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Pimecrolimus Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] . Pimecrolimus Cream, 1% is a calcineurin inhibitor immunosuppressant indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ( 1 )

Pimecrolimus Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. Pimecrolimus Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. ( 4 , 6.2 )

• Should not be used in immunocompromised adults and children, including patients on systemic immunosuppressive medications. ( 5.1 ) • Avoid treatment on malignant or pre-malignant skin conditions, as these can present as dermatitis. ( 5.2 ) • Should not be used in patients with Netherton’s Syndrome or skin diseases with a potential for increased systemic absorption. ( 5.2 ) 5.1 Risk of Immunosuppression Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression. Based on this information and the mechanism of action, there is a concern about a potential risk with the use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 1%. Therefore: • Continuous long-term use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. • Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age. • Pimecrolimus Cream, 1% should not be used in immunocompromised adults …

8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies with Pimecrolimus Cream, 1% in pregnant women. Therefore, Pimecrolimus Cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In dermal embryofetal developmental studies, no maternal or fetal toxicity was observed up to the highest practicable doses tested, 10 mg/kg/day (1% pimecrolimus cream) in rats (0.14X MRHD based on body surface area) and 10 mg/kg/day (1% pimecrolimus cream) in rabbits (0.65X MRHD based on AUC comparisons). The 1% pimecrolimus cream was administered topically for 6 hours/day during the period of organogenesis in rats and …