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ELIDEL ® (pimecrolimus) Cream, 1%
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ELIDEL ® safely and effectively. See full prescribing information for ELIDEL ®.
ELIDEL ® (pimecrolimus) Cream, 1% for topical use
Initial U.S. Approval: 2001
WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED
See full prescribing information for complete boxed 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, 1%. (5.1)
Therefore:
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Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, 1%, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. (2, 5.1)
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ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age. (1, 5.1, 8.4)
INDICATIONS AND USAGE
ELIDEL 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)
DOSAGE AND ADMINISTRATION
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Apply a thin layer of ELIDEL Cream, 1% to the affected skin twice daily. (2)
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If signs and symptoms persist beyond 6 weeks, patients should be re-examined. (2)
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Continuous long-term use of ELIDEL Cream, 1% should be avoided. (2)
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Avoid use with occlusive dressings. (2)
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
ELIDEL® (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)
WARNINGS AND PRECAUTIONS
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Should not be used in immunocompromised adults and children, including patients on systemic immunosuppressive medications. (5.1)
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Avoid treatment on malignant or pre-malignant skin conditions, as these can present as dermatitis. (5.2)
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Should not be used in patients with Netherton’s Syndrome or skin diseases with a potential for increased systemic absorption. (5.2)
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥1%) were application site burning, headache, nasopharyngitis, cough, influenza, pyrexia and viral infection. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 8/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
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