Melanoma

What is Efudex Cream ?

Efudix cream contains the active ingredient fluorouracil, which is a type of medicine known as a cytotoxic antimetabolite. Fluorouracil is a chemotherapy medicine used to treat cancer. Efudix cream is applied to the skin to treat skin cancer and skin conditions that can develop into cancer (pre-malignant skin lesions).

How to use Efudex Cream:

Use Efudex Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Use a nonmetallic applicator or wear rubber gloves while applying Efudex Cream.
• Gently wash the area where you will apply Efudex Cream. Rinse well, pat dry with a towel, and wait 10 minutes before applying Efudex Cream.
• Wash your hands immediately after applying Efudex Cream, unless they are part of the treated area.
• Do not bandage or cover the treated area, unless directed to do so by your doctor.
• Efudex Cream is for external use only. Do not get it in your eyes, nose, mouth, or genital area. If you get it in your eyes, rinse with a generous amount of cool water right away and contact your doctor.
• If you miss a dose of Efudex Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Efudex Cream.

Efudex Side Effects:

Important things to remember about Efudex side effects:

1. Most people do not experience all of the Efudex side effects listed.
2. Efudex side effects are often predictable in terms of their onset and duration.
3. Efudex side effects are almost always reversible and will go away after treatment is complete.
4. There are many options to help minimize or prevent Efudex side effects.
5. There is no relationship between the presence or severity of Efudex side effects and the effectiveness of the medication.

The following Efudex side effects are common (occurring in greater than 30%) for patients taking Efudex:

• Pain, itching, burning, irritation, inflammation, dryness, swelling, tenderness at the site of application. This will heal once the treatment is complete.
• These Efudex side effects are less common side effects (occurring in about 10-29%) of patients receiving Efudex:
• Discoloration of the skin or scarring
• Increased sensitivity to sunlight

 Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here.  However, you should always inform your health care provider if you experience any unusual symptoms.

Before you use efudix cream

Do not use Efudix Cream if you:

• are allergic (hypersensitive) to fluorouracil or any other ingredients in this medicine (these are listed in section 6, “Further Information”).
• are pregnant, think you may be pregnant, or are breast-feeding.
• are using any medicines known as antiviral nucleosides (e.g. brivudine, sorivudine). These medicines are usually used to treat chickenpox or shingles.
• Efudix Cream is not for use in anyone under 18 years of age.

 Take special care with Efudix Cream if you:

• are applying this cream around your eyelids, nose or lips, and avoid contact with the eyes or mouth (see section 3, “How to use Efudix Cream”).
• have open cuts. Do not use this cream on open cuts as this can lead to too much cream being absorbed into the blood, which very rarely, can cause side effects.
• have reduced activity/deficiency of the enzyme DPD (dihydropyrimidine dehydrogenase).

Sunlight may increase the effects of Efudix. This may result in increased skin reactions. To prevent this you must try to stay out of direct sunlight as much as possible while using the cream and must not use a sunlamp or sun bed.

• Exposure to UV-radiation (e.g) natural sunlight, tanning salon) should be avoided.

• Closing bandages or dressing may increase inflammatory reactions of the skin.

Using other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is very important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved.

In particular, tell your doctor if you are using:

• medicines to treat chickenpox or shingles (brivudine, sorivudine) or have used them in the last 4 weeks. These medicines may increase the possibility of unwanted effects with Efudix Cream.
• Pregnancy and breast-feeding

Do not use Efudix Cream and tell your doctor if you are pregnant, think you might be pregnant or you are breast-feeding.

• Driving and using machines
• It is unlikely that the treatment will have any effect on your ability to drive or use machines.
• Important information about some of the ingredients of Efudix Cream

Efudix Cream contains some ingredients that can cause side effects. These are:

    stearyl alcohol and propylene glycol, which can cause local skin irritations (e.g. contact dermatitis, which is an inflammation of the skin).

• E218 (methyl parahydroxybenzoate) and E216 (propyl parahydroxybenzoate), which can cause allergic reactions.
• Do not use Efudix if you are allergic to any of its ingredients.

Warning!

• Take extra care to avoid getting the cream in the eyes, nose or mouth, particularly if you are using the medicine on your face.
• The cream should not be applied to broken skin or open cuts as it may be absorbed into the bloodstream and could cause side effects.
• Sunlight can increase the intensity of the skin reactions to Efudix cream. For this reason you should avoid exposing your skin to direct sunlight as much as possible while using the cream. Do not use sunbeds or sunlamps.