asparaginase erwinia chrysanthemi (recombinant)-rywn

FDA Drug Profile — Rylaze

Drug Details

Generic Name
asparaginase erwinia chrysanthemi (recombinant)-rywn
Brand Names
Rylaze
Application Number
BLA761179
Sponsor
Patheon Manufacturing Services LLC
NDC Codes
2
Dosage Forms
INJECTION
Routes
INTRAMUSCULAR
Active Ingredients
ASPARAGINASE

Indications and Usage

1 INDICATIONS AND USAGE RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. RYLAZE is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. ( 1 )