Miscellaneous immune disorders:

Indications for: BENLYSTA

Active systemic lupus erythematosus (SLE) or active lupus nephritis in patients ≥5yrs receiving standard therapy.

Limitations of Use:

Not evaluated in severe active CNS lupus.

Adults and Children:

For IV regimen (use vials only): give over 1hr; slower if infusion reaction occurs. <5yrs: not established. ≥5yrs (SLE or lupus nephritis): 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 autoinjectors or syringes only): inject into abdomen or thigh. <18yrs: not established. ≥18yrs (SLE): 200mg once weekly; (lupus nephritis): 400mg (two 200mg injections) once weekly for 4 doses, then 200mg once weekly thereafter. Transitioning from IV to SC: (SLE) give first SC dose 1–4 weeks after last IV dose; (lupus nephritis): give first SC dose 1–2 weeks after last IV dose.

BENLYSTA Warnings/Precautions:

Supervise 1st SC inj. Intravenous use should be administered by healthcare providers. Have resuscitative equipment available to manage infusion/hypersensitivity reactions. Discontinue immediately if a serious hypersensitivity reaction occurs. Infusion rate may be slowed or interrupted if infusion-related reactions occur. Severe or chronic infections. Consider interrupting if new infection develops during treatment; 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. Pregnancy. Advise females of reproductive potential to use effective contraception during and for ≥4mos after the last dose. Nursing mothers.

BENLYSTA Classification:

B-lymphocyte stimulator (BLyS)-specific inhibitor.

BENLYSTA Interactions:

Concomitant IV cyclophosphamide: not recommended. Caution when concomitant with other biologics. Immunizations (may get suboptimal response); avoid live vaccines for 30 days prior to and during treatment.

Adverse Reactions:

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.

Note:

To register pregnant women exposed to Benlysta call (877) 681-6296.

Drug Elimination:

Half-life: 19.4 days (IV); 18.3 days (SC).

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (120mg/5mL, 400mg/20mL)—1; single-dose prefilled autoinjector (200mg/mL)—4 (w. needle); single-dose prefilled syringe (200mg/mL)—4 (w. needle)