Elidel Special Precautions

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).
Elidel has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis. Before commencing treatment with Elidel, 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.
Use of Elidel may cause mild and transient reactions at the site of application, such as a feeling of warmth and/or burning sensation. If the application site reaction is severe, the risk-benefit of treatment should be re-evaluated.
Care should be taken to avoid contact with eyes and mucous membranes. If accidentally applied to these areas, the cream should be thoroughly wiped off and/or rinsed off with water.
Physicians should advise patients on appropriate sun protection measures, such as minimisation of the time in the sun, use of sunscreen product and covering the skin with appropriate clothing.
Elidel contains the active substance pimecrolimus, a calcineurin inhibitor. In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies.
Cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers have been reported in patients using pimecrolimus cream. However, patients with atopic dermatitis treated with Elidel have not been found to have significant systemic pimecrolimus levels.
In clinical studies, 14/1,544 (0.9%) cases of lymphadenopathy were reported while using Elidel 10 mg/g 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 aetiology or were known to resolve. Patients who receive Elidel 10 mg/g cream and who develop lymphadenopathy should have the aetiology of their lymphadenopathy investigated. In the absence of a clear aetiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, treatment with pimecrolimus should be discontinued. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Populations with potentially higher risk of systemic exposure: Elidel has not been studied in patients with Netherton's syndrome. Due to the potential for increased systemic absorption of pimecrolimus, Elidel is not recommended in patients with Netherton's syndrome.
As the safety of pimecrolimus has not been established in erythrodermic patients, the use of Elidel in this patient population cannot be recommended.
The use of Elidel under occlusion has not been studied in patients. Occlusive dressings are not recommended.
In patients with severely inflamed and/or damaged skin, the systemic concentrations may be higher.
Elidel contains cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Further Elidel also contains 10 mg benzyl alcohol per 1 g cream, which may cause allergic reactions and mild local irritation. Elidel also contains 50 mg propylene glycol (E 1520), per 1 g cream which may cause skin irritation.
Effects on ability to drive and use machines: Elidel has no known effect on the ability to drive and use machines.