Fudr

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain or pressure in your chest, feeling light-headed, numbness or tingling anywhere in your body;
• fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing;
• severe vomiting or diarrhea;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
• any bleeding that will not stop.

Common side effects may include:

• mild nausea or vomiting, mild diarrhea;
• temporary hair loss; or
• redness or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Do not receive a "live" vaccine while using floxuridine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Other drugs may interact with floxuridine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Half-Life: 16 min

Metabolism: liver

Metabolites: urea, fluorouracil, dihydrofluorouracil, expired CO2 metabolite

Excretion: urine

Mechanism of Action

Metabolized to 5-FU; inhibits DNA synthesis during S phase by inhibition of thymidylate synthetase

You should not use floxuridine if you have an infection, bone marrow suppression, or if you are malnourished.

Your doctor will want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

You should not receive floxuridine if you are allergic to it, or if you have:

• an infection;

• bone marrow suppression; or

• if you are malnourished.

To make sure floxuridine is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease;

• if you have had radiation of your pelvic area; or

• if you have had previous treatment with other chemotherapy medicines.

Do not use floxuridine if you are pregnant. It could harm the unborn baby. Use effective birth control to avoid pregnancy during your treatment with floxuridine. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether floxuridine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Do not receive a "live" vaccine while using floxuridine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Other drugs may interact with floxuridine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Floxuridine belongs to the group of medicines known as antimetabolites. It is used to treat some kinds of cancer.

Floxuridine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by floxuridine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with floxuridine, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Floxuridine is to be administered only by or under the immediate supervision of your doctor.

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:

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