Pimecrolimus

Pimecrolimus cream should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that causes immunosuppression.

Long-term effect on the local skin immune response and on the incidence of skin malignancies is unknown. Pimecrolimus should not be applied to potentially malignant or pre-malignant skin lesions.

Pimecrolimus should not be applied to areas affected by acute cutaneous viral infections (herpes simplex, chicken pox).

Pimecrolimus has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis. Before commencing treatment with pimecrolimus, clinical infections at treatment sites should be cleared.

While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with pimecrolimus may be associated with an increased risk of skin herpes simplex virus infection, or eczema herpeticum (manifesting as rapid spread of vesicular and erosive lesions). In the presence of herpes simplex skin infection, pimecrolimus treatment at the site of infection should be discontinued until the viral infection has cleared.

Patients with severe atopic dermatitis may have an increased risk of skin bacterial infections (impetigo) during treatment with pimecrolimus.

There are no adequate data from the use of pimecrolimus in pregnant women. Animal studies using dermal application do not indicate direct or indirect harmful effects with respect to embryonal/fetal development. Studies in animals after oral application have shown reproductive toxicity. Based on the minimal extent of pimecrolimus absorption after topical application of pimecrolimus, the potential risk for humans is considered limited. However, pimecrolimus should not be used during pregnancy.

Animal studies on milk excretion after topical application were not conducted and the use of pimecrolimus in breastfeeding women has not been studied. It is not known whether pimecrolimus is excreted in the milk after topical application.

However, based on the minimal extent of pimecrolimus absorption after topical application of pimecrolimus, the potential risk for humans is considered limited. Caution should be exercised when pimecrolimus is administered to breastfeeding women.

Breastfeeding mothers may use pimecrolimus but should not apply pimecrolimus to the breast in order to avoid unintentional oral uptake by the newborn.

Fertility

There are no clinical data on the effects of pimecrolimus on male or female fertility.

Pimecrolimus has no known effect on the ability to drive and use machines.