Tecfidera

Tecfidera is a prescription medication used to treat relapsing forms of multiple sclerosis. Tecfidera belongs to a group of drugs called Nrf2 activators. It is thought to work by decreasing inflammation and preventing nerve damage that can lead to symptoms of multiple sclerosis.

This medication comes in capsule form and is taken twice daily, with or without food. Swallow capsules whole and intact. Do not crush, chew, or sprinkle capsule contents on food.

Common side effects of Tecfidera include flushing, stomach pain, diarrhea, and nausea.

Tecfidera is a prescription medication used to treat relapsing forms of multiple sclerosis, or MS. It is not known if eimethyl fumarate is safe and effective in children under 18 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Biogen Idec Inc.

Serious side effects have been reported. See "Tecfidera Precautions".

Common side effects of Tecfidera include:

• flushing (taking Tecfidera with food or taking a non-enteric coated aspirin before taking Tecfidera may help reduce flushing)
• redness
• itching
• rash
• nausea
• vomiting
• diarrhea
• stomach pain
• indigestion

This is not a complete list of Tecfidera side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No Tecfidera drug interactions have been identified. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Tecfidera, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Tecfidera, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Tecfidera or to any of its ingredients
• any other medical conditions
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. 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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Tecfidera crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Tecfidera.

Take Tecfidera exactly as your doctor tells you to take it.

• Tecfidera can be taken with or without food.
• If you experience flushing, taking Tecfidera with food or taking a non-enteric coated aspirin before taking Tecfidera may help reduce flushing.
• 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.

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.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store at 15°C – 30°C (59-86°F).
• Protect the capsules from light. Store in original container.
• Once opened, discard bottles of Tecfidera after 90 days.
• Keep this and all medicines out of the reach of children.