Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2019 Publisher: LEO Pharma Ltd, Auckland, New Zealand Toll Free No. 0800 497 456
Daivonex ointment is indicated for the topical treatment of psoriasis vulgaris, including plaque psoriasis in adults and children (see section 4.4 Special warnings and precautions for use – paediatric population). In adult patients, Daivonex ointment may also be used in combination with systemic acitretin or cyclosporin.
Daivonex ointment should be applied topically to the affected area once or twice daily (i.e. in the morning and/or in the evening). Initially, twice daily application of the ointment is usually preferred. Application may then be reduced to once daily, provided individual clinical response is satisfactory. After satisfactory improvement has occurred, treatment should be discontinued.
If recurrence develops after reduction in frequency of application or after discontinuation, the treatment may be reinstituted at the initial dosage. Experience is lacking in the use of calcipotriol for periods longer than 1 year.
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.
It should be noted that there are no long-term clinical studies assessing the safety of using Daivonex ointment during exposure to sunlight. Therefore, all psoriasis-affected areas treated with calcipotriol should be, where possible, protected from direct sunlight and UVlight with items of clothing. Furthermore, topical calcipotriol should only be used with UV radiation if the physician and patient consider that the potential benefits outweigh the potential risks.
Twice daily application of Daivonex ointment in combination with systemic cyclosporin or acitretin has been shown to enhance the efficacy of cyclosporin or acitretin (see Section 5.1 Pharmacodynamic properties Clinical efficacy and safety).
Children under 6 years: There is limited experience of using Daivonex ointment in this age group. A maximum safe dose has not been established.
Children aged 6 to 12 years: Daivonex ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 50 g.
Children over 12 years: Daivonex ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 75 g.
There is no experience of use of Daivonex ointment in combination with other therapies for psoriasis in children.
Daivonex ointment should not be used for more than 8 weeks in children.
Daivonex ointment is indicated FOR TOPICAL USE ONLY and NOT FOR OPHTHALMIC USE.
Hypercalcaemia has been reported rarely at the recommended dose of Daivonex ointment when used for the approved indication. Excessive use may cause elevated serum calcium, which rapidly subsides when treatment is discontinued; in such cases, the monitoring of serum calcium levels once weekly until the serum calcium returns to normal levels is recommended.
Unopened container: 2 years.
After first opening of container: 6 months.
Store below 25ºC.
For ease of application, do not refrigerate.
Daivonex ointment is available in aluminium tubes of 15 g, 30 g, 100 g or 120 g.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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