HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TOLAK CREAM safely and effectively. See full prescribing information for TOLAK CREAM.

TOLAK (fluorouracil) Cream, 4%, for topical use
Initial US Approval: 1962

INDICATIONS AND USAGE

Tolak (fluorouracil) Cream, 4%, is a nucleoside metabolic inhibitor indicated for the topical treatment of actinic keratosis lesions of the face, ears, and scalp (1).

DOSAGE AND ADMINISTRATION

  • Apply Tolak Cream after washing, rinsing, and drying the treatment area(s) (2).
  • Apply Tolak Cream once daily in an amount sufficient to cover the lesions of the face, ears, and/or scalp with a thin film, using the fingertips to gently massage the medication uniformly into the skin (2).
  • Tolak Cream should be applied for a period of 4 weeks as tolerated (2).
  • Wash hands thoroughly following Tolak Cream application (2).
  • Tolak Cream is for topical use only. Do not apply to eyes, nose, mouth or mucous membranes (2).
  • Not for ophthalmic, oral, or intravaginal use (2).

DOSAGE FORMS AND STRENGTHS

Cream: 40 mg of fluorouracil per gram of cream (4%) (3).

CONTRAINDICATIONS

  • Pregnancy (4.1, 8.1).
  • Dihydropyrimidine dehydrogenase (DPD) deficiency (4.2).

WARNINGS AND PRECAUTIONS

  • Application site adverse reactions are likely to occur during and for 4 weeks after treatment of actinic keratosis with Tolak Cream (5.1).
  • Hypersensitivity reactions may occur with Tolak Cream (5.2).
  • Avoid treatment in the periocular area. Eye disorders, including corneal reactions have occurred with topical fluorouracil use. Avoid accidental transfer of the drug into eyes and to the periocular area. If accidental exposure occurs, seek medical care (5.3).
  • Increased sensitivity to ultraviolet light may occur during and immediately after treatment with Tolak Cream (5.4).
  • Fluorouracil may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception (5.5).
  • Increased fluorouracil exposures may occur in DPD deficiency. Discontinue Tolak Cream if symptoms of fluorouracil’s systemic toxicity develop (5.6).

ADVERSE REACTIONS

The 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 Cream (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Hill Dermaceuticals at 1-800-344-5707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.