- Medicine Name: Benlysta
- API: Belimumab
- Dosage Form & Strength: Injections: 120 mg or 400 mg/vial (for IV use) and 200 mg/mL (for SC use)
- Manufactured By: Human Genome Sciences, Inc.
Benlysta (belimumab) is a B-lymphocyte stimulator (BLyS)-specific inhibitor used for the treatment of:
- 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: The efficacy of this therapeutic drug has not been evaluated in patients with severe active central nervous system lupus. This drug has not been assessed along with other biologics. The use of Benlysta is not recommended in these scenarios.
Recommended Dosage: Benlysta may be administered as an intravenous (IV) infusion in patients aged 5 years and older or as a subcutaneous (SC) injection in patients aged 18 years and older. Benlysta vials are intended for IV use only (not for SC use) and autoinjectors and prefilled syringes are intended for SC use only (not for IV use).
Intravenous Administration in Adults with SLE or Lupus Nephritis and Pediatric Patients with SLE: The recommended IV dosage regimen is 10 mg/kg at 2-week intervals for the initial 3 doses and at 4-week intervals thereafter. Reconstitute, dilute and administer as an IV infusion over a period of 60 minutes. The rate of infusion may be slowed or interrupted in case of an infusion reaction. The infusion must be stopped promptly if the patient experiences a critical hypersensitivity reaction.
Subcutaneous (SC) Administration in Adults with SLE: The recommended dosage is 200 mg once weekly given as an SC injection in the abdomen or thigh. SC dosing is not based on weight. If transitioning from IV therapy with Benlysta to SC administration, administer the first SC dose 1-4 weeks after the last IV dose.
Subcutaneous (SC) Administration in Adults with Lupus Nephritis: The recommended dosage regimen is a 400 mg dose (two 200-mg injections) once weekly for 4 doses, then 200 mg once weekly thereafter. The dose is given via SC injection in the abdomen or thigh. A patient with lupus nephritis may transition from IV therapy with Benlysta to SC therapy any time after the patient completes the first 2 IV doses. In case of transitioning, administer the first SC dose of 200 mg 1-2 weeks after the final intravenous (IV) dose.
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