Indication and Important Safety Information

Indication

TECFIDERA^® (dimethyl fumarate) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Important Safety Information

Do not use TECFIDERA if you have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to TECFIDERA or any of its ingredients.

Before taking and while you take TECFIDERA, tell your doctor about any low white blood cell counts or infections or any other medical conditions.

What are the possible side effects of TECFIDERA?

TECFIDERA may cause serious side effects including:

• Allergic reactions
• PML, which is a rare brain infection that usually leads to death or severe disability
• Decreases in your white blood cell count. Your doctor should check your white blood cell count before you take TECFIDERA and from time to time during treatment
• Liver problems. Your doctor should do blood tests to check your liver function before you start taking TECFIDERA and during treatment if needed. Tell your doctor right away if you get any symptoms of a liver problem during treatment, including:
  • severe tiredness
  • loss of appetite
  • pain on the right side of your stomach
  • dark or brown (tea color) urine
  • yellowing of your skin or the white part of your eyes.

The most common side effects of TECFIDERA include flushing and stomach problems. These can happen especially at the start of treatment and may decrease over time. Taking TECFIDERA with food may help reduce flushing. Call your doctor if these symptoms bother you or do not go away. Ask your doctor if taking aspirin before taking TECFIDERA may reduce flushing.

These are not all the possible side effects of TECFIDERA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. It is not known if TECFIDERA will harm your unborn baby or if it passes into your breast milk. Also tell your doctor if you are taking prescription or over-the-counter medicines, vitamins, or herbal supplements. If you take too much TECFIDERA, call your doctor or go to the nearest hospital emergency room right away.

For additional important safety information, please see full Prescribing Information and Patient Information. This is not intended to replace discussions with your doctor.