ALDARA Cream

For the treatment of external genital and perianal warts/condyloma acuminate in adults.

Dosage

Aldara cream is to be applied 3 times/week, prior to normal sleeping hours, and left on the skin for 6-10 hours. Following the treatment period cream should be removed by washing the treated area with mild soap and water.

Examples of 3 times/week application schedules are: Monday, Wednesday, Friday; or Tuesday, Thursday, Saturday application prior to sleeping hours.

Aldara treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks. Local skin reactions (erythema) at the treatment site are common.

A rest period of several days may be taken if required by the patient’s discomfort or severity of the local skin reaction. Treatment may resume once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton. Underwear may be used in the management of skin reactions.. The technique for proper dose administration should be demonstrated by the prescriber to maximize the benefit of Aldara therapy. Handwashing before and after cream application is recommended. Aldara cream is packaged in single-use packets which contain sufficient cream to external genital/perianal warts. A thin layer is applied to the wart area and rubbed in until the cream is no longer visible. The application site is not to be occluded.

None known.

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.

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.

WARNINGS

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 cream should receive the following information and instructions: The effect of Aldara cream on the transmission of genital/perianal warts is unknown. Aldara cream may weaken condoms and vaginal diaphragms. Therefore, concurrent use is not recommended.

1. This medication is to be used as directed by a physician. It is for external use only. Eye contact should be avoided.

2. The treatment area should not be bandaged or otherwise covered or wrapped as to be occlusive.

3. Sexual (genital, anal, oral) contact should be avoided while the cream is on the skin.

4. It is recommended that 6-10 hours following Aldara cream application the treatment area be washed with mild soap and water.

5. 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.

6. 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.

The mechanism of action of imiquimod in treating genital/perianal warts is unknown. Imiquimod has no direct antiviral activity in cell culture. Mouse skin studies suggest that induces cytokines including interferon-a. However, the clinical relevance of these findings is unknown.