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Cytarabine Injection

[04 November 2014]

Products Affected - Description

Cytarabine injection powder for reconstitution, West-Ward (formerly Bedford product)2
100 mg vial (NDC 55390-0131-10)
500 mg vials (NDC 55390-0132-10)
1 gram vials (NDC 55390-0133-01)

Cytarabine solution for injection, Mylan Institutional (formerly a Pfizer product)4,5
20 mg/mL, 50 mL preservative-free vials (NDC 00069-0154-01) - NDC discontinued
20 mg/mL, 25 mL multi-dose vials (NDC 00069-0153-02) - discontinued
100 mg/mL, 20 mL preservative-free vials (NDC 00069-0155-01) - NDC discontinued

Reason for the Shortage

  • Fresenius Kabi (formerly APP) had cytarabine on shortage due to increased demand.1
  • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including cytarabine injection.2 West-Ward is not actively marketing cytarabine injection.
  • Mylan Institutional acquired cytarabine injection from Pfizer on December 6, 2013.4,5 Mylan discontinued cytarabine 20 mg/mL 25 mL vials in 2014.5
  • Mylan Institutional had cytarabine on shortage due to increased demand and manufacturing delays.5

Available Products

Cytarabine solution for injection, Fresenius Kabi1
100 mg/mL, 20 mL preservative-free vials (NDC 63323-0120-20)

Cytarabine solution for injection, Hospira3
20 mg/mL, 5 mL preservative-free vials (NDC 61703-0305-38)
20 mg/mL, 25 mL multi-dose vials (NDC 61703-0304-36)
20 mg/mL, 50 mL preservative-free vials (NDC 61703-0303-46)
100 mg/mL, 20 mL preservative-free vials (NDC 61703-0319-22)
 
Cytarabine solution for injection, Mylan Institutional (formerly a Pfizer product)4,5
20 mg/mL, 5 mL preservative-free vials (NDC 00069-0152-02)
20 mg/mL, 50 mL preservative-free vials (NDC 67457-0454-50)
100 mg/mL, 20 mL preservative-free vials (NDC 67457-0452-20)

Estimated Resupply Dates

All marketed presentations are currently available.

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, meningeal leukemia, and erythroleukemia. Cytarabine is also labeled for use in non-Hodgkin lymphoma. These regimens are labeled for use in both adult and pediatric patients.6-8
  • Cytarabine is used off-label in adults with Hodgkin disease or undergoing hematopoietic stem cell transplantation.6-8

Safety

  • Chemotherapy agents, such as cytarabine, pose additional safety risks both for patients and for healthcare workers handling these agents.6,7
  • 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).6,7

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.6-8
  • 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. 

Related Shortages

References

  1. Fresenius Kabi (formerly APP) (personal communications). May 12, June 2 and 26, July 7 and 9, August 6, September 2, October 15, November 17, 2008; January 5, February 10, March 3, April 6, May 4, June 9 and 22, July 22 and 29, September 14, October 20, November 18, December 11, 2009; January 12, February 1 and 22, March 10, April 5 and 23, May 11, June 2, July 22 and 28, August 4, September 13, October 13 and 15, November 18 and 19, December 1 and 16, 2010, January 6 and 19, February 15 and 17, April 12 and 20, May 6 and 25, June 22, July 13, August 3, September 9 and 16, October 3 and 27, December 14, 2011; January 31, February 24, March 20, June 19, July 12, November 5, December 13, 2012; March 15 and 29, May 30, July 30, October 15, November 2, and December 6, 2013; and January 3, 15, and 31, February 18, March 14, April 24, May 19, June 25, July 23, August 7 and 27, and October 13 and 29, 2014.
  2. West-Ward (personal communications). July 25 and August 27, 2014.
  3. Hospira (personal communications and website). May 12, June 2 and 26, July 7, August 6, September 2, 3, and 12, October 16, November 17, 2008; January 5, February 10, March 3, April 6, May 4, June 9 and 22, July 22 and 30, September 14, October 20, November 18, December 14, 2009; January 12, February 5 and 22, March 9, April 5 and 23, May 11, June 1, August 5, September 9, October 13 and 20, November 15, December 1 and 17, 2010, January 6 and 18, February 1, 15, and 25, March 7, 23, and 31, April 11 and 18, May 10 and 25, June 21 and 28, July 12 and 27, August 3, September 5 and 13, October 6 and 24, November 21, December 15, 2011; January 31, February 24, March 20, June 18, July 11, August 27, November 12, and December 17, 2012; March 15, April 1 and 2, May 30, July 22, October 15, November 4, and December 9, 2013; and January 6, February 4 and 19, March 4, April 24, May 19, June 24, July 21, August 27, October 15, and November 3, 2014.
  4. Pfizer (personal communications). June 18, July 12, August 28, November 12, December 17, 2012; March 15 and 29, May 30, July 26, October 4, and November 1, 2013.
  5. Mylan Institutional (personal communications). December 9, 2013; and January 7, February 3 and 20, March 20, April 24, May 19, June 26, July 21, August 27, October 15, and November 3, 2014.
  6. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
  7. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
  8. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010.

Updated

Updated November 4, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist; March 15, 2013 by Leslie Jensen, PharmD, Drug Information Specialist. Created September 10, 2010, by Michelle M. Wheeler, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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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