If you become pregnant while taking TECFIDERA or were taking TECFIDERA since your last menstrual period prior to becoming pregnant, it is important for you to know about this pregnancy registry and how you can participate.
The effects of a particular medicine on the health of a baby are often unknown because pregnant women are not usually included in studies where a potential new medicine is being tested. Pregnancy registries aim to collect information that could help women in the future and their doctors make more informed decisions about using a particular medicine during pregnancy. Click here to learn more about relapsing multiple sclerosis (MS) and pregnancy.Learn how you can help. This is a global registry for women with MS who are pregnant and have taken TECFIDERA. Information about health during pregnancy will be collected from participants and their doctors; information on the health of their babies will also be collected from the baby’s doctor. In the future, other pregnant women who are exposed to TECFIDERA may have more information as a result of this registry about how their pregnancies and babies may or may not be affected. Find out how to take part.
TECFIDERA® (dimethyl fumarate) is a prescription medicine used to treat people with relapsing forms of multiple sclerosis.
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.
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 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.
You will then be contacted by your local Registry Coordinating Center (RCC).
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