Efudex

The active ingredient in Efudex is 5-fluorouracil, an anti-metabolite that stops the growth of cancer cells or abnormal keratinic cells while being less damaging to normal skin cells.

When topical fluorouracil is applied to the lesion, the lesion will first become red and inflamed. Over time, it may become dark, ulcer, then crust, scab, and eventually peel off to reveal healthy skin.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Efudex. However, the following is a synopsis of the general guidelines for the use of Efudex:

Before applying Efudex cream or solution, wash the affected area with soap and water.

Apply a thin layer of the cream or solution to the entire affected area twice daily with a nonmetal applicator or gloves.

If you must use your bare hands to apply Efudex, wash your hands with soap and water immediately after the application, unless the affected area is on your hands.

Avoid applying Efudex to the eyes, nostrils, or mouth.

Do not use occlusive bandages to wrap the lesion when using Efudex.

The most common side effects of Efudex include:

-Skin irritation, pain, or itchiness, as well as a burning sensation on the skin.

-Darkening of the skin, skin rash, skin dryness, and scabbing or scarring of the skin.

-Photosensitivity (sensitivity of treated areas to sunlight) and increased risk of sunburn. Wear sunscreen when exposed to the sun and avoid sunlamps and tanning beds.

Although unlikely with topical fluorouracil application, some individuals may experience serious side effects while using Efudex. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

-Nausea, vomiting, stomach pain, bloody diarrhea, mouth sores, and bleeding may be early signs of fluorouracil toxicity.

-Hives, swelling of your face, tongue, or throat, could be signs of an allergic reaction.

These are not all of the possible side effects of Efudex. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Efudex, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

A dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

Are pregnant or plan on becoming pregnant.

Are breastfeeding or plan on breastfeeding.

Efudex is contraindicated in people who:

-Have had an allergic reaction to 5-fluorouracil or other inactive ingredients of the formulation.

-Have a dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

-Are pregnant.

It may take 2-6 weeks for a lesion to become dark, crusty, and scab over. The affected skin may continue to be red, sore, scaly, and peeling off for 1-2 months after Efudex is stopped. After this period, healthy skin should remain.

When Efudex is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

Brivudine, sorivudine, capecitabine, and other similar chemotherapies that inhibit DPD.

Other food or supplement interactions are unclear.

Efudex is available as a 5% fluorouracil cream and a 2% or 5% fluorouracil topical solution.

Store Efudex in a dry place at room temperature.

Efudex is manufactured by Bausch Health, Canada Inc.

There are generic versions of brand-name Efudex cream and topical solution.

You should continue using Efudex until the lesion becomes necrotic: it will darken, crust, and scab. It may take 1-2 months for the skin condition of the area to return to normal after Efudex is stopped.

Efudex is contraindicated in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Efudex is not recommended during breastfeeding. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.