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Lomustine Capsules

Last Updated: May 12, 2014
Status: Resolved

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

Available Products

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

Safety

  • 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.

Related Shortages

References

  1. Bristol Myers Squibb (personal communications). April 23, 2013.  
  2. NextSource Biotechnology (personal communications). April 23, May 15 and 24, July 16, August 5 and 28, October 24, and December 10, 2013; February 24 and May 12, 2014.
  3. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2013.
  4. 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.
  5. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. April 2013.

Updated

Updated May 12, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created April 24, 2013, by Kristen Jefferies, PharmD, Drug Information Specialist. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

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