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Tecfidera

Generic name: dimethyl fumarate (dye METH il FUE mar ate)
Brand name: Tecfidera
Drug class: Selective immunosuppressants

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 7, 2021.

What is Tecfidera?

Tecfidera (dimethyl fumarate) is a prescription medicine used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Tecfidera is available as hard gelatin delayed-release capsules in two strengths containing either 120 mg or 240 mg of dimethyl fumarate.

It is not known if Tecfidera is safe and effective in children under 18 years of age.

Warnings

Before taking and while you take Tecfidera, tell your doctor if you have or have had a low white blood cell counts or an infection.

Tecfidera may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Before taking this medicine

You should not use Tecfidera if you have had a severe allergic reaction to dimethyl fumarate or diroximel fumarate (Vumerity).

To make sure Tecfidera is safe for you, tell your doctor if you have ever had:

  • an active infection; or

  • low white blood cell (WBC) counts.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dimethyl fumarate on the baby.

Tecfidera is not approved for use by anyone younger than 18 years old.

How should I take Tecfidera?

Take Tecfidera exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Tecfidera.

You may take Tecfidera with or without food. Taking the medicine with food may help prevent flushing (sudden warmth, redness, or tingly feeling).

Swallow the capsule whole and do not crush, chew, break, or open it.

While using this medicine, you will need frequent blood tests.

Store this medicine in the original container at room temperature, away from moisture, heat, and light.

Dosing information

Usual Adult Dose for Multiple Sclerosis:

Initial dose: 120 mg orally twice a day for 7 days
Maintenance dose: 240 mg orally twice a day

Approved indication: The treatment of patients with relapsing-remitting multiple sclerosis.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tecfidera side effects

Get emergency medical help if you have signs of an allergic reaction to Tecfidera: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Dimethyl fumarate may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Also call your doctor at once if you have:

  • symptoms of herpes virus - flu-like symptoms, cold sores around your mouth, tingly or painful blistering rash, burning pain in your thigh or lower back;

  • low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or

  • liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Tecfidera side effects include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tecfidera?

Other drugs may interact with dimethyl fumarate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Popular FAQ

Vumerity and Tecfidera are administered in the same way and used to treat the same condition, multiple sclerosis (MS). They also have the same active metabolite, which means that they have the same therapeutic effect - work the same way - in people with MS.

However, Vumerity and Tecfidera do have different chemical structures and Vumerity is better tolerated and causes fewer gastrointestinal problems compared with Tecfidera. Continue reading

88% of patients taking Tecfidera are likely to report stomach-related adverse effects, including upper abdominal pain, nausea, and flatulence. These side effects tend to be more common in the first three weeks of treatment and overall, 54% took some form of treatment for the side effects. Tecfidera is unlikely to cause permanent stomach damage. Continue reading

Yes, Tecfidera does suppress the immune system. Although experts are not sure exactly how Tecfidera does this, Tecfidera has been associated with reductions in lymphocyte counts, and several serious opportunistic viral infections, such as progressive multifocal leukoencephalopathy and herpes zoster, as well as uncommon fungal and bacterial infections. Continue reading

There does not appear to be any rebound disease repercussions associated with stopping Tecfidera abruptly, unlike some other MS drugs such as Tysabri or Gilenya. Studies have shown the majority of patients taking Tecfidera discontinue or switch to another treatment within two years. Continue reading

More FAQ

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Tecfidera only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.