Efudex: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Topical treatment with fluorouracil can be fatal in patients with low levels of dihydropyridine dehydrogenase (DPD; an enzyme made by the liver). If you have low levels of DPD enzyme, your healthcare professional will not prescribe EFUDEX.

• Fluorouracil has teratogenic properties that can cause potential birth defects. Your healthcare professional will not prescribe EDUFEX to you if you are pregnant or planning to become pregnant.

What is EFUDEX used for?

EFUDEX is used in adults to treat:

• pre-cancerous keratosis (keratin growth on the skin), and
• superficial basal cell carcinoma (a type of skin cancer).

How does EFUDEX work?

EFUDEX (fluorouracil) is an antimetabolite medication. It works by interfering with the growth of abnormal cells to kill these cells.

What are the ingredients in EFUDEX?

Medicinal ingredient: Fluorouracil

Non-medicinal ingredients: Propylene Glycol, Polysorbate 60 and Parabens (Methyl and Propyl), Purified Water, Stearyl Alcohol and White Petrolatum

EFUDEX comes in the following dosage forms:

Cream: 40 g in a tube

Do not use EFUDEX if:

• you are allergic to fluorouracil, or any of the other ingredients in EFUDEX .
• you have low levels of DPD (an enzyme made by the liver).
• you are pregnant or planning to become pregnant.
• are breastfeeding or planning to breastfeed.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take EFUDEX. Talk about any health conditions or problems you may have, including if you:

• have or have had severe skin problems. Your doctor may decide to treat these before starting your treatment with EFUDEX.

Other warnings you should know about:

Fluorouracil toxicity

Treatment with EFUDEX can cause fluorouracil toxicity in some patients. Some of the signs of fluorouracil toxicity may include nausea, vomiting, diarrhea, bleeding, mouth sores, stomach ulcers, decreased blood platelets, and decreased white blood cells. If you notice any signs of fluorouracil toxicity:

• stop taking EFUDEX right away,
• wash the treated area with warm water, and
• seek immediate medical attention.

Skin problems

EFUDEX may cause redness, soreness, scaling, and peeling of the affected skin for several weeks after EFUDEX is stopped. In some instances, a pink, smooth area is left when the skin treated with EFUDEX heals. This area will usually fade after 1 to 2 months. If the reaction is very uncomfortable, check with your healthcare professional.

Occlusive dressings

While using EFUDEX, the use of an occlusive dressing (a barrier that covers skin from being exposed) can increase the risk of inflammatory effects to the surrounding normal skin. Do not cover the treated area unless your healthcare professional tells you to.

Ultraviolet (UV) light

UV light exposure can increase the effects of EFUDEX and increase your sensitivity to sunlight. During your treatment with EFUDEX and 1-2 months after your treatment, it is recommended that you:

• Stay out of direct sunlight, especially between 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat and sunglasses.
• Apply a sun block product with a skin protection factor (SPF) of 15 or more. If you have a light skin tone, you may need a product with a higher SPF. If you have any questions about this, talk to your healthcare professional.
• Do not use a sunlamp or tanning bed or booth.

Check-ups and testing

Your healthcare professional will monitor and assess your health, which may include conducting tests. These tests may be performed during or after your treatment with EFUDEX. This is important to check if EFUDEX is working properly and to avoid any unwanted effects.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take EFUDEX:

• Use EFUDEX exactly as prescribed by your healthcare professional. If you are not sure, check with your healthcare professional.
• Do not change your dose or stop using EFUDEX without first checking with your healthcare professional.
• Your healthcare professional will monitor your health during your treatment and may interrupt, reduce, or stop your dose.
• You may not see complete healing of the affect area until 1-2 months after stopping your treatment with EFUDEX.

Instructions for Use:

1. 1. Wash the affected area with soap and water.
2. 2. Carefully dry the affected area and wait until it is completely dry.
3. 3.

   Apply a thin layer of EFUDEX enough to cover the entire area. It is recommended that a cotton-tipped swab or a suitable glove is used to apply EFUDEX. However, if you have to use your fingertips, wash your hands immediately after use.

   Note: Be careful if you are applying EFUDEX to your face and avoid getting any into your eyes, nostrils, or mouth.

4. 4. Wash your hands thoroughly immediately after using EFUDEX.

Usual dose:

• Apply cream on the affected areas of skin two times daily.

Overdose:

Missed Dose:

If you miss a dose of EFUDEX, apply it as soon as you remember. However, if more than a few hours have passed, skip the missed dose and go back to your regular dosing schedule. If you miss more than one dose, check with your healthcare professional.

What are possible side effects from using EFUDEX?

These are not all the possible side effects you may have when taking EFUDEX. If you experience any side effects not listed here, tell your healthcare professional.

Some side effects include:

• pain;
• itchiness;
• darkening of skin;
• burning sensation;
• skin irritation;
• skin rash;
• scarring;
• soreness or tenderness of skin;
• insomnia (a sleep disorder that can make it hard to fall asleep);
• stomatitis (inflammation of the mouth and lips);
• oozing and production of pus;
• scaling of skin;
• swelling;
• change in sense of taste;
• watery eyes;
• leukocytosis (high levels of white blood cells);
• toxic granulation (increased number of dark granules in neutrophils, a type of white blood cells);
• photosensitivity (sensitivity to sunlight): itchiness, or red skin when exposed to sunlight;
• eosinophilia (high levels of certain type of white blood cells): abdominal pain, rash, weight loss, or wheezing.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store EFUDEX between 15ºC and 30ºC
• Store away from heat and direct light
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medication to break down.
• Do not keep outdated medication or medication that is no longer needed. Be sure that any discarded medication is out of the reach of children.
• Keep out of the reach and sight of children.

If you want more information about EFUDEX:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.bauschhealth.ca, or by calling 1-800-361-4261.

Bausch Health, Canada Inc.

2150 St. Elzear Blvd., West,

Laval, QC, H7L 4A8

www.bauschhealth.ca

Last Revised: June 9, 2021