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Rylaze FDA Approval History

Last updated by Judith Stewart, BPharm on July 1, 2021.

FDA Approved: Yes (First approved June 30, 2021)
Brand name: Rylaze
Generic name: asparaginase erwinia chrysanthemi (recombinant)-rywn
Dosage form: Injection
Company: Jazz Pharmaceuticals plc
Treatment for: Acute Lymphoblastic Leukemia

Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) 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).

  • Rylaze is for use in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.
  • Rylaze is administered via intramuscular injection.
  • Common adverse reactions include abnormal liver test, nausea, musculoskeletal pain, fatigue, infection, headache, pyrexia, drug hypersensitivity, febrile neutropenia, decreased appetite, stomatitis, bleeding and hyperglycemia.

Development timeline for Rylaze

DateArticle
Jun 30, 2021Approval FDA Approves Rylaze for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Further information

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