Name of the medicinal product:
ALDARA 5% Cream
Qualitative and quantitative composition:
Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5 %).
100 mg of cream contains 5 mg of imiquimod.
Excipients with known effects:
Methyl hydroxybenzoate (E 218) 2.0 mg/g cream
Propyl hydroxybenzoate (E 216) 0.2 mg/g cream
Cetyl alcohol 22.0 mg/g cream
Stearyl alcohol 31.0 mg/g cream
For the full list of excipients, see section 6.1.
Pharmaceutical form:
Cream.
White to slightly yellow cream.
Clinical particulars
Therapeutic indications:
Imiquimod cream is indicated for the topical treatment of:
• External genital and perianal warts (condylomata acuminata) in adults.
• Small superficial basal cell carcinomas (sBCCs) in adults.
• Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.
Posology and method of administration
Posology:
The application frequency and duration of treatment with imiquimod cream is different for each indication.
External genital warts in adults:
Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday, and Friday; or Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and should remain on the skin for 6 to 10 hours. Imiquimod cream treatment should continue until the clearance of visible genital or perianal warts or for a maximum of 16 weeks per episode of warts.
Superficial basal cell carcinoma in adults:
Apply imiquimod cream for 6 weeks, 5 times per week (example: Monday to Friday) prior to normal sleeping hours, and leave on the skin for approximately 8 hours.
Actinic keratosis in adults:
Treatment should be initiated and monitored by a physician. Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday and Friday) for four weeks prior to normal sleeping hours, and left on the skin for approximately 8 hours. Sufficient cream should be applied to cover the treatment area. After a 4-week treatment-free period, clearance of AKs should be assessed. If any lesions persist, treatment should be repeated for another four weeks.
An interruption of dosing should be considered if intense local inflammatory reactions occur (see section 4.4) or if infection is observed at the treatment site. In this latter case, appropriate other measures should be taken. Each treatment period should not be extended beyond 4 weeks due to missed doses or rest periods.
If the treated area does not show complete clearance at a follow-up examination about 8 weeks after the last 4-weeks course of treatment, an additional 4-weeks course of Aldara treatment may be considered.
Method of administration
External genital warts:
Imiquimod cream should be applied in a thin layer and rubbed on the clean wart area until the cream vanishes. Only apply to affected areas and avoid any application on internal surfaces. Imiquimod cream should be applied prior to normal sleeping hours. During the 6 to 10 hour treatment period, showering or bathing should be avoided. After this period it is essential that imiquimod cream is removed with mild soap and water. Application of an excess of cream or prolonged contact with the skin may result in a severe application site reaction. A single-use sachet is sufficient to cover a wart area of 20 cm2 (approx. 3 inches2). Sachets should not be re-used once opened. Hands should be washed carefully before and after application of cream.
Uncircumcised males treating warts under the foreskin should retract the foreskin and wash the area daily.
