Siltuximab

FDA Drug Profile — Sylvant

Drug Details

Generic Name
Siltuximab
Brand Names
Sylvant
Application Number
BLA125496
Sponsor
Recordati Rare Diseases, Inc.
NDC Codes
2
Dosage Forms
INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
SILTUXIMAB

Indications and Usage

1 INDICATIONS AND USAGE SYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. SYLVANT is an interleukin-6 (IL-6) antagonist indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. ( 1 ) Limitations of Use SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study. Limitations of Use SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study.