Generic Name and Formulations:
Belimumab 120mg/vial, 400mg/vial; pwd for IV infusion after reconstitution and dilution; 200mg/mL prefilled autoinjector or syringe; soln for SC inj; preservative-free.
Indications for BENLYSTA:
Systemic lupus erythematosus, in adults with active, autoantibody-positive SLE on standard therapy. Limitations of use: not evaluated in severe active lupus nephritis or CNS lupus.
For IV regimen (use vials only): give over 1hr; slower if infusion reaction occurs. 10mg/kg every 2 weeks for 3 doses, then 10mg/kg every 4 weeks. May consider premedication for infusion/hypersensitivity reactions prior to initiation. For SC regimen (use prefilled autoinjector or syringe only): 200mg once weekly in the abdomen or thigh. Transitioning from IV to SC: give first SC dose 1–4 weeks after last IV dose.
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. Severe or chronic infections; consider interrupting if new infections develop during treatment and monitor closely. Evaluate if new-onset or deteriorating neurological signs/symptoms develop; discontinue if progressive multifocal leukoencephalopahy (PML) is confirmed. Monitor for malignancies, depression or other mood changes. Elderly. Black/African American. Pregnancy. Females of reproductive potential should use effective contraception during and for ≥4mos after last dose. Nursing mothers.
Human IgG1gamma monoclonal antibody.
Concomitant with other biologics, IV cyclophosphamide: not recommended. Immunizations (may get suboptimal response); avoid live vaccines for 30 days prior to and during treatment.
Nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, inj site reactions (SC form); serious infections (may be fatal), PML, malignancies, infusion and/or hypersensitivity reactions.
To register pregnant women exposed to Benlysta call (877) 681-6296.
Single-dose vial (120mg in 5mL, 400mg in 20mL)—1; single-dose prefilled autoinjector (200mg/mL)—4 (w. needle); single-dose prefilled syringe (200mg/mL)—4 (w. needle)