Products Affected - Description
Cytarabine solution for injection, Mylan Institutional
20 mg/mL, 5 mL preservative-free vial, 10 count (NDC 00069-0152-02)
20 mg/mL, 50 mL preservative-free vial, 1 count (NDC 67457-0454-50)
100 mg/mL, 20 mL preservative-free vial, 1 count (NDC 67457-0452-20)
Reason for the Shortage
- Fresenius Kabi had cytarabine on shortage due to increased demand.1
- Mylan Institutional cannot provide a reason for the shortage.2
- West-Ward discontinued cytarabine injection in September 2014.3
- Hospira has all cytarabine injection available.4
Cytarabine solution for injection, Fresenius Kabi
100 mg/mL, 20 mL preservative-free vial, 1 count (NDC 63323-0120-20)
Cytarabine solution for injection, Hospira
20 mg/mL, 5 mL preservative-free vial, 5 count (NDC 61703-0305-38)
20 mg/mL, 25 mL multiple dose vial, 1 count (NDC 61703-0304-36)
20 mg/mL, 50 mL preservative-free vial, 1 count (NDC 61703-0303-46)
100 mg/mL, 20 mL preservative-free vial, 1 count (NDC 61703-0319-22)
Estimated Resupply Dates
Mylan Institutional has cytarabine 20 mg/mL 5 mL and 50 mL vials and 100 mg/mL 20 mL vials on back order and the company cannot estimate a release date.2
Implications for Patient Care
- Cytarabine is a pyrimidine antimetabolite. It is labeled for use as a single agent or in combination with other antineoplastic agents for a variety of leukemias including acute and chronic myelocytic leukemia, acute lymphocytic leukemia, and meningeal leukemia. These regimens are labeled for use in both adult and pediatric patients.5-7
- Cytarabine is used off-label in adults with Hodgkin disease or undergoing hematopoietic stem cell transplantation. Cytarabine is also used in non-Hodgkin lymphoma.5-7
- Refer to national guidelines such as those from the National Comprehensive Cancer Network (www.nccn.org) or American Society of Clinical Oncology (www.asco.org) for additional information regarding therapeutic use.
- Chemotherapy agents, such as cytarabine, pose additional safety risks both for patients and for healthcare workers handling these agents.5,6
- 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).5,6
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 cytarabine.5-7
- Consider evaluating the health-care system’s total supply of cytarabine before beginning patients on combination chemotherapy regimens containing cytarabine. 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.
- Fresenius Kabi (personal communications). March 11 and 30, May 6, July 23, August 5, September 23, December 2, 2015; January 20, and April 11, 2016.
- Mylan Institutional (personal communications). March 11, May 8, July 24, August 11, September 28, December 7, 2015; January 25, and April 12, 2016.
- West-Ward (personal communications). March 4, 2015.
- Hospira (personal communications and website). March 12 and 30, May 8, July 23, August 12, September 28, December 9, 2015; January 25, and April 12, 2016.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 839-1281.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. March 2015.
- Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.
Updated April 12, 2016 by Michelle Wheeler, PharmD, Drug Information Specialist. Created July 29, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2016, 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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