Denileukin Diftitox Injection

[17 December 2014]

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.

Available Products

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.

Related Shortages


  1. Eisai (personal communications and 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, September 30, December 17, 2013; March 5, June 3, September 16, and December 17, 2014.
  2. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2011.
  3. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2011: 905-1276.
  4. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. June 2011.


Updated December 17, 2014 by Leslie Jensen, PharmD, Drug Information Specialist. Created June 28, 2011, by Leslie Jensen, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2014, 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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