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90% of pediatric and 74% of adult patients reported no application-site burning |
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Reported incidences were mild to moderate, occurred early in treatment, and were transient in nature |
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The overall incidence of adverse events was comparable to placebo cream, and included common childhood ailments |
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Only 1.5% and 3% of ELIDEL patients discontinued therapy due to adverse events,
in 6-week and 1-year pediatric studies, respectively*† |
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ELIDEL blood levels were negligible: |
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With application up to 92% of body surface area in pediatric patients aged 3 to 23 months |
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With intermittent therapy up to 1 year in adults, no systemic accumulation occurred |
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ELIDEL meets the challenges of eczema management without skin atrophy, striae, telangiectasia, hypopigmentation, tachyphylaxis, rebound flares,1 vasoconstriction, or 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 |
Treatment should be discontinued upon resolution of symptoms. Patients should be re-evaluated if symptoms persist beyond 6 weeks, or worsen at any time. Intermittent therapy with ELIDEL has been studied up to 1 year.
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.
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.
In clinical studies, skin papilloma or warts were observed in 1% of ELIDEL patients.
* Data from the 6-week, double-blind phases of two, 26-week, multicenter trials comparing ELIDEL to placebo cream in pediatric patients with mild to moderate eczema aged 2 to 17 years (N=403).
† Data from a 1-year safety study in pediatric patients aged 2 to 17 years involving sequential use of ELIDEL and corticosteroids.
‡ Data from an active-controlled adult study.
Reference:
- Data on file, Novartis Pharmaceuticals Corporation.
Please see complete Prescribing Information.
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