In the U.S., Tecfidera was approved in March 2013 for treating adults with relapsing forms of MS. Approved indications include clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Since 2020, when the patent on Tecfidera’s active ingredient expired, more than a dozen Tecfidera generics have been cleared by the U.S. Food and Drug Administration.
Based on animal studies, Tecfidera use during pregnancy can cause harm to a developing fetus. But a large registry study conducted by Biogen, the therapy’s developer, to monitor outcomes in pregnancies exposed to Tecfidera, suggests that taking the medication just before conception or at any time during pregnancy is not associated with worse pregnancy outcomes. Nonetheless, patients on Tecfidera who become or plan to become pregnant should discuss this topic with their healthcare team.
Alcohol may potentially interfere with Tecfidera, especially if consumed within one hour of taking the medication. Drinking alcohol also can potentially exacerbate some side effects associated with the medication, including nausea, flushing, and diarrhea. Patients on Tecfidera should discuss safe alcohol use with their healthcare provider, who can make the best recommendation based on their medical history.
As each person can respond differently to a medication, there is no standard timeline for when Tecfidera starts to work. In the trials that supported Tecfidera’s approval, a significant reduction in relapse rates in Tecfidera-treated patients could be observed within the first 12 weeks (about three months) of treatment. But patients are advised to talk with their healthcare team on how Tecfidera can help in their particular case.
Weight gain and hair loss were not reported in clinical trials as side effects of Tecfidera, but some people who received the medication after its approval have experienced hair loss, according to post-marketing reports. Patients should talk with their healthcare team if such events occur.
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