Last Updated: January 23, 2015
Products Affected - Description
There are no presentations affected.
Reason for the Shortage
- Fresenius Kabi states bleomycin was on shortage due to increased demand.1
- Hospira states bleomycin was in short supply due to manufacturing delays.2
- Teva states bleomycin was on shortage due to increased demand.3
Bleomycin injection, Fresenius Kabi
15 unit vial (NDC 63323-0136-10)
Bleomycin injection, Hospira
15 unit vial (NDC 61703-0332-18)
15 unit vial (NDC 00703-3154-01)
30 unit vial (NDC 00703-3155-01)
Estimated Resupply Dates
All presentations are currently available.
Implications for Patient Care
- Bleomycin is an antineoplastic antibiotic. It is labeled for use as a single agent or in combination with other antineoplastic agents for the treatment of adults with Hodgkin disease; non-Hodgkin lymphoma; testicular cancer; or squamous cell carcinoma (palliative therapy), including head and neck cancer or cervical cancer. It is also labeled for the treatment of malignant pleural effusion as a sclerosing agent.4,5
- Bleomycin is used off-label for a variety of neoplastic diseases in adults including mycosis fungoides, osteosarcoma, and Kaposi sarcoma (AIDS-related). 4,5It has also been used off-label in children for lymphomas, testicular cancer, and pleural effusions.4
- Chemotherapy agents, such as bleomycin, pose additional safety risks both for patients and for healthcare workers handling these agents.4
- 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).4
Alternative Agents & Management
- 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.4,5
- 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.
- Asparaginase Injection — No Longer Available
- Bendamustine Injection — Resolved
- Busulfan — Resolved
- Capecitabine Tablets — Resolved
- Carboplatin Solution for Injection — Current
- Carmustine Injection — Resolved
- Cisplatin Injection — Current
- Cyclophosphamide Injection — Resolved
- Cyclophosphamide Tablets — No Longer Available
- Cytarabine Injection — Resolved
- Dacarbazine Injection — Current
- Dactinomycin Injection — Resolved
- Daunorubicin Hydrochloride Injection — Current
- Denileukin Diftitox Injection — No Commercially Available Preparations
- Doxorubicin Injection — Current
- Doxorubicin Liposomal Injection — Current
- Etoposide Injection — Resolved
- Fludarabine Injection — Resolved
- Fluorouracil Injection — Resolved
- Gemtuzumab Ozogamicin Injection — No Longer Available
- Idarubicin Hydrochloride Injection — Resolved
- Interferon Alpha-2b, Intron A — Resolved
- Irinotecan Injection — Resolved
- Leuprolide Acetate 14-Day Kit — Current
- Lomustine Capsules — Resolved
- Mercaptopurine Tablets — Current
- Methotrexate Injection — Current
- Methotrexate Tablets — Resolved
- Mitomycin Injection — Resolved
- Paclitaxel Injection — Current
- Pentostatin Injection — Resolved
- Streptozocin For Injection — Resolved
- Tamoxifen Tablets — Current
- Thiotepa for Injection — Current
- Tretinoin Oral Capsules — Resolved
- Vinblastine Injection — Resolved
- Vincristine Injection — Resolved
- Hospira (personal communications and website). July 29, August 21, September 18, October 2, November 10 and 21, December 12, 2014; and January 23, 2015.
- Teva (personal communications). July 28, August 21, September 5 and 30, October 3, November 10 and 21, December 17, 2014; and January 23, 2015.
- Fresenius Kabi (personal communications). July 28, August 19, September 5, 8, 12, 16, and 22, November 12 and 21, and December 15, 2014; and January 20, 2015.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2014 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2014: 917-921.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. July 2014.
Updated January 23, 2015 by Michelle Wheeler, PharmD, Drug Information Specialist. Created September 8, 2010, by Michelle M. Wheeler, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.