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warnings and cautions
5 WARNINGS AND PRECAUTIONS Intense local inflammatory reactions can occur (e.g., skin weeping, erosion). Dosing interruption may be required ( 2 , 5.1 , 6 ). 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 malaise, fever, nausea, myalgias and rigors may occur. Dosing interruption may be required ( 2 , 5.2 , 6 ). Avoid exposure to sunlight and sunlamps. Wear sunscreen daily ( 5.3 ). Safety and efficacy have not been established for repeat courses of treatment to the same area for AK ( 5.4 ). Treatment of urethral, intra-vaginal, cervical, rectal or intra-anal viral disease is not recommended ( 5.6 ). Safety and efficacy in immunosuppressed patients have not been established ( 1.5 ). 5.1 Local Inflammatory Reactions Intense local inflammatory reactions including skin weeping or erosion can occur after few applications of imiquimod cream and may require an interruption of dosing. [see Dosage and Administration ( 2 ) and Adverse Reactions ( 6 )] . Imiquimod cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease. 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 for severe vulvar swelling. Administration of imiquimod cream is not recommended until the skin is completely healed from any previous drug or surgical treatment. 5.2 Systemic Reactions Flu-like signs and symptoms may accompany, or even precede, local inflammatory reactions and may include malaise, fever, nausea, myalgias and rigors. An interruption of dosing should be considered [see Adverse Reactions ( 6 )]. 5.3 Ultraviolet Light Exposure Exposure to sunlight (including sunlamps) should be avoided or minimized during use of imiquimod cream because of concern for heightened sunburn susceptibility. Patients should be warned to use protective clothing (e.g., a hat) when using imiquimod cream. Patients with sunburn should be advised not to use imiquimod 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 imiquimod cream. Imiquimod cream shortened the time to skin tumor formation in an animal photoco-carcinogenicity study [see Nonclinical Toxicology ( 13.1 )] . The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Therefore, patients should minimize or avoid natural or artificial sunlight exposure. 5.4 Unevaluated Uses: Actinic Keratosis Safety and efficacy have not been established for imiquimod cream in the treatment of actinic keratosis with repeated use, i.e. more than one treatment course, in the same area. The safety of imiquimod cream applied to areas of skin greater than 25 cm 2 (e.g. 5 cm X 5 cm) for the treatment of actinic keratosis has not been established [see Clinical Pharmacology ( 12.3 )] . 5.6 Unevaluated Uses: External Genital Warts Imiquimod cream has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease.