Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Fluorouracil Injection, USP is supplied in a single-dose vial available in a box containing one vial, as listed below: NDC 55150-496-01 50 mg/mL in 10 mL single-dose, flip-top vials individually boxed. NDC 55150-496-10 50 mg/mL in 10 individually boxed vials in an outer carton. NDC 55150-497-01 50 mg/mL in 20 mL single-dose, flip-top vials individually boxed. NDC 55150-497-10 50 mg/mL in 10 individually boxed vials in an outer carton. 16.2 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. DO NOT FREEZE. Fluorouracil is a cytotoxic drug. Follow applicable special handling and disposable procedures [see References (15) ] . Also available as pharmacy bulk pack vials as follows: NDC 55150-498-01 : one box with one vial, containing 2.5 g/50 mL (50 mg/mL) fluorouracil NDC 55150-499-01 : one box with one vial, containing 5 g/100 mL (50 mg/mL) fluorouracil The vial stopper is not made with natural rubber latex.; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/10 mL (50 mg/mL) - Container Label Rx only NDC 55150-496-01 Fluorouracil Injection, USP 500 mg/10 mL (50 mg/mL) For Intravenous Use Only CYTOTOXIC AGENT Sterile 10 mL Single-Dose Vial eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/10 mL (50 mg/mL) - Container Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/10 mL (50 mg/mL) - Container-Carton (Mono Carton) Rx only NDC 55150-496-01 Fluorouracil Injection, USP 500 mg/10 mL (50 mg/mL) For Intravenous Use CYTOTOXIC AGENT Sterile 10 mL Single-Dose Vial eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/10 mL (50 mg/mL) - Container-Carton (Mono Carton); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/10 mL (50 mg/mL) - Container-Carton (10 Vials) Rx only NDC 55150-496-10 Contains 10 of NDC 55150-496-01 Fluorouracil Injection, USP 500 mg/10 mL (50 mg/mL) For Intravenous Use CYTOTOXIC AGENT Sterile 10x10 mL Single-Dose Vials eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/10 mL (50 mg/mL) - Container-Carton (10 Vials); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 g/20 mL (50 mg/mL) - Container Label Rx only NDC 55150-497-01 Fluorouracil Injection, USP 1 g/20 mL (50 mg/mL) For Intravenous Use Only CYTOTOXIC AGENT Sterile 20 mL Single-Dose Vial eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 g/20 mL (50 mg/mL) - Container Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 g/20 mL (50 mg/mL) - Container-Carton (Mono Carton) Rx only NDC 55150-497-01 Fluorouracil Injection, USP 1 g/20 mL (50 mg/mL) For Intravenous Use CYTOTOXIC AGENT Sterile 20 mL Single-Dose Vial eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 g/20 mL (50 mg/mL) - Container-Carton (Mono Carton); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 g/20 mL (50 mg/mL) - Container-Carton (10 Vials) Rx only NDC 55150-497-10 Contains 10 of NDC 55150-497-01 Fluorouracil Injection, USP 1 g/20 mL (50 mg/mL) For Intravenous Use CAUTION: CYTOTOXIC AGENT Sterile 10x20 mL Single-Dose Vials eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 g/20 mL (50 mg/mL) - Container-Carton (10 Vials)
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Fluorouracil Injection, USP is supplied in a single-dose vial available in a box containing one vial, as listed below: NDC 55150-496-01 50 mg/mL in 10 mL single-dose, flip-top vials individually boxed. NDC 55150-496-10 50 mg/mL in 10 individually boxed vials in an outer carton. NDC 55150-497-01 50 mg/mL in 20 mL single-dose, flip-top vials individually boxed. NDC 55150-497-10 50 mg/mL in 10 individually boxed vials in an outer carton. 16.2 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. DO NOT FREEZE. Fluorouracil is a cytotoxic drug. Follow applicable special handling and disposable procedures [see References (15) ] . Also available as pharmacy bulk pack vials as follows: NDC 55150-498-01 : one box with one vial, containing 2.5 g/50 mL (50 mg/mL) fluorouracil NDC 55150-499-01 : one box with one vial, containing 5 g/100 mL (50 mg/mL) fluorouracil The vial stopper is not made with natural rubber latex.
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/10 mL (50 mg/mL) - Container Label Rx only NDC 55150-496-01 Fluorouracil Injection, USP 500 mg/10 mL (50 mg/mL) For Intravenous Use Only CYTOTOXIC AGENT Sterile 10 mL Single-Dose Vial eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/10 mL (50 mg/mL) - Container Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/10 mL (50 mg/mL) - Container-Carton (Mono Carton) Rx only NDC 55150-496-01 Fluorouracil Injection, USP 500 mg/10 mL (50 mg/mL) For Intravenous Use CYTOTOXIC AGENT Sterile 10 mL Single-Dose Vial eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/10 mL (50 mg/mL) - Container-Carton (Mono Carton)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/10 mL (50 mg/mL) - Container-Carton (10 Vials) Rx only NDC 55150-496-10 Contains 10 of NDC 55150-496-01 Fluorouracil Injection, USP 500 mg/10 mL (50 mg/mL) For Intravenous Use CYTOTOXIC AGENT Sterile 10x10 mL Single-Dose Vials eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg/10 mL (50 mg/mL) - Container-Carton (10 Vials)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 g/20 mL (50 mg/mL) - Container Label Rx only NDC 55150-497-01 Fluorouracil Injection, USP 1 g/20 mL (50 mg/mL) For Intravenous Use Only CYTOTOXIC AGENT Sterile 20 mL Single-Dose Vial eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 g/20 mL (50 mg/mL) - Container Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 g/20 mL (50 mg/mL) - Container-Carton (Mono Carton) Rx only NDC 55150-497-01 Fluorouracil Injection, USP 1 g/20 mL (50 mg/mL) For Intravenous Use CYTOTOXIC AGENT Sterile 20 mL Single-Dose Vial eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 g/20 mL (50 mg/mL) - Container-Carton (Mono Carton)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 g/20 mL (50 mg/mL) - Container-Carton (10 Vials) Rx only NDC 55150-497-10 Contains 10 of NDC 55150-497-01 Fluorouracil Injection, USP 1 g/20 mL (50 mg/mL) For Intravenous Use CAUTION: CYTOTOXIC AGENT Sterile 10x20 mL Single-Dose Vials eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 g/20 mL (50 mg/mL) - Container-Carton (10 Vials)
Overview
Fluorouracil Injection, USP a nucleoside metabolic inhibitor, is a colorless to yellow, aqueous, sterile, nonpyrogenic injectable solution available in a single-dose vial, a sterile preparation for intravenous administration. Each mL contains 50 mg fluorouracil in water for injection, USP. The pH is adjusted to 8.6 to 9.4 with sodium hydroxide. Chemically, fluorouracil, a fluorinated pyrimidine, is 5-fluoro-2,4 (1 H ,3 H )-pyrimidinedione. Its structural formula is: Molecular formula: C 4 H 3 FN 2 O 2 Molecular weight: 130.08 g/mole Flurouracil Structure
Indications & Usage
Fluorouracil injection is indicated for the treatment of patients with: Fluorouracil injection 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 ) 1.1 Adenocarcinoma of the Colon and Rectum . 1.2 Adenocarcinoma of the Breast . 1.3 Gastric Adenocarcinoma . 1.4 Pancreatic Adenocarcinoma .
Dosage & Administration
Fluorouracil injection is recommended for administration either as an intravenous bolus or as an intravenous infusion. ( 2.2 ) See Full Prescribing Information for dose individualization ( 2.2 ) and dose modifications due to adverse reactions ( 2.7 ) See Full Prescribing Information for recommended doses of fluorouracil injection for adenocarcinoma of the colon and rectum ( 2.3 ) and for recommended doses of fluorouracil injection as a component of a chemotherapy regimen for adenocarcinoma of the breast ( 2.4 ), gastric adenocarcinoma ( 2.5 ), pancreatic adenocarcinoma ( 2.6 ) Single-Dose Vials: Use within 4 hours of puncture ( 2.8 , 2.9 ) 2.1 Evaluation and Testing for DPD Deficiency Before Initiating Fluorouracil Prior to initiating fluorouracil, test patients for genetic variants of the DPYD gene unless immediate treatment is necessary. An FDA-authorized test for the detection of the DPYD gene to identify patients at risk of serious adverse reactions with fluorouracil is not currently available. Currently available tests used to identify DPYD variants may vary in accuracy and design (e.g., which DPYD variant(s) they identify). Avoid use of fluorouracil in patients known to have certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency. No fluorouracil dose has been proven safe for patients with complete DPD deficiency. For patients with partial DPD deficiency, individualize the dosage and modify based on tolerability and intent of treatment [see Warnings and Precautions (5.1) ]. 2.2 General Dosage Information Fluorouracil injection is recommended for administration either as an intravenous bolus or as an intravenous infusion. Do not inject the entire contents of the vial directly into patients. Individualize the dose and dosing schedule of fluorouracil based on tumor type, the specific regimen administered, disease state, response to treatment, and patient risk factors. 2.3 Recommended Dosage for Adenocarcinoma of the Colon and Rectum The recommended dose of fluorouracil injection, administered in an infusional regimen in combination with leucovorin alone, or in combination with leucovorin and oxaliplatin or irinotecan, is 400 mg/m 2 by intravenous bolus on Day 1, followed by 2400 mg/m 2 to 3000 mg/m 2 intravenously as a continuous infusion over 46 hours every two weeks. The recommended dose of fluorouracil injection, if administered in a bolus dosing regimen in combination with leucovorin, is 500 mg/m 2 by intravenous bolus on Days 1, 8, 15, 22, 29, and 36 in 8 week cycles. 2.4 Recommended Dosage for Adenocarcinoma of the Breast The recommended dose of fluorouracil injection, administered as a component of a cyclophosphamide-based multidrug regimen, is 500 mg/m 2 or 600 mg/m 2 intravenously on Days 1 and 8 every 28 days for 6 cycles. 2.5 Recommended Dosage for Gastric Adenocarcinoma The recommended dose of fluorouracil injection, administered as a component of a platinum-containing multidrug chemotherapy regimen, is 200 mg/m 2 to 1000 mg/m 2 intravenously as a continuous infusion over 24 hours. The frequency of dosing in each cycle and the length of each cycle will depend on the dose of fluorouracil injection and the specific regimen administered. 2.6 Recommended Dosage for Pancreatic Adenocarcinoma The recommended dose of fluorouracil injection, administered as an infusional regimen in combination with leucovorin or as a component of a multidrug chemotherapy regimen that includes leucovorin, is 400 mg/m 2 intravenous bolus on Day 1, followed by 2400 mg/m 2 intravenously as a continuous infusion over 46 hours every two weeks. 2.7 Dose Modifications Withhold fluorouracil injection for any of the following: Development of angina, myocardial infarction/ischemia, arrhythmia, or heart failure in patients with no history of coronary artery disease or myocardial dysfunction [see Warnings and Precautions (5.2) ] Hyperammonemic encephalopathy [see Warnings and Precautions (5.3) ] Acute cerebellar syndrome, confusion, disorientation, ataxia, or visual disturbances [see Warnings and Precautions (5.4) ] Grade 3 or 4 diarrhea [see Warnings and Precautions (5.5) ] Grade 2 or 3 palmar-plantar erythrodysesthesia (hand-foot syndrome) [see Warnings and Precautions (5.6) ] Grade 3 or 4 mucositis [see Warnings and Precautions (5.8) ] Grade 4 myelosuppression [see Warnings and Precautions (5.7) ] Upon resolution or improvement to Grade 1 diarrhea, mucositis, myelosuppression, or palmar-plantar erythrodysesthesia, resume fluorouracil injection administration at a reduced dose. There is no recommended dose for resumption of fluorouracil injection administration following development of any of the following adverse reactions: Cardiac toxicity Hyperammonemic encephalopathy Acute cerebellar syndrome, confusion, disorientation, ataxia, or visual disturbances 2.8 Preparation for Administration The 500 mg/10 mL and 1 g/20 mL vial is only intended for preparation in a Pharmacy Admixture Service under appropriate conditions for cytotoxic drugs [see References (15) ]. Store vial at room temperature. Using aseptic conditions, penetrate the container closure once with a suitable sterile transfer device or dispensing set that allows measured distribution of the contents. Withdraw the calculated dose for an individual patient into a sterile syringe. Inspect the solution in syringe for particulate matter and discoloration prior to administration or further dilution. Discard syringe if the solution is discolored or contains particulate matter . 2.9 Administration Do not administer in the same intravenous line concomitantly with other medicinal products. For bolus administration, store undiluted fluorouracil in the syringe for up to 4 hours at room temperature (25°C). Administer fluorouracil as an intravenous bolus through an established intravenous line. Store diluted solutions of fluorouracil for up to 4 hours at room temperature (25°C) prior to administration to the patient. For intravenous infusion regimens, administer through a central venous line using an infusion pump.
Warnings & Precautions
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 ) 5.1 Serious Adverse Reactions or Death from Dihydropyrimidine Dehydrogenase (DPD) Deficiency Patients with certain homozygous or compound heterozygous variants in the DPYD gene known to result in complete or near complete absence of DPD activity (complete DPD deficiency) are at increased risk for acute early-onset toxicity and serious, including fatal, adverse reactions due to fluorouracil (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity). Patients with partial DPD activity (partial DPD deficiency) may also have increased risk of serious, or fatal, adverse reactions. Prior to initiating fluorouracil, test patients for genetic variants of the DPYD gene unless immediate treatment is necessary [see Clinical Pharmacology (12.5) ] . Serious adverse reactions may still occur even if no DPYD variants are identified. Avoid use of fluorouracil in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency. Withhold or permanently discontinue fluorouracil based on clinical assessment of the onset, duration, and severity of adverse reactions in patients with evidence of acute early-onset or unusually severe reactions. No fluorouracil dose has been proven safe for patients with complete DPD deficiency. For patients with partial DPD deficiency, individualize the dosage and modify based on tolerability and intent of treatment. An FDA -authorized test for the detection of genetic variants of the DPYD gene to identify patients at risk of serious adverse reactions with fluorouracil treatment is not currently available. Currently available tests used to identify DPYD variants may vary in accuracy and design (e.g., which DPYD variant(s) they identify). 5.2 Cardiotoxicity Fluorouracil can cause cardiotoxicity, including angina, myocardial infarction/ischemia, arrhythmia, and heart failure, based on postmarketing reports. Reported risk factors for cardiotoxicity are administration by continuous infusion rather than intravenous bolus and presence of coronary artery disease. Withhold fluorouracil for cardiotoxicity. The risks of resumption of fluorouracil in patients with cardiotoxicity that has resolved have not been established. 5.3 Hyperammonemic Encephalopathy Fluorouracil can cause hyperammonemic encephalopathy in the absence of liver disease or other identifiable cause, based on postmarketing reports. Signs or symptoms of hyperammonemic encephalopathy began within 72 hours after initiation of fluorouracil infusion; these included altered mental status, confusion, disorientation, coma, or ataxia, in the presence of concomitant elevated serum ammonia level. Withhold fluorouracil for hyperammonemic encephalopathy and initiate ammonia-lowering therapy. The risks of resumption of fluorouracil in patients with hyperammonemic encephalopathy that has resolved have not been established. 5.4 Neurologic Toxicity Fluorouracil can cause neurologic toxicity, including acute cerebellar syndrome and other neurologic events, based on postmarketing reports. Neurologic symptoms included confusion, disorientation, ataxia, or visual disturbances. Withhold fluorouracil for neurologic toxicity. There are insufficient data on the risks of resumption of fluorouracil in patients with neurologic toxicity that has resolved. 5.5 Diarrhea Fluorouracil can cause severe diarrhea. Withhold fluorouracil for Grade 3 or 4 diarrhea until resolved or decreased in intensity to Grade 1, then resume fluorouracil at a reduced dose. Administer fluids, electrolyte replacement, or antidiarrheal treatments as necessary. 5.6 Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) Fluorouracil can cause palmar-plantar erythrodysesthesia, also known as hand-foot syndrome (HFS). Symptoms of HFS include a tingling sensation, pain, swelling, and erythema with tenderness, and desquamation. HFS occurs more commonly when fluorouracil is administered as a continuous infusion than when fluorouracil is administered as a bolus injection, and has been reported to occur more frequently in patients with previous exposure to chemotherapy. HFS is generally observed after 8 to 9 weeks of fluorouracil administration but may occur earlier. Institute supportive measures for symptomatic relief of HFS. Withhold fluorouracil administration for Grade 2 or 3 HFS; resume fluorouracil at a reduced dose when HFS is completely resolved or decreased in severity to Grade 1. 5.7 Myelosuppression Fluorouracil can cause severe and fatal myelosuppression which may include neutropenia, thrombocytopenia, and anemia. The nadir in neutrophil counts commonly occurs between 9 and 14 days after fluorouracil administration. Obtain complete blood counts prior to each treatment cycle, weekly if administered on a weekly or similar schedule, and as needed. Withhold fluorouracil until Grade 4 myelosuppression resolves; resume fluorouracil at a reduced dose when myelosuppression has resolved or improved to Grade 1 in severity. 5.8 Mucositis Mucositis, stomatitis or esophagopharyngitis, which may lead to mucosal sloughing or ulceration, can occur with fluorouracil. The incidence is reported to be higher with administration of fluorouracil by intravenous bolus compared with administration by continuous infusion. Withhold fluorouracil administration for Grade 3 or 4 mucositis; resume fluorouracil at a reduced dose once mucositis has resolved or decreased in severity to Grade 1. 5.9 Increased Risk of Elevated International Normalized Ratio (INR) with Warfarin Clinically significant elevations in coagulation parameters have been reported during concomitant use of warfarin and fluorouracil. Closely monitor patients receiving concomitant coumarin-derivative anticoagulants such as warfarin for INR or prothrombin time in order to adjust the anticoagulant dose accordingly [see Drug Interactions (7) ]. 5.10 Embryofetal Toxicity Based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. In animal studies, administration of fluorouracil at doses lower than a human dose of 12 mg/kg caused teratogenicity. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus . Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during and for 3 months following cessation of therapy with fluorouracil [see Use in Specific Populations (8.1, 8.6) , Clinical Pharmacology (12.1) , and Nonclinical Toxicology (13.1) ] .
Boxed Warning
SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY Increased Risk of Serious Adverse Reactions or Death in Patients with Complete DPD Deficiency Test patients for genetic variants of DPYD prior to initiating fluorouracil unless immediate treatment is necessary. Avoid use of fluorouracil in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency [see Warnings and Precautions (5.1) ] . WARNING: SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY See full prescribing information for complete boxed warning Serious adverse reactions or death may occur in patients with complete DPD deficiency. Test patients for genetic variants of DPYD prior to initiating fluorouracil unless immediate treatment is necessary. Avoid use of fluorouracil in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency. ( 2.1 , 5.1 )
Contraindications
None. None ( 4 )
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling: Serious Adverse Reactions or Death from Dihydropyrimidine Dehydrogenase (DPD) Deficiency [see Warnings and Precautions (5.1) ] Cardiotoxicity [see Warnings and Precautions (5.2) ] Hyperammonemic encephalopathy [see Warnings and Precautions (5.3) ] Neurologic toxicity [see Warnings and Precautions (5.4) ] Diarrhea [see Warnings and Precautions (5.5) ] Palmar-plantar erythrodysesthesia (hand-foot syndrome) [see Warnings and Precautions (5.6) ] Myelosuppression [see Warnings and Precautions (5.7) ] Mucositis [see Warnings and Precautions (5.8) ] Increased risk of elevated INR when administrated with warfarin [see Warnings and Precautions (5.9) ] To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of fluorouracil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hematologic: pancytopenia [see Warnings and Precautions (5.7) ] Gastrointestinal: gastrointestinal ulceration, nausea, vomiting Allergic Reactions: anaphylaxis and generalized allergic reactions Neurologic: nystagmus, headache Dermatologic: dry skin; fissuring; photosensitivity, as manifested by erythema or increased pigmentation of the skin; vein pigmentation Ophthalmic: lacrimal duct stenosis, visual changes, lacrimation, photophobia Psychiatric: euphoria Miscellaneous: thrombophlebitis, epistaxis, nail changes (including loss of nails)
Drug Interactions
7.1 Anticoagulants and CYP 2C9 Substrates Elevated coagulation times have been reported in patients taking fluorouracil concomitantly with warfarin. While pharmacokinetic data are not available to assess the effect of fluorouracil administration on warfarin pharmacokinetics, the elevation of coagulation times that occurs with the fluorouracil prodrug capecitabine is accompanied by an increase in warfarin concentrations. Thus, the interaction may be due to inhibition of cytochrome P450 2C9 by fluorouracil or its metabolites.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.