Fasenra is a monoclonal antibody that affects the actions of the body's immune system. Benralizumab works by reducing levels of eosinophils, a certain type of white blood cell that may contribute to the symptoms of asthma.

Fasenra injection is a prescription medicine used together with other asthma medicines to help control severe asthma in adults and children who are at least 12 years old.

Fasenra is for people whose asthma is not well controlled with other medications.

Before you receive Fasenra, tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breast-feeding.

Before you start treatment with Fasenra, your doctor may perform tests to measure your eosinophil levels.

Fasenra is injected under your skin (subcutaneously) one time every 4 weeks for the first 3 doses, and then every 8 weeks.

Fasenra comes in a single dose prefilled syringe and in a single dose autoinjector.

A healthcare provider will inject Fasenra using the single-dose prefilled syringe.

If your healthcare provider decides that you or a caregiver can give the injection of Fasenra, you or your caregiver should receive training on the right way to prepare and give the injection using the Fasenra Pen autoinjector.

Follow your doctor's dosing instructions very carefully.

If you've been using a steroid medication, do not stop using it unless your doctor tells you to.

Fasenra is not a rescue medicine for asthma attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your fast-acting medicine does not work.

You may need frequent medical tests to help your doctor determine how long to treat you with Fasenra.

Asthma is often treated with a combination of drugs. Use all medications as directed and read all medication guides. Do not change your dose or dosing schedule without your doctor's advice. Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Tell your doctor if any of your medicines seem to stop working.

Usual Adult Dose for Asthma:

30 mg subcutaneously once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter

Comments:
-This drug should be injected into the upper arm (for caregiver administration only), thigh, or abdomen.

Use: For add-on maintenance therapy of patients with severe asthma with an eosinophilic phenotype

Usual Pediatric Dose for Asthma:

12 years and older:
30 mg subcutaneously once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter

Comments:
-This drug should be injected into the upper arm (for caregiver administration only), thigh, or abdomen.

Use: For add-on maintenance therapy of patients 12 years and older with severe asthma with an eosinophilic phenotype

You should not be treated with Fasenra if you are allergic to benralizumab.

Tell your doctor if you have ever had:

• a parasite infection (such as roundworms or tapeworms); or

• if you use an oral or inhaled steroid medication.

Follow your doctor's instructions about receiving this medicine if you are pregnant. Not treating asthma during pregnancy could harm both mother and baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Fasenra should not be given to a child younger than 12 years old.

Call your doctor for instructions if you miss an appointment for your Fasenra injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Fasenra: hives, rash; difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or worsening asthma symptoms.

Common Fasenra side effects may include:

• sore throat; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with benralizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.