Special Precautions
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.
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Adverse Reactions
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.
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CIMS Class
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ATC Classification
D06BB10 - imiquimod ; Belongs to the class of topical antivirals used in the treatment of dermatological diseases.
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