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Dimethyl fumarate (Oral)

dye-METH-il FUE-ma-rate

Medically reviewed by Drugs.com. Last updated on Mar 7, 2019.

Commonly used brand name(s)

In the U.S.

  • Tecfidera

Available Dosage Forms:

  • Capsule, Delayed Release

Uses for dimethyl fumarate

Dimethyl fumarate is used to treat the relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Dimethyl fumarate will not cure MS, but it may slow some disabling effects and decrease the number of relapses of the disease.

Dimethyl fumarate is available only with your doctor's prescription.

Before using dimethyl fumarate

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For dimethyl fumarate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to dimethyl fumarate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dimethyl fumarate in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of dimethyl fumarate have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of dimethyl fumarate in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking dimethyl fumarate, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using dimethyl fumarate with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Diroximel Fumarate

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of dimethyl fumarate. Make sure you tell your doctor if you have any other medical problems, especially:

  • Infection (eg, herpes zoster) or
  • Liver problems or
  • Lymphopenia (low white blood cells)—Use with caution. May make these conditions worse.

Proper use of dimethyl fumarate

Take dimethyl fumarate exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dimethyl fumarate should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the delayed-release capsule whole. Do not crush or chew it. Do not sprinkle the contents of the capsule on food.

Take dimethyl fumarate with or without food. You may have less skin flushing if you take the medicine with food.

Your doctor may give you other medicine (eg, aspirin) to be taken 30 minutes before taking Tecfidera® to help lessen skin flushing.

Dosing

The dose of dimethyl fumarate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of dimethyl fumarate. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (delayed-release capsules):
    • For multiple sclerosis:
      • Adults—At first, 120 milligrams (mg) 2 times a day. After 7 days, your doctor will increase your dose to 240 mg 2 times a day.
      • Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of dimethyl fumarate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in its original container. Protect from light.

Precautions while using dimethyl fumarate

It is very important that your doctor check your progress at regular visits to make sure dimethyl fumarate is working properly. Blood tests may be needed to check for unwanted effects.

Dimethyl fumarate may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using dimethyl fumarate.

Dimethyl fumarate may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Avoid being near people who are sick or have infections while you are using dimethyl fumarate. Wash your hands often. Tell your doctor if you have lupus or if you have any kind of infection before you start using dimethyl fumarate. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Herpes zoster and other serious infections may occur while taking dimethyl fumarate. Symptoms include painful blisters on the trunk of your body, itching skin, rash, or trouble breathing. These symptoms should be treated first before taking dimethyl fumarate.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Dimethyl fumarate may cause skin flushing. Tell your doctor right away if you have warmth, redness, itching, or a burning sensation in your face, neck, arms, or upper chest while using dimethyl fumarate.

Dimethyl fumarate side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Chills
  • cough
  • feeling of warmth
  • fever
  • hoarseness
  • lower back or side pain
  • painful or difficult urination
  • redness of the face, neck, arms, and occasionally, upper chest

Incidence not known

  • Black, tarry stools
  • chest pain
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, or skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • painful blisters on the trunk of the body
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • tightness in the chest
  • trouble breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Diarrhea
  • nausea
  • stomach pain
  • vomiting

Less common

  • Belching
  • heartburn
  • indigestion
  • stomach discomfort or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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