Usual Adult Dose for Keratosis

0.5% cream (microsphere formulation): Apply to the affected area once a day where actinic keratosis lesions appear, using enough to cover the entire area with a thin film

• Duration of therapy: Apply for up to 4 weeks as tolerated; continued treatment up to 4 weeks results in greater lesion reduction; local irritation is not markedly increased by extending treatment from 2 to 4 weeks, and is generally resolved within 2 weeks of cessation of therapy

1%, 2%, 5% cream or 2%, 5% solution: Apply 2 times a day in an amount enough to cover the lesions; continue until the inflammatory response reaches the erosion stage, then discontinue use

• Duration of therapy: 2 to 4 weeks; complete healing of the lesions may not be evident for 1 to 2 months following cessation of therapy

Comments:

• Response starts with erythema, usually followed by vesiculation, desquamation, erosion and reepithelialization.
• This drug should not be applied near the eyes, nostrils, or mouth.
• Apply 10 minutes after washing, rinsing, and drying the entire area.
• This drug may be applied using the fingertips.
• Immediately after application, the hands should be thoroughly washed.
• Solar keratoses which do not respond to treatment should be biopsied to confirm the diagnosis.

Use: For the topical treatment of multiple actinic or solar keratoses

Usual Adult Dose for Basal Cell Carcinoma

5% cream or solution:

• Apply 2 times a day in an amount sufficient to cover the lesions; continue until the inflammatory response reaches the erosion stage, then discontinue use
• Duration of therapy: 3 to 6 weeks; however, therapy may be required for as long as 10 to 12 weeks before lesions are obliterated

Comments:

• Only the 5% cream or solution is recommended to treat superficial basal cell carcinoma.
• Response starts with erythema, usually followed by vesiculation, desquamation, erosion and reepithelialization.

Use: To treat superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Pregnancy
• In patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Apply with a nonmetal applicator or glove; if applied with the fingers, the hands should be washed immediately afterward.
• Avoid contact with mucous membranes, eyelids, eyes, nostrils, or mouth.
• Avoid prolonged exposure to ultraviolet light or sunlight.
• Avoid occlusive dressings unless clinically indicated.

General:

• Deep, penetrating or nodular basal cell and squamous cell carcinomas do not usually respond to this drug; it should be used only as a palliative therapy in such cases where no other form of treatment is possible.
• The 0.5%, 1% and 2% strengths should not be used in the treatment of basal cell carcinoma.
• When this drug is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion, and reepithelialization.