By Gary M. White, MD
Note: This is a summary only. Please consult the latest information when prescribing.
Elidel is pimecrolimus 1% cream
- ELIDEL® is indicated as second-line therapy for the short-term and noncontinuous 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.
- Elidel is not indicated for children less than 2 years of age.
Black Box Warning
- 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.
- Applied to affected skin BID
- Continuous long-term use of ELIDEL Cream should be avoided, and application should be
limited to areas of involvement with atopic dermatitis.
- ELIDEL Cream should not be used in patients with Netherton’s Syndrome or other skin diseases where there is the potential for increased systemic absorption of pimecrolimus, e.g. generalized erythroderma.
- Before commencing treatment with ELIDEL Cream, bacterial or viral infections at treatment sites should be resolved.
- Patients who develop lymphadenopathy should be evaluated for the cause and monitored to ensure that the lymphadenopathy resolves.
Pregnancy Category C
Other Information Not From the Package Insert
- 10 years of SEERS data do not show any evidence for the increased risk of malignancy with the use of Elidel [JAMA Dermatol 2015 151;594].
Based on the current review of the literature and their clinical experience, a large group of experts in pediatric dermatology concluded that pimecrolimus cream and tacrolimus ointment are safe and effective for the treatment of infants at least 3 months of age with AD [Pimecrolimus in atopic dermatitis: Consensus on safety and the need to allow use in infants. Pediatr Allergy Immunol. 2015 Jun; 26(4): 306–315].
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