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Last Updated: March 7, 2012
Status: Resolved

Products Affected - Description

Busulfex injection, 6 mg/mL, Otsuka American Pharmaceutical, Inc.

10 mL vial, package of 8 (NDC 59148-0070-91) 

Reason for the Shortage

  • Otsuka states the reason for the shortage is manufacturing delay.1
  • Prasco acquired GlaxoSmithKline’s Myleran oral tablets in September, 2011. GlaxoSmithKline states supplies were limited due to increased demand.2,3

Available Products

Myleran oral tablets, 2 mg, Prasco3
25 count package (NDC 00173-0713-25)

Estimated Resupply Dates

Otsuka has Busulfex injection available for drop shipment. Submit orders through wholesalers for drop shipment.1 The company has no plans to change the distribution method from the current drop shipment requirement.1

Implications for Patient Care

Busulfan is an alkylating agent. Busulfan injection labeled for use in allogeneic hematopoietic stem cell transplantation for chronic myelocytic leukemia, in combination with cyclophosphamide. Oral Busulfan is labeled for palliative treatment of chronic myelogenous leukemia. Off-label use of oral busulfan includes allogeneic hematopoietic stem cell transplantation.4-6


  • Use caution and verify dose when switching between busulfan injection and oral busulfan.5,6
  • Chemotherapy agents, such as busulfan, pose additional safety risks both for patients and for healthcare workers handling these agents.4,5
  • 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).4,5

Alternative Agents & Management

  • Use oral busulfan tablets if appropriate.5,6
  • Consider evaluating the health-care system’s total supply of busulfan before beginning patients on combination chemotherapy regimens containing busulfan. 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


  1. Otsuka (personal communications). March 4, 9 and 23, April 12, May 17, June 7, July 12, September 2 and 21, and November 4, 2011; and January 13 and March 7, 2012.
  2. GSK (personal communications). March 4 and 23, April 12, May 17, June 7, July 12, and September 2, 2011.
  3. Prasco (personal communications). November 4, 2011; and January 13, 2012. 
  4. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
  5. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
  6. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010.


Updated March 7, 2012 by Erin R Fox, Pharm.D., Manager, Drug Information Service. Created March 8, 2011, by Jane Chandramouli, Pharm.D., and Michelle M. Wheeler, Pharm.D., Drug Information Specialists. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.