FDUR (Page 2 of 2)

Nonteratogenic Effects:

Floxuridine has not been studied in animals for its effects on peri- and postnatal development. However, compounds which inhibit DNA, RNA and protein synthesis might be expected to have adverse effects on peri- and postnatal development.

Nursing Mothers:

It is not known whether FUDR is excreted in human milk. Because FUDR inhibits DNA and RNA synthesis, mothers should not nurse while receiving this drug.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

Adverse reactions to the arterial infusion of FUDR are generally related to the procedural complications of regional arterial infusion.

The more common adverse reactions to the drug are nausea, vomiting, diarrhea, enteritis, stomatitis and localized erythema. The more common laboratory abnormalities are anemia, leukopenia, thrombocytopenia and elevations of alkaline phosphatase, serum transaminase, serum bilirubin and lactic dehydrogenase.

Other adverse reactions are:

Gastrointestinal: duodenal ulcer, duodenitis, gastritis, bleeding, gastroenteritis, glossitis, pharyngitis, anorexia, cramps, abdominal pain; possible intra- and extrahepatic biliary sclerosis, as well as acalculous cholecystitis.

Dermatologic: alopecia, dermatitis, nonspecific skin toxicity, rash.

Cardiovascular: myocardial ischemia.

Miscellaneous Clinical Reactions: fever, lethargy, malaise, weakness.

Laboratory Abnormalities: BSP, prothrombin, total proteins, sedimentation rate and thrombopenia.

Procedural Complications of Regional Arterial Infusion: arterial aneurysm; arterial ischemia; arterial thrombosis; embolism; fibromyositis; thrombophlebitis; hepatic necrosis; abscesses; infection at catheter site; bleeding at catheter site; catheter blocked, displaced or leaking.

The following adverse reactions have not been reported with FUDR but have been noted following the administration of 5-fluorouracil. While the possibility of these occurring following FUDR therapy is remote because of its regional administration, one should be alert for these reactions following the administration of FUDR because of the pharmacological similarity of these two drugs: pancytopenia, agranulocytosis, myocardial ischemia, angina, anaphylaxis, generalized allergic reactions, acute cerebellar syndrome, nystagmus, headache, dry skin, fissuring, photosensitivity, pruritic maculopapular rash, increased pigmentation of the skin, vein pigmentation, lacrimal duct stenosis, visual changes, lacrimation, photophobia, disorientation, confusion, euphoria, epistaxis and nail changes, including loss of nails.

OVERDOSAGE

The possibility of overdosage with FUDR is unlikely in view of the mode of administration. Nevertheless, the anticipated manifestations would be nausea, vomiting, diarrhea, gastrointestinal ulceration and bleeding, bone marrow depression (including thrombocytopenia, leukopenia and agranulocytosis). No specific antidotal therapy exists. Patients who have been exposed to an overdosage of FUDR should be monitored hematologically for at least 4 weeks. Should abnormalities appear, appropriate therapy should be utilized. The acute intravenous toxicity of floxuridine is as follows:

Species LD50

(mg/kg ± S.E.)

Mouse 880 ± 51
Rat 670 ± 73
Rabbit 94 ± 19.6
Dog 157 ± 46

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.

REFERENCES

  1. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC, US Government Printing Office NIH publication 83-2621.
  2. AMA Council Report. Guidelines for handling parenteral antineoplastics. JAMA. Mar 15,1985, 253:1590-1592.
  3. 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.
  4. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust. Apr 30 , 1983, 1:426-428.
  5. 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.
  6. 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.

Manufactured for:
Mayne Pharma (USA) Inc.
Paramus, NJ 07652

By: Mayne Pharma Pty Ltd
Mulgrave VIC 3170
Australia

480172

FDUR
floxuridine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61703-331
Route of Administration INTRA-ARTERIAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Floxuridine (Floxuridine) Floxuridine 500 mg in 5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61703-331-09 1 VIAL (1 VIAL) in 1 CARTON contains a VIAL
1 5 mL (5 MILLILITER) in 1 VIAL This package is contained within the CARTON (61703-331-09)
Labeler — Mayne Pharma (USA) Inc.

Revised: 11/2007 Mayne Pharma (USA) Inc.

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