The mechanism of action of ZYCLARA Cream in treating AK and EGW lesions is unknown.

ZYCLARA Cream, 2.5% and 3.75% are indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults. ZYCLARA Cream, 3.75% is indicated for the treatment of external genital and perianal warts/condyloma acuminata (EGW) in patients 12 years or older. Limitations of Use: Efficacy of imiquimod cream was not demonstrated for molluscum contagiosum in children 2 to 12 years of age.

Actinic Keratosis: Once daily to the skin of the affected area (either the entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. External Genital Warts: Once daily to the external genital/perianal warts until total clearance or up to 8 weeks.

Most common adverse reactions (>4%) are local skin reactions (erythema, edema, erosion/ulceration, exudate, scabbing/crusting), headache, application site pain, application site irritation, application site pruritus, fatigue, influenza-like illness, and nausea.

None

Intense local skin reactions including skin weeping or erosion can occur after a few applications of ZYCLARA Cream and may require an interruption of dosing. Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling. Severe vulvar swelling can lead to urinary retention; dosing should be interrupted or discontinued. Flu-like systemic signs and symptoms including fatigue, nausea, fever, myalgias, arthralgias, and chills can occur. Dosing interruption may be required. Avoid concomitant use of ZYCLARA Cream and any other imiquimod cream because of increased risk for adverse reactions.