EFUDEX (Fluorouracil)

What is this medication?

Fluorouracil, Efudex/Tolak/Carac/Fluoroplex
Antineoplastic Agent; Antimetabolite; Pyrimidine Derivative

Officially indicated to treat actinic or solar keratosis and basal cell carcinoma.

How does this medication work? 

Fluorouracil, Efudex/Tolak/Carac/Fluoroplex is pyrimidine antimetabolite that interferes with DNA synthesis by blocking the methylation of deoxyuridylic acid to thymidylic acid; blocks DNA synthesis to prevent cell proliferation of fast-growing cells and cause cell death.

How should I take this medication? 

Actinic or Solar Keratosis

Cream (0.5%): Apply thin film to lesions once daily for up to 4 weeks, as tolerated

Cream (1%): Apply to lesions twice daily for 2 to 6 weeks

Cream (4%): Apply to lesions once daily for 4 weeks as tolerated

Cream (5%) or solution (2% and 5%): Apply to lesions twice daily for 2 to 4 weeks; complete healing may not be evident for 1 to 2 months following treatment

Superficial Basal Cell Carcinoma

Cream (5%) or solution (5%): Apply to affected lesions twice daily for 3 to 6 weeks; treatment may be continued for up to 10 to 12 weeks

How to Use Fluorouracil, Efudex/Tolak/Carac/Fluoroplex:  Only apply after 10 minutes of washing and drying the affected areas.  Apply using a non-metal applicator or latex/non-latex glove.  Do not cover the area with an occlusive dressing.  Topical preparations are for external use only; do not apply to the eye, eyelids, mouth, and/or mucous membranes.

What should I watch for while using this medication? 

Delayed hypersensitivity reactions, including allergic contact dermatitis, pruritis and/or eczema can occur at the application site or at a distant site

Local skin reactions can occur when applied to a lesion

Photosensitivity

What if I miss a dose?

If you miss a dose of medication, try to take it as soon as possible. However, if it is almost time for your next dose, take only that scheduled dose. Do not take double or extra doses.

How should I store this medication?

Keep out of the reach of children at all times. Store at room temperature, 59 to 86° F (15 to 30° C). Protect from light. Keep the container tightly closed. Properly dispose of any unused medication after the expiration date.

What are the possible side effects of using this medication?

The frequency of adverse reactions is primarily located at the site of application:

>10%

Dermatologic: Application site scaling (≤95%), application site dryness (70% to ≤95%), stinging of the skin (application site: ≤87%), skin erosion (application site: 25% to 68%)

Local: Application site erythema (90% to 99%), application site reaction (92% to 97%; crusting: 87%), application site burning (60% to ≤87%), application site pruritus (85%), application site edema (14% to 69%), application site pain (31% to 61%)