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Important Safety Information
Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established.
Continuous long-term use of ELIDEL Cream in any age group should be avoided. Application should be limited to areas of involvement with atopic dermatitis.
*ELIDEL (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 people ages 2 and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ELIDEL is not indicated for use in children under 2 years of age.
ELIDEL is contraindicated in patients who are hypersensitive to pimecrolimus or any of the components of the cream. It should not be applied to areas of active cutaneous infections. If patients have lymphadenopathy that is unresolved or of unclear etiology, discontinuation should be considered. Patients should minimize or avoid exposure to natural or artificial sunlight, even when ELIDEL is not on the skin. ELIDEL should not be used with occlusive dressings.
The most common adverse events seen in clinical studies included application-site burning, headache, pharyngitis, nasopharyngitis, cough, influenza, pyrexia, and viral infection.
In clinical studies, skin papilloma or warts were observed in 1% of ELIDEL patients.
*Among topical corticosteroids and topical immunomodulators. IMS National Prescription
Audit Plus. May 2002 through May 2003.
Please see complete Prescribing Information.
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