[28 March 2013]
Products Affected - Description
Daunorubicin hydrochloride solution for injection, 5 mg/mL, Bedford
4 mL single-dose vial (NDC 55390-0108-10)
10 mL single-dose vial (NDC 55390-0108-01)
Daunorubicin hydrochloride lyophilized powder for injection, Bedford
20 mg single-dose vial, package of 10, Novaplus (NDC 55390-0805-10)
Cerubidine lyophilized powder for injection, Bedford
20 mg single-dose vial, package of 10 (NDC 55390-0281-10)
Reason for the Shortage
- Ben Venue voluntarily entered into a consent decree with FDA in late-January, 2013. The terms allow Ben Venue to continue to manufacture over 100 medications as long as they are compliant with the decree. FDA will continue to work with Ben Venue to ensure the products are being made with federal current good manufacturing practice requirements. Ben Venue supplies many multiple products for Bedford Laboratories, a division of Ben Venue.1
- Teva had daunorubicin on shortage due to manufacturing issues.2
Daunorubicin hydrochloride solution for injection, 5 mg/mL, Teva
4 mL single-dose vial (NDC 00703-5233-13)
Estimated Resupply Dates
- Bedford has Cerubidine 20 mg lyophilized powder for injection on back order and the company cannot estimate a release date.1
- Bedford has daunorubicin solution for injection 4 mL and 10 mL vials on back order and the company cannot estimate a release date.1
Implications for Patient Care
- Daunorubicin hydrochloride is an anthracycline antineoplastic antibiotic. It is labeled for the treatment of acute lymphocytic leukemia (adults, children) and for acute myelocytic leukemia (adults), usually used in combination with other antineoplastic agents.3-5
- Daunorubicin hydrochloride is also used off-label for a variety of neoplastic diseases including chronic myelogenous leukemia (combination therapy), acute promyelocytic leukemia (combination therapy), and anaplastic large cell lymphoma (children).3-5
- Chemotherapy agents, such as daunorubicin hydrochloride, pose additional safety risks both for patients and for healthcare workers handling these agents.3,4
- 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).3,4
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 daunorubicin hydrochloride.3-5
- Consider evaluating the health-care system’s total supply of daunorubicin hydrochloride before beginning patients on combination chemotherapy regimens containing daunorubicin hydrochloride. 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.
- Bedford (personal communications). January 26, February 22, March 1 and 10, April 5 and 30, May 20, June 9 and 29, July 27, August 17, and September 29, 2010; and March 1 and 29, April 25, May 11 and 20, June 1, 15, 23, and 30, July 12, August 3 and 16, September 15, October 6, 13 and 31, and November 7 and 21, and December 1 and 14, 2011; January 9, February 28, March 20, April 13, May 1 and 7, June 20, July 11, August 28, October 22, November 26, and December 17, 2012; and February 4 and March 28, 2013.
- Teva (personal communications). January 26, February 22, March 1 and 10, April 5 and 28, May 20, June 8 and 29, July 1 and 27, August 17, and September 29, 2010; March 1 and 30, May 9 and 31, June 14, August 1, September 13, October 4 and 27, and December 14, 2011; January 17, February 27, March 20, April 12, May 9, June 18, July 12, August 28, October 22, and November 27, 2012; and February 5 and March 28, 2013.
- 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 March 28, 2013 by Leslie Jensen, PharmD, Drug Information Specialist. Created September 3, 2010, by Michelle M. Wheeler, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2013, 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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