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Fludarabine Injection

[20 November 2014]

Products Affected - Description

Fludarabine lyophilized powder, Fresenius Kabi, USA (formerly APP)
50 mg vial (NDC 63323-0196-06)
 
Fludarabine solution for injection, Mylan Institutional
25 mg/mL, 2 mL vial (NDC 67457-0238-02)
 
Fludarabine solution for injection, Sandoz
25 mg/mL, 2 mL vial (NDC 66758-0046-01)

Reason for the Shortage

  • Fresenius Kabi, USA (formerly APP) had fludarabine lyophilized powder for injection on shortage due to focus on supplying solution for injection.1
  • Fresenius Kabi, USA had fludarabine solution for injection on shortage due to increased demand.1
  • Teva had fludarabine on shortage due to manufacturing delays.2
  • Sagent had fludarabine on shortage due to manufacturing delays.3
  • Hospira had fludarabine on shortage due to manufacturing delays.4,5
  • Sandoz had fludarabine on back order due to manufacturing delays.6
  • Mylan Institutional temporarily discontinued fludarabine injection in late-April 2013.7
  • Genzyme discontinued Fludara in July, 2012.8

Available Products

Fludarabine solution for injection, Fresenius Kabi, USA (formerly APP)1
25 mg/mL, 2 mL vial (NDC 63323-0192-02)
 
Fludarabine lyophilized powder, Hospira5
50 mg vial (NDC 61703-0344-18)
 
Fludarabine lyophilized powder, Sagent3
50 mg vial (NDC 25021-0205-05)
 
Fludarabine solution for injection, Teva
25 mg/mL, 2 mL vial (NDC 00703-4852-11)
 
Fludarabine lyophilized powder, Teva
50 mg vial (NDC 00703-5854-01)

Estimated Resupply Dates

  • Fresenius Kabi, USA has fludarabine 50 mg lyophilized powder for injection on long-term back order and the company cannot estimate a release date.1
  • Mylan Institutional temporarily discontinued fludarabine injection. The company cannot estimate when product will be available again.7
  • Sandoz has fludarabine 2 mL vials on back order and the company cannot estimate a release date.6

Implications for Patient Care

  • Fludarabine is a purine antimetabolite. It is labeled for use as a single agent or in combination with other antineoplastic agents for the treatment of adults with progressive or refractory chronic B-cell lymphocytic leukemia. Fludarabine can be given orally or intravenously but dosing regimens are different due to the bioavailability of oral fludarabine.9-11
  • Fludarabine is used off-label for a variety of neoplastic diseases in adults including various leukemias and non-Hodgkin lymphoma. Fludarabine has also been used to treat Waldenstrom macroglobulinemia and in conditioning for hematopoietic stem cell transplantation.9-11
  • Fludarabine is used off-label for solid tumors, a variety of acute leukemias, and conditioning for hematopoietic stem cell transplantation in children.9-11

Safety

  • Chemotherapy agents, such as fludarabine, pose additional safety risks both for patients and for healthcare workers handling these agents.9,10
  • 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).9,10

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 fludarabine.9-11
  • Consider evaluating the health-care system’s total supply of fludarabine before beginning patients on combination chemotherapy regimens containing fludarabine. 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, USA [formerly APP] (personal communications). May 12, June 15, July 20, August 24, September 13, November 3, December 17, 2010; February 16, March 16, April 28, June 2, August 3, September 30, November 28, 2011; January 4, February 23, March 12, April 17, May 21, June 18, July 16, August 27, November 1, 2012; January 9, March 6 and 29, May 10, July 16, August 27, October 10, November 5, December 6, 2013; January 3 and 31, March 25, April 14, May 12, June 30, August 14, October 23, and November 11, 2014.
  2. Teva (personal communications). May 12, June 15, July 20, August 25, September 13, October 29, December 17, 2010; February 15, March 24, April 28, June 3, August 3, October 4, November 30, 2011; January 5, February 23, March 12 and 30, April 17, May 21, June 18, July 20, August 27, November 2, 2012; March 8, April 2, December 11 and 17, 2013; January 3, March 27, April 14, May 13, July 3, August 18, and October 23, 2014.
  3. Sagent (personal communications). May 12, June 15, July 20, August 24, September 13, November 3, December 15, 2010; February 17, March 24, April 28, June 2, August 2, October 4, December 1, 2011; January 5, February 23 and 28, March 12 and 28, April 17 and 30, May 21, June 19, July 9, August 30, November 1, 2012; January 9, March 6 and 28, May 7, July 15, October 14, November 7, December 5, 2013; January 3 and 23, March 26, April 16, May 7, June 30, August 15, October 23, and November 13, 2014. 
  4. Hospira (personal communications). May 12, June 14, July 20, August 23, September 9 and 13, October 29, December 15, 2010; February 14, March 23, April 25, June 3, October 6, 2011; March 12, April 17, June 18, August 27, November 1, 2012; January 9, March 6, April 1, May 13, and July 18, 2013.
  5. Hospira (website). August 3 and November 28, 2011; January 4, February 20, May 21, and July 16, 2012; August 26, October 15, November 8, December 11 and 17, 2013; January 3, February 3, March 27, April 16, May 12, June 30, August 18, October 23, and November 19, 2014.
  6. Sandoz (personal communications). May 12, June 15, July 20, August 23, November 4, December 17, 2010; February 14, March 23, April 27, June 3, August 3, October 5, December 1, 2011; February 24, March 14, April 18, May 21, June 15, July 20, August 27, November 1, 2012; January 9, March 6, May 13, July 18, August 26, October 15, November 8, and December 17, 2013; February 3, March 27, May 12, June 30, August 18, October 23, and November 20, 2014.
  7. Mylan Institutional (personal communications). August 11, October 4, December 1, 2011; January 5, February 23, March 12, April 17, May 21, June 19, July 19 and 20, August 27, November 1, 2012; January 9, Marcy 6, April 1, May 13 and 14, July 18, August 26, October 15 and December 11, 2013; February 3, April 14, June 30, August 18, and October 23, 2014. 
  8. Genzyme (personal communications). May 12, June 15, July 20, August 23, September 13, November 3, December 17, 2010; February 17, March 24, April 28, June 2, August 2, October 4, and November 30, 2011; January 5, February 23, March 12, April 17, May 21, June 21, July 20, and August 27, 2012.
  9. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
  10. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
  11. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010.

Updated

Updated November 20, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist; March 8, 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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