[23 April 2013]
Products Affected - Description
Vinblastine lyophilized powder for injection, Bedford
10 mg vial (NDC 55390-0091-10)
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
- APP had their product in short supply due to increased demand for the product and a manufacturing delay.2
Vinblastine sulfate injection, APP2
1 mg/mL, 10 mL vial (NDC 63323-0278-10)
Estimated Resupply Dates
Bedford has vinblastine lyophilized powder for injection on long-term back order and the company cannot estimate a release date. Manufacturing of this product will begin when capacity permits.1
Implications for Patient Care
Vinblastine is labeled to treat a number of disease states including Hodgkin disease, non-Hodgkin lymphoma, mycosis fungoides, advanced testicular carcinoma, Kaposi sarcoma, choriocarcinoma, and breast cancer.3 Vinblastine is also used to treat non-small cell lung carcinoma, bladder cancer, and refractory idiopathic thrombocytopenic purpura.3
- Chemotherapy agents, such as vinblastine, 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 vinblastine.3-5
- Consider evaluating the health-care system’s total supply of vinblastine before beginning patients on combination chemotherapy regimens containing vinblastine. 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 Laboratories, customer service (personal communications). January 11, February 16, March 20, May 3, July 11, August 30, and December 4, 2012; February 25 and April 19, 2013.
- APP, customer service (personal communications). January 11 and 12, February 8 and 22, March 20, May 7, July 9, September 5, and December 4, 2012; February 28 and April 16, 2013.
- Vinblastine. In.Beckwith, M. C. and L. S. Tyler, Eds. (2011). Cancer Chemotherapy Manual (eFacts). St. Louis, MO, Wolters Kluwer Health, Inc.
- 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 April 23, 2013 by Jane Chandramouli, PharmD, Drug Information Specialist. Created January 11, 2012 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2013, University of Utah, Drug Information Service
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