Classes
DEA Class; Rx
Common Brand Names; Fasenra
- Interleukin Inhibitors;
- Monoclonal Antibodies, Anti-asthmatics
Description
Subcutaneous humanized monoclonal antibody directed against interleukin (IL)-5
Used for add-on maintenance treatment of adult and pediatric patients 12 years and older who have severe asthma with an eosinophilic phenotype
Reduces severe exacerbations of asthma, and with maintenance treatment, may allow for oral corticosteroid dose reduction
Indications
Indicated for asthma maintenance add-on therapy in severe asthma (eosinophilic phenotype).
Contraindications
Hypersensitivity to benralizumab or any of its excipients
Adverse Effects
Headache (8%)
Pharyngitis (5%)
Pyrexia (3%)
Hypersensitivity reactions (3%)
Warnings
Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) reported; these reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days); discontinue if hypersensitivity occurs
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiating benralizumab; corticosteroid dose reductions, if appropriate, should be gradual and performed under the direct supervision of a physician; monitor for systemic withdrawal symptoms and/or unmasking of conditions previously suppressed by systemic corticosteroid therapy
Eosinophils may be involved in the immunological response to some helminth infections; unknown if benralizumab influences immunologic response against helminth infections; treat patients with preexisting helminth infections before initiating therapy; if parasitic infection occurs while receiving treatment and does not respond to antihelminth treatment, discontinue benralizumab until infection resolves
Avoid use in acute asthma symptoms or acute exacerbations; do not use to treat acute bronchospasm or status asthmaticus
Pregnancy and Lactation
Monoclonal antibodies are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy
No information is available regarding the presence of benralizumab in human or animal milk, and the effects of benralizumab on the breastfed infant and on milk production are not known
Maximum Dosage
30 mg/dose subcutaneously.
30 mg/dose subcutaneously.
30 mg/dose subcutaneously.
12 years: 30 mg/dose subcutaneously.
1 to 11 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Benralizumab
solution for SC injection (single-dose prefilled syringe)
- 30mg/mL (single-dose prefilled syringe or autoinjector pen)
