AZEMATOP

What it is

Azematop 0.1% contains tacrolimus 1.0 mg/g and is presented as a white to slightly yellowish ointment.

Approved indications

Azematop 0.1% ointment is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents (16 years of age and above). The indication encompasses two treatment contexts: — Treatment of moderate to severe flares of atopic dermatitis 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

Azematop 0.1% can be used for short-term and intermittent long-term treatment, but treatment should not be continuous on a long-term basis. For flare treatment: Treatment should be started with Azematop 0.1% twice a day and treatment should be continued until clearance of the lesion. Generally, improvement is seen within one week of starting treatment; if no signs of improvement are seen after two weeks of treatment, further treatment options should be considered. For maintenance treatment: Patients who are responding to up to 6 weeks treatment using tacrolimus ointment twice daily are suitable for maintenance treatment, and Azematop 0.1% ointment should be applied once a day twice weekly to areas commonly affected by atopic dermatitis to prevent progression to flares. 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. Azematop 0.1% 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.

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 (PUVA) should be avoided during use of Azematop 0.1%. 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, and post-marketing cases of increased tacrolimus blood level have been reported in these conditions. Azematop 0.1% 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 Azematop 0.1% 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 Azematop 0.1% ointment, clinical infections at treatment sites should be cleared. Treatment with Azematop 0.1% may be associated with an increased risk of folliculitis and herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi's varicelliform eruption).

Contraindications

Azematop is contraindicated in patients with hypersensitivity to the active substance, macrolides in general, or to any of the excipients. Azematop 0.1% ointment should not be used in children aged below 16 years until further data are available.

PBS listing

In July 2025, Azematop 0.1% ointment was recommended by the PBAC for moderate to severe atopic dermatitis affecting the body, face and eyelids, with cost no more than 1% pimecrolimus for face/eyelids and cost no more than topical corticosteroid for body.

Regulatory history

Azematop 0.1% (tacrolimus 1 mg/g ointment) was first registered on the ARTG on 11 December 2023. In July 2025, the PBAC recommended the product for moderate to severe atopic dermatitis affecting the body, face and eyelids.