SYSTEMIC ABSORPTION IS LOW

 

  • Pharmacokinetic studies in pediatrics and adults demonstrated blood levels <0.5 ng/mL in the majority of samples.6
  • Overall, a higher proportion of detectable blood levels was seen in the pediatric patient population as compared to the adult population, which may be due to the larger surface area to body mass ratio seen in these younger subjects.6
  • ELIDEL Cream is not indicated for use in children less than 2 years of age.
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INDICATION

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 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.


IMPORTANT SAFETY INFORMATION

WARNING:

Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established. 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.