Products Affected - Description

• • Decitabine injection, Accord, 50 mg vial, 1 count, NDC 16729-0224-05
  • Decitabine injection, Amneal, 50 mg vial, 1 count, NDC 70121-1644-01
  • Decitabine injection, Dr. Reddy's, 50 mg vial, 1 count, NDC 55111-0556-10
  • Decitabine injection, Eugia US, 50 mg vial, 1 count, NDC 55150-0376-01
  • Decitabine injection, Hikma, 50 mg vial, 1 count, NDC 00143-9385-01
  • Decitabine injection, Ingenus Pharmaceuticals, 50 mg vial, 1 count, NDC 50742-0430-01
  • Decitabine injection, Sagent, 50 mg vial, 1 count, NDC 25021-0219-20
  • Decitabine injection, Sun Pharma, 50 mg vial, 1 count, NDC 47335-0361-41

Reason for the Shortage

• • Accord has decitabine on shortage due to manufacturing delays.
  • Amneal did not provide a reason for the shortage.
  • Cipla discontinued decitabine.
  • Dr. Reddy's did not provide a reason for the shortage.
  • Eugia did not provide a reason for the shortage.
  • Hikma did not provide a reason for the shortage.
  • Ingenus did not provide a reason for the shortage.
  • Meitheal has decitabine on shortage due to increased demand.
  • Sagent took over Athenex's product. Sagent did not provide a reason for the shortage.
  • Sun has decitabine on shortage due to manufacturing delays.
  • Viatris did not provide a reason for the shortage.
  • Otsuka discontinued Dacogen in late-2022.

Available Products

• • 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

• • Accord has decitabine 50 mg vials on back order and the company cannot estimate a release date.
  • Amneal has decitabine 50 mg vials on back order and the company cannot estimate a release date.
  • Dr. Reddy's has decitabine 50 mg vials on allocation.
  • Eugia has decitabine 50 mg vials on intermittent back order and the company is releasing product as it becomes available.
  • Hikma has decitabine 50 mg vials on allocation.
  • Ingenus has decitabine 50 mg vials on back order and the company cannot estimate a release date.
  • Sagent has decitabine 50 mg vials on allocation.
  • Sun Pharma has decitabine 50 mg vials on shortage and the company cannot estimate a release date.

• • 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.