Anifrolumab-fnia
Drug Details
- Generic Name
- Anifrolumab-fnia
- Brand Names
- SAPHNELO
- Application Number
- BLA761123
- Sponsor
- AstraZeneca Pharmaceuticals LP
- NDC Codes
- 1
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- ANIFROLUMAB
Indications and Usage
1 INDICATIONS AND USAGE SAPHNELO (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy [see Clinical Studies (14) ] . Limitations of Use The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations. SAPHNELO is a type I interferon (IFN) receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. ( 1 ) Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations. ( 1 )