Tolak (Fluorouracil) Topical Cream 4%

Antineoplastic Agent; Antimetabolite; Pyrimidine Derivative

CSA NA – FDA Approved – REMS (N) – Can Ship

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.

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

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

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.

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%)