Products Affected - Description

• • Bleomycin sulfate, Hikma, 30 unit, vial, 1 count, NDC 00143-9241-01

Reason for the Shortage

• • Fresenius Kabi did not provide a reason for the shortage.
  • Hikma did not provide a reason for the shortage.
  • Pfizer had bleomycin on shortage due to increased demand and manufacturing delays.
  • Teva has bleomycin temporarily suspended with no estimated date to resume manufacturing.

Available Products

• • Bleomycin sulfate lyophilized powder for solution for injection, Fresenius Kabi, 15 unit, vial, 1 count, NDC 63323-0136-10
  • Bleomycin sulfate lyophilized powder for solution for injection, Fresenius Kabi, 30 unit, vial, 1 count, NDC 63323-0137-20
  • Bleomycin sulfate, Hikma, 15 unit, vial, 1 count, NDC 00143-9240-01
  • Bleomycin sulfate, Meitheal Pharmaceuticals, 15 unit, vial, 1 count, NDC 71288-0106-10
  • Bleomycin sulfate, Meitheal Pharmaceuticals, 30 unit, vial, 1 count, NDC 71288-0107-20
  • Bleomycin sulfate lyophilized powder for solution for injection, Pfizer, 15 unit, vial, 1 count, NDC 61703-0332-18
  • Bleomycin sulfate lyophilized powder for solution for injection, Pfizer, 30 unit, vial, 1 count, NDC 61703-0323-22

• • Hikma has short-dated bleomycin 30 unit vials available with an expiration date of July 2024 and January 2025.

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