Tecfidera

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

Tecfidera is used for:

Treating multiple sclerosis (MS).

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

Do NOT use Tecfidera if:

  • you are allergic to any ingredient in Tecfidera

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

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Tecfidera:

Some medical conditions may interact with Tecfidera. 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 Tecfidera. However, no specific interactions with Tecfidera are known at this time.

Ask your health care provider if Tecfidera 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 Tecfidera:

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

  • Take Tecfidera by mouth with or without food. Taking Tecfidera with food may decrease flushing or stomach problems.
  • Swallow Tecfidera whole. Do not break, crush, chew, or open the capsule before swallowing.
  • Take Tecfidera on a regular schedule to get the most benefit from it.
  • Taking Tecfidera at the same times each day will help you remember to take it.
  • Continue to take Tecfidera even if you feel well. Do not miss any doses.
  • If you miss a dose of Tecfidera, 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 Tecfidera.

Important safety information:

  • Tecfidera 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 Tecfidera 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 Tecfidera. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Tecfidera 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 Tecfidera while you are pregnant. It is not known if Tecfidera is found in breast milk. If you are or will be breast-feeding while you use Tecfidera, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tecfidera:

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 Tecfidera:

Store Tecfidera 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 Tecfidera out of the reach of children and away from pets.

General information:

  • If you have any questions about Tecfidera, please talk with your doctor, pharmacist, or other health care provider.
  • Tecfidera 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 Tecfidera 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 Tecfidera. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tecfidera. 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 Tecfidera.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
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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