Erwinaze Gains IV Administration Approval

Erwinaze Gains IV Administration Approval
Erwinaze Gains IV Administration Approval

Jazz Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved the intravenous (IV) administration of Erwinaze (asparaginase Erwinia chrysantheum). Prior to this approval, Erwinaze was intended for use via intramuscular injection.

Erwinaze is indicated as part of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.

RELATED: Acute Lymphoblastic Leukemia Drug Designated Breakthrough Therapy

Erwinaze is an asapargine-specific enzyme that works by catalyzing the deamidation of asparagine to aspartic acid and ammonia, resulting in a reduction in circulating levels of asparagine. Its mechanism is thought to be based on the inability of leukemic cells to synthesize asparagine due to lack of asparagine synthetase activity, resulting in cytotoxicity specific for leukemic cells that depend on an exogenous source of the amino acid asparagine for their protein metabolism and survival.

Erwinaze is available as a lyophilized powder containing 10,000 IU in 3mL vials in 5-count cartons.

For more information call (800) 833-3533 or visit Erwinaze.com.

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