[09 December 2013]
Products Affected - Description
Fluorouracil injection 50 mg/mL, APP1
100 mL vial (NDC 63323-0117-61)
Fluorouracil injection 50 mg/mL, Mylan Institutional3
10 mL vial (NDC 10139-0063-11)
20 mL vial (NDC 10139-0063-12)
50 mL vial (NDC 10139-0063-50)
100 mL vial (NDC 10139-0063-01)
10 mL vial (NDC 00069-0169-02)
20 mL vial (NDC 00069-0173-02)
50 mL vial (NDC 00069-0174-01)
100 mL vial (NDC 00069-0176-01)
Reason for the Shortage
- APP stated fluorouracil was on allocation to prevent excessive purchases.1
- Teva stated their fluorouracil shortage was due to manufacturing delays.2
- Mylan Institutional temporarily discontinued their fluorouracil injection in May 2013.3
- Mylan Institutional acquired fluorouracil injection from Pfizer on December 6, 2013.3
Fluorouracil injection 50 mg/mL, APP1
10 mL vial (NDC 63323-0117-10)
20 mL vial (NDC 63323-0117-20)
50 mL vial (NDC 63323-0117-51)
Fluorouracil injection 50 mg/mL, Teva2
10 mL vial (NDC 00703-3015-13)
50 mL vial (NDC 00703-3018-12)
100 mL vial (NDC 00703-3019-12)
Estimated Resupply Dates
- APP is allocating fluorouracil 100 mL vials.1
- Mylan Institutional has temporarily discontinued fluorouracil injection and the company does not have an estimated date for reintroduction. Mylan Institutional has the fluorouracil injection acquired from Pfizer on back order and the company cannot estimate a release date.3
Implications for Patient Care
- Fluorouracil is a pyrimidine antimetabolite. It is labeled for the treatment of colon, rectal, breast, stomach, and pancreatic carcinomas in adult patients.4-6
- Fluorouracil is used off-label in the treatment of head and neck, esophageal, anal, cervical, endometrial, ovarian, prostate, hepatic, bladder, and renal cell carcinomas. Fluorouracil is not labeled for use in pediatric patients; however, intravenous therapy has been used safely and effectively in this population.4-6
- Chemotherapy agents, such as fluorouracil, pose additional safety risks both for patients and for healthcare workers handling these agents.4,5
- 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
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.4-6
- 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.
- APP (personal communications). May 26, June 1, 16, and 22, July 13 and 28, August 10 and 31, September 19, October 25, November 30, December 20, 2011; February 1 and 14, March 7, April 16, May 30, June 25, August 27, September 25, October 11, November 20 and 30, 2012; January 11, February 26, May 9, July 16, September 16, November 18, and December 6, 2013
- Teva (personal communications). May 26, July 13, August 9, October 27, November 30, December 21, 2011; and January 11, February 1 and 16, April 19, August 27, October 8, 2012; January 11, February 22, May 8, July 16, September 16, and November 18, 2013.
- Mylan Institutional [formerly Bioniche] (personal communications). May 26 June 24, July 11 and 28, August 9 and 31, October 28, November 30, December 21, 2011; January 11 and 31, February 17, March 7, April 19, May 30, June 22, August 21, September 24, October 10, December 5, 2012; January 11, February 27, May 8, July 16, September 16, November 18, and December 9, 2013
- Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010.
Updated December 9, 2013 by Jane Chandramouli, PharmD, PharmD, Drug Information Specialist. Created May 27, 2011 by Megan Dryer, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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