Transcription of Saphnelo full Prescribing Information
{{id}} {{{paragraph}}}
Example: confidence
Saphnelo full Prescribing Information
HIGHLIGHTS OF Prescribing Information These highlights do not include all the Information needed to use SAPHNELOTM safely and effectively. See full Prescribing Information for (anifrolumab-fnia) injection, for intravenous useInitial Approval: 2021--------------------------------- INDICATIONS AND USAGE ---------------------------------SAPHNEL O 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)----------------------------- DOSAGE AND ADMINISTRATION ------------------------------The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks.
The population studied had a mean age of 41 years (range: 18 to 69), of which 93% were female, 60% White, 13% Black/African American, and 10% Asian. In the controlled-clinical trials, adverse reactions, irrespective of causality, were . reported in 87% of patients receiving SAPHNELO and 79% of patients receiving placebo.
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: