FUDR (Injection)

Floxuridine is part of a group of medicines called antimetabolites. It is used to treat certain types of cancer.

Floxuridine affects the growth of cancer cells, leading to their eventual destruction. It can also affect the growth of normal body cells, which may lead to additional effects. Some of these effects can be serious and should be reported to your doctor. Other effects, such as hair loss, may not be serious but could be concerning. Some effects might not appear for months or years after using the medicine.

Before starting treatment with floxuridine, you and your doctor should discuss the benefits of this medicine as well as the risks involved.

Floxuridine must be given only by or under the close supervision of your doctor.

It is very important that your doctor checks your progress at regular visits to make sure this medicine is working properly and to look 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. Additionally, people living in your household should not take oral polio vaccine, as they could pass the polio virus on to you. Also, avoid people 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 your nose and mouth.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine against its benefits. Here are some important points regarding this medicine:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, check the label or package ingredients carefully.

Pediatric

There is no specific information comparing the use of floxuridine in children to its use in other age groups.

Geriatric

Many medicines have not been studied specifically in older adults. Therefore, it may not be clear if they work the same way in older people as they do in younger adults or if they cause different side effects or issues in older people. While there is no specific information comparing the use of floxuridine in elderly patients with its use in other age groups, this medicine is not expected to cause different side effects or problems in older adults than it does in younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In such cases, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Hepatitis (history of)—Increased risk of hepatitis

• Kidney disease or
• Liver disease (other)—Effects of floxuridine may be increased due to slower removal from the body

• Infection—Floxuridine can decrease your body's ability to fight infection

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Also, because of how these medicines work in the body, there is a chance they could cause other unwanted effects that may not appear until months or years after using the medicine. These delayed effects may include certain types of cancer, such as leukemia. Talk to your doctor about these possible effects.

Check with your doctor right away if any of these side effects occur:

More common

• Diarrhea
• Sores in the mouth and on lips
• Stomach pain or cramps

Less common

• Black, tarry stools
• Heartburn
• Nausea and vomiting
• Scaling or redness of hands or feet
• Swelling or soreness of the tongue

Rare

• Blood in urine or stools
• Cough or hoarseness
• Fever or chills
• Lower back or side pain
• Painful or difficult urination
• Pinpoint red spots on skin
• Trouble walking
• Unusual bleeding or bruising
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to suggest ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common or rare

• Loss of appetite
• Skin rash or itching

This medicine sometimes causes temporary thinning of hair. After treatment with floxuridine has ended, normal hair growth should return.

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your health care professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

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 this medicine 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 this medicine. 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.