Fluorouracil

What is fluorouracil used for?

Fluorouracil is a prescription medicine that is used to treat colorectal cancer. It is used to treat breast cancer. Fluorouracil is also used to treat stomach cancer.

It is used to treat pancreatic cancer. Fluorouracil may be given to you for other reasons.

Description

Fluorouracil Cream USP is topical preparations containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite.

Fluorouracil Cream USP contains 5% fluorouracil in a vanishing cream base consisting of methylparaben, polysorbate 60, propylene glycol, propylparaben, purified water, stearyl alcohol, and white petrolatum.

Chemically, fluorouracil is a 5-fluoro-2,4(1 H,3 H)-pyrimidinedione. It is a white to practically white crystalline powder which is sparingly soluble in water and slightly soluble in alcohol. One gram of fluorouracil is soluble in 100 mL of propylene glycol. The molecular weight of 5-fluorouracil is 130.08 and the structural formula is:

Before taking fluorouracil, tell your doctor:

• If you are allergic to fluorouracil; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• 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 fluorouracil.

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

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 fluorouracil with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take fluorouracil?

• Tell all of your health care providers that you take fluorouracil. This includes your doctors, nurses, pharmacists, and dentists.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• If diarrhea or throwing up happens, talk with the doctor. You will need to make sure to avoid dehydration and electrolyte problems.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• The chance of severe and sometimes deadly side effects is raised in patients who do not have the enzyme dihydropyrimidine dehydrogenase (DPD) in the body. These include mouth irritation or sores, diarrhea, low white blood cell counts, or nerve problems.
• This medicine may cause heart problems like heart attack, heart failure, and an abnormal heartbeat. These effects may be more common in people who have had heart disease before. Talk with the doctor.
• Talk with your doctor before getting any vaccines. Use of some vaccines with fluorouracil may either raise the chance of an infection or make the vaccine not work as well.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during treatment and for 3 months after your last dose.
• If you are a man and your sex partner gets pregnant while you take fluorouracil or within 3 months after your last dose, call your doctor right away.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control to prevent pregnancy while taking fluorouracil and for 3 months after the last dose.
• If you get pregnant while taking fluorouracil or within 3 months after your last dose, call your doctor right away.

How is fluorouracil best taken?

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

• It is given as an infusion into a vein over a period of time.
• It may be given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of fluorouracil that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• A heartbeat that does not feel normal.
• Dizziness or passing out.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.
• Very bad belly pain.
• Very upset stomach or throwing up.
• Severe diarrhea.
• Very bad mouth irritation.
• Change in eyesight.
• If bright lights bother your eyes.
• Redness or irritation of the palms of hands or soles of feet.
• Swelling in the feet or hands.
• Feeling confused.
• Change in balance.
• Feeling very sleepy.
• A burning, numbness, or tingling feeling that is not normal.
• Not able to control eye movements.
• Headache.
• This medicine may irritate the vein. If the drug leaks from the vein, it may also cause irritation around that area. Tell your nurse if you have any redness, burning, pain, swelling, or leaking of fluid where the drug is going into your body.
• This medicine may lower the ability of your bone marrow to make blood cells that your body needs. This can lead to very bad and sometimes deadly bleeding problems or infections. Tell your doctor right away if you have signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, a wound that will not heal; any bruising or bleeding; or if you feel very tired or weak.

What are some other side effects of fluorouracil?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Not hungry.
• Diarrhea.
• Mouth irritation or mouth sores.
• Hair loss.
• Dry skin.
• Change in nails.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out fluorouracil?

• If you need to store fluorouracil at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – 40 G TUBE LABEL