TOLERABILITY PROFILE

Skin Application-Site Reactions (%)6

  • Six-week, double-blind phases of two 6-week, multicentre trials in patients aged 2 to 17 years with mild to moderate eczema
    (N=403).6
  • Data from a 1-year safety study in pediatric patients aged 2 to 17 years with mild to moderate eczema (N=347).6
  • § Data from an active-controlled adult study.6
  • Overall application-site reactions were mild to moderate, occurred early in treatment, and were transient in nature.3
  • The most common adverse reactions seen in clinical studies included application-site burning, headache, pharyngitis, nasopharyngitis, cough, influenza, pyrexia, and viral infection.6
  • There were no reported adverse reactions (≥1%) of HPA axis suppression, atrophy or telangiectasia in clinical studies.6
  • In clinical trials, 48 (4%) of the 1,171 ELIDEL patients and 13 (3%) of 408 vehicle-treated patients discontinued therapy due to adverse events. Discontinuations for AEs were primarily due to application-site reactions and cutaneous infections.6
  • In clinical studies, skin papillomas or warts were observed in 1% of ELIDEL patients.

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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.