belimumab
Drug Details
- Generic Name
- belimumab
- Brand Names
- BENLYSTA
- Application Number
- BLA125370
- Sponsor
- Hospira, Inc.
- NDC Codes
- 5
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, SOLUTION, LIQUID
- Routes
- INTRAVENOUS, SUBCUTANEOUS
- Active Ingredients
- BELIMUMAB
Indications and Usage
1 INDICATIONS AND USAGE BENLYSTA is indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and • Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation. BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy; ( 1 ) • Active lupus nephritis who are receiving standard therapy. ( 1 ) Limitations of Use: The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system lupus. Use of BENLYSTA is not recommended in this situation. ( 1 )