Floxuridine

DRUG DESCRIPTION

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 section).

Floxuridine is a fluorinated pyrimidine. Chemically, floxuridine is 2'-Deoxy-5-fluorouridine, with a molecular formula of C9H11FN2O5. 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 molecular weight of floxuridine is 246.20 and the structural formula is:

Floxuridine  Structural Formula Illustration

What are the possible side effects of floxuridine (FUDR)?

If you experience any of the following serious side effects from floxuridine, contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
  • severe vomiting;
  • diarrhea, frequent bowel movements or watery stools; or
  • sores in the...

Read All Potential Side Effects and See Pictures of Floxuridine

What are the precautions when taking floxuridine (Floxuridine)?

Before using floxuridine, tell your doctor or pharmacist if you are allergic to it; 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...

Read All Potential Precautions of Floxuridine


Floxuridine Consumer (continued)

SIDE EFFECTS: 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., unusual sunburn, 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.

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

PRECAUTIONS: Before using floxuridine, tell your doctor or pharmacist if you are allergic to it; 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.

Although unlikely, this medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women use 2 effective forms of birth control (e.g., condoms, birth control pills) while using this medication.

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.


Floxuridine Patient Information Including Side Effects

Brand Names: FUDR

Generic Name: floxuridine (Pronunciation: flox URE i deen)

  • What is floxuridine (Floxuridine)?
  • What are the possible side effects of floxuridine (Floxuridine)?
  • What is the most important information I should know about floxuridine (Floxuridine)?
  • What should I discuss with my healthcare provider before using floxuridine (Floxuridine)?
  • How should I use floxuridine (Floxuridine)?
  • What happens if I miss a dose (Floxuridine)?
  • What happens if I overdose (Floxuridine)?
  • What should I avoid while using floxuridine (Floxuridine)?
  • What other drugs will affect floxuridine (Floxuridine)?
  • Where can I get more information?

What is floxuridine (Floxuridine)?

Floxuridine is a cancer (antineoplastic) medication. Floxuridine interferes with the growth of cancer cells and slows their growth and spread in the body.

Floxuridine is used in the treatment of digestive system cancers that have spread to the liver.

Floxuridine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of floxuridine (Floxuridine)?

If you experience any of the following serious side effects from floxuridine, contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
  • severe vomiting;
  • diarrhea, frequent bowel movements or watery stools; or
  • sores in the mouth or throat; or
  • stomach pain or heartburn or black, bloody or tarry stools.

Other, less serious side effects may be more likely to occur. Continue taking floxuridine and talk to your doctor if you experience:

  • mild to moderate nausea, vomiting or loss of appetite;
  • redness of the palms of the hands or soles of the feet;
  • increased eye watering;
  • balance problems;
  • confusion;
  • rash and itching; or
  • temporary hair loss.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about floxuridine (Floxuridine)?

Floxuridine should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of floxuridine including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); sores in the mouth or throat; severe vomiting or diarrhea; and others. Talk to your doctor about the possible side effects from treatment with floxuridine.

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