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In the open-label phase of the trial, for infants who switched to ELIDEL Cream, 1% from vehicle, the incidence of the above-cited adverse events approached or equaled the incidence of those subjects who remained on ELIDEL Cream, 1%. Elidel also contains propylene glycol (E 1520), which may cause skin irritation.Elidel contains the active substance pimecrolimus, a calcineurin inhibitor. An increased incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis, and urticaria were found in the subjects that had used ELIDEL Cream, 1% and topical corticosteroid sequentially as compared to ELIDEL Cream, 1% alone.In three randomized, double-blind vehicle-controlled pediatric trials and one active-controlled adult trial, 843 and 328 subjects, respectively, were treated with ELIDEL Cream, 1%. If you are a consumer or patient please visit Data from clinical studies support intermittent treatment with Elidel for up to 12 months.If no improvement occurs after 6 weeks, or in case of disease exacerbation, Elidel should be stopped. (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.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%.
In the 5 children treated for 1 year, blood concentrations were consistently low (maximum blood concentration was 1.94 ng/ml in 1 patient). A maximum blood concentration of 0.8 ng/ml was measured in only 2 patients in week 6 of treatment. In addition, a significant increase in the incidence of benign thymoma was noted in another oral (gavage) rat carcinogenicity study in 5 mg/kg/day pimecrolimus treated male animals compared to vehicle control treated male animals. No malformations in the fetuses were noted at 45 mg/kg/day (38X MRHD based on AUC comparisons) in this study. More patients treated with Elidel completed 6 months [children (61% Elidel vs 34% control), infants (70% Elidel vs 33% control)] and 12 months with no flare [children (51% Elidel vs 28% control), infants (57% Elidel vs 28% control)].Elidel had a sparing effect on the use of topical corticosteroids: more patients treated with Elidel did not use corticosteroids in 12 months [children (57% Elidel vs 32% control), infants (64% Elidel vs 35% control)]. The patient should stop using ELIDEL Cream, 1% when signs and symptoms (e.g., itch, rash and redness) resolve and should be instructed on what actions to take if symptoms recur.If signs and symptoms persist beyond 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.Continuous long-term use of ELIDEL Cream, 1% should be avoided, and application should be limited to areas of involvement with atopic dermatitis [see The safety of ELIDEL Cream, 1% under occlusion, which may promote systemic exposure, has not been evaluated. The No Observed Adverse Effect Level (NOAEL) for female fertility was 10 mg/kg/day (= 20 times the maximum human exposure after dermal application). 0187-5100-01, The youngest subject was age 2 and the oldest was age 12.
No teratogenicity was noted in this study at any dose.A second oral embryofetal development study was conducted in rabbits. Therefore Imodium Plus is not recommended during breast feeding. Emollients can be applied immediately after using Elidel.The use of Elidel in patients under 2 years of age is not recommended until further data become available.For children (2-11 years) and adolescents (12-17 years) the posology and method of administration are the same as for adults.Atopic dermatitis (eczema) is rarely observed in patients aged 65 and over.
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