BOX WARNING WARNING
Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established
Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream.
Therefore:
- Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
- ELIDEL Cream is not indicated for use in children less than 2 years of age.
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ELIDEL SUMMARY
Elidel
Elidel® (pimecrolimus) Cream 1% contains the compound pimecrolimus, the 33-epi-chloro-derivative of the macrolactam ascomycin.
Elidel® (pimecrolimus) Cream 1% is indicated for short-term and intermittent long-term therapy in the treat-ment of
mild to moderate
atopic dermatitis in non-immunocompromised patients 2 years of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies
(see DOSAGE AND ADMINISTRATION).
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