Aldara Patient Counseling Information

Information for Patients: General Information: Patients using Aldara should receive the following information and instructions: 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.
Some reports have been received of localized hypopigmentation and hyperpigmentation following Imiquimod (Aldara) Cream use. Follow-up information suggests that these skin color changes may be permanent in some patients.
Patients being Treated for External Genital Warts: It is recommended that the treatment area be washed with mild soap and water 6 to 10 hours following Imiquimod (Aldara) Cream application.
It is common for patients to experience local skin reaction, 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 promptly reported to the prescribing physician. Should severe local skin reaction 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.
Sexual (genital, anal, oral) contact should be avoided while the cream is on the skin.
Application of Imiquimod (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 Imiquimod (Aldara) Cream is not a cure.
The effect of Aldara cream on the transmission of genital/perianal warts is unknown. Aldara may weaken condoms and vaginal diaphragms, therefore concurrent use is not recommended.
Patients being Treated for Superficial Basal Cell Carcinoma: It is recommended that the treatment area be washed with mild soap and water 8 hours following Imiquimod (Aldara) Cream application.
Most patients using Imiquimod (Aldara) Cream for the treatment of sBCC experience erythema, edema, induration, erosion, scabbing/crusting and flaking/scaling at the application site is normal dosing. These local skin reactions generally decrease in intensity or resolve after cessation of Imiquimod (Aldara) Cream therapy. Patients may also experience application site reactions such as itching and/or burning. Local skin reactions may be of such an intensity that patients may require rest periods from treatment. Treatment with Imiquimod (Aldara) Cream can be resumed after the skin reaction has subsided as determined by the physician.
During treatment and until healed, affected skin is likely to appear noticeably different from normal skin.
It is prudent for patients to minimize or avoid exposure to natural or artificial sunlight.
The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 12 weeks after the end of treatment.
Patients should contact their physician if they experience any sign or symptom at the application site that restricts or prohibits their daily activity or makes continued application of the cream difficult.
Patients with sBCC treated with Aldara are recommended to have regular follow up to re-evaluate the treatment site.