Products Affected - Description
Fluorouracil injection, Teva
50 mg/mL, 100 mL vial, 5 count (NDC 00703-3019-12)
Reason for the Shortage
- Accord could not provide a reason for the shortage.1
- Fresenius Kabi states the reason for the shortage was increased demand.2
- Teva states the reason for the shortage is increased demand.3
Fluorouracil injection, Accord
50 mg/mL, 10 mL vial, 10 count (NDC 16729-0276-68)
50 mg/mL, 20 mL vial, 10 count (NDC 16729-0276-67)
50 mg/mL, 50 mL vial, 1 count (NDC 16729-0276-11)
50 mg/mL, 100 mL vial, 1 count (NDC 16729-0276-38)
Fluorouracil injection, Fresenius Kabi
50 mg/mL, 10 mL vial, 10 count (NDC 63323-0117-10)
50 mg/mL, 20 mL vial, 10 count (NDC 63323-0117-20)
50 mg/mL, 50 mL vial, 1 count (NDC 63323-0117-51)
50 mg/mL, 100 mL vial, 1 count (NDC 63323-0117-61)
Fluorouracil injection, Teva
50 mg/mL, 10 mL vial, 10 count (NDC 00703-3015-13)
50 mg/mL, 50 mL vial, 5 count (NDC 00703-3018-12)
Estimated Resupply Dates
Teva has fluorouracil 100 mL vials available on allocation.3
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.4,5,6
- 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.4,5,6
- Refer to national guidelines such as those from the National Comprehensive Cancer Network or American Society of Clinical Oncology for additional information regarding therapeutic use.
- Chemotherapy agents, such as fluorouracil, 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 fluorouracil.4,5,6
- 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.
- Accord (personal communications). January 28, February 25, March 4, 14, 22, and 28, April 6, May 3 and 16, June 2, and July 19, 2016.
- Fresenius Kabi (personal communications). January 28, February 25, March 4, 14, 22, and 28, April 6, May 3, 16, and 23, July 15, and August 1, 3, 11, and 26, 2016.
- Teva (personal communications) January 28, February 25, March 4, 14, 22, and 28, April 6, May 3 and 16, and July 14, 2016.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 839-1281.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. March 2015.
- Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.
Updated August 26, 2016 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 28, 2016 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.
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