Dovobet

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What is Dovobet®?

Dovobet® is a gel that is a combination of calcipotriol and betamethasone dipropionate for the treatment of plaque psoriasis.

It belongs to the group of medicines for application to the skin called known as Vitamin D analogue/corticosteroid combinations. Vitamin D analogues prevent the increased growth of skin cells as seen in plaque psoriasis and have the advantage that they do not smell or stain clothing. The steroid helps to reduce the inflammation.

How does it work?Vitamin D analogues prevent the increased growth of skin cells as seen in plaque psoriasis and have the advantage that they do not smell or stain clothing. The steroid helps to reduce the inflammation.

Who can get it?

Dovobet® is available on prescription. It is recommended that children and adolescents below the age of 18 years do not use the ointment.

How is it used?

Dovobet® should be applied to the affected area once daily. The recommended treatment period is 4 weeks. After this period repeated treatment with Dovobet can be initiated under medical supervision.
The maximum daily dose should not exceed 15 g, the maximum weekly dose should not exceed 100 g, and the treated area should not be more than 30% of the body surface.
Dovobet® is not recommended for the use in children and adolescents below the age of 18 years.

Dovobet®  is also available for the treatment of scalp psoriasis and mild to moderate non-scalp plaque psoriasis. The gel should be applied to the affected area once daily for 4 weeks (scalp) or 8 weeks (other areas)
The maximum daily application should not exceed 15g per day or 100g per week.
Dovobet® gel is not recommended for use in children below the age of 18 years.

What are the side effects?

The trial programme for Dovobet®  has so far included more than 2,500 patients and has shown that approximately 10% of patients can be expected to experience a non-serious undesirable effect.
Based on data from clinical trials and postmarketing use the common undesirable effects are pruritus, rash and burning sensation of skin. Uncommon undesirable effects are skin pain or irritation, dermatitis, erythema, exacerbation of psoriasis, folliculitis and application site pigmentation changes. Pustular psoriasis is a rare undesirable effect.
The undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.
Common: Pruritus
Common: Rash
Common: Burning sensation of skin
Uncommon: Skin pain or irritation
Uncommon: Dermatitis
Uncommon: Erythema
Uncommon: Exacerbation of psoriasis
Uncommon: Folliculitis
Uncommon: Application site pigmentation changes
Rare: Pustular psoriasis
Undesirable effects observed for calcipotriol and betamethasone, respectively:
Calcipotriol
Undesirable effects include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial oedema.
Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria.
Betamethasone (as dipropionate)
This product contains a potent corticosteroid.
Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia. When treating psoriasis there may be a risk of generalised pustular psoriasis.
Systemic effects due to topical use of corticosteroids are rare in adults, however they can be severe. Adrenocortical suppression, cataract, infections and increase of intra-ocular pressure can occur, especially after long term treatment. Systemic effects occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long term treatment. You should not normally use this product if you are pregnant or breast feeding unless your doctor has specifically recommended you to do so.

Marketed by

Dovobet® Gel is available on prescription and is marketed in the UK by Leo Pharma