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Aldara is a brand name for Imiquimod. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Imiquimod cream is indicated for the topical treatment of: External genital and perianal warts (condylomata acuminata) in adults. Small superficial basal cell carcinomas (sBCCs) in adults. Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult…
Verbatim from this product's EMA label. Tap a section to expand.
Posology The application frequency and duration of treatment with imiquimod cream is different for each indication.
External genital warts in adults:
Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday, and Friday; or Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and should remain on the skin for 6 to 10 hours. Imiquimod cream treatment should continue until the clearance of visible genital or perianal warts or for a maximum of 16 weeks per episode of warts.
2 Method of administration. 3 Superficial basal cell carcinoma in adults: Apply imiquimod cream for 6 weeks, 5 times per week (example: Monday to Friday) prior to normal sleeping hours, and leave on the skin for approximately 8 hours.
2 Method of administration. Actinic keratosis in adults Treatment should be initiated and monitored by a physician.
Imiquimod cream should be applied 3 times per week (example:
Monday, Wednesday and Friday) for four weeks prior to normal sleeping hours, and left on the skin for approximately 8 hours. Sufficient cream should be applied to cover the treatment area. After a 4-week treatment-free period, clearance of AKs should be assessed.
If any lesions persist, treatment should be repeated for another four weeks. The maximum recommended dose is one sachet. 4) or if infection is observed at the treatment site. In this latter case, appropriate other measures should be taken.
Each treatment period should not be extended beyond 4 weeks due to missed doses or rest periods. If the treated area does not show complete clearance at a follow-up examination about 8 weeks after the last 4-weeks course of treatment, an additional 4-weeks course of Aldara treatment may be considered.
A different therapy is recommended if the treated lesion(s) shows insufficient response to Aldara. 1).
Information applicable to all indications:
If a dose is missed, the patient should apply the cream as soon as he/she remember and then he/she should continue with the regular schedule. However the cream should not be applied more than once a day. Paediatric population Use in the paediatric patient population is not recommended.
7% of imiquimod treated patients). 5%) were also reported. Patient reported adverse reactions from 2292 patients treated with imiquimod cream in placebo controlled and open clinical studies are presented below. These adverse events are considered at least possibly causally related to treatment with imiquimod.
Superficial basal cell carcinoma:
In trials with 5 times per week dosing 58% of patients experienced at least one adverse event. 1%. 5%) were reported by imiquimod cream patients. Patient reported adverse reactions from 185 patients treated with imiquimod cream in placebo controlled phase III clinical studies for superficial basal cell carcinoma are presented below.
These adverse events are considered at least possibly causally related to treatment with imiquimod. Actinic keratosis 8 In the pivotal trials with 3 times per week dosing for up to 2 courses each of 4 weeks, 56% of imiquimod patients reported at least one adverse event.
The most frequently reported adverse event from these trials judged probably or possibly related to imiquimod cream was application site reactions (22% of imiquimod treated patients). Some systemic adverse reactions, including myalgia (2%) were reported by imiquimod treated patients.
Patient reported adverse reactions from 252 patients treated with imiquimod cream in vehicle controlled phase III clinical studies for actinic keratosis are presented below. These adverse events are considered at least possibly causally related to treatment with imiquimod.
b) Tabular Listing of adverse events: Frequencies are defined as Very common (1/10), Common (1/100 to <1/10) and Uncommon (1/1,000 to <1/100). Lower frequencies from clinical trials are not reported here. External genital warts (3x/ wk,16wks) N = 2292 Superficial basal cell carcinoma (5x/wk, 6 wks) N = 185 Actinic keratosis (3x/wk, 4 or 8 wks) N = 252 Infections and infestations: Infection Common Common Uncommon Pustules Common Uncommon Herpes simplex Uncommon Genital candidiasis Uncommon Vaginitis Uncommon Bacterial infection Uncommon Fungal infection Uncommon Upper respiratory tract infection Uncommon Vulvitis Uncommon Rhinitis Uncommon Influenza Uncommon Blood and lymphatic system disorders: Lymphadenopathy Uncommon Common Uncommon Metabolism and nutrition disorders: Anorexia Uncommon Common Psychiatric disorders: Insomnia Uncommon Depression Uncommon Uncommon Irritability Uncommon Nervous system disorders: Headache Common Common Paraesthesia Uncommon Dizziness Uncommon Migraine Uncommon Somnolence Uncommon Eye disorders Conjunctival irritation Uncommon Eyelid oedema Uncommon Ear and labyrinth disorders: Tinnitus Uncommon Vascular disorders: Flushing Uncommon 9 Respiratory, thoracic and mediastinal disorders: Pharyngitis Uncommon Rhinitis Uncommon Nasal congestion Uncommon Pharyngo laryngeal pain Uncommon Gastrointestinal disorders: Nausea Common Uncommon Common Abdominal pain Uncommon Diarrhoea Uncommon Uncommon Vomiting Uncommon Rectal disorder Uncommon Rectal tenesmus Uncommon Dry mouth Uncommon Skin and subcutaneous tissue disorders: Pruritus Uncommon Dermatitis Uncommon Uncommon Folliculitis Uncommon Rash erythematous Uncommon Eczema Uncommon Rash Uncommon Sweating increased Uncommon Urticaria Uncommon Actinic keratosis Uncommon Erythema Uncommon Face oedema Uncommon Skin ulcer Uncommon Musculoskeletal and connective tissue disorders: Myalgia Common Common Arthralgia Uncommon Common Back pain Uncommon Common Pain in extremity Uncommon Renal and urinary disorders: Dysuria Uncommon Reproductive system and breast disorders: Genital pain male Uncommon Penile disorder Uncommon Dyspareunia Uncommon Erectile dysfunction Uncommon Uterovaginal prolapse Uncommon Vaginal pain Uncommon Vaginitis atrophic Uncommon Vulval disorder Uncommon General disorders and administration site conditions: Application site pruritus Very common Very common Very common Application site pain Very common Common Common Application site burning Common Common Common Application site irritation Common Common Common Application site erythema Common Common Application site reaction Common 10 Application site bleeding Common Uncommon Application site papules Common Uncommon Application site paraesthesia Common Uncommon Application site rash Common Fatigue Common Common Pyrexia Uncommon Uncommon Influenza-like illness Uncommon Uncommon Pain Uncommon Asthenia Uncommon Uncommon Malaise Uncommon Rigors Uncommon Uncommon Application site dermatitis Uncommon Application site discharge Uncommon Uncommon Application site hyperaesthesia Uncommon Application site inflammation Uncommon Application site oedema Uncommon Uncommon Application site scabbing Uncommon Uncommon Application site scar Uncommon Application site skin breakdown Uncommon Application site swelling Uncommon Uncommon Application site ulcer Uncommon Application site vesicles Uncommon Uncommon Application site warmth Uncommon Lethargy Uncommon Discomfort Uncommon Inflammation Uncommon c) Frequently occurring adverse events: External genital warts: Investigators of placebo controlled trials were required to evaluate protocol mandated clinical signs (skin reactions).
External genital warts, superficial basal cell carcinoma and actinic keratosis:
Avoid contact with the eyes, lips and nostrils. Imiquimod has the potential to exacerbate inflammatory conditions of the skin. 5). Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated with a possible worsening of their autoimmune condition.
5). Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated with the possibility of organ rejection or graft-versus-host disease. Imiquimod cream therapy is not recommended until the skin has healed after any previous drug or surgical treatment.
9) 5 The use of an occlusive dressing is not recommended with imiquimod cream therapy. The excipients methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed). g. contact dermatitis).
Benzyl alcohol may cause allergic reactions and mild local irritation. Rarely, intense local inflammatory reactions including skin weeping or erosion can occur after only a few applications of imiquimod cream. Local inflammatory reactions may be accompanied, or even preceded, by flu-like systemic signs and symptoms including malaise, pyrexia, nausea, myalgias and rigors.
An interruption of dosing should be considered. 8d).
External genital warts:
There is limited experience in the use of imiquimod cream in the treatment of men with foreskin- associated warts. The safety database in uncircumcised men treated with imiquimod cream three times weekly and carrying out a daily foreskin hygiene routine is less than 100 patients.
In other studies, in which a daily foreskin hygiene routine was not followed, there were two cases of severe phimosis and one case of stricture leading to circumcision. Treatment in this patient population is therefore recommended only in men who are able or willing to follow the daily foreskin hygiene routine.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Imiquimod in European Union.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
There are no data available on the use of imiquimod in children and adolescents in the approved indications. 1).
Method of administration External genital warts:
Imiquimod cream should be applied in a thin layer and rubbed on the clean wart area until the cream vanishes. Only apply to affected areas and avoid any application on internal surfaces. Imiquimod cream should be applied prior to normal sleeping hours.
During the 6 to 10 hour treatment period, showering or bathing should be avoided. After this period it is essential that imiquimod cream is removed with mild soap and water. 9). A single-use sachet is sufficient to cover a wart area of 20 cm2 (approx.
3 inches2). Sachets should not be re-used once opened. Hands should be washed carefully before and after application of cream. 4).
Superficial basal cell carcinoma:
Before applying imiquimod cream, patients should wash the treatment area with mild soap and water and dry thoroughly. Sufficient cream should be applied to cover the treatment area, including one centimetre of skin surrounding the tumour.
The cream should be rubbed into the treatment area until the cream vanishes. The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours. During this period, showering and bathing should be avoided.
After this period it is essential that imiquimod cream is removed with mild soap and water. Sachets should not be re-used once opened. Hands should be washed carefully before and after application of cream. Response of the treated tumour to imiquimod cream should be assessed 12 weeks after the end of treatment.
4). 4) if the local skin reaction to imiquimod cream causes excessive discomfort to the patient, or if infection is observed at the treatment site. In this latter case, appropriate other measures should be taken.
Actinic keratosis:
Before applying imiquimod cream, patients should wash the treatment area with mild soap and water and dry thoroughly. Sufficient cream should be applied to cover the treatment area. The cream should be rubbed into the treatment area until the cream vanishes.
The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours. During this period, showering and bathing should be avoided. After this period it is essential that imiquimod cream is removed with mild soap and water.
Sachets should not be re-used once opened. Hands should be washed carefully before and after application of cream.
These protocol mandated clinical sign assessments indicate that local skin reactions including erythema (61%), erosion (30%), excoriation/flaking/scaling (23%) and oedema (14%) […]
g. erosion, ulceration, oedema, induration), or increasing difficulty in retracting the foreskin. If these symptoms occur, the treatment should be stopped immediately. Based on current knowledge, treating urethral, intra-vaginal, cervical, rectal or intra-anal warts is not recommended.
Imiquimod cream therapy should not be initiated in tissues where open sores or wounds exist until after the area has healed. Local skin reactions such as erythema, erosion, excoriation, flaking and oedema are common. Other local reactions such as induration, ulceration, scabbing, and vesicles have also been reported.
Should an intolerable skin reaction occur, the cream should be removed by washing the area with mild soap and water. Treatment with imiquimod cream can be resumed after the skin reaction has moderated. 2). However, in rare cases severe local reactions that have required treatment and/or caused temporary incapacitation have been observed in patients who have used imiquimod according to the instructions.
Where such reactions have occurred at the urethral meatus, some women have experienced difficulty in urinating, sometimes requiring emergency catheterisation and treatment of the affected area. No clinical experience exists with imiquimod cream immediately following treatment with other cutaneously applied drugs for treatment of external genital or perianal warts.
Imiquimod cream should be washed from the skin before sexual activity. Imiquimod cream may weaken condoms and diaphragms, therefore concurrent use with imiquimod cream is not recommended. Alternative forms of contraception should be considered.
In immunocompromised patients, repeat treatment with imiquimod cream is not recommended. While limited data have shown an increased rate of wart reduction in HIV positive patients, imiquimod cream has not been shown to be as effective in terms of wart clearance in this patient group.
Superficial basal cell carcinoma:
Imiquimod has not been evaluated for the treatment of basal cell carcinoma within 1 cm of the eyelids, nose, lips or hairline. 6 During therapy and until healed, affected skin is likely to appear noticeably different from normal skin.
Local skin reactions are common but these reactions generally decrease in intensity during therapy or resolve after cessation of imiquimod cream therapy. g. erythema). These local skin reactions may be related to the stimulation of local immune response.
If required by the patient’s discomfort or the severity of the local skin reaction, a rest period of several days may be taken. Treatment with imiquimod cream can be resumed after the skin reaction has moderated. The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 12 weeks after the end of treatment.
No clinical experience exists with the use of imiquimod cream in immunocompromised patients. No clinical experience exists in patients with recurrent and previously treated BCCs, therefore use for previously treated tumours is not recommended.
25 cm2) are less likely to respond to imiquimod therapy. The skin surface area treated […]