Tecfidera (dimethyl fumarate)

Tecfidera® is a medication indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). It comes in delayed-release capsules taken by mouth in strengths of 120 mg and 240 mg. It is a disease-modifying drug (DMD) that may delay the build-up of disability.

What are the ingredients in Tecfidera?

The active ingredient in Tecfidera is dimethyl fumarate.

How does Tecfidera work?

The way Tecfidera works is not well understood. It is thought to act by reducing inflammation and the immune response that attacks myelin. It may also protect nerve cells from damage caused by chemicals released during an immune attack.

What are the possible side effects of Tecfidera?

Many clinical trials evaluated the safety and efficacy of Tecfidera. The most common side effects experienced by those taking Tecfidera include:

  • Flushing (red or hot skin)
  • Abdominal pain
  • Diarrhea
  • Nausea
  • PML (progressive multifocal leukoencephalopathy), a rare brain infection
  • Decrease in white blood cell count

This is not an exhaustive list of all potential side effects of Tecfidera. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Tecfidera, contact your doctor or healthcare provider.

Things to note about Tecfidera

Tecfidera is available in two strengths. It should be stored at room temperature and protected from light. Complete blood and liver function tests should be done before initiating therapy with Tecfidera. Monitoring should be continued every 6-12 months during treatment. Interruption of treatment should be considered if serious infections develop.

Before starting Tecfidera, talk with your doctor if you:

  • Have a history of hypersensitivity to dimethyl fumarate
  • Have a history of anaphylaxis or angioedema
  • Experience PML (progressive multifocal leukoencephalopathy), a rare brain infection
  • Have low white blood cell counts or an infection
  • Have hepatic (liver) injury
  • Are pregnant or planning to get pregnant, as there is limited information on the use of Tecfidera in pregnancy.

Individuals with the above conditions should be monitored closely while taking Tecfidera.

Dosing information

Tecfidera is administered orally with a starting dose of 120 mg twice a day for a week. After 7 days, the dose can be increased to 240 mg twice a day. Tecfidera is available in 30-day starter packs, which contain both strengths, and in larger quantity bottles of either 120mg or 240mg. The capsules should be swallowed whole and intact. They cannot be crushed, chewed, or sprinkled on food. Tecfidera can be taken with or without food.

Dosage can be reduced if there is a problem tolerating the recommended maintenance dose of 240mg twice a day. Within 4 weeks the dose should again be increased to 240 mg. Tecfidera should be discontinued if the maintenance dose cannot be tolerated.

Taking Tecfidera with food may reduce flushing, that is developing red or hot skin, a common side effect. Regular (not-coated) aspirin, up to 325 mg, can be taken 30 minutes prior to Tecfidera dosing to reduce the incidence or severity of flushing.

For additional details, read the full prescribing information of Tecfidera.

Written by Linda Saxl Minton | Last review date: April 2018.
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