The Food and Drug Administration (FDA) has posted an announcement regarding a shortage of Erwinaze (asparaginase Erwinia chrysanthemi Jazz) 10,000 IU.
The shortage affects Erwinaze 10,000 IU lyophilized powder supplied in 3mL glass vials in both the 1-count (NDC 57902-249-01) and 5-count (NDC 57902-249-05) cartons. The product is delayed pending inclusion of additional special handling instructions. This update is applicable for intramuscular administration only and the use of a 5-micron filter needle.
Erwinaze, an asparagine-specific enzyme, is indicated as a component 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. It can be administered as an intramuscular or intravenous injection after reconstitution.
Jazz Pharmaceuticals and the FDA are working to make Erwinaze available as soon as possible. Updates on the supply will be made on the product website as the Company is able.
For more information call (800) 520-5568 or visit Erwinze.com.