Imiquimod topical
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Topical formulations containing imiquimod.
Drugs List
Therapeutic Indications
Uses
Actinic keratoses in adults where other topical therapy contraindicated
Topical treatment of external genital and perianal warts
Treatment of small superficial basal cell carcinomas in adult patients
Cream containing 5% imiquimod
Treatment of external genital and perianal warts.
Treatment of small superficial basal cell carcinomas in adult patients.
Creams containing 3.75% and 5% imiquimod
Treatment of nonhypertrophic, nonhyperkeratotic, clinically typical actinic keratoses of face or scalp in adult immunocompetent patients where other topical treatments are either contraindicated or inappropriate.
Dosage
The application frequency and duration of treatment differs for each indication.
Before application, the treatment area should be washed with mild soap and water and dried thoroughly. Apply the cream prior to normal sleeping hours. The cream should remain on the skin for 6 to 10 hours, and then be removed with soap and water.
Adults
Treatment of external genital warts:
1 application to the affected area three times weekly. Apply a thin layer to the clean wart area (avoiding any application to internal surfaces) and rub in until the cream vanishes.
Continue treatment until visible genital or perianal warts are cleared. Maximum use of 16 weeks per episode of warts.
Uncircumcised males treating warts under the foreskin should retract the skin and wash the area daily.
A single use 5% sachet is sufficient to cover a wart area of 20 square centimetre of skin.
Treatment of superficial basal cell carcinoma:
1 application to the affected area five times weekly. Apply sufficient amount of cream to cover the treatment area, including 1 centimetre of skin surrounding the tumour. Apply to the clean treatment area and rub in until the cream vanishes. Maximum use of 6 weeks.
Assess response of the treated tumour 12 weeks after the end of treatment. If an incomplete response is shown, use alternative therapy.
Local skin reactions are common which decrease in intensity or resolve after cessation of treatment. A treatment break of several days may be taken if localised skin reactions cause excessive irritation to the patient, or if the treatment site becomes infected. Treatment may be resumed once the skin reaction has moderated. In the case of infection at the application site, appropriate other measures should be taken.
There is an association between the complete clearance rate and the intensity of local skin reactions. Local reactions may be related to the stimulation of local immune response.
Data from an open label clinical trial suggests that large tumours (greater than 7.5 centimetres squared) are less likely to respond to imiquimod therapy.
Treatment of actinic keratosis (AKs):
If intense local inflammatory reactions or infection at the treatment site occurs, an interruption in treatment should be considered.
Local skin reactions are common which decrease in intensity or resolve after cessation of treatment. A treatment break of several days may be taken if localised skin reactions cause excessive irritation to the patient, or if the treatment site becomes infected. Treatment may be resumed once the skin reaction has moderated. In the case of infection at the application site, appropriate other measures should be taken.
Maximum treatment period is 4 weeks, even with rest periods and missed doses.
Complete the full treatment course even if all actinic keratosis appear to be gone.
The clinical outcome of therapy has to be determined after regeneration of the treated skin, approximately 8 weeks after the end of treatment and at appropriate intervals. Lesions that do not respond completely to treatment at 8 weeks after the second treatment cycle should be carefully re-evaluated. The maximum duration of treatment should not exceed 8 weeks.
Cream containing 3.75mg imiquimod per 100mg (3.75%):
1 application to the affected area once daily, using a sufficient amount of cream to cover the treatment area. Intended for 2 treatment cycles, use for two weeks followed by a two week no treatment cycle and repeat. Up to 2 sachets may be applied daily.
Cream containing 5mg imiquimod per 100mg (5%):
1 application to the affected area three times per week, for a 4 week period, using a sufficient amount of cream.
The maximum single dose should not exceed 250mg of imiquimod cream 5% (1 sachet).
Children
External genital and perianal warts in children (unlicensed):
1 application to the affected area three times a week at night in a thin layer, until lesions clear.
Maximum treatment period of 16 weeks should not be exceeded.
Cream should be rubbed into the affected area and allowed to remain on the skin for a period of 6 to 10 hours before being washed off with mild soap and water. Uncircumcised males being treated for warts under the foreskin should wash the area daily.
Additional Dosage Information
If a dose is missed, the cream should be applied as soon as is convenient before continuing with the original schedule. Do not apply imiquimod cream more than once daily.
Contraindications
Hypersensitivity to benzyl alcohol
Neonates
Breastfeeding
Precautions and Warnings
Autoimmune disease
Children under 18 years
Immunosuppressed transplant recipients
Immunosuppression
Haematological disorder
Positive HIV status
Pregnancy
May not be as effective in wart clearance in HIV positive patients
Not recommended in urethral,intravaginal,cervical,rectal & intra-anal warts
Actinic keratoses: biopsy atypical or possibly malignant lesions
Not all presentations are licensed for all indications
Treatment to be prescribed under the supervision of a specialist
Contains benzyl alcohol
Contains cetostearyl alcohol: may cause irritation
Advise patient to wash hands after use
Avoid broken or inflamed skin
Avoid contact with eyes
Avoid contact with nostrils or mouth
Avoid occlusive dressings
Before applying, wash treatment area with soap and water. Dry thoroughly
Not for use in open wounds
Interrupt therapy if flu-like symptoms/severe inflammatory reactions occur
May exacerbate inflammatory conditions of the skin
Discontinue if early signs of stricture occur
Discontinue if retraction of foreskin is increasingly difficult
Marked skin irritation - interrupt treatment/reduce application frequency
Male & female: Damages latex condoms and diaphragms
Advise patient not to wash treated area for 8 hours after application
Advise patient residue on clothing/bedding may cause fire hazard
Advise patient to minimise exposure of treated areas to sunlight/sunlamps
Apply sunscreen (SPF15+) to areas at risk of sunlight exposure post therapy
Fire hazard: Keep away from naked flames and potential sources of ignition
Intolerable skin reaction: remove product by washing
Remove product with soap and water after approximately 8 hours
Uncircumcised males & warts under foreskin: perform daily foreskin hygiene
Wash product from skin before sexual activity
Avoid contact with the eyes, lips, nostrils and normal skin (however, for the treatment for superficial basal cell carcinoma, extend 1cm beyond tumour).
Imiquimod cream should be washed off before sexual contact.
Limited data has shown an increased rate of wart reduction in HIV positive patients, however imiquimod cream has not been shown to be as effective in terms of wart clearance in this patient group.
Pregnancy and Lactation
Pregnancy
Use imiquimod cream with caution during pregnancy.
The manufacturer recommends imiquimod is used with caution in pregnancy and only be used if potential benefit justifies the potential risk to the foetus.
At the time of writing there is limited published information regarding the use of imiquimod during pregnancy.
Briggs (2015) suggest that the potential for human developmental toxicity is low.
Animal studies do not indicate direct or indirect harmful effect in respect to pregnancy or embryonal development.
Lactation
Imiquimod is contraindicated during breastfeeding.
At the time of writing there is limited published information regarding the use of imiquimod in breastfeeding.
The manufacturer states that a decision whether to discontinue breastfeeding or imiquimod treatment must be made, taking into account the benefit of breastfeeding for the infant and the benefit of therapy for the woman.
The low molecular weight and long half life suggests imiquimod will be excreted into breast milk. However, the amount absorbed systemically and available for excretion into milk is very low and probably clinically insignificant.
Briggs (2015) concludes that, although the risk to a nursing infant is unknown, use of imiquimod by the mother appears to be compatible with breastfeeding.
Side Effects
Abdominal pain
Actinic keratosis
Alopecia (at treatment site)
Anorexia
Application site reaction
Arthralgia
Asthenia
Back pain
Bacterial infection
Bleeding
Burning sensation
Chest pain
Conjunctival irritation
Crusting of skin
Cutaneous lupus erythematosus
Depression
Dermatitis
Diarrhoea
Dizziness
Dry mouth
Dry skin
Dyspareunia
Dysuria
Eczema
Elevated blood glucose (transient)
Elevation of liver enzymes
Erectile dysfunction
Erosion
Erythema
Erythema multiforme
Erythematous rash
Exacerbation of autoimmune disease
Excoriation
Extremity pain
Eyelid oedema
Facial oedema
Fatigue
Flaking of skin
Flushing
Folliculitis
Formation of pustules
Fungal infection
Genital candidiasis
Genital pain
Haemoglobin decrease
Headache
Herpes simplex
Hyperaesthesia
Hyperpigmentation
Hypopigmentation
Increased sweating
Infections
Inflammation (application site)
Influenza
Influenza-like syndrome
Insomnia
Irritability
Irritation at application site
Lethargy
Lymphadenopathy
Malaise
Migraine
Myalgia
Nasal congestion
Nausea
Oedema at application site
Pain
Pain at application site
Papules
Paraesthesia
Pharyngitis
Pharyngolaryngeal pain
Phimosis
Pruritus
Pyrexia
Rash
Rectal disorders
Reduced neutrophil count
Reduced platelet count
Rhinitis
Rigors
Scaling of skin
Scarring at application site
Skin exfoliation
Skin ulcer
Somnolence
Stevens-Johnson syndrome
Tinnitus
Ulceration (application site)
Upper respiratory tract infection
Urticaria
Uterovaginal prolapse
Vaginal pain
Vaginitis
Vesicles
Vomiting
Vulvovaginal disorders
White blood cell count decreased
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: January 2013
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Aldara 5% cream. Meda Pharmaceuticals. Revised January 2017.
Summary of Product Characteristics: Bascellex 50mg/g cream. Sun Pharmaceutical UK Ltd. Revised May 2019.
Summary of Product Characteristics: Zyclara 3.75% cream. Meda Pharmaceuticals. Revised February 2018.
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 05 June 2018
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