c1 esterase inhibitor recombinant

FDA Drug Profile — Ruconest

Drug Details

Generic Name
c1 esterase inhibitor recombinant
Brand Names
Ruconest
Application Number
BLA125495
Sponsor
Pharming Healthcare Inc.
NDC Codes
1
Dosage Forms
INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
CONESTAT ALFA

Indications and Usage

1 INDICATIONS AND USAGE RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks. RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). ( 1 ) Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks.