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Local skin reactions eg, erythema, erosion, excoriation/flaking and oedema are common. Most skin reactions are mild to moderate. These reactions may be due to the pharmacological response of the body's immune system to Aldara. Should severe local skin reactions occur, the cream should be removed by washing the treatment area with mild soap and water. Treatment with Aldara can be resumed after the skin reaction has subsided. The use of an occlusive dressing is not recommended with Aldara. Higher than recommended doses may lead to increased local skin reactions. Uncircumcised males treating warts under the foreskin should retract the foreskin and clean the area daily.
There is no clinical experience with Aldara therapy immediately following the treatment of genital/perianal warts with other cutaneously applied drugs; therefore, Aldara administration is not recommended until genital/perianal tissue is healed from any previous drug. Aldara has been applied to traumatized genital skin following wart ablation by electrocautery or cryotherapy in two pilot studies and Aldara did not prolong wound healing in these patients.
Aldara, as an immune response modifier, has been shown to induce mRNA for IL-8 and has the potential to exacerbate inflammatory conditions of the skin.
The effect of Aldara on the transmission of genital/perianal warts is unknown. Sexual (genital, anal, oral) contact should be avoided while the cream is on the skin. Aldara may weaken condoms and vaginal diaphragms. Therefore, concurrent use is not recommended.
Carcinogenicity, Mutagenicity & Impairment of Fertility: 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. Orally administered imiquimod is neither mutagenic nor teratogenic in rats and rabbits. Imiquimod applied dermally was not carcinogenic in mice. 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: Pregnancy Category B: 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.
