IMPORTANT SAFETY INFORMATION

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.

Therefore:

  • Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
  • ELIDEL Cream is not indicated for use in children less than 2 years of age.

  • ELIDEL Cream is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.
  • ELIDEL Cream should not be used in immunocompromised patients, including those on systemic immunosuppressive medications.
  • Patients should be reevaluated by their healthcare provider if signs and symptoms of atopic dermatitis do not improve within 6 weeks. The safety of ELIDEL Cream has not been established beyond one year of non-continuous use.
  • The use of ELIDEL Cream should be avoided on malignant or pre-malignant skin conditions.
  • ELIDEL Cream should not be used in patients with Netherton's Syndrome or other skin diseases that increase the potential for systemic absorption of pimecrolimus.
  • ELIDEL Cream may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Localized symptoms are most common during the first few days of application and typically improve as the lesions of atopic dermatitis resolve.
  • Before commencing treatment with ELIDEL Cream, bacterial or viral infections at treatment sites should be resolved. In patients who develop lymphadenopathy of unknown etiology, or in the presence of acute infectious mononucleosis, ELIDEL Cream should be discontinued.
  • During the course of treatment, patients should minimize or avoid natural or artificial sunlight exposure, even while ELIDEL Cream is not on the skin.
  • The most common adverse events seen in clinical studies included application-site burning, headache, pharyngitis, nasopharyngitis, cough, influenza, pyrexia, and viral infection.

To report SUSPECTED ADVERSE REACTIONS contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA
at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please click here for full Prescribing Information.