Efudex

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

· Do not use Efudex on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using Efudex.

· Efudex is in the FDA pregnancy category X. This means that it is known to harm an unborn baby. Miscarriage and birth defects have been reported when Efudex was applied to mucous membrane areas by pregnant women. Do not use Efudex if you are pregnant or planning a pregnancy. Discuss with your doctor appropriate forms of birth control before starting treatment with Efudex.

· Efudex is available in a number of strengths and forms (creams and solutions). It is very important that you use the correct form and strength. Contact your doctor or pharmacist if you have questions regarding which product to use.

· Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with Efudex. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating.

 

What is Efudex?

· Fluorouracil interferes with the growth of skin cells. Fluorouracil works by causing the death of cells which are growing fastest, such as abnormal skin cells.

· Efudex is used to treat scaly overgrowths of skin (actinic or solar keratoses). Efudex may also be used in the treatment of superficial basal cell carcinoma.

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

 

What should I discuss with my healthcare provider before using Efudex?

· Before using Efudex, tell your doctor if you:     ·have ever had an allergic reaction to another form of Efudex (Carac, Efudex, Fluoroplex) or injectable fluorouracil (Adrucil, 5-FU); or     ·have dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

· You may not be able to use Efudex, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

· Efudex is in the FDA pregnancy category X. This means that it is known to harm an unborn baby. Miscarriage and birth defects have been reported when Efudex was applied to mucous membrane areas by pregnant women. Do not use Efudex if you are pregnant or planning a pregnancy. Discuss with your doctor appropriate forms of birth control before starting treatment with Efudex.

· It is not known whether Efudex passes into breast milk. Do not use Efudex without first talking to your doctor if you are breast-feeding a baby.

· The safety and effectiveness of Efudex in patients younger than 18 years of age have not been established.

 

How should I use Efudex?

· Use Efudex exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

· Efudex is available in a number of strengths and forms (creams and solutions). It is very important that you use the correct form and strength. Contact your doctor or pharmacist if you have questions regarding which product to use.

· Clean the area where you will apply Efudex. Rinse well and dry the area with a towel and wait ten minutes before applying the medication.

· Wash your hands before and immediately after applying this medication, unless it is being used to treat a hand condition.

· Apply Efudex to the affected area with the finger tips or a non-metal applicator, smoothing it gently onto the affected skin. Use enough to cover the entire area with a thin film.

· Efudex should not be applied on the eyelids or in the eyes, nose, or mouth. Use caution when applying Efudex around the eyes, nose, or mouth.

· Do not use Efudex on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using Efudex.

· Do not cover the area after applying Efudex. This could cause too much medicine to be absorbed by the body and could be harmful. If a covering is needed, ask your doctor if a porous gauze dressing may be used.

· A moisturizer or sun screen may be applied 2 hours after Efudex has been applied. Do not use any other skin products including creams, lotions, medications, or cosmetics unless instructed by your doctor.

· The reaction of the skin treated with Efudex may be unsightly during treatment, and sometimes, for several weeks after completion of therapy.

· Store Efudex at room temperature away from moisture and heat.

 

What happens if I miss a dose?

· Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not apply a double dose of this medication.

 

What happens if I overdose?

· An overdose of Efudex is unlikely to occur. If you do suspect an overdose, or if Efudex has been ingested, call a poison control center or an emergency room for advice.

 

What should I avoid while using Efudex?

· Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with Efudex. They may interfere with the treatment or increase irritation of the skin.

· Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with Efudex. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating.

 

What are the possible side effects of Efudex?

· Serious side effects are not likely to occur. Stop using Efudex and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

· Efudex may cause skin irritation, dryness, scaling or peeling (exfoliation), rash, and other local reactions. Eye irritation has also been reported. If these side effects are excessive or worsen with continued treatment, contact your doctor.

· Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

 

What other drugs will affect Efudex?

· Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with Efudex. They may interfere with treatment or increase irritation to the skin.

· Drugs other than those listed here may also interact with Efudex. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

 

Where can I get more information?

· Your pharmacist has additional information about Efudex written for health professionals that you may read.