Tecfidera

Tecfidera is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS)

It is not known if Tecfidera is safe and effective in children under 18 years of age

Who should not take Tecfidera?

• Do not use Tecfidera if you have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to Tecfidera or any of its ingredients. 

Before taking and while you take Tecfidera, tell your doctor if you have or have had:

• low white blood cell counts or an infection
• any other medical conditions

Tell your doctor if you are:

• taking prescription or over-the-counter medicines, vitamins, or herbal supplements.

Tecfidera may cause serious side effects including:

• allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing)
• PML a rare brain infection that usually leads to death or severe disability
• decreases in your white blood cell count Your doctor should do a blood test before you start treatment with Tecfidera and while on therapy.
• liver problems. Your doctor should do blood tests to check your liver function before you start taking Tecfidera and during treatment if needed. Tell your doctor right way if you get any of these symptoms of a liver problem during treatment.
  • severe tiredness
  • loss of appetite
  • pain on the right side of your stomach
  • have dark or brown (tea color) urine
  • yellowing of your skin or the white part of your eyes

The most common side effects of Tecfidera include:

• flushing, redness, itching, or rash
• nausea, vomiting, diarrhea, stomach pain, or indigestion
• Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking Tecfidera with food may help reduce flushing. Call your doctor if you have any of these symptoms and they bother you or do not go away. Ask your doctor if taking aspirin before taking Tecfidera may reduce flushing.

These are not all the possible side effects of Tecfidera. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

• The starting dose for Tecfidera is 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose. Within 4 weeks, the recommended dose of 240 mg twice a day should be resumed.
• Discontinuation of Tecfidera should be considered for patients unable to tolerate return to the maintenance dose. The incidence of flushing may be reduced by administration of Tecfidera with food. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to Tecfidera dosing may reduce the incidence or severity of flushing.
• Tecfidera should be swallowed whole and intact. Tecfidera should not be crushed or chewed and the capsule contents should not be sprinkled on food. Tecfidera can be taken with or without food.

Blood Tests Prior to Initiation of Therapy

• Obtain a complete blood cell count (CBC) including lymphocyte count before initiation of therapy.
• Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to treatment with Tecfidera.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Dimethyl Fumarate has no noted severe interactions with any other drugs
• Dimethyl Fumarate has no noted serious interactions with any other drugs
• Dimethyl Fumarate has no noted moderate interactions with any other drugs
• Dimethyl Fumarate has no noted minor interactions with any other drugs

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider about all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or healthcare provider if you have any questions about the medication.

Tell your doctor if you are:

• pregnant or plan to become pregnant. 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 1-866810-1462 or visiting www.tecfiderapregnancyregistry.com. The purpose of this registry is to monitor the health of you and your baby.
• breastfeeding or plan to breastfeed. It is not known if Tecfidera passes into your breast milk. You and your doctor should decide if you will take Tecfidera or breastfeed.