Tecfidera

(Dimethyl Fumarate)

The active ingredient in Tecfidera is dimethyl fumarate.

The exact mechanism of action of dimethyl fumarate in multiple sclerosis is not fully understood. After taking Tecfidera, dimethyl fumarate is quickly converted in the body to its main active metabolite, monomethyl fumarate. Dimethyl fumarate and monomethyl fumarate have been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, which helps cells respond to oxidative stress. This effect may provide protection to nerve cells in the brain and spinal cord.

Tecfidera also affects the immune system by lowering certain white blood cell (lymphocyte) counts. This immune modulation is thought to contribute to its clinical benefits in relapsing-remitting MS and other relapsing forms of MS, but it can also increase the risk of infections.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Tecfidera. However, the following is a synopsis of the general guidelines for the use of Tecfidera:

• Tecfidera is taken by mouth as delayed-release capsules.
• The usual starting dose is 120 mg twice daily for 7 days. After the first week, the recommended maintenance dose is 240 mg twice daily.
• Tecfidera can be taken with or without food. Taking Tecfidera with food may help reduce flushing and some gastrointestinal symptoms, such as nausea or abdominal pain.
• Swallow the capsules whole. Do not crush, chew, or open them, and do not sprinkle the contents on food.
• Your healthcare provider may order blood tests, including blood cell counts and liver tests, before you start taking Tecfidera and at regular intervals during treatment.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Some mild or most common side effects of Tecfidera:

• Flushing (warmth, redness, itching, or rash)
• Abdominal pain
• Diarrhea
• Nausea
• Vomiting
• Indigestion

Some individuals may experience serious side effects while using Tecfidera. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of a life-threatening allergic reaction, including anaphylaxis. This includes hives, rash, swelling of the face, lips, eyes, or tongue, and difficulty breathing.
• Signs of progressive multifocal leukoencephalopathy (PML) such as changes in vision, weakness on one side of the body, clumsiness, confusion, or personality changes. This is a rare brain infection caused by the JC virus that requires prompt medical attention.
• Herpes zoster (shingles) or other serious infections, including symptoms such as painful rash, severe headache, fever, neck stiffness, confusion, or new neurological problems.
• Other serious infections that may affect the brain, spinal cord, lungs, gastrointestinal tract, skin, or other organs, especially if your lymphocyte counts are low.
• Liver injury, such as unusual fatigue, loss of appetite, right-sided upper abdominal pain, dark urine, or yellowing of the skin or eyes.
• Severe or persistent abdominal pain, black or bright red stools, coughing up blood, vomiting blood, or vomit that looks like coffee grounds, which could be signs of serious gastrointestinal reactions, including bleeding, ulcers, blockage, or perforation.

These are not all of the possible side effects of Tecfidera. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Tecfidera, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• A history of low white blood cell (lymphopenia) or lymphocyte counts
• Any other significant medical conditions
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Do not use Tecfidera if you have an allergy to dimethyl fumarate or any of the other ingredients in Tecfidera.

Tecfidera is intended as a long-term disease-modifying therapy for relapsing forms of multiple sclerosis. In clinical trials of relapsing-remitting MS, Tecfidera reduced relapse rates and the number of new brain lesions over a period of months compared with placebo. Some patients may notice fewer relapses and improved control of MS symptoms over time, but the effects of Tecfidera may not be obvious right away. Your healthcare provider will monitor your response through clinical evaluations and MRI findings.

When Tecfidera is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other medicines that affect the immune system or act as immunosuppressants which may increase the risk of infections
• Other disease-modifying therapies for multiple sclerosis, such as interferon beta products or glatiramer acetate, if switching treatments

Tecfidera is available in the following dosage forms and strengths:

• 120 mg delayed-release capsules
• 240 mg delayed-release capsules

Tecfidera should be stored at room temperature in its original container, away from light and moisture, and out of reach of children.

Tecfidera is manufactured by Biogen Inc.

A generic version of Tecfidera is available.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Tecfidera. Stopping treatment suddenly could affect your MS symptoms or your overall disease control. Your healthcare provider will guide you on whether Tecfidera should be stopped or changed and how to safely do so.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. It is not known if Tecfidera will harm your unborn baby. Your healthcare provider will weigh the benefits of continuing therapy against any potential risks. They may also review other treatment options and current MS symptoms when making this decision.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. It is not known if dimethyl fumarate or its active metabolite, monomethyl fumarate, passes into human breast milk. Your healthcare provider will help you decide whether to take Tecfidera while breastfeeding, taking into account the benefits of breastfeeding, the mother’s need for Tecfidera, and potential adverse effects on the breastfed infant.