BENLYSTA (belimumab) injection

BENLYSTA (Belimumab)

BENLYSTA

belimumab

Inj-120 mg or 400 mg ;for Subcutaneous Inj-200 mg/mL

Human Genome Sciences, Inc.

Medical Use

Benlysta (belimumab) is a B-lymphocyte stimulator (BLyS)-specific inhibitor used to treat:

  • -Patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.
  • -Adults with active lupus nephritis (LN) who are receiving standard therapy.

Limitations of Use: Benlysta’s efficacy has not been evaluated in patients with severe active central nervous system lupus, nor has it been assessed in combination with other biologics. Therefore, its use is not recommended in these scenarios.

Recommended Dosage:

  • -Intravenous (IV) Administration:
    • For adults with SLE or lupus nephritis and pediatric patients with SLE: The recommended IV dosage is 10 mg/kg at 2-week intervals for the first 3 doses, followed by 4-week intervals. Reconstitute, dilute, and administer as an IV infusion over 60 minutes. The infusion rate may be slowed or interrupted if an infusion reaction occurs. Stop the infusion immediately if a severe hypersensitivity reaction occurs.
  • -Subcutaneous (SC) Administration:
    • For adults with SLE: The recommended dosage is 200 mg once weekly, administered as an SC injection in the abdomen or thigh. SC dosing is not weight-based. If transitioning from IV to SC administration, give the first SC dose 1-4 weeks after the last IV dose.
    • For adults with lupus nephritis: The recommended dosage is 400 mg (two 200 mg injections) once weekly for the first 4 doses, then 200 mg once weekly thereafter. Administer the dose via SC injection in the abdomen or thigh. Transition from IV to SC therapy can occur any time after completing the first 2 IV doses, with the first SC dose given 1-2 weeks after the last IV dose.