Skilarence (dimethyl fumarate)

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Skilarence (dimethyl fumarate)

Skilarence (dimethyl fumarate) is a medication used for the treatment of moderate to severe plaque psoriasi.

How to buy Skilarence (dimethyl fumarate): You can order Skilarence (dimethyl fumarate) from TheSocialMedwork if the drug has not been approved or is not available in your country.


Dermatology Psoriasis
Marketing Authorisation Holder Almirall, S.A.
Mode of Action Nrf2 activator with immunomodulating and antiinflammatory effects
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union

What is Skilarence (dimethyl fumarate)?

Skilarence (dimethyl fumarate) is an immunomodulator indicated for the treatment of psoriasis1. The same active ingredient, dimethyl fumarate, is indicated for the treatment of multiple sclerosis4.

Who is Skilarence (dimethyl fumarate) for?

Skilarence (dimethyl fumarate) is for patients with moderate to severe plaque psoriasis for whom treatments applied direct to the skin do not work well enough1.

How does Skilarence (dimethyl fumarate) work?

Psoriasis causes the body’s immune system (defence mechanisms) to be overactive and attack its own cells. The active substance in Skilarence, dimethyl fumarate, reduces  T cells (a type of white blood cell that forms part of the immune system) and thereby reduces the activity of the immune system. In this way, it prevents the T cells from producing substances that cause inflammation and lead to psoriasis2.

Where has Skilarence (dimethyl fumarate) been approved?

Skilarence (dimethyl fumarate) was approved for the treatment of patients with moderate to severe plaque psoriasis by:

  • European Medical Agency (EMA), European Union, June 23, 20172.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Skilarence (dimethyl fumarate) taken?

It is recommended to begin treatment with a low initial dose with subsequent gradual increases1.

The standard dosage is:

  • Week 1: 30 mg (1 30 mg tablet) once daily

  • Week 2: 30 mg (1 30 mg tablet) twice daily (1 tablet in the morning and 1 in the evening).

  • Week 3: 30 mg (1 30 mg tablet) 3 times daily (1 tablet in the morning, 1 at midday and 1 in the evening).

  • Week 4: 120 mg daily ( 1 120 mg tablet) once daily (in the evening)

  • Week 5: 120 mg (1 120 mg tablet) twice daily (1 tablet in the morning and 1 in the evening).

  • Week 6: 120 mg (1 120 mg tablet) 3 times daily (1 tablet in the morning, 1 at midday and 1 in the evening).

  • Week 7: 120 mg (1 120 mg tablet) twice per day ( 1 tablet in the morning and 1 tablet at midday), and 240 mg (2 120 mg tablets) once per day (2 tablets in the evening)

  • Week 8: 240 mg (2 120 mg tablets) twice per day ( 1 tablet in the morning and 1 tablet in the evening), and 120 mg (1 120 mg tablet) once per day (1 tablets at midday)

  • Week 9+: 240 mg (2 120 mg tablets) 3 times per day (2 tablets in the morning, 2 at midday and 2 in the evening).

If a particular dose increase is not tolerated, it may be temporarily reduced to the last tolerated dose1.

If treatment success is observed before the maximum dose is reached, no further increase in dosage is necessary. After clinically relevant improvement of the skin lesions has been achieved, consideration should be given to gradual reduction of the daily dose of Skilarence to the maintenance dose required by the individual1.

Warning: Skilarence (dimethyl fumarate) might reduce the number of white blood cell and thus facilitate infections.

Complete information about Skilarence (dimethyl fumarate) dosage and administration can be found in the official prescribing information listed in our resources section1.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects or adverse reactions of Skilarence (dimethyl fumarate)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include1:

  • alterations in blood counts: lymphopenia, leukopenia, eosinophilia, leukocytosis

  • decreased appetite

  • headache

  • paresthesia (an abnormal sensation, typically tingling or pricking)

  • gastrointestinal disorders (diarrhoea, abdominal distension, abdominal pain, nausea, vomiting, dyspepsia, constipation, abdominal discomfort, flatulence

  • skin and subcutaneous tissue disorders (erythema, skin burning sensation, pruritus)

  • general disorders (fatigue, feeling hot, asthenia)

  • increased hepatic (liver) enzymes.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1:

  • acute lymphatic leukaemia (very rare)

  • pancytopenia (deficiency of all three cellular components of the blood) (very rare)

  • infections

Use in specific populations

Skilarence (dimethyl fumarate) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding1.


For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1.

More Information
Working ingredient dimethyl fumarate
Shipping method Standard (not temperature controlled)
Therapeutic Area Dermatology
Dermatology Psoriasis
Indication Plaque psoriasis
Administration Oral
Mode of Action Nrf2 activator with immunomodulating and antiinflammatory effects
Regulatory agency approval European Medical Agency (EMA), European Union
Marketing Authorisation Holder Almirall, S.A.

The European Medical Agency (EMA), European Union, approval of Skilarence (dimethyl fumarate) for plaque psoriasis in previously treated patients was  based on one double-blind, 3-arm, placebo- and active comparator-controlled Phase III study (Study 1102). This study involved a total of 704 patients with moderate to severe plaque psoriasis. Patients were randomly assigned to one of 3 groups to receive Skilarence, an active comparator (Fumaderm, a combination product with the same content of dimethyl fumarate plus 3 monoethyl fumarate salts) and placebo in a ratio of 2:2:1. Patients received treatment for up to 16 weeks and follow-up visits were planned for up to 12 months after treatment was stopped1.

Results

The major efficacy outcome measures were the Physician Global Assessment (PGA) and the Psoriasis Area and Severity Index (PASI)1.

The PGA is a measure of the status of the psoriatic lesions of a patient (i.e. plaque thickness/induration, erythema, scaling) on a severity scale from 0 (=clear) to 5 (=severe). The PASI additionally to the severity of the lesions takes into account the body surface area covered with psoriatic lesions3.

The PGA score clear or almost clear was:

  • 33% with Skilarence (dimethyl fumarate)

  • 13% with placebo

  • 37.4% with fumaderm

The PASI 75 was:

  • 37.5% with Skilarence (dimethyl fumarate)

  • 15.3% with placebo

  • 40.3% with fumaderm

Shipping Type Standard
Shipping method Standard (not temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.