Products Affected - Description
Dacarbazine powder for injection, Bedford
200 mg vial (NDC 55390-0090-10)
Dacarbazine powder for injection, Fresenius Kabi
200 mg vial (NDC 63323-0128-20)
Dacarbazine powder for injection, Teva
200 mg vial (1 count, 00703-5075-01)
200 mg vial (10 count, 00703-5075-03)
Reason for the Shortage
- Teva has dacarbazine on back order due to manufacturing delays.1
- Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.2
Dacarbazine powder for injection, Fresenius Kabi4
100 mg vial (NDC 63323-0127-10)
Dacarbazine powder for injection, Hospira3
100 mg vial (NDC 61703-0327-22)
Estimated Resupply Dates
- Bedford has dacarbazine powder for injection 200 mg vials on long-term back order and the company cannot estimate a release date. Ben Venue manufactured dacarbazine for Bedford.2
- Fresenius Kabi has dacarbazine powder for injection 200 mg vials on back order and the company estimates a release date in early-August 2014. 4
- Teva has dacarbazine powder for injection 200 mg vials in 1 and 10 count on back order and the company estimates a release date in late-September 2014.1
Implications for Patient Care
- Dacarbazine is an alkylating agent. It is labeled for use as a single agent for malignant metastatic melanoma or in combination with other antineoplastic agents for the treatment of adults with Hodgkin disease.5-7
- Dacarbazine is used off-label for a variety of neoplastic diseases in adults including medullary carcinoma of the thyroid, various soft-tissue sarcomas, and islet cell carcinomas.5-7
- Dacarbazine is used off-label for Hodgkin lymphoma, neuroblastoma, and solid tumors in children.5-7
- Chemotherapy agents, such as dacarbazine, pose additional safety risks both for patients and for healthcare workers handling these agents.5,6
- 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
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 dacarbazine.5-7
- Consider evaluating the health-care system’s total supply of dacarbazine before beginning patients on combination chemotherapy regimens containing dacarbazine. 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.
- Teva (personal communications). June 18, July 20, August 25, September 21, October 29, November 19, December 22, 2010; February 15, March 22, May 31, July 19, August 1, September 7, October 4, and November 29, 2011; January 3, and February 15, July 16, November 12, and December 21, 2012; March 1, May 30, July 30, September 30, and December 17, 2013; and April 7, June 9, and July 17, 2014.
- Bedford (personal communications). June 18, July 21 and 22, August 24, September 9, 22, and 28, October 12, November 4 and 19, December 21, 2010; February 15, March 22, May 2, June 23, July 20, August 3, September 7, October 6, and November 21 and 29, 2011; February 2, April 13, May 7, June 7, July 11, September 26, November 12, and December 19, 2012; February 26, March 28, May 30, July 30, September 19, October 7 and 21, December 16, 2013; and January 8, April 2 and 21, May 27, and July 17, 2014.
- Hospira (personal communications). June 18, July 20, August 23, September 9 and 27, October 11 and 29, November 8 and 22, December 22, 2010; February 14, March 23, April 29, May 31, June 21, July 19, August 2, September 7, October 6, November 21 and 28, 2011; January 3, February 13 and 27, March 12 and 20, April 24, May 7, June 7, July 16, September 26, November 12, and December 19, 2012; February 27, April 1, May 30, July 30, September 30, October 7, December 17, 2013; and January 21, April 7 and 21, June 9, and July 17,2014.
- Fresenius Kabi (personal communications). June 18, July 19 and 22, August 25, September 13 and 30, November 3 and 24, December 22, 2010; February 16, March 25, April 29, June 1 and 22, July 21, August 3, and September 7, October 3, and November 28, 2011; January 4, February 14, April 24, May 7, June 7, July 16, September 26, November 12, and December 19, 2012; February 26, March 29, May 30, July 30, September 23, October 7 and 14, December 16, 2013; and January 18, April 4 and 21, June 3, and July 17, 2014.
- Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010.
Updated July 21, 2014 by Leslie Jensen, PharmD, Drug Information Specialist; March 1, 2013 by Jane Chandramouli, PharmD, Drug Information Specialist. Created September 10, 2010, by Michelle M. Wheeler, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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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