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Trade Names:
FUDR
- Powder for injection 500 mg
- Solution for injection 100 mg/mL

Mechanism of Action

Pharmacology

The primary effect is to interfere with the synthesis of DNA and to a lesser extent inhibit the formation of RNA.

Pharmacokinetics

Metabolism

When given by rapid intra-arterial injection, floxuridine is rapidly catabolized to 5-fluorouracil. When given by continuous intra-arterial infusion, direct anabolism to floxuridine-monophosphate is enhanced. Floxuridine is metabolized in the liver.

Elimination

The drug is excreted intact as urea, fluorouracil, alpha-fluoro-beta-ureidopropionic acid, dihydrofluorouracil, alpha-fluoro-beta-guanidopropionic acid, and alpha-fluoro-beta alanine in the urine. It also is expired as respiratory carbon dioxide.

Indications and Usage

Palliative management of GI adenocarcinoma metastatic to the liver administered by continuous regional intra-arterial infusion as long as cancer does not extend beyond area perfused by a single artery.

Unlabeled Uses

Tumors of the liver, gallbladder, bile ducts, or kidneys.

Contraindications

Patients in a poor nutritional state, those with depressed bone marrow function or those with potentially serious infections.

Dosage and Administration

Implantable pump Using an implantable pump, administer 0.1 to 0.6 mg/kg/day for 1 to 6 wk, followed by a 14-day rest period between courses. Repeat cycles as long as response continues.

IV infusion 0.5 to 1 mg/kg/day for 6 to 15 days or until toxicity occurs.

Drug Interactions

Cimetidine may increase the bioavailability of floxuridine.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Arterial aneurysm; ischemia; thrombosis; embolism; fibromyositis.

Dermatologic

Localized erythema; alopecia; rash.

GI

Nausea and vomiting; diarrhea; enteritis; mucositis; duodenal ulcers; elevated LFTs; hepatic necrosis; hepatic abscesses; intra- and extrahepatic biliary sclerosis; acalculous cholecystitis.

Hematologic

Bone marrow suppression, nadir at 9 to 14 days; bleeding at the catheter site.

Miscellaneous

Fever and malaise; infection of the catheter site.

Precautions

Pregnancy

Category D .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Special Risk Patients

Use with extreme caution in poor-risk patients who have had high-dose pelvic irradiation or previous use of alkylating agents, who have wide-spread involvement of bone marrow by metastatic tumors, or impaired hepatic or renal function.

Discontinue use

According to product labeling, promptly discontinue floxuridine if any of the following occur: myocardial ischemia, mucositis or esophagopharyngitis, leukopenia with WBC less than 3,500/mm ³ , intractable vomiting, frequent diarrhea, GI ulcer or bleeding, thrombocytopenia with platelets less than 100,000/mm ³ , or hemorrhage from any site.

Extravasation

Local irritation or phlebitis may occur. Refer to your institution-specific protocol.

Overdosage

Symptoms

Nausea, vomiting, diarrhea, GI ulceration and bleeding, bone marrow depression (eg, thrombocytopenia, leukopenia, agranulocytosis).

Patient Information

• Contraceptive measures are recommended for men and women during therapy.
• Notify health care provider if chills, nausea, vomiting, unusual bleeding or bruising, yellowing of skin or eyes, abdominal pain, flank or joint pain, or swelling of feet or legs occurs.
• Notify health care provider if the following become pronounced: diarrhea, fever, weakness
• Drink plenty of liquids while taking this drug.
• Inform patients of expected toxic effects, particularly oral manifestations.
• Alert patient to the possibility of alopecia as a result of therapy, and inform patient that alopecia is usually a transient effect.