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10/4/2017

Fludarabine Injection

Reason for the Shortage

    • Actavis has fludarabine available.[1]
    • Fresenius Kabi had fludarabine on shortage due to increased demand.[2]
    • Pfizer had fludarabine on shortage due to increased demand.[3]
    • Sagent had fludarabine 25 mg/mL 2 mL vials on shortage due to manufacturing delays.[4]

Available Products

    • Fludarabine intravenous injection, Actavis, 25 mg/mL, 2 mL vial, 1 count, NDC 45963-0621-51
    • Fludarabine intravenous lyophilized powder for solution for injection, Actavis, 50 mg, vial, 1 count, NDC 45963-0309-55
    • 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
    • Fludarabine intravenous injection, Sagent, 25 mg/mL, 2 mL vial, 1 count, NDC 25021-0242-02
    • Fludarabine intravenous lyophilized powder for solution for injection, Sagent, 50 mg, vial, 1 count, NDC 25021-0237-06

Estimated Resupply Dates

    • All marketed presentations are available.

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.[5-7]
    • 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.[5-7]
    • Fludarabine is used off-label for solid tumors, a variety of acute leukemias, and conditioning for hematopoietic stem cell transplantation in children.[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.

Safety

    • Chemotherapy agents, such as fludarabine, pose additional safety risks both for patients and for healthcare workers handling these agents.[5-7]
    • 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).[5-7]

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 fludarabine.[5-7]
    • 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 at http://www.ashp.org/DocLibrary/Policy/DrugShortages/ASHP_shortage_guide09.pdf for more guidance on developing a multidisciplinary plan when the supply must be allocated.

References

    1. Actavis (personal communication). January 10, and March 20, 2017.
    2. Fresenius Kabi, USA (personal communication). January 9 and 28, February 13 and 20, March 21, April 24, June 20, July 27, August 24, and September 28, 2017.
    3. Pfizer (personal communication and website). January 9 and 30, February 13 and 21, March 24, April 21, June 23, July 28, August 23, and October 4, 2017.
    4. Sagent (personal communication). January 9, 12, and 27, February 13, 16, and 28, March 23, April 20, June 22, July 27, August 24, and September 28, 2017.
    5. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2016 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2016: 873-1348.
    6. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc.; January 2017.
    7. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2017.

Updated

Updated October 4, 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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