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ALDARA CREAM (IMIQUIMOD): PATIENT COUNSELING INFORMATION
General Information: All Indications
Imiquimod (Aldara) cream 5% should be used as directed by a physician.
Aldara cream is for external use only. Contact with the eyes, lips and nostrils should be avoided.
The treatment area should not be bandaged or otherwise occluded. Partially-used packets should be discarded and not reused. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara (Imiquimod) therapy.
It is recommended that patients wash their hands before and after applying Imiquimod (Aldara) cream.
Local Skin Reactions: All Indications
Patients may experience local skin reactions during treatment with Aldara cream (even with normal dosing). Potential local skin reactions include edema, erythema, vesicles, erosions / ulcerations, flaking / scaling / dryness, weeping / exudate, and scabbing / crusting. These reactions can range from mild to severe in intensity and may extend beyond the application site onto the surrounding skin. Patients may also experience application site reactions such as itching and/or burning.
Local skin reactions may be of such intensity that patients may require rest periods from treatment. Treatment with Aldara (Imiquimod) cream can be resumed after the skin reaction has subsided, as determined by the physician. Patients should contact their physician promptly 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.
Because of local skin reactions, during treatment and until healed, the treatment area is likely to appear noticeably different from normal skin. Localized hypopigmentation and hyperpigmentation have been reported following use of Aldara (Imiquimod) topical cream. These skin color changes may be permanent in some patients.
Systemic Reactions: All Indications
Patients may experience flu-like systemic signs and symptoms during treatment with Aldara cream (even with normal dosing). Systemic signs and symptoms may include malaise, fever, nausea, myalgias and rigors. An interruption of dosing should be considered.
Patients Being Treated for Actinic Keratosis (AK)
Dosing is 2 times per week for a full 16 weeks, unless otherwise directed by the physician. However, the treatment period should not be extended beyond 16 weeks due to missed doses or rest periods.
It is recommended that the treatment area be washed with mild soap and water 8 hours following Aldara (Imiquimod) cream 5% application.
Most patients using Imiquimod (Aldara) cream for the treatment of AK experience erythema, flaking / scaling / dryness and scabbing / crusting at the application site with normal dosing.
Use of sunscreen is encouraged, and patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Imiquimod (Aldara) topical cream.
Sub-clinical AK lesions may become apparent in the treatment area during treatment and may subsequently resolve.
Patients Being Treated for Superficial Basal Cell Carcinoma (sBCC)
Dosing is 5 times per week for a full 6 weeks, unless otherwise directed by the physician. However, the treatment period should not be extended beyond 6 weeks due to missed doses or rest periods.
It is recommended that the treatment area be washed with mild soap and water 8 hours following Imiquimod (Aldara) cream 5% application.
Most patients using Aldara (Imiquimod) for the treatment of sBCC experience erythema, edema, induration, erosion, scabbing / crusting and flaking / scaling at the application site with normal dosing.
Use of sunscreen is encouraged, and patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Imiquimod (Aldara).
The clinical outcome of therapy can be determined after resolution of application site reactions and/or local skin reactions.
Patients with sBCC treated with Aldara (Imiquimod) cream should have regular follow-up to re-evaluate the treatment site.
Patients Being Treated for External Genital Warts
Dosing is 3 times per week to external genital / perianal warts. Aldara (Imiquimod) topical cream treatment should continue until there is total clearance of the genital / perianal warts or for a maximum of 16 weeks.
It is recommended that the treatment area be washed with mild soap and water 6-10 hours following Aldara (Imiquimod) cream 5% application.
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.
Sexual (genital, anal, oral) contact should be avoided while Imiquimod (Aldara) cream is on the skin.
Application of Imiquimod (Aldara) topical 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 severe swelling, and may cause difficulty in passing urine or inability to urinate.
Uncircumcised males treating warts under the foreskin should retract the foreskin and clean the area daily.
New warts may develop during therapy, as Imiquimod (Aldara) cream 5% is not a cure.
The effect of Aldara on the transmission of genital / perianal warts is unknown.
Aldara (Imiquimod) cream may weaken condoms and vaginal diaphragms; therefore, concurrent use is not recommended.
Should severe local skin reaction occur, the cream should be removed by washing the treatment area with mild soap and water.
Manufactured by 3M Health Care
Distributed by Graceway Pharmaceuticals
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