Skilarence
Authorised
This medicine is authorised for use in the European Union
dimethyl fumarate
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Skilarence. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Skilarence.
For practical information about using Skilarence, patients should read the package leaflet or contact their doctor or pharmacist.
Skilarence is a medicine used to treat plaque psoriasis, a disease that causes thickened, red and inflamed areas of skin with scaly patches. It is used in patients with moderate or severe disease for whom treatments applied direct to the skin do not work well enough.
Skilarence contains the active substance dimethyl fumarate.
Skilarence can only be obtained with a prescription and it should be used under the supervision of a doctor who has experience in diagnosing and treating psoriasis.
Skilarence is available as tablets (30 and 120 mg). The starting dose is 30 mg once a day and the dose is increased every week according to the schedule shown in the package leaflet until the psoriasis starts improving or until the patient is taking the maximum dose of 240 mg three times a day. Tablets should be swallowed whole during or immediately after a meal. The doctor may reduce the dose when the psoriasis has been brought under control.
For further information, see the package leaflet.
Psoriasis results from over-activity of the body’s immune (defence) system. The active substance in Skilarence, dimethyl fumarate, reduces the activity of the immune system. It is thought to act on T cells (a type of white blood cell that forms part of the immune system) to prevent the cells from producing substances that cause inflammation and lead to psoriasis.
A main study involving 704 patients with moderate to severe plaque psoriasis found that Skilarence was more effective than placebo (dummy treatment) at treating the disease and as effective as Fumaderm (a psoriasis medicine that contains dimethyl fumarate and monoethyl fumarate). The main measure of effectiveness was the proportion of patients who achieved a 75% reduction in their score for disease severity. After 16 weeks of treatment, 37% of patients taking Skilarence achieved this reduction, compared with 15% taking placebo and 40% taking Fumaderm.
The most common side effects with Skilarence (which may affect more than 1 in 10 people) are effects on the digestive system (diarrhoea, bloating, belly ache and nausea), flushing (reddening of the skin) and low levels of lymphocytes (type of white blood cells) or of white blood cells in general. For the full list of all side effects reported with Skilarence, see the package leaflet.
Skilarence must not be used in patients who have severe problems of the digestive system, liver or kidneys. It must also not be used by women during pregnancy or if breast-feeding.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Skilarence’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the main study has shown Skilarence’s short-term effectiveness, and published studies with similar medicines show that the effectiveness is maintained with continued use. Most side effects are mild or moderate. Because Skilarence reduces the activity of the immune system, there is a risk of serious infections, including progressive multifocal leukoencephalopathy (PML, a brain infection), but the risk can be minimised by regular tests for white blood cell counts and stopping treatment if necessary.
The company that markets Skilarence will supply educational materials to healthcare professionals about the risk of serious infections, including PML, and how to minimise this risk.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Skilarence have also been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the European Union for Skilarence on 23 June 2017.
For more information about treatment with Skilarence, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: N/0031
22/09/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Skilarence
- Active substance
- dimethyl fumarate
- International non-proprietary name (INN) or common name
- dimethyl fumarate
- Therapeutic area (MeSH)
- Psoriasis
- Anatomical therapeutic chemical (ATC) code
- L04AX07
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
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