nivolumab

FDA Drug Profile — OPDIVO

Drug Details

Generic Name
nivolumab
Brand Names
OPDIVO
Application Number
BLA125554
Sponsor
E.R. Squibb & Sons, L.L.C.
NDC Codes
6
Dosage Forms
INJECTION, INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
NIVOLUMAB

Indications and Usage

1 INDICATIONS AND USAGE OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. (1)