Floxuridine

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.

Floxuridine is injected into an artery through an infusion pump. A healthcare provider will give you this injection.

You will be watched closely while receiving floxuridine, to make sure you do not have a severe reaction to the medication. Your blood will also need to be tested during treatment.

Floxuridine can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches, sores in your mouth or throat).

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Because you will receive floxuridine in a clinical setting, you are not likely to miss a dose.

Floxuridine for Injection, USP, an antineoplastic antimetabolite, is available as a sterile, nonpyrogenic, lyophilized powder for reconstitution. Each vial contains 500 mg of floxuridine which is to be reconstituted with 5 mL of sterile water for injection. An appropriate amount of reconstituted solution is then diluted with a parenteral solution for intra-arterial infusion (see DOSAGE AND ADMINISTRATION).

Floxuridine is a fluorinated pyrimidine. Chemically, floxuridine is 2'-deoxy-5-fluorouridine. It is a white to off-white odorless solid which is freely soluble in water. The 2% aqueous solution has a pH of between 4.0 and 5.5. The structural formula is:

The possibility of overdosage with floxuridine 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 floxuridine 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:

General

• Consult specialized references for procedures for proper handling and disposal of antineoplastics.105

Administration

Intra-arterial Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by continuous regional intra-arterial infusion via a catheter inserted into the arterial blood supply of the tumor.105 a

Use an appropriate infusion pump to overcome pressure in large arteries and to ensure uniform rate of infusion.105

Sterile water for injection may be infused between courses to keep catheter open.a

Reconstitute vial containing 500 mg of floxuridine with 5 mL of sterile water for injection to provide a solution containing 100 mg/mL.105

Dilute calculated daily dose with 5% dextrose or 0.9% sodium chloride injection to a volume appropriate for infusion apparatus used.105

Dosage

Adults

0.1–0.6 mg/kg daily.105

For hepatic artery infusion, use higher dosages (0.4–0.6 mg/kg daily); the liver metabolizes the drug, thus reducing risk of systemic toxicity.105

Continue therapy until toxicity occurs (see General Precautions under Cautions);105 1–6 weeks of continuous administration generally adequate.a Maintain therapy as long as response continues.105

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

• It is used to treat cancers which have spread.

• If you have an allergy to floxuridine or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: An infection, low blood cell counts, or poor diet.
• If you are breast-feeding. Do not breast-feed while you take floxuridine.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take floxuridine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into an artery over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Injection:

Generic: 0.5 g (1 ea)

Colorectal cancer, hepatic metastases: Intra-arterial: 0.1-0.6 mg/kg/day as a continuous infusion; continue until intolerable toxicity

Administer as a continuous intra-arterial infusion using an infusion pump.

Data not available