What is the treatment regimen for Efudex (fluorouracil) in skin conditions?

From the Guidelines

Efudex (fluorouracil) treatment for skin conditions, such as actinic keratoses, typically involves applying a thin layer of the 5% cream to affected areas once or twice daily for 2-4 weeks. The most recent and highest quality study, 1, published in 2021, recommends the use of topical 5-fluorouracil as a field treatment for actinic keratoses, with a strength of recommendation of "Strong" and a quality of evidence of "Moderate". Some key points to consider when using Efudex include:

• Applying the medication with a non-metal applicator or gloved finger to avoid normal skin when possible
• Expecting redness, burning, inflammation, and crusting as the medication works, which indicate the treatment is effective
• Minimizing sun exposure during treatment and using sunscreen when outdoors
• Not covering the treated area with occlusive dressings unless directed by a physician
• Washing hands immediately after application
• Understanding that the medication works by interfering with DNA synthesis in rapidly dividing cells, preferentially affecting abnormal skin cells
• Being aware that complete healing may take 1-2 months after stopping treatment
• Temporarily discontinuing use and consulting a healthcare provider if severe irritation occurs. Additionally, the study 1 conditionally recommends the use of diclofenac, based on lower quality of evidence, and notes that the benefits of 5-FU treatment for AK were assessed as moderate or large. It's also worth noting that other studies, such as 1 and 1, provide similar recommendations and guidelines for the use of Efudex in treating skin conditions. However, the most recent and highest quality study, 1, takes precedence in guiding treatment decisions.

From the FDA Drug Label

DOSAGE AND ADMINISTRATION: When Fluorouracil Cream USP is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion, and re-epithelialization. Fluorouracil Cream USP should be applied preferably with a nonmetal applicator or suitable glove If Fluorouracil Cream USP is applied with the fingers, the hands should be washed immediately afterward. Actinic or Solar Keratosis: Apply cream 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 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 Fluorouracil Cream USP therapy. Superficial Basal Cell Carcinomas: Only the 5% strength is recommended. Apply cream twice daily in an amount sufficient to cover the lesions. Treatment should be continued for at least 3 to 6 weeks. Therapy may be required for as long as 10 to 12 weeks before the lesions are obliterated. The treatment regimen for Efudex (fluorouracil) in skin conditions is as follows:

• Actinic or Solar Keratosis: Apply cream twice daily for 2 to 4 weeks, until the inflammatory response reaches the erosion stage.
• Superficial Basal Cell Carcinomas: Apply 5% strength cream twice daily for at least 3 to 6 weeks, and up to 10 to 12 weeks if necessary 2.

From the Research

Treatment Regimen for Efudex (Fluorouracil) in Skin Conditions

The treatment regimen for Efudex (fluorouracil) in skin conditions involves the application of a topical solution or cream, typically containing 0.5% to 5% fluorouracil. The specific treatment protocol may vary depending on the condition being treated and the individual patient's response to the medication.

Application and Dosage

• The usual method of treatment is twice daily application of a 1 percent FU solution in propylene glycol, as described in the study by 3.
• A one-week treatment with once-daily fluorouracil cream 0.5% has been shown to be effective in reducing actinic keratoses lesions, with minimal adverse events 4.
• The treatment duration can be extended up to 4 weeks to further improve lesion clearance rates, as suggested by 4.

Indications and Efficacy

• Topical fluorouracil is an effective agent for treating multiple actinic keratoses, Bowen's disease, actinic cheilitis, and other skin conditions, as reported by 3.
• The evidence is strongest for topical 5-FU use in the treatment of actinic keratosis, squamous cell carcinoma, and basal cell carcinoma, according to the review by 5.
• Topical fluorouracil has been shown to be more effective than diclofenac in terms of lesion disappearance one month after the end of treatment, as indicated by 6.

Adverse Events and Tolerability

• The most frequent treatment-related adverse events are facial and eye irritations, which are predominantly mild to moderate in severity, as reported by 4.
• Local adverse effects, such as contact dermatitis, skin rash, and dry skin, can occur, but are generally less intense than with topical fluorouracil, as noted by 6.
• Older patients may require careful attention to expectations, needs, and preferences to ensure maximal adherence and prevent treatment failure, as suggested by 7.