Encourage patients to enroll in the Tecfidera Pregnancy Registry if they become pregnant while taking Tecfidera. Advise patients to call 1-800-456-2255 for more information [See Use in Specific Populations()8.1].

Lymphocyte Counts
Inform patients that Tecfidera may decrease lymphocyte counts. A recent blood test (i.e., within 6 months) should be available before they start therapy to identify patients with pre-existing low lymphocyte counts. Blood tests are also recommended annually and as clinically indicated [See Warnings and Precautions (5.1), Adverse Reactions ()6.1].

41347-02

Manufactured by:

Biogen Idec, Inc., Cambridge, MA 02142

Tecfidera is a trademark of Biogen Idec.

© 2013 Biogen Idec

FDA-Approved Patient Labeling

Patient Information

Tecfidera™ (tek" fi de' rah)

(dimethyl fumarate) delayed-release capsules

What is Tecfidera?

Tecfidera is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS)
It is not known if Tecfidera is safe and effective in children under 18 years of age
Before taking and while you take Tecfidera, tell your doctor if you have or have had:

low white blood cell counts or an infection
any other medical conditions
Tell your doctor if you are:

pregnant or plan to become pregnant. It is not known if Tecfidera will harm your unborn baby.
If you become pregnant while taking Tecfidera, talk to your doctor about enrolling in the Tecfidera Pregnancy Registry. You can enroll in this registry by calling 1-800-456-2255. The purpose of this registry is to monitor the health of you and your baby.
breastfeeding or plan to breastfeed. It is not known if Tecfidera passes into your breast milk. You and your doctor should decide if you will take Tecfidera or breastfeed.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements
How should I take Tecfidera?

Take Tecfidera exactly as your doctor tells you to take it
The recommended starting dose is one 120 mg capsule taken by mouth 2 times a day for 7 days
The recommended dose after 7 days is one 240 mg capsule taken by mouth 2 times a day
Tecfidera can be taken with or without food
Swallow Tecfidera whole. Do not crush, chew, or sprinkle capsule contents on food.
Protect Tecfidera from light. You can do this by storing the capsules in their original container. Throw away opened Tecfidera after 90 days.
What are the possible side effects of Tecfidera?

Tecfidera may cause serious side effects including:

decreases in your white blood cell count
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. Call your doctor if you have any of these symptoms and they bother you or do not go away.

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.

General Information about the safe and effective use of Tecfidera

Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. Do not use Tecfidera for a condition for which it was not prescribed. Do not give Tecfide