General: Local skin reactions eg, erythema, erosion, excoriation/flaking and edema are common. Should severe local skin reaction occur, the cream should be removed by washing the treatment area with mild soap and water. Treatment with Aldara cream can be resumed after the skin reaction has subsided. There is no clinical experience with Aldara cream therapy immediately following the treatment of genital/perianal warts with other cutaneously applied drugs; therefore, Aldara cream administration is not recommended until genital/perianal tissue is healed from any previous drug or surgical treatment. Aldara has the potential to exacerbate inflammatory conditions of the skin.
Information for Patients: Patients using Aldara should receive the following information and instructions: The effect of Aldara on the transmission of genital/perianal warts is unknown. Aldara may weaken condoms and vaginal diaphragms. Therefore, concurrent use is not recommended.
Aldara is to be used as directed by a physician. It is for external use only. Eye contact should be avoided.
The treatment area should not be bandaged or otherwise covered or wrapped as to be occlusive.
Sexual (genital, anal, oral) contact should be avoided while the cream is on the skin.
It is recommended that 6-10 hrs following Aldara cream application, the treatment area be washed with mild soap and water.
It is common for patients to experience local skin reactions eg, erythema, erosion, excoriation/flaking and edema at the site of application or surrounding areas. Most skin reactions are mild to moderate. Severe skin reactions can occur and should be reported promptly to the prescribing physician.
Uncircumcised males treating warts under the foreskin should retract the foreskin and clean the area daily.
Patients should be aware that new warts may develop during therapy, as Aldara is not a cure.
Carcinogenicity, Mutagenicity & Impairment of Fertility: Rodent carcinogenicity data are not available. Imiquimod was without effect in a series of 8 different mutagenicity assays including Ames, mouse lymphoma, CHO chromosome aberration, human lymphocyte chromosome aberration, SHE cell transformation, rat and hamster bone marrow cytogenetics, and mouse dominant lethal test. Daily oral administration of imiquimod to rats, at doses up to 8 times the recommended human dose on a mg/m2 basis throughout mating, gestation, parturition and lactation, demonstrated no impairment of reproduction.
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Imiquimod was not found to be teratogenic in rat or rabbit teratology studies. In rats at a high maternally toxic dose (28 times human dose on a mg/m2 basis), reduced pup weights and delayed ossification were observed. In developmental studies with offspring of pregnant rats treated with imiquimod (8 times human dose), no adverse effects were demonstrated.
Use in lactation: It is not known whether topically applied imiquimod is excreted in breast milk.
Use in children: Safety and efficacy in patients <18 years have not been established.