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ALDARA CREAM (IMIQUIMOD): USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C

Note: The Maximum Recommended Human Dose (MRHD) was set at 2 packets per treatment of Aldara cream (Imiquimod 25 mg) for the animal multiple of human exposure ratios presented in this label. If higher doses than 2 packets of Aldara (Imiquimod) 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 Imiquimod (Aldara) was noted in the clinical pharmacokinetic study conducted in actinic keratosis subjects. The AUC after topical application of 6 packets of this drug was 8 fold greater than the AUC after topical application of 2 packets of Aldara (Imiquimod) cream in actinic keratosis subjects. Therefore, if a dose of 6 packets per treatment of Aldara (Imiquimod) topical 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.

Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 1, 5 and 20 mg / kg per day imiquimod were administered during the period of organogenesis (gestational days 6-15) to pregnant female rats. In the presence of maternal toxicity, fetal effects noted at 20 mg / kg per day (577X MRHD based on AUC comparisons) included increased resorptions, decreased fetal body weights, delays in skeletal ossification, bent limb bones, and two fetuses in one litter (2 of 1567 fetuses) demonstrated exencephaly, protruding tongues and low-set ears. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 5 mg / kg per day (98X MRHD based on AUC comparisons). Intravenous doses of 0.5, 1 and 2 mg / kg per day imiquimod were administered during the period of organogenesis (gestational days 6-18) to pregnant female rabbits. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 2 mg / kg per day (1.5X MRHD based on BSA comparisons), the highest dose evaluated in this study, or 1 mg / kg per day (407X MRHD based on AUC comparisons).

A combined fertility and peri- and post-natal development study was conducted in rats. Oral doses of 1, 1.5, 3 and 6 mg / kg per day imiquimod were administered to male rats from 70 days prior to mating through the mating period and to female rats from 14 days prior to mating through parturition and lactation. No effects on growth, fertility, reproduction or post-natal development were noted at doses up to 6 mg / kg per day (87X MRHD based on AUC comparisons), the highest dose evaluated in this study. In the absence of maternal toxicity, bent limb bones were noted in the F1 fetuses at a dose of 6 mg / kg per day (87X MRHD based on AUC comparisons). This fetal effect was also noted in the oral rat embryofetal development study conducted with imiquimod. No treatment related effects on teratogenicity were noted at 3 mg / kg per day (41X MRHD based on AUC comparisons).

There are no adequate and well-controlled studies in pregnant women. Aldara (Imiquimod) cream 5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether imiquimod is excreted in human milk following use of Imiquimod (Aldara) cream. Because many drugs are excreted in human milk, caution should be exercised when Imiquimod (Aldara) topical cream is administered to nursing women.

Pediatric Use

AK and sBCC are not conditions generally seen within the pediatric population. The safety and efficacy of Imiquimod (Aldara) cream 5% for AK or sBCC in patients less than 18 years of age have not been established.

Safety and efficacy in patients with external genital / perianal warts below the age of 12 years have not been established.

Aldara cream was evaluated in two randomized, vehicle-controlled, double-blind trials involving 702 pediatric subjects with molluscum contagiosum (MC) (470 exposed to Aldara; median age 5 years, range 2-12 years). Subjects applied Aldara (Imiquimod) or vehicle 3 times weekly for up to 16 weeks. Complete clearance (no MC lesions) was assessed at Week 18. In Study 1, the complete clearance rate was 24% (52/217) in the Imiquimod (Aldara) group compared with 26% (28/106) in the vehicle group. In Study 2, the clearance rates were 24% (60/253) in the Aldara (Imiquimod) cream group compared with 28% (35/126) in the vehicle group. These studies failed to demonstrate efficacy.

Similar to the studies conducted in adults, the most frequently reported adverse reaction from 2 studies in children with molluscum contagiosum was application site reaction. Adverse events which occurred more frequently in Aldara-treated subjects compared with vehicle-treated subjects generally resembled those seen in studies in indications approved for adults and also included otitis media (5% Aldara vs. 3% vehicle) and conjunctivitis (3% Aldara vs. 2% vehicle).

Erythema was the most frequently reported local skin reaction. Severe local skin reactions reported by Aldara-treated subjects in the pediatric studies included erythema (28%), edema (8%), scabbing/crusting (5%), flaking/scaling (5%), erosion (2%) and weeping/exudate (2%).

Systemic absorption of imiquimod across the affected skin of 22 subjects aged 2 to 12 years with extensive MC involving at least 10% of the total body surface area was observed after single and multiple doses at a dosing frequency of 3 applications per week for 4 weeks. The investigator determined the dose applied, either 1, 2 or 3 packets per dose, based on the size of the treatment area and the subjectfs weight. The overall median peak serum drug concentrations at the end of week 4 was between 0.26 and 1.06 ng / ml except in a 2-year old female who was administered 2 packets of study drug per dose, had a Cmax of 9.66 ng / mL after multiple dosing. Children aged 25 years received doses of 12.5 mg (one packet) or 25 mg (two packets) of imiquimod and had median multiple-dose peak serum drug levels of approximately 0.2 or 0.5 ng / mL, respectively. Children aged 6-12 years received doses of 12.5 mg, 25 mg, or 37.5 mg (three packets) and had median multiple dose serum drug levels of approximately 0.1, 0.15, or 0.3 ng / ml, respectively.

Among the 20 subjects with evaluable laboratory assessments, the median WBC count decreased by 1.4*109 / L and the median absolute neutrophil count decreased by 1.42*109 / L.

Geriatric Use

Of the 215 subjects treated with Aldara (Imiquimod) topical cream in the AK clinical studies, 127 subjects (59%) were 65 years and older, while 60 subjects (28%) were 75 years and older. Of the 185 subjects treated with Aldara (Imiquimod) cream 5% in the sBCC clinical studies, 65 subjects (35%) were 65 years and older, while 25 subjects (14%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. No other clinical experience has identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.



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