WARNINGS
Aldara cream has not been evaluated for the treatment
of urethral, intra-vaginal, cervical, rectal, or intra-anal
human papilloma viral disease and is not recommended for
these conditions.
PRECAUTIONS
General
Local skin reactions such as 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 5% cream should receive the following
information and instructions: The effect of Aldara 5%
cream on the transmission of genital/ perianal warts is
unknown. Aldara 5% cream may weaken condoms and vaginal
diaphragms. Therefore, concurrent use is not recommended.
This medication 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 hours following Aldara 5%
cream application the treatment area be washed with mild
soap and water.
It is common for patients to experience local skin reactions
such as 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.
Application of Aldara cream in the vagina is considered
internal and should be avoided. Female patients should
take special care if applying the cream at the opening
of the vagina because local skin reactions on the delicate
moist surfaces can result in pain or swelling, and may
cause difficulty in passing urine.
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, Mutagenesis, and Impairment of Fertility
Rodent carcinogenicity data are not available. 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. 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.
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.
Nursing Mothers
It is not known whether topically applied imiquimod is
excreted in breast milk.
Pediatric Use
Safety and efficacy in patients below the age of 12 years
have not been established.
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