Tecfidera (dimethyl fumarate)

What is Tecfidera (dimethyl fumarate)?

Tecfidera (dimethyl fumarate) is an oral Nrf2 pathway activator and anti-inflammatory medicine used to treat adults with multiple sclerosis (MS), specifically relapsing-remitting MS (RRMS)^[1,2].

How does Tecfidera (dimethyl fumarate) work?

Multiple sclerosis (MS) is a disease where the body’s immune system does not work properly and starts attacking the brain and spinal cord (parts of the central nervous system).

This causes inflammation and damages the protective sheath around the nerves. The active ingredient of Tecfidera (dimethyl fumarate) works to reduce the inflammation and is thought to help regulate the activity of the immune system^[1,2].

Where has Tecfidera (dimethyl fumarate) been approved?

Tecfidera (dimethyl fumarate) was approved for multiple sclerosis (MS) by:

• The Food and Drug Administration (FDA), US, March 2013^[1]
• Therapeutic Goods Administration (TGA), Australia, January 2014^[3]
• European Medicines Agency (EMA), EU, January 2014^[2]
• Health Canada, February 2014^[4]
• Medsafe (New Zealand), July 2014^[5].

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 Tecfidera (dimethyl fumarate) taken?

The recommended dosage is^[1]:

• starting dose of 120 mg (120 mg-tablets) taken orally twice daily
• maintenance dose of 240 mg (240 mg-tablets) taken orally twice daily.

Adjustment in dose may be required based on symptoms and experienced side effects^[1].

Complete information about Tecfidera (dimethyl fumarate) dosage and administration can be found in the official prescribing information listed in our references section^[1].

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

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

Common adverse reactions

The most common adverse reactions listed in the prescribing information include^[1]:

• abdominal pain
• diarrhoea
• nausea
• vomiting
• pruritus
• rash.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include^[1]:

• anaphylaxis and angioedema
• progressive multifocal leukoencephalopathy
• lymphopenia
• liver Injury
• flushing.

Use in a specific population

The safety and efficacy of Tecfidera (dimethyl fumarate) has not been established for children and adolescents aged 10 to 18. There were insufficient numbers of patients aged over 65 to determine whether they respond differently to the younger patients. However, based on the mode of action of the active substance it is deemed an adjustment in dose is not necessary. There is no relevant use of Tecfidera for children aged less than 10 years for the treatment of relapsing remitting multiple sclerosis (RRMS). Tecfidera (dimethyl fumarate) can be fatal for a foetus, it is advised to avoid pregnancies and breastfeeding while taking this medicine^[1,2].

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information^[1,2].

References

1. Summary of Product Characteristics [FDA]: Tecfidera (dimethyl fumarate)[PDF]

Biogen, March 2013.

2. Summary of Product Characteristics [EMA]: Tecfidera (dimethyl fumarate)[PDF]

Biogen Netherlands, January 2014.

3. Summary of Product Characteristics [TGA]: Tecfidera (dimethyl fumarate)[PDF]

Biogen Australia, July 2013.

4. Summary of Product Characteristics [Health Canada]: Tecfidera (dimethyl fumarate)[PDF]

Biogen Canada, February 2014.

5. Product detail [Medsafe]: Tecfidera (dimethyl fumarate)

Biogen NZ, March 2020.