10/21/2023

Asparaginase Erwinia chrysanthemi

Products Affected - Description

- Erwinaze lyophilized powder for injection, Clinigen, 10,000 unit, vial, 1 count, NDC 57902-0249-01
- Erwinaze lyophilized powder for injection, Clinigen, 10,000 unit, vial, 5 count, NDC 57902-0249-05

Reason for the Shortage

- Erwinaze supply disruption is due to ongoing manufacturing issues and capacity constraints at Porton Biopharma Limited (PBL), the sole manufacturer of Erwinaze.
- Jazz Pharmaceuticals has Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) available through specialty distributors. Additional information can be found at https://www.rylaze.com/ordering-information.

Available Products

- Rylaze solution for injection, Jazz Pharmaceuticals, 10 mg, 0.5 mL single dose vial, 3 count, NDC 68727-0900-03

Estimated Resupply Dates

- Clinigen is not currently supplying Erwinaze and the company cannot estimate when product will be available again.

Implications for Patient Care

- As of mid-December 2021, Clinigen is no longer providing Erwinase for personal importation

Updated

Updated October 21, 2023 by Elyse MacDonald, PharmD, MS, BCPS. Created October 11, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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