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ZYCLARA (imiquimod) Cream 3.75% is indicated for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults.
IMPORTANT SAFETY INFORMATION FOR ZYCLARA CREAM
- 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. ZYCLARA Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.
- Administration of ZYCLARA Cream is not recommended until the skin is healed from any previous drug or surgical treatment.
- Flu-like signs and symptoms may accompany, or even precede, local skin reactions and may include fatigue, nausea, fever, myalgias athralgias, malaise and chills.
- ZYCLARA Cream should be used with caution in patients with pre-existing autoimmune conditions because imiquimod activates immune cells.
- Exposure to sunlight (including sunlamps) should be avoided or minimized during use of ZYCLARA Cream. Patients should be warned to use protective clothing (e.g., hat) when using ZYCLARA Cream. Patients with sunburn should be advised not to use ZYCLARA Cream until fully recovered. Patients who may have considerable sun exposure, e.g., due to their occupation, and those patients with inherent sensitivity to sunlight should exercise caution when using ZYCLARA Cream.
- Avoid concomitant use of ZYCLARA Cream and any other imiquimod cream because of increased risk for adverse reactions.
- 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.
Please click here for Prescribing Information, including Patient Information.
References: 1. ZYCLARA Cream Package Insert.Scottsdale, AZ: Medicis, the Dermatology Company; February 2012. 2. Data on file. Valeant Pharmaceuticals International Inc. 3. Jorizzo JL, Markowitz O,Lebwohl MG, et al. A randomized, double-blinded, placebo-controlled, multicenter, efficacy and safety study of 3.75% imiquimod cream following cryosurgery for the treatment of actinic keratoses. J Drugs Dermatol. 2010;9(9):1101–1108.