Medicinal Products

ALDARA 5%

Generic drug of the therapeutic class: Dermatology
Active ingredients: Imiquimod
laboratory: Meda AB

Cream
Box of 12 bags for single use
All forms

Indication

Imiquimod cream is indicated for the topical treatment of:
- Genital and external perianal warts (condyloma acuminata) of the adult.
- Small superficial basal cell carcinomas (CBCs) in adults. - Clinically typical, non-hypertrophic, non-hyperkeratotic actinic keratosis of the face or scalp, in adult immunocompetent when the size or number of lesions limits the efficacy and / or the tolerance of cryotherapy and if the other topical treatments are contraindicated or less appropriate.

Dosage ALDARA 5% Cream Box of 12 single use sachets

Dosage:
The frequency of applications and the duration of treatment with imiquimod cream are different for each indication.
- External genital warts of the adult:
The imiquimod cream must be applied three times a week (for example: Monday, Wednesday and Friday, or Tuesday, Thursday and Saturday) before bedtime and must remain in contact with the skin for 6 to 10 hours. Treatment with imiquimod cream should be continued until visible genital or perianal warts disappear or for up to 16 weeks per wart episode. For the quantity to be applied see Method of administration.
- Superficial basal cell carcinoma of the adult:
Apply the imiquimod cream for 6 weeks, 5 times a week (for example, Monday to Friday), before bedtime, and leave it in contact with the skin for about eight hours. For the quantity to be applied see Method of administration. - Actinic keratosis of the adult:
The treatment must be initiated and followed by a doctor.The cream imiquimod must be applied 3 times a week (for example: Monday, Wednesday and Friday) for 4 weeks before bedtime and stay in contact for about eight hours . A sufficient amount of cream should be applied to cover the entire area to be treated. The disappearance of keratosis should be evaluated 4 weeks after the treatment period.
The maximum recommended dose is one sachet. The maximum recommended treatment time is 8 weeks. Interruption of treatment should be considered if local inflammatory reactions develop (see section on warnings and precautions for use) or if infection is observed at the application site. In the latter case, it is necessary to take appropriate measures.
Even in case of forgetfulness or periods of rest the treatment should not be extended beyond 4 weeks.
If the response of the treated lesions is incomplete at the follow-up examination at 4-8 weeks after the second treatment period, another treatment should be considered (see Warnings and Precautions section).
- Information applicable to all indications:
In case of forgetting an administration, the patient should apply the cream as soon as possible then continue the usual rhythm of applications. However, the cream should not be applied more than once a day.
- Children:
Use in children is not recommended. No data on the use of imiquimod in children and adolescents are available in the approved indications. Aldara should not be used in children with molluscum contagiosum due to lack of efficacy in this indication (see section 5.1). Administration mode :
- External genital warts:
The imiquimod cream should be applied in a thin layer on the affected area, massaging until the cream penetrates. Limit the application to affected areas avoiding any application on internal surfaces. The imiquimod cream must be applied before bedtime. During 6 to 10 hours of treatment, baths and showers should be avoided. After this period, it is essential to remove the imiquimod cream with water and a mild soap. Applying an excessive amount of cream or prolonged contact with the skin may cause a severe local reaction at the application site (see warnings and precautions for use, side effects and overdose). A disposable sachet is sufficient to cover a 20 cm² area of ​​warts. Bags should not be reused once opened. It is necessary to wash your hands thoroughly before and after applying the cream.
Uncircumcised men treated for preputial warts should decant the glans and wash the affected area daily (see Warnings and Precautions section).
- Superficial basal cell carcinoma:
. Before applying imiquimod cream, patients should clean the area to be treated with water and mild soap and dry thoroughly. A sufficient amount of cream should be applied to cover the entire area to be treated plus a 1 cm skin margin all around the tumor. Massage to penetrate the cream in the area to be treated. The cream should be applied before bedtime and remain in contact with the skin for about eight hours. Showers and baths should be avoided during this time. It is essential then to remove the imiquimod cream with water and a mild soap.
Bags should not be reused once opened. It is necessary to wash your hands thoroughly before and after applying the cream.
. The tumor response treated with imiquimod cream should be evaluated 12 weeks after the end of treatment. If the response of the treated tumor is incomplete, another treatment should be tried (see section on warnings and precautions for use).
. A rest period of several days may be decided (see section on warnings and precautions for use) if the local skin reaction to imiquimod cream causes excessive discomfort to the patient or in case of infection at the application site. In the latter case, it is necessary to take appropriate measures. - Actinic keratosis:
Before applying imiquimod cream, patients should clean the area to be treated with water and mild soap and dry thoroughly. A sufficient amount of cream should be applied to cover the entire area to be treated. Massage to penetrate the cream in the area to be treated. The cream should be applied before bedtime and remain in contact with the skin for about eight hours. Showers and baths should be avoided during this time. It is essential then to remove the imiquimod cream with water and a mild soap. Bags should not be reused once opened. It is necessary to wash your hands thoroughly before and after applying the cream.

Against indications

CONTRAINDICATED:
Known hypersensitivity to the active substance or to any of the excipients of the cream. NOT RECOMMENDED :
- Children: use in children is not recommended. No data on the use of imiquimod in children and adolescents are available in the approved indications. Aldara should not be used in children with molluscum contagiosum due to lack of efficacy in this indication (see section 5.1).
- The use of an occlusive dressing is not recommended with treatment with imiquimod cream.
- Imiquimod cream can weaken condoms and diaphragms, therefore their concomitant use with imiquimod cream is not recommended.

Aldara side effects

The following excipients methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetyl alcohol and stearyl alcohol may cause allergic reactions.
a) General description :
- External genital warts:
. In the pivotal studies using an application three times a week, the most commonly reported adverse reactions that were probably or possibly attributable to treatment with imiquimod cream were local reactions at the warts treatment site (33.7% of treated patients). with imiquimod). Some systemic adverse reactions, such as headache (3.7%), flu-like illness (1.1%) and myalgia (1.5%), have also been reported.
. The adverse reactions reported in the 2292 patients treated with imiquimod cream in placebo-controlled or open-label clinical studies are presented below. The imputability of these adverse events to treatment with imiquimod is considered at least possible.
- Superficial basal cell carcinoma:
. In trials using an application five times a week, 58% of patients experienced at least one adverse event. The most commonly reported adverse reactions, possibly or probably attributable to imiquimod cream, were application site defects, with a frequency of 28.1%. Some systemic reactions, including low back pain (1.1%) and flu-like symptoms (0.5%), have been reported in patients using imiquimod cream.
. The adverse reactions reported by 185 patients treated with imiquimod cream for superficial basal cell carcinoma in Phase III placebo-controlled clinical trials are presented below. The imputability of these adverse events to treatment with imiquimod is considered at least possible.
- Actinic keratosis:
. In pivotal studies using an application of imiquimod cream 3 times a week for 2 courses of 4 weeks each, 56% of patients reported at least one adverse event. The most commonly reported adverse reactions that were probably or possibly attributable to treatment with imiquimod cream were local reactions at the site of application (22% of patients treated with imiquimod). Some systemic adverse reactions such as myalgia (2%) have also been reported.
. Adverse reactions reported in 252 patients treated with imiquimod cream for actinic keratosis in placebo-controlled Phase III clinical trials are presented below. The imputability of these adverse events to treatment with imiquimod is considered at least possible.
b) Tables of adverse events :
Frequencies are defined as follows: Very common (> = 1/10); Frequent (> = 1/100 to = 1/1000 to <1/100). The lower frequencies observed in clinical trials are not reported here.
External genital warts (x 3 / week, 16 weeks) N = 2292 / Superficial basal cell carcinoma (x 5 / week, 6 weeks) N = 185 / Actinic keratosis (x 3 / week, 4 or 8 weeks) N = 252 .
- Infections and infestations:
. Infection: Frequent / Frequent / Uncommon.
. Pustules: - / Frequent / Uncommon.
. Herpes simplex: Uncommon / - / -.
. Genital candidiasis: Uncommon / - / -.
. Vaginitis: Uncommon / - / -.
. Bacterial infection: Uncommon / - / -.
. Mycosis: Uncommon / - / -.
. Upper respiratory infection: Uncommon / - / -.
. Vulvite: Uncommon / - / -.
. Rhinitis: - / - / Uncommon.
. Flu: - / - / Uncommon.
- Hematological and lymphatic system disorders:
Lymphadenopathy: Uncommon / Frequent / Uncommon.
- Metabolism and nutrition disorders:
Anorexia: Uncommon / - / Frequent.
- Psychiatric disorders:
. Insomnia: Uncommon / - / -.
. Depression: Uncommon / - / Uncommon.
. Irritability: - / Uncommon / -.
- disorders of the nervous system:
. Headache: Frequent / - / Frequent.
. Paresthesia: Uncommon / - / -.
. Dizziness: Uncommon / - / -.
. Migraine: Uncommon / - / -.
. Drowsiness: Uncommon / - / -.
- Eye disorders:
. Conjunctival irritation: - / - / Uncommon.
. Edema of the eyelids: - / - / Uncommon.
- Affections of the ear and labyrinth:
Tinnitus: Uncommon / - / -.
- Vascular disorders:
Flushing: Uncommon / - / -.
- Respiratory, thoracic and mediastinal disorders:
. Pharyngitis: Uncommon / - / -.
. Rhinitis: Uncommon / - / -.
. Nasal congestion: - / - / Uncommon.
. Pharyngolaryngeal pain: - / - / Uncommon.
- Gastrointestinal disorders:
. Nausea: Frequent / Uncommon / Frequent.
. Abdominal pain: Uncommon / - / -.
. Diarrhea: Uncommon / - / Uncommon.
. Vomiting: Uncommon / - / -.
. Rectal disorders: Uncommon / - / -.
. Rectal tenesmus: Uncommon / - / -.
. Oral dryness: - / Uncommon / -.
- Skin and subcutaneous tissue disorders:
. Pruritus: Uncommon / - / -.
. Dermatitis: Uncommon / Uncommon / -.
. Folliculitis: Uncommon / - / -.
. Erythematous eruption: Uncommon / - / -.
. Eczema: Uncommon / - / -.
. Rash: Uncommon / - / -.
. Hypersudation: Uncommon / - / -.
. Urticaria: Uncommon / - / -.
. Actinic keratosis: - / - / Uncommon.
. Erythema: - / - / Uncommon.
. Facial edema: - / - / Uncommon.
. Cutaneous ulcer: - / - / Uncommon.
- Musculoskeletal and systemic disorders:
. Myalgia: Frequent / - / Frequent.
. Arthralgia: Uncommon / - / Frequent.
. Lumbago: Uncommon / Frequent / -.
. Pain of extremities: - / - / Uncommon.
- Renal and urinary disorders:
Dysuria: Uncommon / - / -.
- Disorders of the reproductive organs and the breast:
. Genital pain in men: Uncommon / - / -.
. Penile disorders: Uncommon / - / -.
. Dyspareunia: Uncommon / - / -.
. Erection Disorders: Uncommon / - / -.
. Uterovaginal prolapse: Uncommon / - / -.
. Vaginal pain: Uncommon / - / -.
. Atrophic vaginitis: Uncommon / - / -.
. Vulvar disorders: Uncommon / - / -.
- General disorders and anomalies at the site of administration:
. Pruritus at the application site: Very common / Very common / Very common.
. Application Site Pain: Very Common / Frequent / Frequent.
. Burn at the application site: Frequent / Frequent / Frequent.
. Irritation at the application site: Frequent / Frequent / Frequent.
. Erythema at the application site: - / Frequency / Frequent.
. Reaction to the application site: - / - / Frequent.
. Bleeding at the application site: - / Frequent / Uncommon.
. Papules at the application site: - / Frequent / Uncommon.
. Paresthesia at the application site: - / Frequent / Uncommon.
. Eruption at the application site: - / Frequency / -.
. Fatigue: Frequent / - / Frequent.
. Fever: Uncommon / - / Uncommon.
. Influenza - like illness: Uncommon / Uncommon / -.
. Pain: Uncommon / - / -.
. Asthenia: Uncommon / - / Uncommon.
. Malaise: Uncommon / - / -.
. Chills: Uncommon / - / Uncommon.
. Dermatitis at the application site: - / - / Uncommon.
. Flow at the application site: - / Uncommon / Uncommon.
. Hyperesthesia at the application site: - / - / Uncommon.
. Inflammation at the application site: - / Uncommon / -.
. Edema at the application site: - / Uncommon / Uncommon.
. Desquamation at the application site: - / Uncommon / Uncommon.
. Scar at the application site: - / - / Uncommon.
. Skin effraction at the application site: - / Uncommon / -.
. Swelling at the application site: - / Uncommon / Uncommon.
. Ulceration at the application site: - / - / Uncommon.
. Vesicles at the application site: - / Uncommon / Uncommon.
. Heat at the application site: - / - / Uncommon.
. Lethargy: - / Uncommon / -.
. Gene: - / - / Uncommon.
. Inflammation: - / - / Uncommon.
c) Common adverse events :
- External genital warts:
The investigators of the placebo-controlled trials were asked to evaluate the clinical signs mentioned by the protocol (skin reactions). These assessments show that local skin reactions including erythema (61%), erosions (30%), excoriation / desquamation (23%) and edema (14%) were common in these placebo-controlled clinical trials. with the imiquimod cream applied three times a week (see section on warnings and precautions for use). Local skin reactions, eg erythema, are probably a consequence of the pharmacological effects of imiquimod cream.
Remote cutaneous reactions, mainly erythema (44%), have also been reported in the placebo-controlled trials. These reactions affected areas without warts that may have been in contact with imiquimod cream. Most skin reactions were mild to moderate and disappeared within 2 weeks of stopping treatment. In some cases, however, these reactions were severe and required treatment and / or disability. In very rare cases, severe reactions in the urethral meatus have caused dysuria in women (see section cautionary statements and precautions for use).
- Superficial basal cell carcinoma:
. Investigators of placebo-controlled clinical trials were asked to evaluate the clinical signs mentioned by the protocol (skin reactions). These evaluations show that severe erythema (31%), severe erosions (13%) and severe peeling / crusting (19%) were very common in these trials with imiquimod cream applied 5 times a week. Local skin reactions, eg erythema, are probably a consequence of the pharmacological effects of imiquimod cream.
. Skin infections have been observed during treatment with imiquimod. Although no serious sequelae has resulted, the risk of an infection at the level of a cutaneous breakthrough must always be considered.
- Actinic keratosis:
In clinical trials with imiquimod cream 3 times weekly for 4 or 8 weeks, the most common adverse reactions at the application site were itching (14%) and burning (5%). Severe erythema (24%) and severe excoriation / desquamation (20%) were very common. Local skin reactions, such as erythema, are probably a consequence of the pharmacological effects of imiquimod cream. See Dosage and Administration, and Warnings and Precautions for more details on resting periods.
Skin infections have been observed during treatment with imiquimod. Although no serious sequelae have been observed the possibility of infection of the damaged skin should always be considered.
d) Adverse events applicable to all indications :
- Localized cases of hypopigmentation and hyperpigmentation have been reported after use of imiquimod cream. Follow-up data suggest that these changes in skin color may be definitive in some patients.
- Clinical studies examining the use of imiquimod in the treatment of actinic keratosis have detected the appearance of alopecia in 0.4% of cases (5/1214) at the site of application or the surrounding area. In addition, there are pharmacovigilance reports regarding suspicions of alopecia during the treatment of superficial basal cell carcinomas and external genital warts.
Decreases in hemoglobin, leukocyte count, absolute neutrophil count, and platelet count were observed in clinical trials. These decreases are not considered clinically significant in patients with normal hematologic reserve. Patients with reduced haematological reserves have not been studied in clinical trials. Pharmacovigilance reports have reported decreases in haematological parameters requiring clinical intervention.
- Rare cases of autoimmune disease outbreaks have been reported.
- Rare cases of dermatological reactions distant from the application site, including erythema multiforme, have been reported in clinical trials. Since it was first marketed, imiquimod has been the subject of reports of serious skin reactions, including erythema multiforme, Stevens-Johnson syndrome, and cutaneous lupus erythematosus.

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