IMPORTANT SAFETY INFORMATION

INDICATION AND IMPORTANT SAFETY INFORMATION

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.

WARNING:
The safety of ELIDEL has not been established beyond one year of non-continuous use. Application should be limited to areas of involvement with atopic dermatitis.

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 (pimecrolimus) Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.

Patients should be reevaluated if symptoms persist beyond 6 weeks or worsen at any time. Treatment should be discontinued upon resolution of symptoms.

The safety of ELIDEL Cream has not been established beyond one year of non-continuous use. Application should be limited to areas of involvement with atopic dermatitis.

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.

The most common adverse events seen in clinical studies included application-site burning, headache, pharyngitis, nasopharyngitis, cough, influenza, pyrexia, and viral infection.

The most common local adverse event seen in clinical studies was application-site burning, which occurred in 8% to 26% of patients treated with ELIDEL Cream. In clinical studies, skin papillomas or warts were observed in 1% of ELIDEL patients.

If patients have lymphadenopathy that is unresolved or of unclear etiology, discontinuation should be considered.

ELIDEL should not be used with occlusive dressings. ELIDEL should not be applied to areas of active cutaneous infections.

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 potential effects of ELIDEL on skin response to ultraviolet damage are unknown.