Special Warning : אזהרת שימוש

WARNINGS

Long-term Safety of Topical Calcineurin Inhibitors 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 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.

Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies.
These risks are associated with the intensity and duration of immunosuppression.
Based on this information and the mechanism of action, there is a concern about a potential risk with the use of topical calcineurin inhibitors, including ELIDEL Cream.
While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including Elidel Cream. Therefore:
• Elidel Cream should not be used in immunocompromised adults and children.
• If signs and symptoms of atopic dermatitis do not improve within 6 weeks, patients should be re-examined by their healthcare provider and their diagnosis be confirmed (see PRECAUTIONS).
• The safety of Elidel Cream has not been established beyond one year of non- continuous use.

(See CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS,
INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION).

PRECAUTIONS
General
The use of Elidel Cream should be avoided on malignant or pre-malignant skin conditions. Malignant or pre-malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), can present as dermatitis.

Elidel Cream should not be used in patients with Netherton’s Syndrome or other skin diseases where there is the potential for increased systemic absorption of pimecrolimus. The safety of Elidel Cream has not been established in patients with generalized erythroderma.

The use of 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 Elidel Cream application and typically improve as the lesions of atopic dermatitis resolve (see ADVERSE REACTIONS).

Bacterial and Viral Skin Infections: Before commencing treatment with Elidel Cream, bacterial or viral infections at treatment sites should be resolved. Studies have not evaluated the safety and efficacy of Elidel Cream in the treatment of clinically infected atopic dermatitis.

While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with Elidel Cream may be independently associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum.

In clinical studies, 15/1544 (1%) cases of skin papilloma (warts) 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.
Patients with Lymphadenopathy: In clinical studies, 14/1544 (0.9%) 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, Elidel Cream should be discontinued.
Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.

Sun Exposure: During the course of treatment, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure, even while Elidel is not on the skin.
The potential effects of Elidel Cream on skin response to ultraviolet damage are not known.

Immunocompromised Patients: The safety and efficacy of Elidel Cream in immunocompromised patients have not been studied.

Information for Patients

Patients using Elidel should receive the following information and instructions: 
What is the most important information a patient should know about Elidel Cream?

The safety of using Elidel Cream for a long period of time is not known. A very small number of people who have used Elidel Cream have had cancer (for example, skin or lymphoma). However, a link with Elidel Cream use has not been shown. Because of this concern:
• A patient should not use Elidel Cream continuously for a long time.
• Elidel Cream should be used only on areas of skin that have eczema.

How should a patient use Elidel Cream?
• A patient should use Elidel Cream exactly as prescribed.
• A patient should use Elidel Cream only on areas of skin that have eczema.
• A patient should use Elidel Cream for short periods, and if needed, treatment may be repeated with breaks in between.
• A patient should stop Elidel Cream when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by the physician.
• A patient should follow the physician’s advice if symptoms of eczema return after a treatment with Elidel Cream.
• A patient should contact the physician if: • symptoms get worse with Elidel Cream
• the patient gets a skin infection
• symptoms do not improve after 6 weeks of treatment.

To apply Elidel Cream:
• A patient or caregiver should wash their hands before using Elidel Cream. When applying Elidel Cream after a bath or shower, the skin should be dry.
• A patient or caregiver should apply a thin layer of Elidel Cream only to the affected skin areas, twice a day, as directed by the physician.
• A patient or caregiver should use the smallest amount of Elidel Cream needed to control the signs and symptoms of eczema.
• Caregivers applying Elidel Cream to a patient, or a patient who is not treating the hands should wash their hands with soap and water after applying Elidel Cream. This should remove any cream left on the hands.
• A patient should not bathe, shower or swim right after applying Elidel Cream. This could wash off the cream.
• A patient can use moisturizers with Elidel Cream. They should be sure to check with the physician first about the products that are right for them. Because the skin of patients with eczema can be very dry, it is important they keep up good skin care practices. If a patient uses moisturizers, he or she should apply them after Elidel Cream.

What should a patient avoid while using Elidel Cream?

• A patient should not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with Elidel Cream.
• A patient should limit sun exposure during treatment with Elidel Cream even when the medicine is not on the skin. If a patient needs to be outdoors after applying Elidel Cream, the patient should wear loose fitting clothing that protects the treated area from the sun. The physician should advise the patient about other types of protection from the sun.
• A patient should not cover the skin being treated with bandages, dressings or wraps.
A patient can wear normal clothing.
• 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.
• A patient should not swallow Elidel Cream and should contact the physician if they do.

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