Version May 2024
Asthma, severe eosinophilic: Note: May consider as add-on therapy in patients with severe eosinophilic asthma (peripheral blood eosinophils ≥150 cells/mcL) inadequately controlled on standard therapies (eg, an inhaled glucocorticoid with a long-acting beta agonist). The eosinophil threshold required for patients on systemic glucocorticoids is less clear (Ref).
SUBQ: 30 mg every 4 weeks for the first 3 doses, then once every 8 weeks. A minimum of 4 months of treatment is suggested to determine efficacy (Ref).
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.
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.
Refer to adult dosing.
(For additional information see "Benralizumab: Pediatric drug information")
Asthma, eosinophilic phenotype; add-on maintenance therapy: Children ≥12 years and Adolescents: SubQ: 30 mg every 4 weeks for the first 3 doses then once every 8 weeks
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.
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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Immunologic: Antibody development (13%; neutralizing: 12%)
1% to 10%:
Central nervous system: Headache (8%)
Respiratory: Pharyngitis (5%)
Miscellaneous: Fever (3%)
Postmarketing: Anaphylaxis, angioedema, hypersensitivity reaction
Hypersensitivity to benralizumab or any component of the formulation
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.
Disease-related concerns:
• Asthma: Not indicated for the treatment of acute asthma symptoms (eg, acute bronchospasm) or acute exacerbations, including status asthmaticus.
• 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.
Other warnings/precautions:
• 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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous [preservative free]:
Fasenra Pen: 30 mg/mL (1 mL)
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Fasenra: 30 mg/mL (1 mL)
No
Solution Auto-injector (Fasenra Pen Subcutaneous)
30 mg/mL (per mL): $6,812.10
Solution Prefilled Syringe (Fasenra Subcutaneous)
30 mg/mL (per mL): $6,812.10
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Fasenra Pen: 30 mg/mL (1 mL)
Solution Prefilled Syringe, Subcutaneous:
Fasenra: 30 mg/mL (1 mL)
SUBQ: Prior to administration, allow syringe/autoinjector to warm at room temperature for ~30 minutes. Administer SubQ into the upper arm, thigh, or abdomen. Prefilled syringe should only be administered by a health care provider; autoinjector may be administered by patient or caregiver after proper training. Refer to the manufacturer's labeling for additional administration instructions.
SubQ: May be administered undiluted subcutaneously into the upper arm, thigh, or abdomen. Do not inject within 2 inches of the belly button or within 1 inch of last injection. Prior to administration, allow prefilled syringe or autoinjector 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 or autoinjector may contain a small air bubble; do not expel the air bubble prior to administration. Prefilled syringe should only be administered by a health care provider; autoinjector may be administered by patient or caregiver after proper training. Patients should not self-inject into the arm.
Asthma, severe eosinophilic : 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.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Data related to the use of monoclonal antibodies for the treatment of asthma during pregnancy are limited. The long half-life of monoclonal antibodies should be considered when prescribing to patients planning to become pregnant (Pfaller 2021). Use of an agent other than benralizumab may be preferred (ERS/TSANZ [Middleton 2020]).
Benralizumab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Outcome data following maternal use of benralizumab during pregnancy are limited (Manetz 2021; Naftel 2023; Saco 2018).
Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low-birth-weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes). Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]; GINA 2023).
Data related to the use of monoclonal antibodies for the treatment of severe asthma during pregnancy are limited (GINA 2023). Use of monoclonal antibodies may be considered when conventional therapies are insufficient; (ERS/TSANZ [Middleton 2020]). In general, monoclonal antibodies should not be initiated during pregnancy, but patients who become pregnant during therapy may continue treatment as part of a shared decision-making process (Dorscheid 2022, Pfaller 2021, Shakuntulla 2022).
Data collection to monitor pregnancy and infant outcomes following exposure to benralizumab is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) (877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.
It is not known if benralizumab is present in breast milk.
Benralizumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Use of monoclonal antibodies for the treatment of asthma in lactating patients may be considered when conventional therapies are insufficient; use of an agent other than benralizumab may be preferred (ERS/TSANZ [Middleton 2020]).
Anaphylaxis/hypersensitivity reactions (during and after administration); peak flow, and/or other pulmonary function tests; monitor for signs of infection
Benralizumab, a humanized afucosylated, monoclonal antibody (IgG1, kappa) that binds to the alpha subunit of the interleukin-5 receptor. 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 and basophils through antibody dependent cell-mediated cytotoxicity; however, the mechanism of benralizumab action in asthma has not been definitively established.
Note : Pharmacokinetic data in pediatric patients 12 to 17 years of age is similar to adult observations
Distribution: 3.1 L (central); 2.5 L (peripheral)
Metabolism: Undergoes proteolytic degradation via enzymes that are widely distributed in the body and not restricted to hepatic tissue.
Bioavailability: ~59%
Half-life elimination: ~15.5 days
Excretion: Nonrenal
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