Fasenra

— THERAPEUTIC CATEGORIES —
  • Asthma/COPD
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Fasenra Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Benralizumab 10mg/0.5mL, 30mg/mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Interleukin-5 antagonist.

    How Supplied

    Single-dose prefilled syringe (10mg/0.5mL, 30mg/mL)—1; Single-dose autoinjector (30mg/mL)—1

    Manufacturer

    AstraZeneca Pharmaceuticals

    Generic Availability

    NO

    Mechanism of Action

    Benralizumab is a humanized afucosylated, monoclonal antibody (IgG1, kappa) that directly binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with a dissociation constant of 11 pM. The IL-5 receptor is expressed on the surface of eosinophils and basophils. In an in vitro setting, the absence of fucose in the Fc domain of benralizumab facilitates binding (45.5 nM) to FcɣRIII receptors on immune effector cells, such as natural killer (NK) cells, leading to apoptosis of eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity (ADCC).

    Fasenra Indications

    Indications

    As add-on maintenance treatment of severe asthma in patients ≥6yrs old, and with an eosinophilic phenotype.

    Limitations of Use

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

    Fasenra Dosage and Administration

    Adult

    Give by SC inj into upper arm, thigh, or abdomen. ≥12yrs: 30mg once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter.

    Children

    <6yrs: not established. Give by SC inj into upper arm, thigh, or abdomen. 6–11yrs (<35kg): 10mg once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter; (≥35kg): 30mg once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter.

    Fasenra Contraindications

    Not Applicable

    Fasenra Boxed Warnings

    Not Applicable

    Fasenra Warnings/Precautions

    Warnings/Precautions

    Not for treating acute asthma symptoms or exacerbations. Discontinue if hypersensitivity reactions occur. Treat preexisting helminth infections before initiating therapy; discontinue Fasenra if treatment-resistant infection occurs while on therapy until resolves. Avoid abrupt discontinuation of systemic or inhaled corticosteroids; reduce dose gradually upon Fasenra initiation, if appropriate. Reduction may be associated with systemic withdrawal symptoms and/or unmask previously suppressed conditions. Pregnancy. Nursing mothers.

    Fasenra Pharmacokinetics

    Absorption

    Absolute bioavailability: ~59%.

    Distribution

    Volume of distribution: 3.1 L (central); 2.5 L (peripheral).

    Elimination

    Half-life: ~15.5 days.

    Fasenra Interactions

    Not Applicable

    Fasenra Adverse Reactions

    Adverse Reactions

    Headache, pharyngitis, pyrexia, hypersensitivity reactions.

    Fasenra Clinical Trials

    See Literature

    Fasenra Note

    Not Applicable

    Fasenra Patient Counseling

    See Literature

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