Indication and Important
Safety Information

What is TECFIDERA^® (dimethyl fumarate)?

• TECFIDERA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

• It is not known if TECFIDERA is safe and effective in children under 18 years of age

Important Safety Information

Who should not take TECFIDERA?

• 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 healthcare provider if you have or have had:

• low white blood cell counts or an infection

• any other medical conditions

Tell your healthcare provider if you are:

• pregnant or plan to become pregnant. It is not known if TECFIDERA will harm your unborn baby. You and your doctor will have to decide if you should take TECFIDERA while you are pregnant or if you plan to become pregnant

• breastfeeding or plan to breastfeed. It is not known if TECFIDERA passes into your breast milk. You and your healthcare provider should decide if you will take TECFIDERA or breastfeed

• taking prescription or over-the-counter medicines, vitamins, or herbal supplements

What are the possible side effects of TECFIDERA?

TECFIDERA may cause serious side effects, including:

• allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing)

• PML a rare brain infection that usually leads to death or severe disability

• decreases in your white blood cell count Your healthcare provider should do a blood test before you start treatment with TECFIDERA and while on therapy

• liver problems. Your healthcare provider should do blood tests to check your liver function before you start taking TECFIDERA and during treatment if needed. Tell your healthcare provider right away if you get any of these symptoms of a liver problem during treatment

  • severe tiredness

  • loss of appetite

  • pain on the right side of your stomach

  • have dark or brown (tea color) urine

  • yellowing of your skin or the white part of your eyes

• herpes zoster infections (shingles), including central nervous system infections

• other serious infections

• serious gastrointestinal problems, including bleeding, ulcers, blockage, and tears (perforation) of the stomach or intestines. Tell your healthcare provider right away if you have any of these symptoms during treatment:

  • stomach-area pain that does not go away

  • bright red or black stools (that look like tar)

  • severe vomiting

  • severe diarrhea

  • coughing up blood or blood clots

  • vomiting blood or your vomit looks like “coffee grounds”

The most common side effects of TECFIDERA include:

• flushing, redness, itching, or rash

• nausea, vomiting, diarrhea, stomach pain, or indigestion

• Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking TECFIDERA with food may help reduce flushing. Call your healthcare provider if you have any of these symptoms and they bother you or do not go away. Ask your healthcare provider if taking aspirin before taking TECFIDERA may reduce flushing

These are not all the possible side effects of TECFIDERA. Call your healthcare provider 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.

Please see full Prescribing Information, including Patient Information.

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.