Important Safety Information
TOLAK® (fluorouracil) Cream, 4%, is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp.
IMPORTANT SAFETY INFORMATION
- TOLAK is contraindicated in women who are nursing, pregnant, or may become pregnant during therapy because of potential harm to the baby or fetus.
- Do not use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Increased fluorouracil availability may occur in DPD deficiency leading to systemic toxicity. Discontinue TOLAK if symptoms of Fluorouracil’s toxicity develop such as severe abdominal pain, bloody diarrhea, vomiting, fever and chills.
WARNINGS AND PRECAUTIONS
- For topical use only; not for ophthalmic, oral or intravaginal use. Avoid treatment in the periocular area, mouth, lips and mucous membranes. Eye disorders, including corneal and conjunctival reactions can occur. Avoid accidental transfer of the drug into eyes and to the periocular area by washing hands after application. If accidental exposure occurs, flush eyes with water and seek medical care.
- Application site adverse reactions, such as erythema, scaling/dryness, edema, crusting, erosions, stinging/burning, and pruritus, are likely to occur during and for 4 weeks after treatment of actinic keratosis with TOLAK.
- Allergic contact dermatitis (delayed type hypersensitivity reaction) has been noted for topical fluorouracil drugs. Delayed type hypersensitivity should be suspected in the event of severe pruritus or eczema at the application site or at a distant site. TOLAK contains peanut oil. Discontinue use if signs of hypersensitivity occur.
- Exposure to sunlight, including sunlamps, should be avoided or minimized during and immediately after treatment with TOLAK as photosensitivity reactions including severe sunburn can occur. Patients should be warned to use sun protection measures such as wearing protective clothing and sunscreen.
Most common (incidence > 68%) adverse reactions occur at the application site and include erythema, scaling/dryness, crusting, pruritus, stinging/burning, edema, and erosions. Erythema is observed in 99% of patients with actinic keratosis treated with TOLAK.
This safety information is not comprehensive. Please see Full Prescribing Information.