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Floxuridine - FUDR®
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| FOR INTRA-ARTERIAL INFUSION ONLY .
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.1
|Stability / Miscellaneous|
FOR INTRA-ARTERIAL INFUSION ONLY
Floxuridine is a fluorinated pyrimidine. Chemically, floxuridine is 2’-deoxy-5-fluorouridine with an empirical formula of C9H11FN2O5. It is a white to off-white odorless solid which is freely soluble in water.
Floxuridine is metabolized in the liver. The drug is excreted intact and as urea, fluorouracil, a-fluoro-bureidopropionic acid, dihydrofluorouracil, a-fluoro-b-guanidopropionic acid and a-fluoro-b-alanine in the urine; it is also expired as respiratory carbon dioxide. Pharmacokinetic data on intra-arterial infusion of FUDR are not available.
INDICATIONS AND USAGE
FUDR should be used with extreme caution in poor risk patients with impaired hepatic or renal function or a history of high-dose pelvic irradiation or previous use of alkylating agents. The drug is not intended as an adjuvant to surgery.
FUDR may cause fetal harm when administered to a pregnant woman. It has been shown to be teratogenic in the chick embryo, mouse (at doses of 2.5 to 100 mg/kg) and rat (at doses of 75 to 150 mg/kg). Malformations included cleft palates; skeletal defects; and deformed appendages, paws and tails. The dosages which were teratogenic in animals are 4.2 to 125 times the recommended human therapeutic dose.
There are no adequate and well-controlled studies with FUDR in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
Therapy is to be discontinued promptly whenever one of the following signs of toxicity appears:
Stomatitis or esophagopharyngitis, at the first visible sign
Leukopenia (WBC under 3500) or a rapidly falling white blood count
Diarrhea, frequent bowel movements or watery stools
Gastrointestinal ulceration and bleeding
Thrombocytopenia (platelets under 100,000)
Hemorrhage from any site
DOSAGE AND ADMINISTRATION
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.
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.
| 1) [PACKAGE INSERT DATA] : FUDR (Floxuridine) injection, powder, lyophilized, for solution. [Mayne Pharma (USA) Inc.] Paramus, NJ 07652. Revised: 11/2007.
2) Solimando, Dominic A. Drug Information Handbook for Oncology: A Complete Guide to Combination Chemotherapy Regimens, 8th ed. Hudson, OH: Lexi-Comp, Inc.; 2010.
Procedures for proper handling and disposal: Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC, US Government Printing Office NIH publication 83-2621. AMA Council Report. Guidelines for handling parenteral antineoplastics. JAMA. Mar 15,1985, 253:1590-1592. National Study Commission on Cytotoxic Exposure: Recommendations for handling cytotoxic agents. Available from Louis P. Jeffrey, ScD, Director of Pharmacy Services, Rhode Island Hospital, 593 Eddy Street, Providence, Rhode Island 02902. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust. Apr 30 , 1983, 1:426-428. Jones, RB, Frank R, Mass T: Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA. Sept-Oct, 1983, 33:258-263. ASHP American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs in Hospitals. Am J. Hosp Pharm Jan, 1985, 42:131-137