Product Dossier

DAIVONEX

Product Dossier for DAIVONEX (calcipotriol, LEO Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

Daivonex is a topical ointment containing calcipotriol 50 microgram per gram . It is a smooth, white preservative free ointment base . Calcipotriol is a non-steroidal antipsoriatic agent, derived from vitamin D . Calcipotriol induces differentiation and suppresses proliferation of keratinocytes, thus reversing the abnormal keratinocyte changes in psoriasis .

Approved indications

— Topical treatment of chronic stable plaque type psoriasis vulgaris in adults and children — In adult patients, combination use with systemic acitretin or ciclosporin

Dosing overview

In adults, Daivonex ointment should be applied topically to the affected area once or twice daily (in the morning and/or in the evening). Initially, twice daily application is usually preferred. Application may then be reduced to once daily, provided individual clinical response is satisfactory . The maximum recommended weekly dose of Daivonex ointment is 100 g/week . When using a combination of ointment and cream the total maximum dose should not exceed 100 g per week . Children aged 6 to 12 years should have Daivonex ointment applied to the affected area twice daily with a maximum weekly dose not exceeding 50 g. Children over 12 years should have the ointment applied twice daily with a maximum weekly dose not exceeding 75 g . Daivonex ointment should not be used for more than 8 weeks in children .

Key safety warnings

In view of the risk of hypercalcaemia secondary to excessive absorption of calcipotriol when there is extensive skin involvement, Daivonex ointment should not be used for severe extensive psoriasis . Daivonex ointment is not recommended for use in patients with generalised pustular psoriasis, guttate psoriasis and erythrodermic exfoliative psoriasis . Daivonex ointment is not recommended for use on the face since it may give rise to itching and erythema of the facial skin . Serum calcium and renal function should be monitored at 3 monthly intervals during periods of usage of topical calcipotriol. If the serum calcium level is observed to be elevated, treatment with Daivonex ointment should be discontinued. The levels of serum calcium should be measured once weekly until the serum calcium levels return to normal values . Treated areas should be protected from sunlight and UV light, particularly where exposure may be considerable. Furthermore, topical calcipotriol should only be used with UV radiation if the physician and patient consider that the potential benefits outweigh the potential risks .

Contraindications

Allergic sensitisation to any constituent of Daivonex ointment . Patients with known disorders of calcium metabolism .

Regulatory history

Daivonex calcipotriol 50 micrograms/g ointment was first listed on the ARTG on 26 April 1994 . The product information was most recently revised on 16 July 2024 .