Imiquimod

Topical/Cutaneous
Actinic keratoses
Adult: For treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable cases: As 2.5% or 3.75% cream: Apply thinly onto entire face or balding scalp once daily before bedtime for 2 weeks; after 2-week treatment-free interval, repeat 2nd 2-week treatment course. Assess response 8 weeks after the 2nd course. Max: 2 sachets/day or 2 full pump actuations/day. Rest periods may be taken if local skin reactions occur, but treatment period must not be extended due to missed doses or rest periods. As 5% cream: Apply onto face or scalp 3 times each week before bedtime for 4 weeks; after 4-week treatment-free interval, assess response then repeat another 4-week treatment course if any lesions persist. Alternatively, apply onto face or scalp 2 times each week for 16 weeks. Max: 1 sachet at each application. Rest periods may be taken if local skin reactions occur, but treatment period must not be extended beyond 4 weeks or 16 weeks due to missed doses or rest periods.

Topical/Cutaneous
Perianal warts
Adult: As 3.75% cream: Apply thinly onto the affected area(s) once daily before bedtime; leave on the skin for approx 8 hours, then wash with mild soap and water. Continue treatment until total clearance or for a Max duration of 8 weeks. As 5% cream: Apply thinly 3 times each week (on alternate days) before bedtime; leave on the skin for 6-10 hours, then wash with mild soap and water. Continue treatment until total clearance or for a Max duration of 16 weeks. Dosage and treatment recommendations may vary among individual products or between countries (refer to specific product or local guidelines).

Topical/Cutaneous
Genital warts
Adult: As 3.75% cream: Apply thinly onto the affected area(s) once daily before bedtime; leave on the skin for approx 8 hours, then wash with mild soap and water. Continue treatment until total clearance or for a Max duration of 8 weeks. As 5% cream: Apply thinly 3 times each week (on alternate days) before bedtime; leave on the skin for 6-10 hours, then wash with mild soap and water. Continue treatment until total clearance or for a Max duration of 16 weeks. Dosage and treatment recommendations may vary among individual products or between countries (refer to specific product or local guidelines).

Topical/Cutaneous
Superficial basal cell carcinoma
Adult: For the treatment of biopsy-confirmed cases with a max tumour diameter of 2 cm located on the neck, trunk (except anogenital skin), or extremities (except hands and feet) when surgical methods are less appropriate and patient follow-up can be assured: As 5% cream: Apply sufficient amount to cover the lesion and 1 cm beyond it 5 times each week (on consecutive days) before bedtime; leave on skin for approx 8 hours, then wash with mild soap and water. Treatment duration: 6 weeks. Assess response 12 weeks after treatment completion.

Patient with pre-existing autoimmune disorders, inherent sensitivity to sunlight or potential for considerable sun exposure (e.g. occupational reasons); reduced haematologic reserve. Immunocompromised patients, including organ transplant patients. Uncircumcised males. Not indicated for urethral, cervical, rectal, intravaginal, or intra-anal HPV disease. Not recommended to be used until the skin has healed from any previous sunburn, drug or surgical treatment. Not intended for oral, nasal, or ophthalmic use. Pregnancy and lactation. Patient Counselling Avoid contact with eyes, lips, nostrils and broken skin. Avoid or minimise exposure to sunlight, UV lights, and tanning beds; use protective clothing during therapy. Avoid the use of excessive amounts of cream or occlusive dressing. Avoid sexual contact while the cream is on the skin as it may weaken condoms and diaphragms (when used for external genital or perianal warts). Monitoring Parameters Establish a histological basis for superficial basal cell carcinoma prior to therapy. Periodically assess response to treatment, particularly for a reduction in lesion size. Monitor for local skin reactions and signs and symptoms of hypersensitivity.

Significant: Intense local inflammatory reactions (e.g. skin weeping or erosion), photosensitivity, severe vulvar swelling which may lead to urinary retention; flu-like symptoms (e.g. chills, fever, fatigue, arthralgia, malaise); may exacerbate autoimmune disorders or inflammatory skin conditions (including graft-versus-host-disease). Blood and lymphatic system disorders: Lymphadenopathy. Cardiac disorders: Chest pain. Gastrointestinal disorders: Nausea, vomiting, diarrhoea. General disorders and administration site conditions: Application site reactions (e.g. dryness, pruritus, pain, irritation, burning sensation, rash, erythema, oedema, paraesthesia, discharge, scabbing, exfoliation, ulceration). Infections and infestations: Fungal infection, herpes simplex. Investigations: Increased blood glucose. Metabolism and nutrition disorders: Anorexia. Musculoskeletal and connective tissue disorders: Myalgia, back pain. Neoplasms benign, malignant and unspecified: Squamous cell carcinoma. Nervous system disorders: Headache, dizziness. Psychiatric disorders: Insomnia. Reproductive system and breast disorders: Bacterial vaginosis. Respiratory, thoracic and mediastinal disorders: URTI, sinusitis. Skin and subcutaneous tissue disorders: Skin hypopigmentation or hyperpigmentation, dermatitis, erythema multiforme.

Imiquimod is an immune response modifier and a Toll-like receptor 7 agonist that activates immune cells. Its exact mechanism of action has not been determined; however, it may induce the release of interferon-α (IFN-α) and other cytokines and enhance cell-mediated cytolytic antiviral activity.
Absorption: Minimal systemic absorption. Time to peak plasma concentration: 9-12 hours.
Excretion: Via urine (<3% as unchanged drug and metabolites).

Topical/Cutaneous: Store below 25°C. Do not freeze. Keep the cream in pump bottle upright.

Other Dermatologicals

D06BB10 - imiquimod ; Belongs to the class of topical antivirals used in the treatment of dermatological diseases.