[10 May 2013]
Products Affected - Description
Mitomycin Powder for Injection (Mannitol Formulation), Accord
40 mg single dose vial (NDC 16729-0116-38)
Mitomycin Powder for Injection (Mannitol Formulation), Bedford
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
- Bedford has mitomycin injection on shortage due to manufacturing delays. Bedford anticipates full availability of each presentation the company reintroduces to market.1,2
- Ben Venue voluntarily entered into a consent decree with FDA in late-January 2013 which allows Ben Venue to manufacture over 100 medications as long as they are compliant with the decree. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.1,2
Accord states the reason for the shortage was increased demand.3
Available Products
Mitomycin Powder for Injection (Mannitol Formulation), Accord
5 mg single dose vial (NDC 16729-0115-05)
20 mg single dose vial (NDC 16729-0108-11)
Estimated Resupply Dates
- Accord has mitomycin 40 mg single dose vials on back order and the company estimates a release date in mid-May 2013.3
- Bedford has all sizes of mitomycin single dose vials are on back order and the company will start manufacturing products once capacity permits.1,2
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 topically during otolaryngologic procedures to treat tracheal stenosis.4-6
Safety
- 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.
Related Shortages
References
- 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, and May 10, 2013.
- Accord (personal communications). April 18, May 17, June 3, July 5 and 27, August 4, September 1 and 21, October 4 and 26, November 30, and 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, and May 10, 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
Updated: May 10 by Leslie Jensen, 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 2013, 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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