Reason for the Shortage

• • Fresenius Kabi had bleomycin on back order due to shortage of active pharmaceutical ingredient.[1]
  • Pfizer has bleomycin available.[2]
  • Teva has bleomycin available.[3]
  • FDA was allowing temporary importation of bleomycin sulfate powder for injection 15,000 IU (15 units bleomycin sulfate USP). These vials were manufactured for Amneal Australia. The labeling and bar coding for the imported product is different from the US version. The imported product should be used in the same way as the US product. FDA has the Dear Healthcare Professional letter linked on their website http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Bleomycin+Sulfate+for+Injection&panels=0&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery. The product should be available through major wholesalers while supplies last.[4]

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 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
  • Bleomycin sulfate lyophilized powder for solution for injection, Teva, 15 unit, vial, 1 count, NDC 00703-3154-01
  • Bleomycin sulfate lyophilized powder for solution for injection, Teva, 30 unit, vial, 1 count, NDC 00703-3155-01
  • Bleomycin sulfate powder for solution for injection, Amneal, 15 unit, vial, 1 count, NDC 70121-1561-01

• • All marketed presentations are available.

• • Bleomycin is a cytotoxic glycopeptide antibiotic. It is labeled for use in combination with other antineoplastic agents for the treatment of adults with squamous cell carcinomas (head and neck, cervical, penis, and vulva), testicular cancer, and Hodgkin or non-Hodgkin lymphoma. It is also labeled for use as a sclerosing agent for the treatment of malignant pleural effusion.[5-7]
  • Bleomycin is used off-label for a variety of neoplastic diseases including AIDS-related Kaposi sarcoma, osteosarcoma, mycosis fungoides, ovarian germ cell tumors, and intracranial germ cell tumors. It has also been used off-label in children to treat lymphomas, testicular carcinoma, germ cell tumors, and sclerosis of pleural effusions.[5-7]
  • Refer to national guidelines such as those from the National Comprehensive Cancer Network (www.nccn.org) or American Society of Clinical Oncology (www.asco.org) for additional information regarding therapeutic use

• • Chemotherapy agents, such as bleomycin, pose additional safety risks both for patients and for healthcare workers handling these agents.[5-7]
  • Use additional caution when processing orders for chemotherapy drugs, especially when switching between chemotherapy agents or when processing orders for chemotherapy agents with which staff may be unfamiliar (eg, those not normally prescribed at a specific institution).[5-7]

• • 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.[5-7]
  • 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.
  • 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. http://www.ashp.org/DocLibrary/Policy/DrugShortages/ASHP_shortage_guide09.pdf

• 1. Fresenius Kabi (personal communications). April 13, 18, and 27, August 3, September 2 and 28, October 27, November 21, 2016; January 4, March 10, April 13, June 2, July 6, and August 24, 2017.
  2. Pfizer (personal communications). April 13, 18, and 27, August 11, September 7, October 4, November 4 and 22, 2016; January 12, March 14, April 7, June 2, July 10, and August 28, 2017.
  3. Teva (personal communications). April 13, 18, and 27, August 11, October 3 and 21, 2016; January 10, March 6, June 13, and August 28, 2017.
  4. FDA (website). Accessed on July 13, 2016.
  5. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 839-1281.
  6. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. (http://online.factsandcomparisons.com/index.aspx). March 2015.
  7. Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.