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Benralizumab (Monograph)

Brand name: Fasenra
Drug class: Interleukin Antagonists

Medically reviewed by Drugs.com on Jun 18, 2023. Written by ASHP.

[Web]

Introduction

Antiasthmatic agent; a recombinant DNA-derived afucosylated humanized monoclonal antibody specific for the alpha chain of the interleukin-5 (IL-5) receptor (IL-5Rα) and an IgG1 kappa immunoglobulin.

Uses for Benralizumab

Asthma

Adjunctive maintenance therapy in patients ≥12 years of age with severe eosinophilic asthma.

Reduces asthma exacerbation rate, decreases oral corticosteroid dosage requirements, and improves FEV1 from baseline.

Not indicated for treatment of other eosinophilic conditions.

Not indicated for relief of acute bronchospasm or status asthmaticus.

Several clinical practice guidelines on asthma management are available, including the Global Initiative for Asthma (GINA) guidelines. In GINA, stepwise approach to treatment is recommended where specific drugs are added or adjusted up or down through a series of steps (1 through 5) to achieve symptom control while keeping the patient on the lowest effective treatment.

Biologic agents such as benralizumab are generally recommended as add-on therapy for severe asthma.

Benralizumab Dosage and Administration

General

Pretreatment Screening

Patient Monitoring

Other General Considerations

Administration

Sub-Q Administration

Administer by sub-Q injection into the upper arm, thigh, or abdomen.

Commercially available in prefilled syringes and autoinjectors. Prefilled syringe intended for administration by a clinician. Autoinjector pen may be administered by patient or caregiver after proper training provided and healthcare provider determines it is appropriate.

Remove syringe or autoinjector from refrigerator and allow to sit at room temperature for about 30 minutes prior to injection; use within 24 hours or discard.

Contains no preservatives; intended for single use only.

Inject entire contents of prefilled syringe (1 mL providing 30 mg).

Dosage

Pediatric Patients

Asthma
Sub-Q

Adolescents ≥12 years of age: Initially, 30 mg every 4 weeks for 3 doses followed by 30 mg every 8 weeks.

Adults

Asthma
Sub-Q

Initially, 30 mg every 4 weeks for 3 doses followed by 30 mg every 8 weeks.

Special Populations

Geriatric Patients

The manufacturer makes no specific dosage recommendations for geriatric patients.

Hepatic Impairment

The manufacturer makes no specific dosage recommendations for patients with hepatic impairment.

Renal Impairment

The manufacturer makes no specific dosage recommendations for patients with renal impairment.

Cautions for Benralizumab

Contraindications

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) reported, generally occurring within hours or possibly days following administration. If hypersensitivity reaction occurs, discontinue benralizumab.

Deterioration of Disease and Acute Episodes

Not indicated for treatment of acute asthma symptoms or exacerbations, acute bronchospasm, or status asthmaticus.

Reduction of Corticosteroid Dosage

Do not abruptly discontinue systemic or inhaled corticosteroid therapy upon initiation of benralizumab therapy. If appropriate, reduce corticosteroid dosage gradually and supervise such reduction carefully.

Parasitic Infection

Immune response against some parasitic (helminth) infections may be altered. Not studied in patients with known parasitic infections. Treat patients with preexisting parasitic (helminth) infections before initiating benralizumab. If parasitic infection occurs and does not respond to anthelmintic treatment, interrupt benralizumab therapy until infection resolves.

Immunogenicity

Potential for immunogenicity. Development of anti-benralizumab antibodies detected in 13% of patients and associated with increased drug clearance and increased blood eosinophil concentrations; development of neutralizing antibodies also detected. Evidence of an association between anti-benralizumab antibodies and efficacy or safety of the drug not observed.

Specific Populations

Pregnancy

No evidence of fetal harm in monkeys following IV benralizumab during pregnancy. Potential effects of monoclonal antibodies (e.g., benralizumab) on the fetus more likely to occur in the third trimester.

Registry information is available by calling 1-877-311-8972 or visiting [Web].

Lactation

Not known whether distributed into human milk. Since IgG distributes into milk in humans, benralizumab is expected to distribute into human milk.

Consider benefits of breast-feeding and importance of drug to the woman; also consider potential adverse effects on the breast-fed child from the drug or underlying maternal condition.

Pediatric Use

Safety and efficacy not established in children <12 years of age.

Evaluated in 62 adolescent patients 12–17 years of age with asthma; adverse effect profile generally similar to that observed in adults.

Geriatric Use

No overall differences in safety and efficacy in patients ≥65 years of age relative to younger adults, but increased sensitivity cannot be ruled out.

Hepatic Impairment

Pharmacokinetics not studied in patients with hepatic impairment.

Renal Impairment

Pharmacokinetics not studied in patients with renal impairment.

Common Adverse Effects

Common adverse effects (≥5%): headache, pharyngitis.

Drug Interactions

No formal drug interaction studies to date.

Drugs Metabolized by Hepatic Microsomal Enzymes

CYP substrates: Pharmacokinetic interactions unlikely.

Drugs Affected by Efflux Transport Systems

Substrates of efflux transport systems: Pharmacokinetic interactions unlikely.

Benralizumab Pharmacokinetics

Absorption

Bioavailability

Absolute bioavailability following sub-Q administration approximately 58%.

Relatively slow absorption with an absorption half-life of approximately 3.6 days following sub-Q administration.

Dose-proportional pharmacokinetics over a sub-Q dosage range of 20–200 mg and an IV dosage range of 0.03–3 mg/kg.

Onset

Decreased blood eosinophil count observed 24 hours after IV administration.

Duration

Decreased blood eosinophil count reported to last for at least 8–12 weeks.

Special Populations

Age, sex, and tobacco smoking history did not affect pharmacokinetics of benralizumab in healthy volunteers or those with asthma.

Distribution

Extent

Not known whether distributed into human milk.

Potential for limited distribution into extravascular tissues.

Elimination

Metabolism

Metabolized by widely distributed proteolytic enzymes.

Elimination Route

Not excreted renally. No evidence of clearance through a target receptor-mediated pathway.

Half-life

Approximately 15 days following sub-Q administration.

Special Populations

Hepatic impairment: Changes in hepatic function not expected to influence clearance.

Renal impairment: Comparable clearance in patients with Clcr between 30–80 mL/minute and those with normal renal function. Limited data in those with Clcr <30 mL/minute.

Anti-benralizumab antibody titers ≥400: 4.6-fold increase in drug clearance.

Age, gender, and race did not affect clearance.

Stability

Storage

Parenteral

Injection

2–8°C in original package and protect from light. Do not freeze or shake.

Actions

Advice to Patients

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Benralizumab is available only from a designated specialty pharmacy. The manufacturer should be contacted for additional information.

Benralizumab

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for subcutaneous use

30 mg/mL

Fasenra (available as single-dose prefilled syringe or autoinjector pen)

AstraZeneca

AHFS DI Essentials™. © Copyright 2024, Selected Revisions June 18, 2023. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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