"The US Food and Drug Administration (FDA) is warning that a case of definite multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking fingolimod (Gilenya, Novartis) for relapsing forms of mult"...
(tek“ fi de' rah)
(dimethyl fumarate) Delayed-release Capsules
What is 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. See below for a complete list of 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:
- 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.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements
How should I take TECFIDERA?
- Take TECFIDERA exactly as your doctor tells you to take it
- The recommended starting dose is one 120 mg capsule taken by mouth 2 times a day for 7 days
- The recommended dose after 7 days is one 240 mg capsule taken by mouth 2 times a day
- TECFIDERA can be taken with or without food
- Swallow TECFIDERA whole. Do not crush, chew, or sprinkle capsule contents on food.
- Protect TECFIDERA from light. You can do this by storing the capsules in their original container.
- If you take too much TECFIDERA, call your doctor or go to the nearest hospital emergency room right away.
What are the possible side effects of TECFIDERA?
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.
General Information about the safe and effective use of TECFIDERA
- Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. Do not use TECFIDERA for a condition for which it was not prescribed. Do not give TECFIDERA to other people, even if they have the same symptoms that you have. It may harm them.
- If you would like more information, talk to your doctor or pharmacist. You can ask your doctor or pharmacist for information about TECFIDERA that is written for healthcare professionals.
What are the ingredients in TECFIDERA?
Active ingredient: dimethyl fumarate
Inactive ingredients: microcrystalline cellulose, silicified microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal silicon dioxide, magnesium stearate, triethyl citrate, methacrylic acid copolymer -Type A, methacrylic acid copolymer dispersion, simethicone (30% emulsion), sodium lauryl sulphate, and polysorbate 80. Capsule Shell: gelatin, titanium dioxide, FD&C blue 1; brilliant blue FCF, yellow iron oxide and black iron oxide.
Last reviewed on RxList: 2/6/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Tecfidera Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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