Asparaginase (1 brand name, 1 dosage form, 0 routes)
Available dosage forms: VIAL.
Brand Names
- ELSPAR
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.
Contraindications
RYLAZE is contraindicated in patients with: •History of serious hypersensitivity reactions to Erwinia asparaginase, including anaphylaxis [see Warnings and Precautions (5.1)]; •History of serious pancreatitis during previous asparaginase therapy [see Warnings and Precautions (5.2)]; •History of serious thrombosis during previous asparaginase therapy [see Warnings and Precautions (5.3)]; •History of serious hemorrhagic events during previous asparaginase therapy [see Warnings and Precautions (5.4)]; •Severe hepatic impairment [see Warnings and Precautions (5.5)].
Adverse Reactions
The following clinically significant adverse reactions are described in greater detail in other sections of the labeling: •Hypersensitivity Reactions [see Warnings and Precautions (5.1)] •Pancreatic Toxicity [see Warnings and Precautions (5.2)] •Thrombosis [see Warnings and Precautions (5.3)] •Hemorrhage [see Warnings and Precautions (5.4)] •Hepatotoxicity, including VOD [see Warnings and Precautions (5.5)]
Mechanism of Action
Asparaginase erwinia chrysanthemi (recombinant)-rywn is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect of RYLAZE is based on the killing of leukemic cells due to depletion of plasma asparagine. Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize asparagine, and therefore depend on an exogenous source of asparagine for survival.