dimethyl fumarate

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Pronunciation: dye METH il FUE mar ate

Brand: Tecfidera

What is the most important information I should know about dimethyl fumarate?

Dimethyl fumarate 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.

What is dimethyl fumarate?

Dimethyl fumarate is used to treat relapsing multiple sclerosis.

Dimethyl fumarate may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking dimethyl fumarate?

You should not use dimethyl fumarate if you are allergic to it.

To make sure dimethyl fumarate is safe for you, tell your doctor if you have an active infection.

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

It is not known whether dimethyl fumarate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of dimethyl fumarate on the baby.

It is not known whether dimethyl fumarate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take dimethyl fumarate?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take dimethyl fumarate with or without food.

Do not crush, chew, break, or open a dimethyl fumarate capsule. Swallow it whole.

Dimethyl fumarate is usually given in two different strengths, one for a starter dose and the other for a maintenance dose. The starter dose is usually taken for only 7 days. Follow your doctor's dosing instructions very carefully.

Store at room temperature away from moisture, heat, and light. Throw away any unused capsules 90 days after you first opened the bottle.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking dimethyl fumarate?

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

What are the possible side effects of dimethyl fumarate?

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

Dimethyl fumarate may cause a serious viral infection of the brain that can lead to disability or death. Symptoms may start gradually and get worse quickly. 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.

Call your doctor at once if you have:

  • fever, pain when swallowing, cold or flu symptoms;
  • severe stomach pain; or
  • severe feeling of warmth or tingling, or a burning sensation.

Common side effects may include:

  • nausea, diarrhea, stomach pain; or
  • flushing (warmth, redness, or tingly feeling).

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 dimethyl fumarate?

Other drugs may interact with dimethyl fumarate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about dimethyl fumarate.

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

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