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In long-term safety studies with pediatric and adult patients, ELIDEL was applied at the first signs or symptoms of eczema, and through resolution:
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In the 6-month adult study, significantly more ELIDEL patients than placebo cream patients had 0 flares requiring corticosteroids3 |
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Over a similar 1-year pediatric study, significantly more ELIDEL patients than placebo cream patients had 0 flares requiring corticosteroids4
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Manage eczema with confidence
NO Tachyphylaxis
NO Rebound Flares1
NO Skin atrophy
NO Striae
NO Telangiectasia
NO Vasoconstriction
NO HPA axis suppression
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ELIDEL may be used on all skin surfaces including the face, around the eyes, neck, hands, and other sensitive skin areas in people ages 2 and older.
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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 should not be applied to areas of active cutaneous infections.
The efficacy and safety of ELIDEL have not been studied beyond one year.
The most common adverse events seen in clinical studies included application-site burning, headache, pharyngitis, nasopharyngitis, cough, influenza, pyrexia, and viral infection.
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.
* A flare was defined as an exacerbation of the eczema, requiring corticosteroids.
† 6-month, randomized, double-blind, parallel-group, multicenter study investigating the efficacy and safety of ELIDEL in the long-term management of adults with moderate AD (N=130).
‡ A flare was defined as an episode of eczema with an IGA score of 4 or 5. IGA measures eczema signs from 0 ("clear") to 5 ("very severe").
§ One-year double-blind, multicenter, controlled study of the use of ELIDEL in the long-term management of pediatric patients with mild to moderate AD (N=711)
References:
- Data on file, Novartis Pharmaceuticals Corporation.
- Meurer M, Fölster-Holst R, Wozel G, et al. Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. Dermatology.
2002;205:271-277.
- Wahn U, Bos JD, Goodfield M, et al. Efficacy and safety of pimecrolimus cream in the long-term management of atopic dermatitis in children. Pediatrics. 2002;110:e2.
Please see complete Prescribing Information.
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