[30 September 2013]
Products Affected - Description
Ontak injection, 150 mcg/mL, Eisai
2 mL vial (NDC 62856-0603-01)
Reason for the Shortage
- Eisai is working to resolve a manufacturing problem.1
- Eisai is the sole manufacturer of denileukin diftitox.
No presentations are available.
Estimated Resupply Dates
Eisai has Ontak on back order and the company cannot estimate a release date.1
Implications for Patient Care
- Denileukin diftitox is a recombinant DNA-derived cytotoxic protein. It is labeled for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) whose malignant cells express the CD25 component of the interleukin-2 (IL-2) receptor.2-4
- Denileukin diftitox is used off-label for the treatment of chronic lymphocytic leukemia refractory to fludarabine and in non-Hodgkin lymphoma.2-4
- Chemotherapy agents, such as denileukin diftitox, pose additional safety risks both for patients and for healthcare workers handling these agents.2,3
- 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).2,3
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 denileukin diftitox.2-4
- 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.
- Eisai (personal communications and www.ontak.com). June 28, July 12, August 12, September 16, November 4, December 9, 2011; January 13, March 22, June 5, August 8, and October 10, 2012; and January 7, April 17, July 25, and September 30, 2013.
- Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2011.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2011: 905-1276.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. June 2011.
Updated September 30, 2013 by Jane Chandramouli, PharmD, Drug Information Specialist. Created June 28, 2011, by Leslie Jensen, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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