PACROLIM

What it is

PACROLIM contains tacrolimus 1.0 mg/g (0.1%) . It is a white to slightly yellowish ointment . Tacrolimus is classified as an other dermatological preparation with ATC code D11AH01 .

Approved indications

— Treatment of moderate to severe atopic dermatitis in adults and adolescents aged 16 years and above, for flare treatment in patients who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids . — Prevention of flares and prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations who have responded to tacrolimus treatment during flares .

Dosing overview

PACROLIM can be used for short-term and intermittent long-term treatment, but should not be continuous on a long-term basis .

For flare treatment: Treatment should be started with PACROLIM twice a day and continued until clearance of the lesion . Generally, improvement is seen within one week of starting treatment, and if no signs of improvement are seen after two weeks of treatment, further treatment options should be considered .

For maintenance treatment: PACROLIM ointment should be applied once a day twice weekly to areas commonly affected by atopic dermatitis to prevent progression to flares . Between applications there should be 2–3 days without PACROLIM treatment . After 12 months treatment, a review of the patient's condition should be conducted by the physician and a decision taken whether to continue maintenance treatment in the absence of safety data for maintenance treatment beyond 12 months . PACROLIM ointment should be applied as a thin layer to affected or commonly affected areas of the skin and may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes . PACROLIM ointment should not be applied under occlusion because this method of administration has not been studied in patients .

Key safety warnings

Exposure of the skin to sunlight should be minimised and the use of ultraviolet light from a solarium, therapy with UVB or UVA in combination with psoralens should be avoided during use of PACROLIM. Physicians should advise patients on appropriate sun protection methods, such as minimisation of the time in the sun, use of a sunscreen product and covering of the skin with appropriate clothing . The use of tacrolimus ointment is not recommended in patients with a skin barrier defect, such as Netherton's syndrome, lamellar ichthyosis, generalised erythroderma or cutaneous Graft Versus Host Disease, as these skin conditions may increase systemic absorption of tacrolimus . PACROLIM should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression . 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. Patients with atopic dermatitis treated with tacrolimus have not been found to have significant systemic tacrolimus levels and the role of local immunosuppression is unknown. Based on the results of long-term studies and experience a link between PACROLIM ointment treatment and development of malignancies has not been confirmed, but definitive conclusions cannot be drawn . Patients with atopic dermatitis are predisposed to superficial skin infections. Tacrolimus ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis. Before commencing treatment with PACROLIM ointment, clinical infections at treatment sites should be cleared . Treatment with PACROLIM may be associated with an increased risk of folliculitis and herpes viral infections including herpes simplex dermatitis, herpes simplex and Kaposi's varicelliform eruption . In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application. Burning sensation and pruritus were very common, usually mild to moderate in severity and tended to resolve within one week of starting treatment .

Contraindications

PACROLIM is contraindicated in patients with hypersensitivity to the active substance, macrolides in general, or to any of the excipients . PACROLIM ointment should not be used in children aged below 16 years until further data are available .

Regulatory history

PACROLIM was first approved on 11th December 2023 .