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Fluorouracil Injection

Last Updated: June 20, 2018
Status: Current

Products Affected - Description
    • Fluorouracil injection, Accord, 50 mg/mL, 10 mL vial, 10 count, NDC 16729-0276-68
    • Fluorouracil injection, Accord, 50 mg/mL, 20 mL vial, 10 count, NDC 16729-0276-67
    • Fluorouracil injection, Accord, 50 mg/mL, 50 mL vial, 1 count, NDC 16729-0276-11
    • Fluorouracil injection, Fresenius Kabi, 50 mg/mL, 10 mL vial, 10 count, NDC 63323-0117-10
    • Fluorouracil injection, Fresenius Kabi, 50 mg/mL, 100 mL vial, 1 count, NDC 63323-0117-61
    • Fluorouracil injection, Fresenius Kabi, 50 mg/mL, 50 mL vial, 1 count, NDC 63323-0117-51
    • Fluorouracil injection, Teva, 50 mg/mL, 10 mL vial, 10 count, NDC 00703-3015-13
    • Fluorouracil injection, Teva, 50 mg/mL, 100 mL vial, 5 count, NDC 00703-3019-12
    • Fluorouracil injection, Teva, 50 mg/mL, 50 mL vial, 5 count, NDC 00703-3018-12
Reason for the Shortage
    • Accord did not provide a reason for the shortage.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Teva has fluorouracil injection on allocation due to increased demand.
Available Products
    • Fluorouracil injection, Accord, 50 mg/mL, 100 mL vial, 1 count, NDC 16729-0276-38
    • Fluorouracil injection, Fresenius Kabi, 50 mg/mL, 20 mL vial, 10 count, NDC 63323-0117-20

Estimated Resupply Dates

    • Accord has fluorouracil 50 mg/mL 10 mL and 20 mL vials on back order and the company estimates release dates of mid-July 2018. The 50 mL vials are on back order and the company estimates release dates of late-July 2018.
    • Fresenius Kabi has fluorouracil 50 mg/mL 10 mL and 50 mL vials on back order and the company estimates release dates of early-July 2018. The 100 mL vials are on back order and the company estimates a release date of late-July 2018.
    • Teva has Adrucil 50 mg/mL 10 mL, 50 mL, and 100 mL vials on allocation.

Implications for Patient Care

    • Fluorouracil is an antimetabolite antineoplastic agent. Fluorouracil is labeled for the palliative management of breast, colon, rectal, pancreatic, and stomach cancers.[1-3]
    • Fluorouracil is used off-label for a variety of neoplastic diseases including ovarian, cervical, bladder, hepatic, prostate, endometrial, esophageal, head and neck, penile, and thymic cancers. It is also used off-label for the treatment of renal cell carcinoma and carcinoid tumors.[1-3]
    • 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 fluorouracil, pose additional safety risks both for patients and for healthcare workers handling these agents.[1-3]
    • 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).[1-3]

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 fluorouracil.[1-3]
    • Consider evaluating the health-care system's total supply of fluorouracil before beginning patients on combination chemotherapy regimens containing fluorouracil. 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. http://www.ashp.org/DocLibrary/Policy/DrugShortages/ASHP_shortage_guide09.pdf

References

    1. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2017 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2017: 926-1421.
    2. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. (http://online.factsandcomparisons.com/index.aspx). February 2018.
    3. Lexi-Drugs Online. Lexi-Comp, Inc.; 2018.

Updated

Updated June 20, 2018 by Anthony Trovato, Pharmacy Resident. Created February 28, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

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