Other dermatologicals

Pimecrolimus

1g of cream contains 10 mg of pimecrolimus.

Cream. Whitish and homogeneous.

Treatment of patients aged 2 years and over with mild or moderate atopic dermatitis where treatment with topical corticosteroids is either inadvisable or not possible. This may include:

• Intolerance to topical corticosteroids

• Lack of effect of topical corticosteroids

• Use on the face and neck where prolonged intermittent treatment with topical corticosteroids may be inappropriate

Elidel should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.

Elidel can be used in the short term for the treatment of the signs and symptoms of atopic eczema and intermittently in the long term for the prevention of progression to flares.

Elidel treatment should begin at the first appearance of signs and symptoms of atopic dermatitis. Elidel should only be applied to areas affected with atopic dermatitis. Elidel should be used for as short period as possible during flares of disease. The patient or caregiver should stop using Elidel when signs and symptoms resolve. Treatment should be intermittent, short-term and not continuous. Elidel should be applied thinly to the affected areas twice daily.

Data from clinical studies support intermittent treatment with Elidel for up to 12 months.

If no improvement occurs after 6 weeks, or in case of disease exacerbation, Elidel should be stopped. The diagnosis of atopic dermatitis should be re-evaluated and further therapeutic options considered.

Adults

Apply a thin layer of Elidel to the affected skin twice daily and rub in gently and completely. Each affected region of the skin should be treated with Elidel until clearance occurs and then treatment should be discontinued.

Elidel may be used on all skin areas, including the head and face, neck and intertriginous areas, except on mucous membranes. Elidel should not be applied under occlusion.

In the long-term management of atopic dermatitis (eczema), Elidel treatment should begin at first appearance of signs and symptoms of atopic dermatitis to prevent flares of the disease. Elidel should be used twice daily. Emollients can be applied immediately after using Elidel.

Paediatric patients

The use of Elidel in patients under 2 years of age is not recommended until further data become available.

For children (2-11 years) and adolescents (12-17 years) the posology and method of administration are the same as for adults.

The use of Elidel in patients under 2 years of age is not recommended until further data become available. For children (2-11 years) and adolescents (12-17 years) the posology and method of administration are the same as for adults.

Atopic dermatitis (eczema) is rarely observed in patients aged 65 and over. Clinical studies with Elidel did not include a sufficient number of patients in this age range to determine whether they respond differently from younger patients.

Hypersensitivity to pimecrolimus, other macrolactams or to any of the excipients

Elidel 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. Elidel should not be applied to potentially malignant or pre-malignant skin lesions.

Elidel 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 Elidel 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, Elidel 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 Elidel.

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 cetyl alcohol and stearyl alcohol which may cause local skin reactions. Elidel also contains propylene glycol, which may cause skin irritation.

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 10mg/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 etiology or were known to resolve. Patients who receive Elidel 10mg/g 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 10mg/g cream should be discountinued. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.

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 Elidel has not been established in erythrodermic patients, the use of the product 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.

Potential interactions between Elidel and other medicinal products have not been systematically evaluated. Pimecrolimus is exclusively metabolised by CYP 450 3A4. Based on its minimal extent of absorption, interactions of Elidel with systemically administered medicinal products are unlikely to occur.

The present data indicate that Elidel can be used simultaneously with antibiotics, antihistamines and corticosteroids (oral/nasal/inhaled).

Based on the minimal extent of absorption, a potential systemic interaction with vaccination is unlikely to occur. However, this interaction has not been studied. Therefore, in patients with extensive disease, it is recommended to administer vaccinations during treatment-free intervals.

There is no experience with concomitant use of immunosuppressive therapies given for atopic eczema such as UVB, UVA, PUVA, azathioprine and cyclosporin A.

Elidel has no photocarcinogenic potential in animals. However, since the relevance to man is unknown excessive exposure of the skin to ultraviolet light including light from a solarium, or therapy with PUVA, UVA or UVB should be avoided during treatment with Elidel.

The most common adverse events were application site reactions which were reported by approximately 19% of the patients treated with Elidel and 16% of patients in the control groups. These reactions generally occurred early in treatment, were mild/moderate and were of short duration.

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common (1/10); common (1/100, <1/10); uncommon (1/1,000, <1/100); rare (1/10,000, <1/1,000); very rare (<1/10,000, including isolated reports).

Post marketing: Cases of malignancy, including cutaneous and other types of lymphoma, and skin cancers, have been reported in patients using pimecrolimus cream.

Novartis

(POM)

11 August 2009