Reason for the Shortage

• • Accord has flourouracil available.[1]
  • Fresenius Kabi has flourouracil available.[2]
  • Teva has flourouracil available.[3]

Available Products

• • Fluorouracil injection, Accord, 50 mg/mL, 10 mL vial, 10 count, NDC 16729-0276-68
  • Fluorouracil injection, Accord, 50 mg/mL, 100 mL vial, 1 count, NDC 16729-0276-38
  • 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, 20 mL vial, 10 count, NDC 63323-0117-20
  • 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

• • All marketed presentations are available.

• • 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 (www.nccn.org) or American Society of Clinical Oncology (www.asco.org) 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]

• • 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. http://www.ashp.org/DocLibrary/Policy/DrugShortages/ASHP_shortage_guide09.pdf

• 1. Accord (personal communications). January 28, February 25, March 4, 14, 22, and 28, April 6, May 3 and 16, June 2, July 19, and October 11, 2016.
  2. Fresenius Kabi (personal communications). January 28, February 25, March 4, 14, 22, and 28, April 6, May 3, 16, and 23, July 15, August 1, 3, 11, and 26, and October 17, 2016.
  3. Teva (personal communications) January 28, February 25, March 4, 14, 22, and 28, April 6, May 3 and 16, July 14, and October 21, 2016.
  4. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 839-1281.
  5. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. (http://online.factsandcomparisons.com/index.aspx). March 2015.
  6. Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.