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warnings and cautions
5 WARNINGS AND PRECAUTIONS Local Skin Reactions: Intense local inflammatory reactions can occur (e.g., skin weeping, erosion). Dosage interruption may be required. Severe vulvar swelling may occur and lead to urinary retention; interrupt dosing or discontinue for severe vulvar swelling. ( 2.2 , 2.3, 5.1 ) Systemic Reactions : Flu-like signs and symptoms have occurred. Consider dosage interruption for systemic reactions. ( 5.2 ) Ultraviolet Light Exposure Risks : Avoid or minimize exposure to sunlight and sunlamps. Wear protective clothing. ( 5.3 ) 5.1 Local Skin Reactions Local skin reactions including skin weeping or erosion have been reported with use of Imiquimod Cream and can occur after a few applications [see Adverse Reactions (6)]. Concomitant use of Imiquimod Cream and any other imiquimod products, in the same treatment area, may increase the risk for and severity of local skin reactions. 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 and to urinary retention. Avoid sexual (genital, anal, oral) contact while Imiquimod Cream is on the skin. To reduce the risk of local skin reactions and manage local skin reactions that occur with Imiquimod Cream treatment: Avoid concomitant use of Imiquimod Cream with any other imiquimod product in the same treatment area. Avoid application of Imiquimod Cream to skin that is not intact (i.e., any area with an abrasion, cut, burn, rash, infection, or other condition that has altered skin integrity). An interruption of dosing may be required for local skin reactions [see Dosage and Administration (2.2 , 2.3) ] . Interrupt dosing or discontinue Imiquimod Cream for severe vulvar swelling [see Dosage and Administration (2.3) ] . If severe local skin reactions occur, instruct patients to remove Imiquimod Cream by washing the treatment area with mild soap and water. 5.2 Systemic Reactions Flu-like signs and symptoms have been reported with use of Imiquimod Cream and may accompany, or even precede, local skin reactions [see Adverse Reactions (6) ] . Signs and symptoms may include fatigue, nausea, fever, myalgias, arthralgias, malaise and chills. Concomitant use of Imiquimod Cream and any other imiquimod products may increase the risk for and severity of systemic reactions. Lymphadenopathy occurred in 2% of subjects with AK treated with Imiquimod Cream, 3.75% and in 3% of subjects treated with Imiquimod Cream, 2.5% and in no patients in the vehicle arm [see Adverse Reactions (6.1) ]. This reaction resolved in all subjects by 4 weeks after completion of treatment. Consider an interruption of dosing if systemic reactions occur . 5.3 Ultraviolet Light Exposure Risks Imiquimod Cream may cause heightened sunburn susceptibility. Avoid or minimize exposure to sunlight (including sunlamps) during use of Imiquimod Cream. Instruct patients to use sunscreen and wear protective clothing (e.g., a hat). Advise patients not to use Imiquimod Cream until fully recovered from a sunburn. 5.4 Immune Cell Activation in Autoimmune Disease Imiquimod activates immune cells [see Clinical Pharmacology (12.2) ] . Carefully monitor patients with pre-existing autoimmune conditions who are using Imiquimod Cream.