Curatoderm Lotion

1. Name Of The Medicinal Product

Curatoderm 4 micrograms/ g Lotion

2. Qualitative And Quantitative Composition

Tacalcitol 4 micrograms/ g (as monohydrate)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Cutaneous emulsion

A white, thin emulsion

4. Clinical Particulars

4.1 Therapeutic Indications

Psoriasis vulgaris, especially on the scalp

4.2 Posology And Method Of Administration

Adults and the Elderly: Apply once daily to the affected areas, preferably at bedtime. The amount applied should not exceed 10 ml of lotion/day. When used together with Curatoderm Ointment, the total dose of tacalcitol should not exceed 280 μg/week (e.g. 30 ml of Curatoderm Lotion plus 40 g of Curatoderm Ointment). Normally duration of treatment depends on the severity of the lesions and should be decided by the physician.

There is clinical trial experience with continuous and intermittent treatment in adults with tacalcitol ointment up to 18 months, and with tacalcitol lotion for up to 8 weeks.

Curatoderm Lotion can be used on all areas of the body (including face, hairline, scalp, axilla and other flexures).

Children: Not recommended. There is limited clinical experience with tacalcitol in children.

4.3 Contraindications

Hypersensitivity to any of the constituents. Hypercalcaemia. Other known disorders of calcium metabolism.

4.4 Special Warnings And Precautions For Use

At the doctor's discretion, in patients at risk of hypercalcaemia, or patients taking high Vitamin D preparations (in excess of 500 IU vitamin D) albumin corrected serum calcium levels should be closely monitored. Treatment should be stopped if hypercalcaemia occurs. Serum calcium levels should also be monitored in patients with renal impairment.

Care should be exercised in patients with generalised pustular or erythrodermic exfoliative psoriasis as the risk of hypercalcaemia may be enhanced.

When applying to the face avoid contact with the eyes. If Curatoderm Lotion accidentally comes into contact with the eyes, thorough rinsing with water is recommended. Patients should be advised to wash their hands after applying the lotion to avoid inadvertent transfer to other parts of the body.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interactions are likely in patients using multivitamin preparations with up to 500 IU vitamin D.

UVB radiation can be combined with Curatoderm Lotion. This approach increases the efficacy of tacalcitol treatment and shortens the radiation period. UV radiation should be given in the morning and Curatoderm Lotion at bedtime. There has been limited experience of the concomitant use of tacalcitol with topical corticosteroids, urea, emollients, dithranol cream and PUVA.

4.6 Pregnancy And Lactation

For Curatoderm Lotion no clinical data on exposed pregnancies are available. Animal Studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

It is not known whether tacalcitol is excreted in human milk. Given the low systemic exposure in humans following topical treatment with tacalcitol, it is probably not necessary to stop breast-feeding during treatment, unless the breast area is affected. In that case, either the breast area should not be treated in lactating women who are breast-feeding, or breast-feeding should be stopped.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Skin and subcutaneous tissue disorders: Local skin reactions (itching, erythema, burning) are uncommon. In general, these local reactions are mild and transient.

4.9 Overdose

Overdosing by ingestion of a lotion is very unlikely. It cannot be excluded that topical application of excessive amounts may lead to hypercalcaemia. In this case Curatoderm treatment and other possible vitamin D or calcium supplement intakes must be stopped until serum calcium returns to normal.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other antipsoriatics for topical use

ATC Code: D05A X04.

Tacalcitol is a vitamin D3 derivative, which inhibits keratinocyte hyper-proliferation and induces differentiation of these cells. The normalisation of these mechanisms is the basis for the efficacy in the treatment of psoriasis. In biopsies from patients treated with tacalcitol specific indicators for inflammation were improved. Tacalcitol binds to the keratinocyte vitamin D receptor to the same extent as natural active vitamin D₃.

5.2 Pharmacokinetic Properties

Single or repeated application of tacalcitol ointment in humans results in less than 0.5% of the drug being systemically absorbed through psoriatic skin. Tacalcitol is completely bound to plasma proteins (vitamin D binding protein) The main metabolite is 1α, 24, 25 (OH)₃ vitamin D₃, a metabolite shared with the natural active vitamin, with 5-10 times less vitamin D activity. Tacalcitol and metabolites are excreted mainly in the faeces in rat and dog studies with excretion in urine in man. It cannot therefore be excluded that if there is sufficient systemic absorption accumulation may occur in patients with renal failure.

5.3 Preclinical Safety Data

The toxic effects of tacalcitol are typical of those expected from excessive pharmacological activity of calciferols and resultant hypercalcaemia. The NOEL in rats treated subcutaneously for 12 months was 4 ng/kg/day. Reproductive toxicity studies in rats and rabbits revealed no teratogenic effects. Tacalcitol was negative in a battery of in vitro mutagenicity studies.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified water

Light liquid paraffin

Medium-chain triglycerides

Propylene glycol

Octyldodecanol

Macrogol (21) stearylether

Diisopropyl adipate

Phenoxyethanol

Disodium phosphate dodecahydrate

Xanthan gum

Potassium dihydrogen phosphate

Disodium edetate

Dodecyl gallate

6.2 Incompatibilities

Tacalcitol must not be mixed with salicylic acid.

6.3 Shelf Life

2 years

6 months after first opening the container

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep bottle in the outer carton.

6.5 Nature And Contents Of Container

20 ml, 30 ml or 50 ml HDPE Plastic bottle and with HDPE screw cap.

6.6 Special Precautions For Disposal And Other Handling

External use only.

7. Marketing Authorisation Holder

Almirall Hermal GmbH

Scholtzstrasse 3

D-21465,

Reinbek

Germany

8. Marketing Authorisation Number(S)

PL 33016/0011

9. Date Of First Authorisation/Renewal Of The Authorisation

19^th July 2007

10. Date Of Revision Of The Text

24^th August 2010