Benralizumab (Systemic)
Brand names: Fasenra
Drug class:
Antineoplastic Agents
Usage of Benralizumab (Systemic)
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.
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How to use Benralizumab (Systemic)
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-QAdolescents ≥12 years of age: Initially, 30 mg every 4 weeks for 3 doses followed by 30 mg every 8 weeks.
Adults
Asthma Sub-QInitially, 30 mg every 4 weeks for 3 doses followed by 30 mg every 8 weeks.
Prescribing Limits
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.
Warnings
Contraindications
Warnings/Precautions
Sensitivity Reactions
HypersensitivityHypersensitivity 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
PregnancyNo 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].
LactationNot 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 UseSafety 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 UseNo overall differences in safety and efficacy in patients ≥65 years of age relative to younger adults, but increased sensitivity cannot be ruled out.
Hepatic ImpairmentPharmacokinetics not studied in patients with hepatic impairment.
Renal ImpairmentPharmacokinetics not studied in patients with renal impairment.
Common Adverse Effects
Common adverse effects (≥5%): headache, pharyngitis.
What other drugs will affect Benralizumab (Systemic)
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.
Disclaimer
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The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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