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Fdur (Floxuridine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

FUDR is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents.

DOSAGE AND ADMINISTRATION

Each vial must be reconstituted with 5 mL of sterile Water for Injection to yield a solution containing approximately 100 mg of floxuridine /mL. The calculated daily dose(s) of the drug is then diluted with 5% dextrose or 0.9% sodium chloride injection to a volume appropriate for the infusion apparatus to be used. The administration of FUDR is best achieved with the use of an appropriate pump to overcome pressure in large arteries and to ensure a uniform rate of infusion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

The recommended therapeutic dosage schedule of FUDR by continuous arterial infusion is 0.1 to 0.6 mg/kg/day. The higher dosage ranges (0.4 mg to 0.6 mg) are usually employed for hepatic artery infusion because the liver metabolizes the drug, thus reducing the potential for systemic toxicity. Therapy can be given until adverse reactions appear (see PRECAUTIONS section). When these side effects have subsided, therapy may be resumed. The patient should be maintained on therapy as long as response to FUDR continues.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-6 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HOW SUPPLIED

NDC 61703-331-09 - 500 mg Sterile FUDR (floxuridine) powder in a 5 mL vial packaged individually.

This is to be reconstituted with 5 mL sterile water for injection. The sterile powder should be stored at 15°C to 30°C (59°F to 86°F). Reconstituted vials should be stored under refrigeration 2°C to 8°C (36°F to 46°F) for not more than 2 weeks.

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