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Dimethyl fumarate

Generic Name: dimethyl fumarate ((dye-METH-il FUE-ma-rate))
Brand Name: Tecfidera

Dimethyl fumarate is used for:

Treating multiple sclerosis (MS).

Dimethyl fumarate is a fumaric acid derivative. Exactly how it works to treat MS is not known.

Do NOT use dimethyl fumarate if:

  • you are allergic to any ingredient in dimethyl fumarate

Contact your doctor or health care provider right away if any of these apply to you.

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Before using dimethyl fumarate:

Some medical conditions may interact with dimethyl fumarate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have an infection or low white blood cell counts

Some MEDICINES MAY INTERACT with dimethyl fumarate. However, no specific interactions with dimethyl fumarate are known at this time.

Ask your health care provider if dimethyl fumarate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use dimethyl fumarate:

Use dimethyl fumarate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take dimethyl fumarate by mouth with or without food. Taking dimethyl fumarate with food may decrease flushing or stomach problems.
  • Swallow dimethyl fumarate whole. Do not break, crush, chew, or open the capsule before swallowing.
  • Take dimethyl fumarate on a regular schedule to get the most benefit from it.
  • Taking dimethyl fumarate at the same times each day will help you remember to take it.
  • Continue to take dimethyl fumarate even if you feel well. Do not miss any doses.
  • If you miss a dose of dimethyl fumarate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use dimethyl fumarate.

Important safety information:

  • Dimethyl fumarate may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Tell your doctor or dentist that you take dimethyl fumarate before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including complete blood cell counts, may be performed while you use dimethyl fumarate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Dimethyl fumarate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using dimethyl fumarate while you are pregnant. It is not known if dimethyl fumarate is found in breast milk. If you are or will be breast-feeding while you use dimethyl fumarate, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of dimethyl fumarate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; flushing (warmth, redness, itching, or burning feeling); indigestion; mild stomach pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever, chills, or persistent sore throat; severe or persistent diarrhea, indigestion, nausea, stomach pain, or vomiting; severe or persistent flushing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of dimethyl fumarate:

Store dimethyl fumarate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Throw away any medicine left in the bottle 90 days after opening. Keep dimethyl fumarate out of the reach of children and away from pets.

General information:

  • If you have any questions about dimethyl fumarate, please talk with your doctor, pharmacist, or other health care provider.
  • Dimethyl fumarate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take dimethyl fumarate or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about dimethyl fumarate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to dimethyl fumarate. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using dimethyl fumarate.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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