Dimethyl Fumarate, Oral

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KEY POINTS

• This medicine is taken by mouth to treat relapsing multiple sclerosis. Take it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause a severe or life-threatening brain infection or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: multiple sclerosis treatment

Generic and brand names: dimethyl fumarate, oral; Tecfidera

What is this medicine used for?

This medicine is taken by mouth to treat flare-ups (relapses) caused by multiple sclerosis (MS).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Low levels of lymphocytes (white blood cells)

Tell your healthcare provider if you have a cough, fever, or infection.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking it without your healthcare provider’s approval.

Check with your healthcare provider before using this medicine in children under 18.

Do not open, break, chew, or crush the capsules. Swallow them whole. You may take this medicine with or without food. Taking it with food may reduce the chance that it will cause flushing.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may lower the number of white blood cells in your body. As a result, you may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

Rarely, this medicine may cause an infection of the brain that may cause death. Contact your provider right away if you: are weak on one side of the body, are confused or having trouble thinking, or if you cannot control your muscles.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Severe nausea, vomiting, or stomach pain; unusual tiredness or weakness, increasing weakness on one side of your body; memory problems; changes in thinking or behavior; confusion; sore throat, unexplained fever, chills, or cough.

Other: Nausea, diarrhea, indigestion, stomach pain, flushing.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature in the original container. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Discard any unused medicine 90 days after you open the medicine bottle.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.