fluorouracil

Pronunciation

Generic Name: fluorouracil (injection) (FLOOR oh URE a sil)
Brand Name: Adrucil

What is fluorouracil?

Fluorouracil is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Fluorouracil is used to treat cancer of the colon, rectum, breast, stomach, or pancreas.

Fluorouracil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about fluorouracil?

You should not use this medicine if you have bone marrow depression, a serious infection, or if you are malnourished or are not receiving proper nutrition.

Slideshow: Flashback: FDA Drug Approvals 2013

What should I discuss with my healthcare provider before receiving fluorouracil?

You should not receive this medicine if you are allergic to fluorouracil, or if you have:

  • bone marrow depression;

  • a serious infection; or

  • if you are malnourished or are not receiving proper nutrition.

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

  • cancer that has spread to your bone marrow;

  • liver disease;

  • kidney disease; or

  • if you have ever had radiation treatment of your pelvic area.

Tell your doctor about all other cancer medications you have received in the past, especially BiCNU, CeeNU, Cytoxan, DTIC-Dome, Gliadel, Leukeran, Myeleran, Neosar, Temodar, or Zanosar.

FDA pregnancy category D. Do not use fluorouracil if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

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

How is fluorouracil given?

Fluorouracil is injected into a vein through an IV. A healthcare provider will give you this injection.

Your first dose of fluorouracil will be given in a hospital setting where you can be closely watched in case the medication causes serious side effects.

Fluorouracil injections are usually given daily for 3 or 4 days in a row, and then every other day for another 3 or 4 days. This treatment cycle may be repeated once a month. You may also receive a weekly dose. Follow your doctor's instructions.

How often you need fluorouracil injections will depend on many factors, including side effects and how your body responds to the medication. Try not to miss any appointments for your fluorouracil injections.

Fluorouracil can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your fluorouracil injection.

What happens if I overdose?

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

What should I avoid while receiving fluorouracil?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using fluorouracil, 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.

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). 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. Patients and caregivers should wear rubber gloves while cleaning up 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.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Fluorouracil side effects

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

Call your doctor at once if you have:

  • signs of infection such as fever, chills, sore throat, flu symptoms;

  • white patches or sores inside your mouth or throat, or on your lips;

  • pale skin, easy bruising or bleeding (nosebleeds, bleeding gums, or any bleeding that will not stop);

  • weakness or fainting;

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • coughing up blood or vomit that looks like coffee grounds;

  • watery diarrhea, ongoing or severe vomiting;

  • pain, redness, numbness, and peeling skin on your hands or feet;

  • numbness or tingling anywhere in your body, loss of muscle control; or

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects may include:

  • temporary hair loss;

  • mild to moderate nausea and vomiting, loss of appetite;

  • mild, itchy skin rash;

  • eye dryness, watering, or increased sensitivity to light; or

  • temporary loss of your fingernails or toenails.

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.

See also: Side effects (in more detail)

Fluorouracil dosing information

Usual Adult Dose for Colorectal Cancer:

For palliative management of colorectal cancer:

Initial Dose: 12 mg/kg intravenously once daily for 4 successive days.
Maximum Dose: 800 mg/day.
If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day. (No therapy is given on days 5, 7, 9, or 11.) Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state:
Initial Dose: 6 mg/kg/day for 3 days.
Maximum Dose: 400 mg/day.
If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9. (No therapy is to be administered on days 4, 6, or 8.) Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance Therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

1) Repeat the dosage of the first course every 30 days after the last day of the previous course, or

2) When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose.
Maximum Dose: 1 g/week

The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Usual Adult Dose for Stomach Cancer:

For palliative management of stomach cancer:

Initial Dose: 12 mg/kg intravenously once daily for 4 successive days.
Maximum Dose: 800 mg/day.
If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day. (No therapy is given on days 5, 7, 9, or 11.) Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state:
Initial Dose: 6 mg/kg/day for 3 days.
Maximum Dose: 400 mg/day.
If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9. (No therapy is to be administered on days 4, 6, or 8.) Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance Therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

1) Repeat the dosage of the first course every 30 days after the last day of the previous course, or

2) When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose.
Maximum Dose: 1 g/week

The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Usual Adult Dose for Pancreatic Cancer:

For palliative management of pancreatic cancer:

Initial Dose: 12 mg/kg intravenously once daily for 4 successive days.
Maximum Dose: 800 mg/day.
If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day. (No therapy is given on days 5, 7, 9, or 11.) Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state:
Initial Dose: 6 mg/kg/day for 3 days.
Maximum Dose: 400 mg/day.
If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9. (No therapy is to be administered on days 4, 6, or 8.) Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance Therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

1) Repeat the dosage of the first course every 30 days after the last day of the previous course, or

2) When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose.
Maximum Dose: 1 g/week

The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Usual Adult Dose for Breast Cancer:

For palliative management of carcinoma of the breast:

Initial Dose: 12 mg/kg intravenously once daily for 4 successive days.
Maximum Dose: 800 mg/day.
If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day. (No therapy is given on days 5, 7, 9, or 11.) Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state:
Initial Dose: 6 mg/kg/day for 3 days.
Maximum Dose: 400 mg/day.
If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9. (No therapy is to be administered on days 4, 6, or 8.) Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance Therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

1) Repeat the dosage of the first course every 30 days after the last day of the previous course, or

2) When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose.
Maximum Dose: 1 g/week

The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Usual Adult Dose for Cervical Cancer:

(In combination with cisplatin)
1000 mg/m2 IV on day 1
The cycle is repeated every 21 days.

Usual Pediatric Dose for Malignant Disease:

The manufacturer has reported that the safety and effectiveness of fluorouracil have not been established in children. However, the drug has been used in children following adult guidelines.

Initial Dose: 12 mg/kg intravenously once daily for 4 successive days.
Maximum Dose: 800 mg/day.
If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day. (No therapy is given on days 5, 7, 9, or 11.) Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state:
Initial Dose: 6 mg/kg/day for 3 days.
Maximum Dose: 400 mg/day.
If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9. (No therapy is to be administered on days 4, 6, or 8.) Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance Therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

1) Repeat the dosage of the first course every 30 days after the last day of the previous course, or

2) When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose.
Maximum Dose: 1 g/week

The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

What other drugs will affect fluorouracil?

Tell your doctor about all other cancer medications you are receiving, especially leucovorin.

Other drugs may interact with fluorouracil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about fluorouracil.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.03. Revision Date: 2014-07-10, 1:45:52 PM.

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