EFUDEX is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with EFUDEX Cream and Solution is approximately 93%, based on 113 lesions in 54 patients. Twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures.

When EFUDEX is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion, and re-epithelialization. EFUDEX should be applied preferably with a nonmetal applicator or suitable glove. If EFUDEX is applied with the fingers, the hands should be washed immediately afterward. Actinic or Solar Keratosis: Apply cream or solution twice daily in an amount sufficient to cover the lesions. Medication should be continued until the inflammatory response reaches the erosion stage, at which time the use of the drug should be terminated. The usual duration of therapy is from 2 to 4 weeks. Complete healing of the lesions may not be evident for 1 to 2 months following cessation of EFUDEX therapy.

See package insert for complete information.

The most frequent adverse reactions to EFUDEX occur locally and are often related to an extension of the pharmacological activity of the drug. These include burning, crusting, allergic contact dermatitis, pruritus, scarring, rash, soreness, and ulceration. Ulcerations, other local
reactions, cases of miscarriage, and a birth defect (ventricular septal defect) have been reported when EFUDEX was applied to mucous membrane areas. Leukocytosis is the most frequent hematological side effect. Although a causal relationship is remote, other adverse reactions which have been reported infrequently are Central Nervous System: Emotional upset, insomnia, and irritability. Gastrointestinal: Medicinal taste, stomatitis.
Hematological: Eosinophilia, thrombocytopenia, toxic granulation. Integumentary: Alopecia, blistering, bullous pemphigoid, discomfort, ichthyosis, scaling, suppuration, swelling, telangiectasia, tenderness, urticaria, skin rash. Special Senses: Conjunctival reaction, corneal reaction, lacrimation, nasal irritation. Miscellaneous: Herpes simplex.

EFUDEX may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. One birth defect (cleft lip and palate) has been reported in the newborn
of a patient using EFUDEX as recommended. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when EFUDEX was applied to mucous membrane areas. Multiple birth defects have been reported in the fetus of a patient treated with intravenous fluorouracil. Animal reproduction studies have not been conducted with EFUDEX. Fluorouracil administered parenterally has been shown to be teratogenic in mice, rats, and hamsters when given at doses equivalent to the usual human intravenous dose; however, the amount of fluorouracil absorbed systemically after topical administration to actinic keratoses is minimal (see CLINICAL PHARMACOLOGY). 

See package insert for complete information.

General: There is a possibility of increased absorption through ulcerated or inflamed skin. Information for Patients: Patients should be forewarned that the reaction in the treated areas may be unsightly during therapy and, usually, for several weeks following cessation of therapy. Patients should be instructed to avoid exposure to ultraviolet rays during and immediately following treatment with EFUDEX because the intensity of the reaction may be increased. If EFUDEX is applied with the fingers, the hands should be washed immediately afterward. EFUDEX should not be applied on the eyelids or directly into the eyes, nose, or mouth because irritation may occur. Fluorouracil, including EFUDEXmay be fatal if ingested by pets. Avoid allowing pets to contact the EFUDEX container or the skin where EFUDEX has been applied. Store EFUDEX out of reach of pets.
Safely discard or clean any cloth or applicator that may retain EFUDEX and avoid leaving any residues of EFUDEX on your hands, clothing, carpeting, or furniture.

See package insert for complete information.