[16 January 2014]
Products Affected - Description
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
- Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 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.1,2
- Accord states the reason for the shortage was increased demand.3
Mitomycin Powder for Injection (Mannitol Formulation), Accord
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
Bedford has all mitomycin vials on long-term back order and the company cannot estimate a release date. Ben Venue manufactured mitomycin for Bedford.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
- 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, and November 20, 2013; January 9, 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, and December 2, 2013; January 15, 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 January 16, 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.
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