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Benralizumab

    Brands

    DEA Class; Rx

    Common Brand Names; Fasenra

    • Interleukin Inhibitors; 
    • Monoclonal Antibodies, Anti-asthmatics

    Subcutaneous humanized monoclonal antibody directed against interleukin (IL)-5
    Used for add-on maintenance treatment of adult and pediatric patients 12 years and older who have severe asthma with an eosinophilic phenotype
    Reduces severe exacerbations of asthma, and with maintenance treatment, may allow for oral corticosteroid dose reduction

    Indicated for asthma maintenance add-on therapy in severe asthma (eosinophilic phenotype).

     

    Hypersensitivity to benralizumab or any of its excipients

    Headache (8%)

    Pharyngitis (5%)

    Pyrexia (3%)

    Hypersensitivity reactions (3%)

    Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) reported; these reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days); discontinue if hypersensitivity occurs

    Do not discontinue systemic or inhaled corticosteroids abruptly upon initiating benralizumab; corticosteroid dose reductions, if appropriate, should be gradual and performed under the direct supervision of a physician; monitor for systemic withdrawal symptoms and/or unmasking of conditions previously suppressed by systemic corticosteroid therapy

    Eosinophils may be involved in the immunological response to some helminth infections; unknown if benralizumab influences immunologic response against helminth infections; treat patients with preexisting helminth infections before initiating therapy; if parasitic infection occurs while receiving treatment and does not respond to antihelminth treatment, discontinue benralizumab until infection resolves

    Avoid use in acute asthma symptoms or acute exacerbations; do not use to treat acute bronchospasm or status asthmaticus

    Monoclonal antibodies are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy

    No information is available regarding the presence of benralizumab in human or animal milk, and the effects of benralizumab on the breastfed infant and on milk production are not known

    Adults

    30 mg/dose subcutaneously.

    Geriatric

    30 mg/dose subcutaneously.

    Adolescents

    30 mg/dose subcutaneously.

    Children

    12 years: 30 mg/dose subcutaneously.
    1 to 11 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Benralizumab 

    solution for SC injection (single-dose prefilled syringe)

    • 30mg/mL (single-dose prefilled syringe or autoinjector pen)