Floxuridine Injection

In the U.S.

• FUDR

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

Floxuridine sometimes causes nausea and vomiting. Tell your doctor if this occurs, especially if you have stomach pain.

Dosing

The dose of floxuridine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of floxuridine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

It is very important that your doctor check your progress at regular visits to make sure that floxuridine is working properly and to check for unwanted effects.

While you are being treated with floxuridine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Floxuridine may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Nausea, vomiting, mild diarrhea, loss of appetite, tiredness, redness at the injection site, or dry skin may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Many people using this medication have some serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever or chills.

Tell your doctor right away if you have any serious side effects, including: mouth sores, sore throat, painful/difficult swallowing, persistent or severe vomiting/diarrhea, easy or unusual bruising/bleeding, black stools, blood/mucus in the stools, vomit that looks like coffee grounds, cramps/pain in the stomach/abdomen, yellowing eyes/skin, dark urine, weakness, weight loss, skin problems (e.g., peeling/darkening of the skin), muscle/joint pain.

Get medical help right away if any of these rare but very serious side effects occur: chest/jaw/left arm pain, warmth/swelling/pain/leaking at the injection site, pain/swelling/redness/weakness of the arms or legs, calf pain/swelling that is warm to the touch, shortness of breath, coughing up blood, sudden vision changes, weakness on one side of the body, severe clumsiness/trouble walking, slurred speech, confusion, severe headache.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using floxuridine, tell your doctor or pharmacist if you are allergic to it; or to fluorouracil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: poor nutrition, decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia), a serious infection.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, past high-dose radiation treatment of the pelvis.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.