Dovonex^® Ointment

Calcipotriol 50 micrograms per g

For full list of excipients, see section 6.1

Ointment

Slightly translucent white to yellowish ointment.

Dovonex^® Ointment is indicated for the topical treatment of plaque psoriasis (psoriasis vulgaris) amenable to topical therapy.

Adults: Dovonex^® Ointment should be applied to the affected area once or twice daily. For maximum benefit use the ointment twice daily. Maximum weekly dose should not exceed 100g.

Children over 12 years: Dovonex^® Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 75g.

Children aged 6 to 12 years: Dovonex^® Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 50g.

Children under 6 years: There is limited experience of the use of Dovonex^® Ointment in this age group. A maximum safe dose has not been established.

These dose recommendations are based on extensive experience in adults. In respect of children, clinical experience in children has shown Dovonex^® to be safe and effective over eight weeks at a mean dose of 15g per week but with wide variability in dose among patients. Individual dose requirement depends on the extent of psoriasis but should not exceed the above recommendations. There is no experience of use of Dovonex^® in combination with other therapies in children.

Dovonex^® Ointment is contra-indicated in patients with known disorders of calcium metabolism. As with other topical preparations, Dovonex^® Ointment is contra-indicated in patients with hypersensitivity to any of the ingredients.

Dovonex^® Ointment should not be used on the face. Patients should be advised to wash their hands after applying the ointment and to avoid inadvertent transfer to other body areas, especially the face. Patients should be advised to use no more than the recommended dose (see section 4.2) since hypercalcaemia, which rapidly reverses on cessation of treatment, may occur.

During treatment with Dovonex^® Ointment physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UV radiation only if the physician and patient consider that the potential benefits outweigh the potential risks (see section 5.3).

There is no experience of concomitant therapy with other antipsoriatic products applied to the same skin area at the same time.

Safety for use during human pregnancy has not yet been established, although studies in experimental animals have not shown teratogenic effects. Avoid use in pregnancy unless there is no safer alternative. It is not known whether calcipotriol is excreted in breast milk.

Not applicable.

Approximately 25% of the patients treated with Dovonex^®Ointment could experience an adverse reaction. These reactions are usually mild.

Immune system disorders

Metabolism and nutrition disorders

Skin and subcutaneous tissue disorders

*Various types of rash reactions such as scaly, erythematous, maculo-papular, pustular, bullous have been reported.

Hypercalcaemia may occur in patients with plaque psoriasis who use more than the recommended dose of Dovonex^® Ointment weekly and has been reported at lower doses in patients with generalized pustular or erythrodermic exfoliative psoriasis.

ATC Code: D05A X02

Pharmacotherapeutic group: Antipsoriatics for topical use

Calcipotriol is a vitamin D derivative. In vitro data suggest that calcipotriol induces differentiation and suppresses proliferation of keratinocytes. This is the proposed basis for its effect in psoriasis.

Data from a single study containing 5 evaluable patients with psoriasis treated with 0.3 - 1.7g of a 50 micrograms/g tritium labelled calcipotriol ointment suggested that less than 1% of the dose was absorbed.

However, total recovery of the tritium label over a 96 hour period ranged from 6.7 to only 32.6%, figures maximised by uncorrected chemiluminescence. There were no data on ³H tissue distribution or excretion from the lungs.

The effect on calcium metabolism is approximately 100 times less than that of the hormonally active form of vitamin D₃.

A dermal carcinogenicity study in mice revealed no special hazard to humans.

In a study where albino hairless mice were repeatedly exposed to both ultraviolet (UV) radiation and dermally administered calcipotriol for 40 weeks at dose levels corresponding to 9, 30 and 90µg/m²/day (equivalent to 0.25, 0.84, 2.5 times the maximum recommended daily dose for a 60 kg adult, respectively), a reduction in the time required for UV radiation to induce the formation of skin tumours was observed (statistically significant in males only), suggesting that calcipotriol may enhance the effect of UV radiation to induce skin tumours. The clinical relevance of these findings is unknown.

Disodium edetate, disodium phosphate dihydrate, DL-α-tocopherol, liquid paraffin, macrogol (2) stearyl ether, propylene glycol, purified water and white soft paraffin.

Should not be mixed with other medicinal products.

2 years.

Do not store above 25°C.

Lacquered aluminium tube with polypropylene screw cap.

Pack sizes: 30, 60, 100g and 120g.

Sample packs of 5 and 15g.

Polyethylene - aluminium laminate tube with screw cap.

Pack size: 240g.

Not all pack sizes may be marketed.

No special requirements

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks

HP27 9RR

PL 0043/0177

10 January 1991

October 2008