Select therapeutic use:
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.
Give by IV infusion 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.
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: not recommended.
Concomitant with other biologics, IV cyclophosphamide: not recommended. Immunizations (may get suboptimal response); avoid live vaccines for 30 days prior to and during treatment.
Human IgG1gamma monoclonal antibody.
Nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis; serious infections (may be fatal), PML, malignancies, infusion and/or hypersensitivity reactions.
To register pregnant women exposed to Benlysta call (877) 681-6296.
Single-use vials (120mg in 5mL, 400mg in 20mL)—1