Prescribing InformationPatient Information
Important Safety Information and Indication
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 about any low white blood cell counts or infections or any other medical conditions.
What are the possible side effects of TECFIDERA?
TECFIDERA may cause serious side effects including allergic reactions, PML, which is a rare brain infection that usually leads to death or severe disability, and decreases in your white blood cell count. Your doctor may check your white blood cell count before you take TECFIDERA and from time to time during treatment.
The most common side effects of TECFIDERA include flushing and stomach problems. These can happen especially at the start of treatment and may decrease over time. Taking TECFIDERA with food may help reduce flushing. Call your doctor if these symptoms 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 www.dailymed.nlm.nih.gov.
Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. It is not known if TECFIDERA will harm your unborn baby or if it passes into your breast milk. Also tell your doctor if you are taking prescription or over-the-counter medicines, vitamins, or herbal supplements.
For additional important safety information, please see full Prescribing Information and Patient Information. This is not intended to replace discussions with your doctor.
Tecfidera® (dimethyl fumarate) is a prescription medicine used to treat people with relapsing forms of multiple sclerosis.