Tecfidera

Generic Name: dimethyl fumarate (Oral route)

dye-METH-il FUE-ma-rate

Commonly used brand name(s)

In the U.S.

  • Tecfidera

Available Dosage Forms:

  • Capsule, Delayed Release

Uses For Tecfidera

Dimethyl fumarate is used to treat the relapsing forms of multiple sclerosis (MS). This medicine will not cure MS, but it may slow some disabling effects and decrease the number of relapses of the disease.

Slideshow: Flashback: FDA Drug Approvals 2013

This medicine is available only with your doctor's prescription.

Before Using Tecfidera

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Infection or
  • Lymphopenia (low white blood cells)—May make these conditions worse.

Proper Use of Tecfidera

Take this medicine 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.

This medicine should come with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

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

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

Dosing

The dose of this medicine 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 this medicine. 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) two times a day. After 7 days, your doctor will increase your dose to 240 mg two times a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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. Once you have opened a bottle, throw away any unused medicine after 90 days.

Precautions While Using Tecfidera

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

This medicine may lower the number of white blood cells in your blood. This may increase your chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine 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 this medicine.

Tecfidera 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
  • Cough or hoarseness
  • feeling of warmth
  • fever or chills
  • 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
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • 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
  • Abdominal or stomach pain
  • diarrhea
  • itching skin
  • nausea
  • rash
  • vomiting
Less common
  • Acid or sour stomach
  • 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.

See also: Side effects (in more detail)

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