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Generic Name for BENLYSTA
Belimumab 120mg/vial, 400mg/vial; pwd for IV infusion after reconstitution and dilution.
Legal Classification:
Rx
Pharmacological Class for BENLYSTA
Human IgG1gamma monoclonal antibody.
Manufacturer of BENLYSTA
Human Genome Sciences and GlaxoSmithKline
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Indications for BENLYSTA
Systemic lupus erythematosus, in adults with active, autoantibody-positive SLE on standard therapy.
Adult dose for BENLYSTA
Give by IV infusion over 1 hour; slower if infusion reaction occurs. 10mg/kg every 2 weeks for 3 doses, then 10mg/kg every 4 weeks. May premedicate for infusion/hypersensitivity reactions (eg, APAP, diphenhydramine).
Children's dosing for BENLYSTA
Not recommended.
Warnings/Precautions for BENLYSTA
Severe active lupus nephritis or CNS lupus: not recommended. More deaths reported with Benlysta than placebo in clinical trials. Supervise infusion; have resuscitative equipment and trained personnel available in case of infusion/hypersensitivity reactions. Chronic infections: do not start therapy; if initiated, consider suspending if new infections develop and monitor closely. Monitor for malignancies, depression or other mood changes. Elderly. Black/African American. Pregnancy (Cat. C). Nursing mothers: not recommended.
Interactions for BENLYSTA
Immunizations (may get suboptimal response); avoid live vaccines for 30 days prior to and during treatment. Concomitant other biologicals or IV cyclophosphamide: not recommended.
Adverse Reactions for BENLYSTA
Infections (eg, URI, UTI, nasopharyngitis, sinusitis, bronchitis, influenza; may be serious/fatal), psychological effects (eg, depression, insomnia, anxiety, suicide), GI upset, fever, migraine, extremity pain, infusion and/or hypersensitivity reactions.
How is BENLYSTA supplied?
Single-use vials (120mg in 5mL, 400mg in 20mL)—1