emicizumab

FDA Drug Profile — Hemlibra

Drug Details

Generic Name
emicizumab
Brand Names
Hemlibra
Application Number
BLA761083
Sponsor
Genentech, Inc.
NDC Codes
8
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
EMICIZUMAB, EMICIZUMAB-KXWH

Indications and Usage

1 INDICATIONS AND USAGE HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. HEMLIBRA is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. ( 1 )