LEO Pharma

Dovonex^® 50 micrograms/ml Scalp Solution

Calcipotriol 50 micrograms/ml (as the hydrate).

For excipients, see 6.1

Scalp solution.

A clear, colourless, slightly viscous scalp solution with an odour of menthol.

Dovonex^® Scalp Solution is indicated for the topical treatment of scalp psoriasis.

Adults: Dovonex^® Scalp Solution should be applied twice daily (morning and evening) to the affected areas. Maximum weekly dose should not exceed 60 ml.

When used together with Dovonex^® Cream or Ointment, the total dose of calcipotriol should not exceed 5mg in any week.

Children: There is no experience of the use of Dovonex^® Scalp Solution in children.

Known hypersensitivity to any of the ingredients.

Due to the content of calcipotriol, Dovonex^® is contraindicated in patients with known disorders of calcium metabolism.

Dovonex^® Scalp Solution should not be used on the face. The patients must be instructed in correct use of the product to avoid application and accidental transfer to the face. Hands must be washed after each application.

Use of Dovonex^® should be avoided in patients with severe renal failure or severe hepatic disorders.

The risk of hypercalcaemia is minimal when the dosage recommendations are followed. Hypercalcaemia may occur if the maximum weekly dose (60 ml) is exceeded. However, serum calcium is quickly normalised when treatment is discontinued.

During Dovonex^® treatment physicians may wish 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).

Propylene glycol may cause skin irritation.

None known.

Standard reproduction studies in animals have shown no evidence of drug related abnormality. There is no experience of use in humans in pregnancy and lactation, therefore use should be limited to that considered essential by the physician.

None.

Very common > 1/10

Common > 1/100 and < 1/10

Uncommon > 1/1,000 and < 1/100

Rare > 1/10,000 and < 1/1,000

Very rare < 1/10,000

The most frequently reported undesirable effects are various skin reactions and in particular application site reactions. Hypercalcaemia and allergic reactions have been reported very rarely.

Based on clinical data for Dovonex^® Scalp Solution undesirable effects occurred in approximately 25% of the patients.

Burning and stinging sensation are very common. Pruritus, skin irritation, dry skin, erythema and rash are common. Contact dermatitis, eczema and aggravated psoriasis are uncommon.

Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria, cf. section 4.4.

Post-market data on Dovonex^® cream, ointment and scalp solution

Transient changes in skin pigmentation, transient photosensitivity reactions and hypersensitivity reactions including urticaria, angioedema, periorbital or facial oedema have been reported very rarely. Perioral dermatitis may occur rarely.

Based on post-marketing data the total 'reporting rate' of undesirable effect is very rare being approximately 1:10,000 treatment courses.

The undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

Skin and subcutaneous tissue disorders:

Pruritus

Skin burning sensation

Skin stinging sensation

Skin irritation

Skin dry

Erythema

Rash*

Eczema

Contact Dermatitis

Aggravated Psoriasis

Skin hyperpigmentation

Skin depigmentation

Photosensitivity reaction

Urticaria

Facial oedema

Periorbital oedema

Angioedema

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

Metabolism and nutrition disorders:

Hypercalcaemia

Hypercalciuria

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

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

Calcipotriol is only slightly absorbed from the skin.

The effect on the calcium metabolism is approximately 100 times less than that of the hormonally active form of vitamin D_3.

A dermal carcinogenicity study in mice showed no indications of increased carcinogenic risks. Calcipotriol solution was applied topically for up to 24 months at doses of 3, 10 and 30 µg/kg/day (corresponding to 9, 30 and 90 µg/m²/day). The high-dose was considered to be the Maximum Tolerated Dose for dermal treatment of mice with calcipotriol. Survival was decreased at 10 and 30 µg/kg/day, particularly in the males. The reduced survival was associated with an increased incidence of obstructive uropathy, most probably caused by treatment-related changes in the urinary composition. This is an expected effect of treatment with high doses of calcipotriol or other vitamin D analogues. There were no dermal effects and no dermal or systemic carcinogenicity.

In a study where albino hairless mice were repeatedly exposed to both ultraviolet (UV) radiation and topically applied calcipotriol for 40 weeks at the same dose levels as in the dermal carcinogenicity study, 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.

hyprolose

isopropyl alcohol

levomenthol

sodium citrate

propylene glycol

purified water.

None known.

2 years.

Store below 25°C.

White HDPE bottles fitted with an LDPE nozzle and blue HDPE screw cap.

Pack size: 60 ml

The alcohol base is flammable.

LEO Laboratories Limited, Cashel Rd., Dublin 12

PA 46/61/3

8^th September 1994/ 25^th February 2006

July 2006

Prescription only medicine.