Dovonex^® Cream

Calcipotriol 50 micrograms per g (as the hydrate)

For full list of excipients, see section 6.1

Cream

Soft white cream

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

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^® Cream is contra-indicated in patients with known disorders of calcium metabolism and patients with severe liver and kidney disease. As with other topical preparations, Dovonex^® Cream is contra-indicated in patients with hypersensitivity to the active substance or any of the excipients.

Dovonex^® Cream should not be used on the face. Patients should be advised to wash their hands after applying the cream and to avoid inadvertent transfer to other body areas, especially the face.

The risk of hypercalcaemia is minimal when the dosage recommendations are followed. Hypercalcaemia may occur if the maximum weekly dose is exceeded. Care should be exercised in patients with other types of psoriasis, since hypercalcaemia, which rapidly reversed on cessation of treatment, has been reported in patients with generalized pustular or erythrodermic exfoliative psoriasis. However, serum calcium is quickly normalised when treatment is discontinued.

During treatment with Dovonex^® Cream 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.

Pregnancy

The safety of the use of calcipotriol during human pregnancy has not been established, and studies in animals have shown reproductive toxicity when calcipotriol was administered orally. Calcipotriol should not be used during pregnancy unless clearly necessary.

Lactation

It is not known whether calcipotriol is excreted in breast milk. A decision on whether to abstain from breast-feeding or to abstain from therapy with Dovonex^® should be made taking into account the benefit of breast-feeding to the newborn/infant and the benefit of Dovonex^® therapy to the woman.

Calcipotriol has no or negligible influence on the ability to drive and to use machines.

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

Use above the recommended dose may cause elevated serum calcium which rapidly subsides when the treatment is discontinued.

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.

Calcipotriol is only slightly absorbed from the skin.

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

Calcipotriol has shown maternal and foetal toxicity in rats and rabbits when given by the oral route at doses of 54 µg/kg/day and 12 µg/kg/day, respectively. The foetal abnormalities observed with concomitant maternal toxicity included signs indicative of skeletal immaturity (incomplete ossification of the pubic bones and forelimb phalanges, and enlarged fontanelles) and an increased incidence of supernumerary ribs.

There is insufficient pharmacokinetic data available to quantify the safety margin for the embryofoetal effects.

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.

Macrogol cetostearyl ether, cetostearyl alcohol, chloroallylhexaminium chloride, disodium edetate, disodium phosphate dihydrate, glycerol 85%, liquid paraffin, sodium hydroxide, purified water, white soft paraffin.

Should not be mixed with other medicinal products.

2 years.

Store below 25°C

Aluminium tubes of 30g (OP), 60g (OP), 100g (OP) and 120g (OP).

Physician Sample Packs: Aluminium tubes of 15g

Polyethylene – aluminium laminate tubes with screw cap of 240g (OP).

Not all pack sizes may be marketed.

No special requirements.

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks

HP27 9RR

PL 0043/0188

10 August 1993

October 2010

Legal categories

• POM

Active ingredients/generics

• calcipotriol hydrate

Patient Information Leaflets (PILs):

• Dovonex Cream