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. Risk of depression and 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 to use effective contraception during and for ≥4mos after the 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)