Elidel

Elidel Special Precautions

pimecrolimus

Manufacturer:

Viatris

Distributor:

Pharmline Marketing
Full Prescribing Info
Special Precautions
Long-term safety of Elidel 1% cream 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 1% cream (see ADVERSE REACTIONS).
As the long-term effect on the local skin immune response and on the incidence of skin malignancies is unknown, Elidel 1% cream should not be applied to potentially malignant or pre-malignant skin lesions.
Elidel 1% cream should not be applied to areas affected by acute cutaneous viral infections.
In the presence of a dermatological bacterial or fungal infection, the use of an appropriate antimicrobial agent should be instituted. If resolution of the infection does not occur, Elidel 1% cream should be discontinued until the infection has been adequately controlled.
The safety of Elidel 1% cream has not been established in patients with Netherton's syndrome and generalised erythroderma. Elidel is not recommended in patients with Netherton's syndrome or severely inflamed or damaged skin (e.g. erythroderma) where there is a potential for increased absorption.
The safety and efficacy of Elidel 1% cream in immunocompromised patients have not been studied. The use in immunocompromised patients is therefore not recommended.
In clinical studies, 14/1,544 (0.9%) cases of lymphadenopathy were reported while using Elidel 1% 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 be resolved. Patients who receive Elidel 1% 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, Elidel 1% cream should be discontinued. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
Throughout the course of treatment, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure. The potential effects of Elidel 1% Cream on skin response to ultraviolet damage are not known (see Pharmacology: Toxicology: PRECLINICAL SAFETY DATA under Actions).
Use of Elidel 1% cream may cause mild and transient reactions at the site of application, such as feeling of warmth and/or burning sensation. Patients should see a physician if an application site reaction is severe.
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 rinsed off with water.
Effects on the Ability to Drive and Use Machines: Elidel 1% cream has no known effect on the ability to drive and use machines.
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