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Pronunciation:

(floks YOOR i deen)

U.S. Brand Names:

FUDR®

Synonyms:

Fluorodeoxyuridine; FUDR; 5-FUDR; NSC-27640

Generic Available:

Yes

Canadian Brand Names:

FUDR®

Use:

Management of hepatic metastases of colorectal and gastric cancers

Pregnancy Risk Factor:

Lactation:

Excretion in breast milk unknown/contraindicated

Contraindications:

Hypersensitivity to floxuridine, fluorouracil, or any component of the formulation; pregnancy

Warnings/Precautions:

The U.S. Food and Drug Administration (FDA) currently recommends that procedures for proper handling and disposal of antineoplastic agents be considered.

Impaired kidney or liver function; the drug should be discontinued if intractable vomiting or diarrhea, precipitous fall in leukocyte or platelet counts, or myocardial ischemia occur. Use with caution in patients with poor nutritional status; depressed (leukocyte count <5000/mm³ or platelet count <100,000/mm³) bone marrow function; potentially serious infections. Use with caution in patients who have had high-dose pelvic radiation or previous use of alkylating agents. Use of floxuridine with pentostatin has been associated with a high incidence of fatal pulmonary toxicity; this combination is not recommended.

Adverse Reactions:

>10%:

Gastrointestinal: Stomatitis, diarrhea; may be dose-limiting

Hematologic: Myelosuppression, may be dose-limiting; leukopenia, thrombocytopenia, anemia

Onset: 4-7 days

Nadir: 5-9 days

Recovery: 21 days

1% to 10%:

Dermatologic: Alopecia, photosensitivity, hyperpigmentation of the skin, localized erythema, dermatitis

Gastrointestinal: Anorexia

Hepatic: Biliary sclerosis, cholecystitis, jaundice

<1%: Nausea, vomiting, intrahepatic abscess

Drug Interactions:

Patients may experience impaired immune response to vaccines

Possible infection after administration of live vaccines in patients receiving immunosuppressants

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (due to GI irritation).

Stability:

Store intact vials at room temperature of 15°C to 30°C (59°F to 86°F). Reconstituted vials are stable for up to 2 weeks under refrigeration at 2°C to 8°C (36°C to 46°C). Solutions in 0.9% sodium chloride are stable in some ambulatory infusion pumps for up to 21 days. Reconstitute with 5 mL SWI for a final concentration of 100 mg/mL. Contains no preservative. Further dilution in 500-1000 mL D5W or NS is stable for 2 weeks at room temperature.

Compatibility:

Stable in D5W, NS, sterile water for injection

Y-site administration: Compatible: Amifostine, aztreonam, etoposide phosphate, filgrastim, fludarabine, gemcitabine, granisetron, melphalan, ondansetron, paclitaxel, piperacillin/tazobactam, sargramostim, teniposide, thiotepa, vinorelbine. Incompatible: Allopurinol, cefepime

Compatibility when admixed: Compatible: Carboplatin, cisplatin, cisplatin with etoposide, cisplatin with leucovorin, etoposide, fluorouracil, leucovorin

Mechanism of Action:

Mechanism of action and pharmacokinetics are very similar to fluorouracil; floxuridine is the deoxyribonucleotide of fluorouracil. Floxuridine is a fluorinated pyrimidine antagonist which inhibits DNA and RNA synthesis and methylation of deoxyuridylic acid to thymidylic acid.

Pharmacodynamics/Kinetics:

Metabolism: Hepatic; Active metabolites: Floxuridine monophosphate (FUDR-MP) and fluorouracil; Inactive metabolites: Urea, CO2, -fluoro--alanine, -fluoro--guanidopropionic acid, -fluoro--ureidopropionic acid, and dihydrofluorouracil

Excretion: Urine: Fluorouracil, urea, -fluoro--alanine, -fluoro--guanidopropionic acid, -fluoro--ureidopropionic acid, and dihydrofluorouracil; exhaled gases (CO2)

Dosage:

Refer to individual protocols.

Intra-arterial:

0.1-0.6 mg/kg/day

4-20 mg/day

I.V.:

0.15 mg/kg/day for 7-14 days

0.5-1 mg/kg/day for 6-15 days

30 mg/kg/day for 5 days, then 15 mg/kg/day every other day, up to 11 days

Administration:

Infused for intra-arterial use, use infusion pump, either external or implanted.

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. This drug can only be administered by infusion. Follow instructions of prescriber for care of implantable pump. Avoid alcohol. It is important to maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake, and nutrition (small, frequent meals may help). You will be more susceptible to infection (avoid crowds and exposure to infection and do not have any vaccinations without consulting prescriber). May cause nausea or vomiting (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); loss of hair (reversible); diarrhea (buttermilk, boiled milk, or yogurt may help reduce diarrhea); mouth sores (use a soft toothbrush or cotton swabs for oral care); or sterility. Increased emotional or physical stress will adversely affect the response to this medication. Notify prescriber if you are experiencing unusual or elevated levels of stress. Report extreme fatigue; pain or numbness in extremities; severe GI upset or diarrhea; bleeding or bruising; fever, chills, or sore throat; vaginal discharge; or signs of fluid retention (eg, swelling extremities, respiratory difficulty, unusual weight gain). Pregnancy/breast-feeding precautions: Do not get pregnant while taking this medication and for 1 month following therapy. Consult prescriber for appropriate barrier contraceptives. Do not breast-feed.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Stomatitis.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause drowsiness

Mental Health: Effects on Psychiatric Treatment:

May rarely cause agranulocytosis; use caution with clozapine and carbamazepine

Oncology: Emetic Potential:

Very low (<10%)

Oncology: Vesicant:

Dosage Forms:

Injection, powder for reconstitution: 500 mg

International Brand Names:

FUDR® (CA)

References

Davidson BS, Izzo F, Chase JL, et al, "Alternating Floxuridine and 5-Fluorouracil Hepatic Arterial Chemotherapy for Colorectal Liver Metastases Minimizes Biliary Toxicity,"Am J Surg, 1996, 172(3):244-7.

DeConti RC, Kaplan SR, Papac RJ, et al, "Continuous Infusions of 5-Fluoro-2-Deoxyuridine in the Treatment of Solid Tumors,"Cancer, 1973, 31(4):894-8.

de Takats PG, Kerr DJ, Poole CJ, et al, "Hepatic Arterial Chemotherapy for Metastatic Colorectal Carcinoma,"Br J Cancer, 1994, 69(2):372-8.

Hrushesky WJ, von Roemeling R, Lanning RM, et al, "Circadian-Shaped Infusions of Floxuridine for Progressive Metastatic Renal Cell Carcinoma,"J Clin Oncol, 1990, 8(9):1504-13.

Kemeny N, Seiter K, Conti JA, et al, Hepatic Arterial Floxuridine and Leucovorin for Unresectable Liver Metastases From Colorectal Carcinoma. New Dose Schedules and Survival Update,"Cancer, 1994, 73(4):1134-42.

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