Aldara Special Precautions

Aldara Cream 5% w/w has not been evaluated for the treatment of internal genital warts and should not be used to treat urethral, intra-vaginal, cervical, rectal, or intra-anal warts due to unknown local tolerance and potential systemic absorption. Aldara Cream 5% w/w has not been evaluated for the treatment of warts in these locations.
Local skin reactions such as 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 Cream 5% w/w. 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 5% w/w can be resumed after the skin reaction has subsided. The use of an occlusive dressing is not recommended with Aldara Cream 5% w/w. 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 Cream 5% w/w therapy immediately following the treatment of genital/perianal warts with other cutaneously applied drugs; therefore, Aldara Cream 5% w/w administration is not recommended until genital/perianal tissue is healed from any previous drug. Aldara Cream 5% w/w has been applied to traumatized genital skin following wart ablation by electrocautery or cryotherapy in two pilot studies and Aldara Cream 5% w/w did not prolong wound healing in these patients.
Aldara Cream 5% w/w, 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 Cream 5% w/w 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 Cream 5% w/w may weaken condoms and vaginal diaphragms. Therefore, concurrent use is not recommended.
Carcinogenicity, Mutagenesis, and Impairment of Fertility: Imiquimod was without effect in a series of eight 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 noimpairment of reproduction.
Use in children: Safety and efficacy in patients below the age of 18 years have not been established.