ALDARA

What it is

Aldara contains imiquimod. Imiquimod is 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine. Each gram of the 5% cream contains 50 mg of imiquimod in an off-white oil-in-water vanishing cream base. Aldara is supplied as a cream sachet or as a cream pump. Imiquimod is an immune response modifier.

Approved indications

— Treatment of solar (actinic) keratosis on the face and scalp. — Primary treatment of confirmed superficial basal cell carcinoma where surgery is considered inappropriate. — Treatment of external genital and perianal warts/condyloma acuminata in adults.

Dosing overview

The dosing frequency of Aldara for the treatment of superficial basal cell carcinoma is different to that for the treatment of solar keratosis and external genital warts. Aldara is to be applied to the affected area prior to normal sleeping hours and should be left on the skin for approximately 8 hours (6-10 hours). A rest period of several days may be taken if required due to the patient's discomfort or severity of the local skin reaction.

Key safety warnings

Local skin reactions such as erythema, erosion, excoriation/flaking, and oedema are common, with other local reactions such as induration, ulceration, scabbing, and vesicles also reported. Most skin reactions are mild to moderate. Local skin reactions generally resolve after cessation of therapy with Aldara and are generally less intense during a second course of therapy. Treatment with Aldara can be resumed after the skin reaction has subsided. Localised hypopigmentation and hyperpigmentation have been reported following use of Aldara, and follow-up information suggests that these skin colour changes may be permanent in some patients. Aldara, as an immune response modifier, has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease. Rare reports have been received of exacerbation of autoimmune conditions. Aldara should be used with caution in organ transplant patients and in patients with pre-existing autoimmune conditions. Exposure to sunlight (including sunlamps) should be avoided or minimised during use of Aldara because of concern for heightened sunburn susceptibility. Patients should be warned to use protective clothing when using Aldara. Patients with sunburn should be advised not to use Aldara until fully recovered.

Contraindications

Hypersensitivity to any ingredient is a contraindication. Aldara should not be used to treat urethral, intra-vaginal, cervical, rectal, or intra-anal warts due to the unknown local tolerance and potential systemic absorption.

PBS listing

Aldara cream 50 mg per g, 2 g is listed on the PBS. There are 2 PBS items listed with authority required restriction. The ex-manufacturer price is A$78.01.

Regulatory history

Aldara Imiquimod 50 mg/g cream sachet was first registered on the ARTG on 18 August 1998. Aldara Pump imiquimod 50 mg/g cream pump was first registered on the ARTG on 10 January 2012.