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.
Supervise 1st SC inj. Intravenous use should be administered by healthcare providers. Have resuscitative equipment and trained personnel available to manage infusion/hypersensitivity reactions. Risk of severe or chronic infections; consider interrupting if new infection develops during treatment and monitor closely. Evaluate if new-onset or deteriorating neurological signs/symptoms develop; consider discontinuing 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. 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.
Generic Drug Availability:
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)