These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION.
FLUOROURACIL injection, for intravenous use
Pharmacy Bulk Package - Not for Direct Infusion
Initial U.S. Approval: 1962
INDICATIONS AND USAGE
Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with
• Adenocarcinoma of the Colon and Rectum (1.1)
• Adenocarcinoma of the Breast (1.2)
• Gastric Adenocarcinoma (1.3)
• Pancreatic Adenocarcinoma (1.4)
DOSAGE AND ADMINISTRATION
• Fluorouracil is recommended for administration either as an intravenous bolus or as an intravenous infusion. (2.1)
• See Full Prescribing Information for dose individualization (2.1) and dose modifications due to adverse reactions (2.6)
• See Full Prescribing Information for recommended doses of Fluorouracil for adenocarcinoma of the colon and rectum (2.2) and for recommended doses of Fluorouracil as a component of a chemotherapy regimen for adenocarcinoma of the breast (2.3), gastric adenocarcinoma (2.4), pancreatic adenocarcinoma (2.5)
• Pharmacy Bulk Package: Prepare doses for more than one patient in a Pharmacy Admixture Service under appropriate conditions for cytotoxic drugs. Do not inject entire contents of vial directly into patients. Use within 4 hours of puncture (2.7, 2.8)
DOSAGE FORMS AND STRENGTHS
Injection: 2.5 g in a 50 mL vial in a pharmacy bulk package (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
• Increased Risk of Serious or Fatal Adverse Reactions in Patients with Low or Absent Dipyrimidine Dehydrogenase Activity: Withhold or permanently discontinue Fluorouracil in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of dipyrimidine dehydrogenase (DPD) activity. No Fluorouracil dose has been proven safe in patients with absent DPD activity. (5.1)
• Cardiotoxicity: Fluorouracil can cause cardiotoxicity, including angina, myocardial infarction/ischemia, arrhythmia, and heart failure. Withhold Fluorouracil for cardiac toxicity. (5.2)
• Hyperammonemic Encephalopathy: Altered mental status, confusion, disorientation, coma, or ataxia with elevated serum ammonia level can occur within 72 hours of initiation of Fluorouracil. Withhold Fluorouracil and initiate ammonia-lowering therapy. (5.3)
• Neurologic Toxicity: Fluorouracil can cause acute cerebellar syndrome, confusion, disorientation, ataxia, or visual disturbances. Withhold Fluorouracil for neurologic toxicity. (5.4)
• Diarrhea: Fluorouracil can cause severe diarrhea. Withhold Fluorouracil for severe diarrhea until resolved. (5.5)
• Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome): Fluorouracil can cause hand-foot syndrome. If severe, discontinue Fluorouracil until resolved or decreased to Grade 1, then resume at a reduced dose. (5.6)
• Myelosuppression: Fluorouracil can cause severe and fatal myelosuppression. Withhold Fluorouracil until severe myelosuppression resolves, then resume at a reduced dose. (5.7)
• Mucositis: Fluorouracil can cause severe mucositis. Discontinue Fluorouracil until resolved or decreased to Grade 1, then resume at a reduced dose. (5.8)
• Increased Risk of Elevated INR with Warfarin: Concurrent administration with warfarin can result in clinically significant increases in coagulation parameters: Closely monitor INR and prothrombin time.(5.9)
• Embryofetal Toxicity: Fluorouracil can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus. (5.10, 8.1, 8.6)
ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch (6)
USE IN SPECIFIC POPULATIONS
• Nursing Mothers: Discontinue drug or discontinue nursing. (8.3)
• Females and Males of Reproductive Potential: Provide pregnancy planning and prevention counseling. (5.10, 8.1, 8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 1/2023
