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Fludarabine Injection

[12 January 2017]

Products Affected - Description

Fludarabine intravenous injection, Fresenius Kabi
25 mg/mL, 2 mL vial, 1 count (NDC 63323-0192-02)
 
Fludarabine intravenous lyophilized powder for solution for injection, Pfizer
50 mg, vial, 1 count (NDC 61703-0344-18)

Reason for the Shortage

  • Fresenius Kabi has fludarabine on shortage due to increased demand.1
  • Pfizer has fludarabine on shortage due to increased demand.2
  • Sagent had fludarabine lyophilized powder on shortage due to manufacturing delays. They are no longer marketing fludarabine 25 mg/mL 2 mL vials.3

Available Products

Fludarabine intravenous lyophilized powder for solution for injection, Sagent
50 mg, vial, 1 count (NDC 25021-0237-06)

Estimated Resupply Dates

  • Fresenius Kabi has fludarabine 25 mg/mL 2 mL vials on back order and the company estimates a release date of mid-January 2017.1
  • Pfizer has fludarabine lyophilized powder 50 mg vials on back order and the company estimates a release date of late-1st quarter 2017.2

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.4,5,6
  • 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.4,5,6
  • Fludarabine is used off-label for solid tumors, a variety of acute leukemias, and conditioning for hematopoietic stem cell transplantation in children.4,5,6
  • 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.

Safety

  • Chemotherapy agents, such as fludarabine, pose additional safety risks both for patients and for healthcare workers handling these agents.4,5,6
  • 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).4,5,6

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 fludarabine.4,5,6
  • 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 (personal communication). January 9, 2017.
  2. Pfizer (personal communication and website). January 9, 2017.
  3. Sagent (personal communication). January 9 and 12, 2017.
  4. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2016 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2016: 873-1348.
  5. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc.; January 2017.
  6. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2017.

Updated

Updated January 12, 2017 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 9, 2017 by Benjamin Witt, PharmD, BCPS, Drug Information Specialist. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient 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. Vizient, 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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