DAIVOBET

What it is

Daivobet 50/500 is a gel containing 50 micrograms of calcipotriol (as monohydrate) and 500 micrograms of betamethasone (as dipropionate) per gram. It is presented as an almost clear, colourless to slightly off-white gel. Daivobet combines the pharmacological effects of calcipotriol monohydrate as a synthetic vitamin D3 analogue and betamethasone dipropionate as a synthetic corticosteroid.

Approved indications

— Topical treatment of scalp psoriasis. — Topical treatment of mild to moderate plaque psoriasis on the body in adults.

Dosing overview

For body psoriasis, Daivobet should be applied once daily for up to 8 weeks. If there is no response after 4 weeks, treatment should be ceased. For scalp psoriasis, Daivobet should be applied once daily for up to 4 weeks, after which it may be used according to need under medical supervision. Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp. The maximum daily dose should not exceed 15 g and the maximum weekly dose should not exceed 100 g. The total body surface area treated with calcipotriol should not exceed 30%.

Key safety warnings

Adverse reactions found in connection with systemic corticosteroid treatment may occur during topical corticosteroid treatment due to systemic absorption. Application under occlusive dressings should be avoided, as should application on large areas of damaged skin or on mucous membranes or in skin folds. Hypercalcaemia may occur if the maximum daily dose of 15 g or the maximum weekly dose of 100 g is exceeded. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are followed. All psoriasis-affected areas treated with Daivobet should be, where possible, protected from direct sunlight and UV-light with items of clothing. The phototoxic effects of calcipotriol and betamethasone gel have not been studied in psoriasis patients. When treating psoriasis vulgaris with topical corticosteroids, there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.

Contraindications

Hypersensitivity to the active substances or to any of the excipients. Patients with known disorders of calcium metabolism. Due to the corticosteroid content, contraindications include viral lesions of the skin (such as herpes or varicella), fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, rosacea, ulceration and wounds, perianal and genital pruritus, and guttate, erythrodermic, exfoliative and pustular psoriasis. Patients with severe renal insufficiency or severe hepatic disorders.

PBS listing

The 30 g strength holds a Restricted Benefit listing and the 60 g strength holds an Authority Required (Streamlined) listing for chronic stable plaque psoriasis.

Regulatory history

Daivobet 50/500 ointment was first registered on the ARTG on 26 August 2004, followed by the gel formulation on 22 July 2010. The TGA approved the gel indication extension on 19 March 2013, extending its approved therapeutic uses. In November 2015, the PBAC recommended the gel on a cost-minimisation basis against calcipotriol and betamethasone ointment.