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imiquimod 5% for genital warts Important

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1/12/2020 - imiquimod 5% for genital warts Important

Long-lasting cutaneous warts are a therapeutic challenge, especially widespread or symptomatic recalcitrant warts in children. It can be speculated that natural immunity to these human papillomavirus (HPV)- induced lesions is extremely poor. Can you buy imiquimod Therefore ideally treatment should focus on increasing local immune response. Recently imiquimod, a topical immune modifier, has been successfully used in the treatment of external genital warts. Our purpose is to report on our experiences with imiquimod 5% cream applied to therapy-resistant, long-lasting (duration 2-7 years) common warts in children. In 18 children, imiquimod cream was self-applied by the patients or by their parents to the warts twice a day. Assessment for response and occurrence of adverse effects was performed every 4 weeks until clinical cure. Follow-ups could be arranged in 14 of the 18 patients 1-2 years after total clearance. Sixteen of 18 patients experienced total clearance of their warts; 2 showed partial improvement but were lost to follow-up. The mean duration of treatment was 5.8 months. Two of the 14 patients in whom a follow-up was performed showed a small number of new warts after a period of at least 1 year without recurrence. Our data demonstrate that the topical application of imiquimod 5% cream is an effective treatment for long-lasting cutaneous warts in children.

HPV (Human Papillomavirus) Infection

HPVs or human papillomaviruses are a group of viral infections of the skin and mucous membranes. Certain high-risk types of HPV infection cause certain cancers (cervical, penile, anal, vaginal, and oral). There are no signs or symptoms of HPV infection. HPV infection is an extremely common STD and is highly contagious. People are at higher risk of getting HPV infection if they have multiple sex partners, a weakened immune system, or breaks in the skin. HPV vaccinations prevent HPV infection. Treatment for HPV infection is antiviral medication. There is no cure for HPV infection.

When they are used

5-FU, a chemotherapy approved to treat certain internal cancers, has also been FDA-approved in topical form for superficial BCCs, with cure rates between 80 and 90 percent. Imiquimod is approved for superficial BCCs, with cure rates between 80 and 90 percent. Oftentimes tumors diagnosed on biopsy to be superficial will have other invasive areas within the same lesion, making appropriate tumor selection for this treatment intrinsically difficult.

When weighing the pros and cons of treatment options, it’s important to consider that radiation, cryosurgery and topical medications all have one significant drawback in common — no tissue is examined under the microscope, so there is no way to determine how completely the tumor was removed.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Note: The Maximum Recommended Human Dose (MRHD) was set at 2 packets per treatment of Aldara Cream (25 mg imiquimod) for the animal multiple of human exposure ratios presented in this label. If higher doses than 2 packets of Aldara Cream are used clinically, then the animal multiple of human exposure would be reduced for that dose. A non-proportional increase in systemic exposure with increased dose of Aldara Cream was noted in the clinical pharmacokinetic study conducted in actinic keratosis subjects ( see Pharmacokinetics ). The AUC after topical application of 6 packets of Aldara Cream was 8 fold greater than the AUC after topical application of 2 packets of Aldara Cream in actinic keratosis subjects. Therefore, if a dose of 6 packets per treatment of Aldara Cream was topically administered to an individual, then the animal multiple of human exposure would be either 1/3 of the value provided in the label (based on body surface area comparisons) or 1/8 of the value provided in the label (based on AUC comparisons). The animal multiples of human exposure calculations were based on weekly dose comparisons for the carcinogenicity studies described in this label. The animal multiples of human exposure calculations were based on daily dose comparisons for the reproductive toxicology studies described in this label.

In an oral (gavage) rat carcinogenicity study, imiquimod was administered to Wistar rats on a 2 × /week (up to 6 mg/kg/day) or daily (3 mg/kg/day) dosing schedule for 24 months. No treatment related tumors were noted in the oral rat carcinogenicity study up to the highest doses tested in this study of 6 mg/kg administered 2 × /week in female rats (87 × MRHD based on weekly AUC comparisons), 4 mg/kg administered 2 × /week in male rats (75 × MRHD based on weekly AUC comparisons) or 3 mg/kg administered 7 × /week to male and female rats (153 × MRHD based on weekly AUC comparisons).

In a dermal mouse carcinogenicity study, imiquimod cream (up to 5 mg/kg/application imiquimod or 0.3% imiquimod cream) was applied to the backs of mice 3 × /week for 24 months. A statistically significant increase in the incidence of liver adenomas and carcinomas was noted in high dose male mice compared to control male mice (251 × MRHD based on weekly AUC comparisons). An increased number of skin papillomas was observed in vehicle cream control group animals at the treated site only. The quantitative composition of the vehicle cream used in the dermal mouse carcinogenicity study is the same as the vehicle cream used for Aldara Cream, minus the active moiety (imiquimod).

In a 52-week dermal photoco-carcinogenicity study, the median time to onset of skin tumor formation was decreased in hairless mice following chronic topical dosing (3 × /week; 40 weeks of treatment followed by 12 weeks of observation) with concurrent exposure to UV radiation (5 days per week) with the Aldara Cream vehicle alone. No additional effect on tumor development beyond the vehicle effect was noted with the addition of the active ingredient, imiquimod, to the vehicle cream.

Imiquimod revealed no evidence of mutagenic or clastogenic potential based on the results of five in vitro genotoxicity tests (Ames assay, mouse lymphoma L5178Y assay, Chinese hamster ovary cell chromosome aberration assay, human lymphocyte chromosome aberration assay and SHE cell transformation assay) and three in vivo genotoxicity tests (rat and hamster bone marrow cytogenetics assay and a mouse dominant lethal test).

Daily oral administration of imiquimod to rats, throughout mating, gestation, parturition and lactation, demonstrated no effects on growth, fertility or reproduction, at doses up to 87 × MRHD based on AUC comparisons.

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