Products Affected - Description

• • Mitomycin lyophilized powder for injection, Accord, 20 mg vial, 1 count, NDC 16729-0108-11
  • Mitomycin lyophilized powder for injection, Accord, 40 mg vial, 1 count, NDC 16729-0116-38
  • Mitomycin lyophilized powder for injection, Accord, 5 mg vial, 1 count, NDC 16729-0115-05
  • Mitomycin lyophilized powder for injection, Eugia US, 20 mg vial, 1 count, NDC 55150-0451-01
  • Mitomycin lyophilized powder for injection, Eugia US, 40 mg vial, 1 count, NDC 55150-0452-01
  • Mitomycin lyophilized powder for injection, Eugia US, 5 mg vial, 1 count, NDC 55150-0450-01
  • Mitomycin lyophilized powder for injection, Hikma, 40 mg vial, 1 count, NDC 00143-9280-01

Reason for the Shortage

• • Accord has mitomycin injection on shortage due to manufacturing delays.
  • Archis has mitomycin injection available.
  • Eugia did not provide a reason for the shortage.
  • Hikma did not provide a reason for the shortage.
  • Fresenius Kabi has mitomycin injection available.
  • Meitheal has mitomycin injection available.
  • Sagent has mitomycin injection available.

Available Products

• • Mitomycin lyophilized powder for injection, Archis Pharma, 20 mg vial, 1 count, NDC 72819-0153-02
  • Mitomycin lyophilized powder for injection, Archis Pharma, 40 mg vial, 1 count, NDC 72819-0154-04
  • Mitomycin lyophilized powder for injection, Archis Pharma, 5 mg vial, 1 count, NDC 72819-0152-95
  • Mitomycin lyophilized powder for injection, Fresenius Kabi, 20 mg vial, 1 count, NDC 65219-0566-20
  • Mitomycin lyophilized powder for injection, Fresenius Kabi, 40 mg vial, 1 count, NDC 65219-0568-00
  • Mitomycin lyophilized powder for injection, Fresenius Kabi, 5 mg vial, 1 count, NDC 65219-0564-20
  • Mitomycin lyophilized powder for injection, Hikma, 20 mg vial, 1 count, NDC 00143-9279-01
  • Mitomycin lyophilized powder for injection, Meitheal Pharmaceuticals, 20 mg vial, 1 count, NDC 71288-0138-50
  • Mitomycin lyophilized powder for injection, Meitheal Pharmaceuticals, 40 mg vial, 1 count, NDC 71288-0139-51
  • Mitomycin lyophilized powder for injection, Meitheal Pharmaceuticals, 5 mg vial, 1 count, NDC 71288-0137-20
  • Mitomycin lyophilized powder for injection, Sagent, 20 mg vial, 1 count, NDC 25021-0251-50
  • Mitomycin lyophilized powder for injection, Sagent, 40 mg vial, 1 count, NDC 25021-0252-51
  • Mitomycin lyophilized powder for injection, Sagent, 5 mg vial, 1 count, NDC 25021-0250-20

• • Accord has mitomycin 5 mg vials on intermittent back order with regular releases. The 20 mg and 40 mg vials are on intermittent back order with allocations on release.
  • Eugia has mitomycin 5 mg, 20mg, and 40 mg vials on intermittent back order and the company is releasing product as it becomes available.
  • Hikma has mitomycin 40 mg vials on allocation.

• • Consider evaluating the health-care system's total supply of mitomycin before beginning patients on combination chemotherapy regimens containing mitomycin. 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 mitomycin.
  • 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.