Imiquimod

Registered South African indications:

• Genital warts
• Perianal warts
• Actinic keratosis
• Basal cell carcinoma

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Contact with eyes, lips, nostrils
• Inflammatory conditions of the skin
• Autoimmune disorders
• Organ transplant patients
• Application to broken skin
• Reduced haematological reserve
• Occlusive dressings
• Foreskin associated warts
• Urethral, intra-vaginal, cervical, rectal or intra-anal warts
• High doses
• Barrier contraceptives
• Immunocompromised patients
• Basal cell carcinoma within 1cm of eyelids, lips, nose or hairline
• Previously treated tumours
• Large tumours > 7.25cm²
• Solar exposure
• Actinic keratosis with marked hyperkeratosis or hypertrophy
• Actinic keratosis on the eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border
• Actinic keratoses in anatomical locations other than the face and scalp
• Prolonged treatment

Forms avail. in SA and covered in this monograph: cre

External genital and perianal warts 

• Topical (cre): Apply small quantity to affected area(s), 3 times per week, prior to sleeping and should remain on the skin for 6-10hrs; Treatment duration: Until clearance of visible genital or perianal warts OR for a maximum of 16 weeks per episode of warts

Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses
- 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

• Topical (cre): Apply small quantity to affected area(s), 3 times per week, prior to sleeping and should remain on the skin for 8hrs; Treatment duration: 4-8 weeks

May only be applied once per day

Before applying, wash the treatment area with soap and water and dry thoroughly

Can be re-treated with 1-2 courses after a 12 week treatment pause

Do not use occlusive dressing

Superficial basal cell carcinoma

Consult specialist for dosages and regimens

Not established for use in children below 18 years

Pregnancy

• Caution
• No clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women

Breastfeeding

• Caution
• As no quantifiable levels (> 5 ng/ml) of imiquimod are detected in the serum after single and multiple topical doses, no specific advice can be given on whether to use or not in breastfeeding mothers

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly 

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Paraesthesia
• Dizziness
• Migraine
• Somnolence
• Insomnia
• Depression
• Irritability
• Fatigue
• Lethargy

Cardiovascular Disorders

• Flushing

Respiratory Disorders

• Upper respiratory tract infection
• Rhinitis
• Pharyngitis
• Nasal congestion
• Pharyngolaryngeal pain

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal pain
• Diarrhoea
• Rectal disorder
• Rectal tenesmus
• Dry mouth

Genitourinary Disorders

• Genital candidiasis
• Vaginitis
• Vulvitis
• Dysuria
• Genital pain 
• Penile disorder
• Dyspareunia
• Erectile dysfunction
• Uterovaginal prolapse
• Vaginal pain
• Vaginitis atrophic
• Vulval disorder

Endocrine and Metabolic Disorders

• Anorexia

Musculoskeletal Disorders

• Myalgia
• Arthralgia
• Back pain
• Pain in extremity

Skin and Subcutaneous Tissue Disorders

• Application site reactions
• Pruritus
• Dermatitis
• Folliculitis
• Rash erythematous
• Eczema
• Rash
• Increased sweating 
• Urticaria
• Actinic keratosis
• Erythema
• Facial oedema
• Skin ulcer

Immune, Blood and Lymphatic System Disorders

• Infection
• Pustules
• Herpes simplex
• Bacterial infection
• Fungal infection
• Influenza
• Lymphadenopathy
• Pyrexia
• Influenza-like illness
• Rigours
• Inflammation

Sensory Disorders

• Eye disorders
• Conjunctival irritation
• Eyelid oedema
• Tinnitus

• Immunosuppressive agents

None routine

Imiquimod is an immune response modifier that is not a nucleoside analogue. The exact mechanism of action is unknown. The activity is principally related to induction of alpha interferon, but other cytokines are also involved.

Cream 

• Aldara (iNova) originator
• Glentriz Cream 5% (Glenmark Pharmaceuticals South Africa)