Products Affected - Description
Mitomycin Powder for Injection (Mannitol Formulation), Ben Venue Laboratories (formerly Bedford product)
5 mg single dose vial, package of 1 (NDC 55390-0251-01)
20 mg single dose vial, package of 1 (NDC 55390-0252-01)
40 mg single dose vial, package of 1 (NDC 55390-0253-01)
Reason for the Shortage
Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.1,2
Mitomycin Powder for Injection (Mannitol Formulation), Accord3
5 mg single dose vial (NDC 16729-0115-05)
5 mg single dose Novaplus vial (NDC 16729-0246-05)
20 mg single dose vial (NDC 16729-0108-11)
40 mg single dose vial (NDC 16729-0116-38)
40 mg single dose Novaplus vial (NDC 16729-0248-38)
Estimated Resupply Dates
All marketed presentations are currently available.
Implications for Patient Care
- Mitomycin is an antineoplastic antibiotic. It is labeled for the palliative treatment of disseminated adenocarcinoma of the stomach or pancreas as combination therapy in adults.4-6
- Mitomycin is used off-label in adults for mesothelioma, squamous cell carcinoma of the head and neck, lungs or cervix, and anal, bladder (intravesicular use), breast, colorectal, and hepatocellular (intraarterial use) cancers. It is also used to prevent scarring in glaucoma surgery and as a topical agent in otolaryngologic procedures to treat tracheal stenosis.4-6
- Mitomycin is used off-label in children as a topical agent during otolaryngologic procedures to treat tracheal stenosis.4-6
- Chemotherapy agents, such as mitomycin, 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
- 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 mitomycin.4,5
- Consider evaluating the health-care system’s total supply of mitomycin before beginning patients on combination chemotherapy regimens containing carboplatin. 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). April 18, May 17, June 30, July 27, September 2, October 13 and 24, and December 1, 2011; February 16, July 11, and December 17, 2012; January 29, 2013.
- Bedford (website). December 29, 2011; January 9, March 27, April 10, May 4 and 29, June 19, August 13, and October 26, 2012; January 31, February 20, March 20, May 10 and 21, June 25, July 17, August 1 and 29, October 1 and 21, November 20, 2013; January 9, March 31, May 19, and August 4, 2014.
- Accord (personal communications). April 18, May 17, June 3, July 5, July 27, August 4, September 1 and 21, October 4 and October 26, November 30, December 28, 2011; January 24, February 7 and 17, March 2, 15, and 27, April 10, May 4, June 1 and 28, August 1 and 24, and October 26, 2012; January 30, February 20, May 10 and 28, June 27, July 25, August 12 and 29, October 16 and 23, November 1 and 18, December 2, 2013; January 15, March 31, May 19, August 4, and October 7, 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 October 7, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist; March 29, 2013 by David M. Peterson, PharmD, Drug Information Specialist. Created September 21, 2010, by David M. Peterson, 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.
« Back to Drug Shortage Product Bulletins