Benralizumab

What is Benralizumab?

• Benralizumab (Fasenra) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) used for the treatment of asthma.

What are the uses of this medicine?

• This medicine is used with other asthma medicines for the maintenance treatment of asthma in people 12 years and older whose asthma is not controlled with their current asthma medicines.
• Fasenra helps prevent severe asthma attacks (exacerbations) and may improve your breathing.
• Medicines such as Fasenra reduce blood eosinophils.
• Eosinophils are a type of white blood cell that may contribute to your asthma.

Limitations of Use:

• Not for treatment of other eosinophilic conditions.
• Not for relief of acute bronchospasm or status asthmaticus.

How does this medicine work?

• Benralizumab (ben" ra liz' ue mab) is a recombinant, humanized IgG1 monoclonal antibody to the IL-5 receptor alpha which blocks the cytokine from inducing maturation and proliferation of eosinophils.
• IL-5 is a cytokine growth and stimulating factor which has a selective role in recruiting eosinophils from the bone marrow and promoting their differentiation, activation and survival.
• Both circulating and sputum eosinophils are decreased by benralizumab therapy and these effects are reversed when it is discontinued.
• Benralizumab therapy has been shown to reduce the requirement for inhaled corticosteroids and lower the frequency of exacerbations of eosinophilic asthma.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to benralizumab or any of its excipients.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Recommended Dosage:

• The recommended dose of Fasenra is 30 mg administered once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter by subcutaneous injection into the upper arm, thigh, or abdomen.

Administration

• Administer by subcutaneous injection.
• 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.
• Do not try to inject Fasenra until you have been shown the right way by your healthcare provider.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 30 mg/mL solution in a single-dose prefilled syringe.
• Injection: 30 mg/mL solution in a single-dose autoinjector Fasenra PEN.

This medicine is available in fallowing brand namesː

• Fasenra

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• sore throat

Fasenra may cause serious side effects, including:

• allergic (hypersensitivity) reactions, including anaphylaxis

What special precautions should I follow?

• Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred after administration of Fasenra. Discontinue in the event of a hypersensitivity reaction.
• Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with Fasenra. Decrease corticosteroids gradually, if appropriate.
• Do not use Fasenra to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with Fasenra.
• Treat patients with pre-existing helminth infections before therapy with Fasenra. If patients become infected while receiving Fasenra and do not respond to anti-helminth treatment, discontinue Fasenra until the parasitic infection resolves.

What to do in case of emergency/overdose?

• Doses up to 200 mg were administered subcutaneously to patients with eosinophilic disease. There are no evidence of dose-related toxicities.

Management for overdosage:

• There is no specific treatment for an overdose with benralizumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.

Can this medicine be used in pregnancy?

• The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Fasenra during pregnancy. Healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting MOTHERTOBABY.ORG/Fasenra.

Can this medicine be used in children?

• The safety and efficacy in patients younger than 12 years of age has not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: benralizumab
• Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20, α,α-trehalose dihydrate, and Water for Injection

Who manufactures and distributes this medicine?

• Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-15185
• Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

What should I know about storage and disposal of this medication?

• Store Fasenra in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Fasenra may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days.
• Once removed from the refrigerator and brought to room temperature Fasenra must be used within 14 days or thrown away.
• Store Fasenra in the original carton until you are ready to use it to protect it from light.
• Do not freeze Fasenra. Do not use Fasenra that has been frozen.
• Do not expose Fasenra to heat.
• Do not use Fasenra past the expiration date.
• Keep Fasenra and all medicines out of the reach of children.

• Dailymed label info on Benralizumab
• FDA Benralizumab