use. Read the patient information leaflet with your prescription and ask your healthcare provider if you have any questions.

A healthcare provider should train you or your caregiver on injecting the dose. It can feel intimidating at first to give yourself an injection, but after a few times, your comfort level will increase, and you will feel more confident in your ability to inject yourself.

Your healthcare provider will instruct you if you need to change your other medications. Do not stop taking your steroid medications unless your healthcare provider has instructed you to.

Fasenra does not treat an acute exacerbation of asthma or acute bronchospasm. Always carry a rescue inhaler, which is fast-acting. It can be helpful to have two rescue inhalers, one to keep at home and one at work or school. Be sure to regularly check the expiration date and how many puffs are remaining. Call in refills to the pharmacy several days ahead to ensure you never run out.