No

Skin and Mucous Membrane Agent; Topical Skin Product

Treatment of external genital and perianal warts/condyloma acuminata in adults

B

Hypersensitivity to imiquimod

Imiquimod has not been evaluated for the treatment of urethral, intravaginal, cervical, rectal, or intra-anal human papilloma viral disease and is not recommended for these conditions. Topical imiquimod is not intended for ophthalmic use. Topical imiquimod administration is not recommended until genital/perianal tissue is healed from any previous drug or surgical treatment. Imiquimod has the potential to exacerbate inflammatory conditions of the skin.

>10%: Local, mild/moderate: Erythema, itching, erosion, burning, excoriation/flaking, edema

1% to 10%:

Local, severe: Erythema, erosion, edema

Local, mild/moderate: Pain, induration, ulceration, scabbing, vesicles, soreness

Overdosage is unlikely because of minimal percutaneous absorption. Persistent topical overdosing of imiquimod could result in severe local skin reactions. The most clinically serious adverse event reported following multiple oral imiquimod doses of greater than or equal to 200 mg was hypotension that resolved following oral or I.V. fluid administration.

Treat symptomatically

Do not store at greater than or equal to 30°C (86°F); avoid freezing

Mechanism of action is unknown; however, induces cytokines, including interferon-alpha and others

Absorption: Minimal

Elimination: Less than 0.9% of dose is excreted in urine and feces following topical administration

Adults: Topical: Apply 3 times/week prior to normal sleeping hours and leave on the skin for 6-10 hours. Following treatment period, remove cream 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. Continue imiquimod treatment until there is total clearance of the genital/perianal warts for less than or equal to 16 weeks. 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.

Nonocclusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions. Handwashing before and after cream application is recommended. Imiquimod is packaged in single-use packets that contain sufficient cream to cover a wart area of up to 20 cm²; avoid use of excessive amounts of cream. Instruct patients to apply imiquimod to external or perianal warts. Apply a thin layer to the wart area and rub in until the cream is no longer visible. Do not occlude the application site.

Reduction in wart size is indicative of a therapeutic response; patients should be monitored for signs and symptoms of hypersensitivity to imiquimod

None reported

None reported

No information available to require special precautions

No effects or complications reported

Imiquimod may weaken condoms and vaginal diaphragms; therefore, concurrent use is not recommended. This medication is for external use only; avoid contact with eyes. Do not occlude the treatment area with bandages or other covers or wraps. Avoid sexual (genital, anal, oral) contact while the cream is on the skin. Wash the treatment area with mild soap and water 6-10 hours following application of imiquimod.

Imiquimod is not a cure; new warts may develop during therapy.

Apply only to external or perianal warts; wash hands before and after application of the cream; cotton gauze or underwear may be used to manage treatment area; do not occlude treatment area; avoid sexual contact while cream is on skin; cream may weaken condoms or diaphragms, concurrent use is not recommended

Cream, topical: 5% (250 mg single dose packets in boxes of 12)