Benralizumab

Benralizumab is used to treat severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). It is a subcutaneous injection given every 4 to 8 weeks, depending on the condition. Benralizumab is a brand name for Fasenra.

Benralizumab is a monoclonal antibody that targets eosinophils. These are white blood cells that drive inflammation in the airways (asthma), tissues (EGPA), or blood and tissues (HES). Benralizumab works by binding to a protein called IL-5Ra on the surface of eosinophils, which activates natural killer cells from the immune system. These cells release substances that destroy eosinophils, reducing their levels in both tissues and blood, and reducing inflammation.

Benralizumab received FDA approval on November 14, 2017, under the brand Fasenra for eosinophilic asthma. Approval was extended on September 17, 2024, to include EGPA, and on May 13, 2026, to include HES. There is no generic.

Benralizumab (Fasenra) is approved for:

• Add-on maintenance treatment of adults and children 6 years and older with severe asthma, and with an eosinophilic phenotype.
• Eosinophilic granulomatosis with polyangiitis (EGPA) in adults
• Hypereosinophilic syndrome (HES) without an identifiable nonhematologic secondary cause in adults and children 12 years and older.

Do not try to inject benralizumab (Fasenra) until you have been shown the right way to do so by your healthcare provider.

• Read the “Fasenra Instructions for Use” that comes with benralizumab for information on how to prepare and inject your benralizumab injection.
• Benralizumab is available as a single-dose prefilled syringe and a single-dose autoinjector (Fasenra Pen).
• A healthcare provider uses the single-dose prefilled syringe to inject benralizumab.
• In children aged 6 to 11 years, benralizumab should only be given by a caregiver or healthcare provider.

Benralizumab is injected under your skin (subcutaneously [SC]):

• Once every 4 weeks for the first 3 doses and then every 8 weeks for asthma.
• Once every 4 weeks for EGPA and HES.

If you are giving yourself the benralizumab injection, the recommended injection site is the front of your thigh or the lower part of your stomach (abdomen).

• In addition to these sites, a caregiver may inject you in the upper arm.

For each injection, choose a different site that is at least 1 inch (3 cm) away from where you last injected. Do not inject:

• into the 2-inch (5-cm) area around your belly button
• where the skin is tender, bruised, scaly, or hard
• into scars or damaged skin
• through clothing.

Benralizumab is not a rescue medicine for asthma attacks.

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

Do not receive a benralizumab injection if you are allergic to benralizumab, benralizumab, or any inactive ingredients in the injection.

Before receiving benralizumab, 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
• Are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not stop taking your other medicines for your condition unless your healthcare provider tells you to

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

Do not stop taking your other medicines for your condition unless your healthcare provider tells you to.

Pregnancy

It is not known if benralizumab will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with benralizumab.

Breastfeeding

It is not known if benralizumab passes into your breast milk. You and your healthcare provider should decide if you will use benralizumab and breastfeed. Talk to your healthcare provider about the best way to feed your baby if you use benralizumab.

Common side effects

The most common side effects of benralizumab in:

• Asthma, are headaches, and sore throat
• EGPA, is a headache
• HES, include headaches, allergic reactions, and flu-like symptoms.

Serious side effects and warnings

Benralizumab may cause serious side effects, including:

• Allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your benralizumab 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.

Age restrictions for benralizumab vary by condition:

• Eosinophilic asthma: not for children under 6
• EGPA: not for anyone under 18
• HES: not for children under 12.

Benralizumab 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.

These are not all the possible side effects of benralizumab. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA1088.

The cost of benralizumab (Fasenra) varies significantly depending on your insurance coverage. Most patients pay far less than the list price of $6,022 (30mg) or $2,007 (10mg):

• Employer-provided or Individual Private Policy: ~$46/dose (savings program may reduce to $0 if you are eligible for the Fasenra 360 Savings Program)
• Medicare Advantage: ~$90/dose
• Medicaid: ~$2–$9/dose
• No insurance: varies by pharmacy.

See Fasenra Prices, Coupons, Copay Cards & Patient Assistance for more information.

Dose of Benralizumab for Asthma

• Adults and Pediatrics 12+: Benralizumab 30 mg subcutaneously every 4 weeks for the first 3 doses, followed by 30 mg subcutaneously once every 8 weeks thereafter
• Pediatrics 6 to 11 years, less than 35 kg: Benralizumab 10 mg subcutaneously every 4 weeks for the first 3 doses, followed by 10 mg subcutaneously once every 8 weeks thereafter
• Pediatrics 6 to 11 years, 35 kg or more: Benralizumab 30 mg subcutaneously every 4 weeks for the first 3 doses, followed by 30 mg subcutaneously once every 8 weeks thereafter.

Dose of Benralizumab for EGPA and HES

• All patients: Benralizumab 30 mg subcutaneously every 4 weeks.

If you miss a dose of benralizumab, call your healthcare provider.

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.

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.

• Store benralizumab in the refrigerator between 36°F and 46°F (2°C and 8°C).
• Store benralizumab in the original carton to protect from light.
• Benralizumab may be stored at room temperature up to 77°F (25°C) for up to 14 days.
• After benralizumab is removed from the refrigerator and brought to room temperature, it must be used within 14 days or thrown away (disposed of).
• Do not freeze. Do not shake. Do not expose to heat.
• Do not use benralizumab past the expiration (EXP) date.

Keep out of the reach of children

Active ingredient: benralizumab

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20, α,α-trehalosedihydrate, and Water for Injection.

Benralizumab is manufactured under the brand name Fasenra by AstraZeneca AB, Södertälje, Sweden SE-15185, U.S. License Number 2059. It is distributed by AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850.