Aldara 5% Cream

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.

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.

For quantity to be applied see section 4.2 Method of administration.

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.

For quantity to be applied see 4.2 Method of administration.

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.

A different therapy is recommended if the treated lesion(s) shows insufficient response to Aldara.

Actinic keratosis lesions that have cleared after one or two courses of treatment and subsequently recur can be re-treated with one or two further courses of Aldara cream following an at least 12 weeks treatment pause (see section 5.1).

Information applicable to all indications:

If a dose is missed, the patient should apply the cream as soon as he/she remember and then he/she should continue with the regular schedule. However the cream should not be applied more than once a day.

Paediatric population

Use in the paediatric patient population is not recommended. There are no data available on the use of imiquimod in children and adolescents in the approved indications.

Aldara should not be used in children with molluscum contagiosum due to lack of efficacy in this indication (see section 5.1).

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 (see sections 4.4, 4.8 and 4.9). 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