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Bleomycin Injection

[13 June 2012]

Products Affected - Description

Bleomycin injection

Reason for the Shortage

  • Bedford discontinued bleomycin in May, 2011 to concentrate on the manufacturing of other products.1
  • Hospira states bleomycin was in short supply due to increased demand for the product.2
  • Teva states bleomycin was on shortage due to manufacturing delays.3
  • Bristol-Myers Squibb has discontinued both Blenoxane 15 and 30 unit vials.4

Available Products

Bleomycin injection, Teva-Sicor
15 unit vial (NDC 00703-3154-01)
30 unit vial (NDC 00703-3155-01)

Bleomycin injection, APP5
15 unit vial (NDC 63323-0136-10)
30 unit vial (NDC 63323-0137-20)
 
Bleomycin injection, Hospira2
15 unit vial (NDC 61703-0332-18)
30 unit vial (NDC 61703-0323-22)

Estimated Resupply Dates

All presentations are 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.6-8
  • Bleomycin is used off-label for a variety of neoplastic diseases in adults including mycosis fungoides, osteosarcoma, and Kaposi sarcoma (AIDS-related). It has also been used off-label in children for lymphomas, testicular cancer, and pleural effusions.6-8

Safety

  • Chemotherapy agents, such as bleomycin, pose additional safety risks both for patients and for healthcare workers handling these agents.6,7
  • 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).6,7

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.6-8
  • 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.

Related Shortages

References

  1. Bedford (personal communications). March 15, April 24, May 7, June 11 and 29, July 25, August 20, September 17, October 3, November 14, 2007; February 11, March 4, April 14, May 28, July 9, August 11, October 6 and 16, November 11, December 15, 2008; January 12, February 18, March 16, April 27, June 1, July 22 and 30, September 14, November 17, 2009; January 21, March 25 and 30, May 21, July 6, August 2, September 7, October 21, November 2 and 24, 2010; January 3, April 4, and May 3, 2011.
  2. Hospira (personal communications). March 15, April 24, May 7, June 11 and 29, July 25, August 20, September 17, 2007; February 11, March 4, April 14, May 28, July 9, August 11, October 6 and 16, November 11, December 15, 2008; January 12, February 18, April 28, June 1, July 22 and 30, September 14, November 6 and 17, 2009; January 21, March 24, May 21, June 7, July 8, August 5, September 7, October 22, November 3, and December 1, 2010; January 3, February 14, March 23, April 5, May 23, June 16, July 11, August 2 and 16, September 5, 15, and 27, October 18, and November 1 and 29, 2011; January 17, February 20 and 23, March 5, April 2, June 5 and 13, 2012.
  3. Teva (personal communications). March 15, April 24, May 7, June 11 and 29, July 25, August 20, September 17, 2007; February 11, March 4, April 14, May 28, July 10, August 11, October 6, November 11, December 15, 2008; January 12, February 18, March 17, April 27, June 1, July 22, September 14, November 17, 2009; January 21, March 25, May 21, July 6, August 2, September 7 and 28, October 20, and November 24, 2010; January 3 and 24, and February 15 and 25, March 22, April 4, May 4 and 31, June 14, August 3 and 18, September 7 and 27, October 17, and November 1 and 28, 2011; January 17, February 22, April 2, and June 5, 2012.
  4. Bristol-Myers Squibb (personal communications). March 15, April 24, May 7, June 11 and 29, July 25, August 20, September 17, 2007.
  5. APP (personal communications). February 18, March 16, April 27, June 1, July 22 and 29, September 14, November 6 and 17, 2009; January 21, March 25 and 30, May 21, June 8, July 6, August 4, September 8 and 30, October 22, November 3, December 2, 2010; January 7, February 16, March 2 and 25, June 8, July 11, August 3 and 16, September 7 and 16, October 17, and November 3, 2011; February 21, March 5, April 4, and June 4, 2012.
  6. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
  7. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
  8. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010.

Updated

Updated June 13, 2012, by Megan Dryer, Pharm.D., Drug Information Specialist. Created September 8, 2010, by Michelle M. Wheeler, Pharm.D., and M. Christina Beckwith, Pharm.D., Drug Information Specialists. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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