Aubagio was approved by the U.S. Food and Drug Administration in September 2012 for adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Since 2018, more than a dozen generic formulations of Aubagio have also been cleared in the U.S., but those will only become commercially available starting in 2023.
Based on animal data, Aubagio may cause harm to a developing fetus. Human data suggest that taking Aubagio in the first trimester of pregnancy followed by an accelerated elimination procedure is not associated with an increased rate of malformations or miscarriage. However, the number of pregnancies reported in these studies is not sufficient to draw conclusions. Thus, Aubagio is not recommended for anyone who is pregnant or planning a pregnancy. Patients able to become pregnant should use effective contraception while receiving this therapy.
There are no known interactions between Aubagio and alcohol. But because both can cause liver damage, people who drink alcohol while on Aubagio may have a greater likelihood of experiencing such side effects. Patients receiving the medication should discuss with their healthcare providers whether and how much alcohol is safe for them to drink.
Because not all patients respond to a treatment in the same way, there is no standard timeline for when Aubagio might become effective. Patients should talk with their healthcare provider about when and how Aubagio is expected to help in their particular case.
Hair thinning or hair loss (alopecia) has been reported as one of the most common side effects of Aubagio, affecting up to 13% of patients in clinical trials. This side effect is mostly mild to moderate and becomes evident about three months after starting therapy. It does resolve spontaneously in most patients without stopping treatment. Weight gain has not been reported in studies as a side effect associated with Aubagio.
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