Miscellaneous immune disorders:
Indications for BENLYSTA:
Active, autoantibody-positive systemic lupus erythematosus (SLE) in patients receiving standard therapy.
Limitations of Use:
Not evaluated in severe active lupus nephritis or CNS lupus.
Adults and Children:
For IV regimen (use vials only): give over 1hr; slower if infusion reaction occurs. <5yrs: not established. ≥5yrs: 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): inject into abdomen or thigh. <18yrs: not established. ≥18yrs: 200mg once weekly. 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. Depression. Suicidality. Assess patient's medical history, current psychiatric status prior to initiation and monitor during therapy. Reevaluate periodically. Malignancy. Elderly. Black/African American. Pregnancy. Advise females of reproductive potential should to effective contraception during and for ≥4mos after last dose. Nursing mothers.
B-lymphocyte stimulator (BLyS)-specific inhibitor.
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, psychiatric disorders, 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)