Local treatment: wart warts (genital warts) of the external genital and anal area in adults; superficial outbreaks of basal cell carcinoma (sBCC) in adults; actinic keratosis (AKs) - without evidence of hyperplasia and hyperkeratosis, typical clinical course - on the face or scalp, in patients with a viable immune system, when the size or number of lesions limits the effectiveness and / or the possibility of cryotherapy and when other local treatment methods are contraindicated or inappropriate.
Composition:
1 sachet contains 12.5 mg imiquimod (100 mg cream contains 5 mg imiquimod). The drug contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol and stearyl alcohol.
Action:
Modulator of immune response. Saturation saturation studies suggest the existence of a membrane receptor for imiquimod on immune response cells. Imiquimod does not have direct antiviral activity. In animal studies, it has been shown to be an effective antiviral and antineoplastic agent, mainly due to the induction of Interferon alpha and other cytokines. After topical application, less than 0.9% of the dose is absorbed through the skin in humans.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients.
Precautions:
No data are available on the use of imiquimod in children and adolescents in approved indications (treatment of warts, actinic keratoses and superficial basal cell carcinoma) - use in this age group is not recommended. The drug should not be used in infectious children and adolescents due to lack of efficacy in this indication. Caution should be exercised in patients with autoimmune diseases and organ transplants; in these patient groups, a balance of benefits from imiquimod treatment and risk of worsening autoimmune disease, transplant rejection, or graft versus host disease is recommended. In addition, caution should be exercised in patients with reduced hematopoietic reserve. Treatment should not be started before the skin is healed, because in this case there is a risk of increased systemic absorption of imiquimod, leading to an increased risk of side effects. Imiquimod may exacerbate skin inflammation. In case of skin reactions of intolerance, the cream should be washed with soap and water; a few-day break can be used if necessary; after relieving skin reactions, imiquimod treatment can be resumed. Local cutaneous reactions may be accompanied (or even preceded) by general signs and symptoms of flu-like symptoms, including malaise, fever, nausea, muscle pain and chills; in such cases, discontinuation of treatment should be considered. Avoid contact of the cream with the eyes, lips and nostrils. An occlusive dressing is not recommended during treatment.Warts of the external genitalia. Experiences in the treatment of imiquimod cream in men with foreskin warts are limited; treatment is only recommended for men who are able or willing to follow the daily foreskin hygiene procedures; treatment should be discontinued immediately if early signs of foreskin stenosis occur, which may include local skin reactions (eg erosion, ulcer, swelling, induration) or a growing difficulty in removal of the foreskin. Based on the current state of knowledge, treatment of urethral, intravaginal, cervical, rectal or intrarectal warts is not recommended. Treatment with imiquimod cream should not be started on tissues with open wounds or injuries before they heal. There is no experimental data on the use of the preparation immediately after treatment with other, applied drugs on the skin to treat external genital warts or anal areas. Repeat treatment is not recommended for immunocompromised patients.Imiquimod cream may have limited efficacy in the treatment of HIV-infected patients.Superficial basal cell carcinoma. The drug has not been evaluated in the treatment of basal cell carcinoma located less than 1 cm from the eyelids, nose, lips or hairline. There are no clinical data on the use of the drug in immunocompromised patients. There are no clinical data on patients with recurrent sBCC or patients previously treated with sBCC - treatment of patients who have previously received anticancer treatment is not recommended. For tumors of considerable size (> 7.25 cm2) the likelihood of responding to imiquimod treatment is less.Actinic keratosis. The effectiveness of the preparation in the treatment of actinic keratosis of the eyelids, inner surfaces of the nostrils, ears and lips has not been evaluated. Treatment with imiquimod of actinic keratoses located outside the face and scalp and changes with features of significant hyperkeratosis or hypertrophy is not recommended. There are no clinical data on the use of the preparation in immunocompromised patients. Treatment with relapsing AKs is not recommended in patients who have relapsed after 1-2 treatment cycles. The percentage of total resolution of AK symptoms is lower in patients with more than 8 outbreaks of AK. The drug contains methyl hydroxybenzoate, propyl hydroxybenzoate, which can cause allergic reactions (possible late-type reactions) and cetyl alcohol and stearyl alcohol, which can cause local skin reactions (eg contact dermatitis).
Pregnancy and lactation:
Caution should be exercised when prescribing to pregnant women. Since no measurable levels of imiquimod have been detected after a single dose and multiple topical doses (> 5 ng / ml), no specific advice can be given on the use or non-use of breastfeeding women.
Side effects:
Adult genital warts in adults: very common - pruritus and pain at the site of application; often - burning and irritation at the injection site, infection, headache, nausea, muscle pain, fatigue; uncommon - herpes simplex, genital candidosis, vaginitis, bacterial infections, fungal infections, upper respiratory tract infections, vulvitis, lymphadenopathy, anorexia, insomnia, depression, paresthesia, dizziness, migraine, drowsiness, tinnitus, hot flushes , pharyngitis, rhinitis, abdominal pain, diarrhea, vomiting, ailments of the rectum, painful stool pressure, pruritus, dermatitis, folliculitis, erythema with erythema, eczema, rash, increased sweating, urticaria, joint pain, pain back pain, dysuria, genital pain in men, penile problems, dyspareunia, erectile dysfunction, prolapse of the uterus and vagina, vaginal pain, atrophic vaginosis, vulvar discomfort, fever, flu-like symptoms, pain, weakness, malaise, chills. Superficial basal cell carcinoma in adults: very common - pruritus at the application site; often - infection, pustules, lymphadenopathy, back pain, reactions at the application site (pain, burning, irritation, erythema, bleeding, erythema, papules, paresthesia, rash); uncommon - irritability, nausea, dry mouth, dermatitis, flu-like symptoms, reactions at the application site (discharge, inflammation, swelling, flaking, skin rupture, swelling, vesicles), lethargy. Actinic keratosis: very common - pruritus at the application site; often - anorexia, headache, nausea, muscle pain, joint pain, reactions at the injection site (pain, burning, irritation, erythema, reaction), fatigue; uncommon - infection, pustules, rhinitis, influenza, lymphadenopathy, depression, conjunctival irritation, eyelid edema, nasal congestion, sore throat or larynx, diarrhea, actinic keratosis, erythema, facial edema, skin ulceration, limb pain, reactions at the application site (bleeding, papules, paraesthesia, dermatitis, secretion, hyperaesthesia, edema, flaking, scar, swelling, ulceration, vesicles, increase in tissue heat), fever, weakness, chills, discomfort, inflammation.In addition, in all indications, cases of skin reactions occurring at sites unrelated to the site of the disease were rarely observed, including severe skin reactions (erythema multiforme, Stevens-Johnson syndrome and cutaneous form of Lupus Erythematosus) and exacerbation of autoimmune diseases. Local discoloration or discoloration of the skin has been reported (which in some patients may be permanent) and the occurrence of baldness at the application site or its surroundings. Reductions in haematological parameters were observed, indicating the need for treatment and cases of increased liver enzymes.
Dosage:
Outwardly. Adults:Warts of the external genitalia - Apply the cream three times a week (every other day) before bedtime. It should be left on the skin for 6-10 h. Treatment should be continued until the visible genital warts and papillae of the anal area disappear or for a maximum of 16 weeks. The cream should be applied with a thin layer and rub into the cleaned surface of the warts until the cream is absorbed. Avoid showering or bathing for 6-10 hours after applying the cream. After this time, the drug should be washed with water and mild soap. One-use sachet cream is enough to cover 20 cm warts2. Superficial basal cell carcinoma - the cream should be applied 5 times a week (daily) before bedtime, for 6 weeks. Leave the medicine on the skin for 8 hours. Before applying the cream, wash the treated area with mild soap and dry it thoroughly. A sufficient amount of cream should be applied to cover the treated area, with an additional one-centimeter skin margin surrounding the tumor tissue. Rub the cream until it is completely absorbed. Do not use the bath and shower for 8 hours after applying the cream. After this time, it is necessary to wash the medicine with water and mild soap. Answer the clinical response to treatment 12 weeks after the end of treatment. In the case of an unsatisfactory response, a different method of treatment should be used.Actinic keratosis - apply the cream three times a week (every other day) before bedtime, for 4 weeks Leave the medicine on the skin for about 8 hours. Before applying the cream, wash the treated area with mild soapy water and dry thoroughly. Apply the amount of cream sufficient to cover the area to be treated and rub in until completely absorbed. Do not use the bath and shower for 8 hours after applying the cream. After this time, it is necessary to wash the preparation with water and mild soap. If necessary, continue treatment for another 4 weeks. If the response is unsatisfactory after 4-8 weeks, another treatment should be used.
(C)
