Skip to main content

Decitabine Injection Shortage

Last Updated: December 5, 2024
Status: Current

Products Affected - Description
    • Decitabine injection, Amneal, 50 mg vial, 1 count, NDC 70121-1644-01 - discontinued
    • Decitabine injection, Eugia US, 50 mg vial, 1 count, NDC 55150-0376-01
    • Decitabine injection, Ingenus Pharmaceuticals, 50 mg vial, 1 count, NDC 50742-0430-01 - discontinued
    • Decitabine injection, Sun Pharma, 50 mg vial, 1 count, NDC 47335-0361-41 - discontinued
Reason for the Shortage
    • Accord has decitabine injection available.
    • Amneal discontinued decitabine in mid-2024.
    • Cipla discontinued decitabine.
    • Dr. Reddy's has decitabine injection available.
    • Eugia did not provide a reason for the shortage.
    • Hikma did not provide a reason for the shortage.
    • Ingenus discontinued decitabine in June 2024.
    • Meitheal has decitabine injection available.
    • Sagent has decitabine injection available.
    • Sun discontinued decitabine in 2024.
    • Viatris has decitabine injection available.
    • Otsuka discontinued Dacogen in late-2022.
Available Products
    • Decitabine injection, Accord, 50 mg vial, 1 count, NDC 16729-0224-05
    • Decitabine injection, Dr. Reddy's, 50 mg vial, 1 count, NDC 55111-0556-10
    • Decitabine injection, Hikma, 50 mg vial, 1 count, NDC 00143-9385-01
    • Decitabine injection, Meitheal Pharmaceuticals, 50 mg vial, 1 count, NDC 71288-0119-20
    • Decitabine injection, Mylan Institutional (Viatris), 50 mg vial, 1 count, NDC 67457-0316-25
    • Decitabine injection, Sagent, 50 mg vial, 1 count, NDC 25021-0219-20

Estimated Resupply Dates

    • Eugia has decitabine 50 mg vials on intermittent back order and the company is releasing product as it becomes available.

Alternative Agents & Management

    • Consider evaluating the health-care system's total supply of decitabine before beginning patients on combination chemotherapy regimens containing decitabine. If adequate supplies are not available, select an alternative regimen.
    • The choice of an alternative agent must be patient-specific and based on renal function, liver function, and the neoplasm type and location. No single agent can be substituted for decitabine.
    • Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
    • Refer to the ASHP Guidelines on Managing Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/managing-drug-product-shortages.pdf
    • Refer to national guidelines such as those from the National Comprehensive Cancer Network (www.nccn.org) or American Society of Clinical Oncology (http://www.asco.org/) for additional information regarding therapeutic use.
    • Taiho Oncology has Inqovi (decitabine 35 mg/cedazuridine 100 mg) tablets available.

Updated

Updated December 5, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 2, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.