[10 December 2013]
Products Affected - Description
CeeNu, Bristol-Myers Squibb1
10 mg capsules, 20 count (NDC 00015-3030-20) – discontinued
40 mg capsules, 20 count (NDC 00015-3031-20) – discontinued
100 mg capsules, 20 count (NDC 00015-3032-20) – discontinued
Reason for the Shortage
- Bristol-Myers Squibb discontinued CeeNu capsules.1
- NextSource Biotechnology took over distribution of lomustine capsules in April 2013 and is now the sole supplier of lomustine capsules.2
- Due to the critical shortage of lomustine, FDA is allowing NextSource Biotechnology to import product. Initial shipments of lomustine capsules will include an unapproved trade name, CCNSB. Future supplies will only include the non-proprietary name.
Lomustine Capsules, NextSource Biotechnology2
10 mg capsules, 5 count (NDC 58181-3030-05)
40 mg capsules, 5 count (NDC 58181-3031-05)
100 mg capsules, 5 count (NDC 58181-3032-05)
Estimated Resupply Dates
All lomustine presentations are available.
Implications for Patient Care
- Lomustine is a derivative of nitrosourea and acts as an alkylating agent. 3-5
- Lomustine is labeled for use in children and adults to treat of primary and metastatic brain tumors (when used in combination with other antineoplastic agents and appropriate surgical and radiotherapeutic treatments) and Hodgkin disease (when used as monotherapy or in combination with other antineoplastic agents).3-5
- Lomustine is used off-label for many other neoplastic diseases including breast cancer, colon cancer, lung cancer, melanoma, multiple myeloma, non-Hodgkin lymphoma, and renal carcinoma.3-5
- Chemotherapy agents, such as lomustine, pose additional safety risks both for patients and for healthcare workers handling these agents.
- 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).
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 lomustine.
- Consider evaluating the health-care system’s total supply of lomustine before beginning patients on combination chemotherapy regimens containing lomustine. 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.
- Bristol Myers Squibb (personal communications). April 23, 2013.
- NextSource Biotechnology (personal communications). April 23, May 15 and 24, July 16, August 5 and 28, October 24, and December 10, 2013
- Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2013.
- McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS Drug Information (Lexi-Comp Online). Bethesda, MD: American Society of Health-Systems Pharmacists; 2013.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. April 2013.
Updated December 10, 2013 by Jane Chandramouli, PharmD, Drug Information Specialist. Created April 24, 2013, by Kristen Jefferies, PharmD, Drug Information Specialist. 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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