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Warnings & Precautions
PRECAUTIONS
General Elidel® (pimecrolimus) Cream 1% should not be applied to areas of active cutaneous viral infections.
Studies have not evaluated the safety and efficacy of Elidel Cream in the treatment of clinically infected atopic dermatitis. Before commencing treatment with Elidel Cream, clinical infections at treatment sites should be cleared. Text Continues Below
While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with Elidel Cream may be associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum. In the presence of these skin infections, the balance of risks and benefits associated with Elidel Cream use should be evaluated. In clinical studies, 14 cases of lymphadenopathy (0.9%) were reported while using Elidel Cream. These cases of lymphadenopathy were usually related to infections and noted to resolve upon appropriate antibiotic therapy. Of these 14 cases, the majority had either a clear etiology or were known to resolve. Patients who receive Elidel Cream and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, discontinuation of Elidel Cream should be considered. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
In clinical studies, 15 cases of skin papilloma or warts (1%) were observed in patients using Elidel Cream. The youngest patient was age 2 and the oldest was age 12. In cases where there is worsening of skin papillomas or they do not respond to conventional therapy, discontinuation of Elidel Cream should be considered until complete resolution of the warts is achieved.
The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Despite the absence of observed phototoxicity in humans (see ADVERSE REACTIONS), Elidel Cream shortened the time to skin tumor formation in an animal photo-carcinogenicity study (see Carcinogenesis, Mutagenesis, Impairment of Fertility). Therefore, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure.
The use of Elidel Cream in patients with Netherton’s Syndrome is not recommended due to the potential for increased systemic absorption of pimecrolimus. There are no data to support use of Elidel in immunocompromised patients. The use of Elidel Cream may cause local symptoms such as skin burning. Localized symptoms are most common during the first few days of Elidel Cream application and typically improve as the lesions of atopic dermatitis resolve. Most application site reactions lasted no more than 5 days, were mild to moderate in severity, and started within 1-5 days of treatment. (See ADVERSE REACTIONS.)
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