Fluorouracil Topical (patient information)

Why this medication is prescribed

Fluorouracil cream and topical solution are used to treat actinic or solar keratoses (scaly or crusted lesions [skin areas] caused by years of too much exposure to sunlight). Fluorouracil cream and topical solution are also used to treat a type of skin cancer called superficial basal cell carcinoma if usual types of treatment cannot be used. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing cells such as the abnormal cells in actinic keratoses and basal cell carcinoma.

How this medication should be used

Fluorouracil comes as a solution and a cream to apply to the skin. It is usually applied to the affected areas twice a day . To help you remember to use fluorouracil , apply it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use fluorouracil exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor.

If you are using fluorouracil to treat actinic or solar keratoses, you should continue using it until the lesions start to peel off. This usually takes about 2 to 4 weeks. However, the lesions may not be completely healed until 1 or 2 months after you stop using fluorouracil.

If you are using fluorouracil to treat basal cell carcinoma, you should continue using it until the lesions are gone. This usually takes at least 3 to 6 weeks, but may take as long as 10 to 12 weeks.

During the first few weeks of treatment, the skin lesions and surrounding areas will feel irritated and look red, swollen, and scaly. This is a sign that fluorouracil is working. Do not stop using fluorouracil unless your doctor has told you to do so.

Apply fluorouracil cream with a nonmetal applicator, a glove, or your finger. If you apply fluorouracil cream with your finger, be sure to wash your hands well immediately afterwards. Do not cover the treated areas with a bandage or dressing unless your doctor tells you to.

Do not apply fluorouracil cream or topical solution to the eyelids or the eyes, nose, or mouth.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions

Before using fluorouracil:

• tell your doctor and pharmacist if you are allergic to fluorouracil or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking, especially other topical medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (a lack of a naturally occurring enzyme in your body).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using fluorouracil , call your doctor immediately. Fluorouracil can harm the fetus.
• plan to avoid unnecessary or prolonged exposure to sunlight and UV light (such as tanning booths) and to wear protective clothing, sunglasses, and sunscreen. Fluorouracil may make your skin sensitive to sunlight.

Special dietary instructions

Unless your doctor tells you otherwise, continue your normal diet.

What to do if you forget a dose

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.

Side effects

Minor side effects

Fluorouracil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• burning, crusting, redness, discoloration, irritation, pain, itching, rash, or soreness at the *site of application

Severe side effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• severe stomach pain
• bloody diarrhea
• vomiting
• fever
• chills
• severe red skin rash

Fluorouracil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Other information

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Efudex®

Other names

• 5-FU