(ben ra LIZ ue mab)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Fasenra: 30 mg/mL (1 mL)
Brand Names: U.S.
- Interleukin-5 Receptor Antagonist
- Monoclonal Antibody, Anti-Asthmatic
Benralizumab, a humanized monoclonal antibody (IgG1, kappa), is an interleukin-5 antagonist. IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils (a cell type associated with inflammation and an important component in the pathogenesis of asthma). Benralizumab, by inhibiting IL-5 signaling, reduces the production and survival of eosinophils; however, the mechanism of benralizumab action in asthma has not been definitively established.
3.2 L (central); 2.5 L (peripheral)
Undergoes proteolytic degradation via enzymes that are widely distributed in the body and not restricted to hepatic tissue.
Use: Labeled Indications
Asthma: Add-on maintenance treatment of severe asthma in adults and children ≥12 years of age with an eosinophilic phenotype
Limitations of use: Not indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus
Hypersensitivity to benralizumab or any component of the formulation
Asthma: SubQ: 30 mg every 4 weeks for the first 3 doses, and then once every 8 weeks.
Refer to adult dosing.
Asthma: Children ≥12 years and Adolescents: SubQ: Refer to adult dosing.
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, adjustment based on renal function is unlikely to be necessary as benralizumab is not renally cleared.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, adjustment based on hepatic function is unlikely to be necessary as benralizumab is degraded by widely distributed proteolytic enzymes that are not restricted to hepatic tissue.
Prior to administration, remove prefilled syringe from refrigerator and allow to warm at room temperature for about 30 minutes. Solution is clear to opalescent, colorless to slight yellow liquid; particles may be present in the solution that appear translucent or white to off-white; do not use if cloudy or discolored. Syringe may contain a small air bubble; do not expel the air bubble prior to administration.
SubQ: Administer SubQ into the upper arm, thigh, or abdomen.
Store in original carton at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light. Use within 24 hours after removal from refrigerator.
Belimumab: Monoclonal Antibodies may enhance the adverse/toxic effect of Belimumab. Avoid combination
>10%: Immunologic: Antibody development (13%; neutralizing: 12%)
1% to 10%:
Central nervous system: Headache (8%)
Respiratory: Pharyngitis (5%)
Miscellaneous: Fever (3%)
Frequency not defined: Hypersensitivity: Hypersensitivity reaction
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) may occur, typically within hours of administration. Delayed hypersensitivity reactions, occurring days after administration, have also been reported. Discontinue use in patients who experience a hypersensitivity reaction.
• Asthma: Not indicated for the treatment of acute asthma symptoms (eg, acute bronchospasm) or acute exacerbations, including status asthmaticus. Appropriate rescue medication should be available. Patients who experience continued uncontrolled asthma or worsening of symptoms following treatment initiation with benralizumab should seek medical attention.
• Helminth infections: It is unknown if administration of benralizumab will influence a patient's immune response against parasitic infections. Therefore, patients with preexisting helminth infections should undergo treatment of the infection prior to initiation of benralizumab therapy. Patients who become infected during benralizumab treatment and do not respond to antihelminth therapy should discontinue benralizumab until the infection resolves.
• Corticosteroids: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of benralizumab. Reductions in corticosteroid dose should be gradual, if appropriate. Clinicians should note that a reduction in corticosteroid dose may be associated with withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Anaphylaxis/hypersensitivity reactions (during and after infusion); peak flow, and/or other pulmonary function tests; monitor for signs of infection
Adverse events were not observed in animal reproduction studies. IgG monoclonal antibodies, including benralizumab, are expected to cross the placenta with higher concentrations in the third trimester.
Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of preeclampsia, preterm birth, low birth weight infants). Asthma should be closely monitored in pregnant women.