Aubagio (teriflunomide)

A once-daily oral tablet for adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive MS. It is not approved for children. Aubagio slows the multiplication of immune cells that attack the nervous system, reducing the frequency of MS relapses.

Teriflunomide blocks an enzyme called dihydroorotate dehydrogenase (DHODH) that rapidly dividing immune cells need to make new DNA. Without this enzyme, activated T and B lymphocytes cannot proliferate as quickly. Since these are the cells that drive MS attacks, slowing their growth reduces inflammation in the brain and spinal cord.

Carries a black box warning for hepatotoxicity (liver damage) and teratogenicity (birth defects). Monthly liver function monitoring is required for the first 6 months. It must not be used by people with severe liver impairment, by pregnant women, by women who could become pregnant and are not using effective birth control, or together with leflunomide. It can lower white blood cell counts and raise the risk of serious infections, so a recent blood count and a tuberculosis test are needed before starting, and it should not be started during an active infection. Severe allergic reactions (anaphylaxis) have happened, as have serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS, which have sometimes been fatal; stop taking it and get medical care right away if they appear. Lung inflammation (interstitial lung disease), which can be fatal, has also been reported. The label also warns about skin ulcers and slow wound healing, nerve damage in the hands and feet, higher blood pressure (checked before and during treatment), and pancreatitis seen in a trial in children. Hair thinning is common in the first few months. Diarrhea, nausea, and elevated liver enzymes can occur. An accelerated elimination procedure is available if the drug needs to be cleared quickly.

Taken as one tablet (7 mg or 14 mg) by mouth once daily. The drug has a very long half-life (about 18 to 19 days); it takes about 8 months on average, and up to 2 years, to clear naturally. An accelerated elimination protocol with cholestyramine is available when faster clearance is needed.

Yes, Teriflunomide (Aubagio) is FDA approved (2012) for the treatment of Multiple Sclerosis.

Teriflunomide is teratogenic, meaning it can cause serious birth defects if taken during pregnancy. Animal studies showed significant developmental toxicity. Because of the drug's extremely long half-life (about 18 to 19 days), it can remain in the body for up to 2 years after the last dose. For women of childbearing potential, pregnancy must be excluded before starting, reliable contraception is required during treatment, and an accelerated elimination procedure with cholestyramine is recommended before attempting conception.

Because teriflunomide has a very long half-life, it can take up to 2 years to clear from the body naturally. The accelerated elimination procedure uses cholestyramine (8 g 3 times daily for 11 days) or activated charcoal (50 g twice daily for 11 days) to rapidly clear the drug. This is used when a patient needs to stop teriflunomide quickly, such as before pregnancy, before surgery, or when switching to another MS therapy. Blood levels are then verified to confirm the drug has been adequately cleared.

Both are oral first-line MS therapies with similar efficacy (about 30-50% reduction in relapses). Key differences include side effect profiles: teriflunomide commonly causes hair thinning and requires liver monitoring, while dimethyl fumarate commonly causes flushing and GI symptoms. Teriflunomide has the pregnancy contraindication and long wash-out period, which is a significant consideration for women of childbearing age. Both are available as generics, making them cost-effective options.

Hair thinning (not complete hair loss) is a common side effect, occurring in about 10-13% of patients in clinical trials. It typically begins within the first 6 months of treatment and is usually mild and reversible. Most patients see their hair return to normal thickness even while continuing treatment. Complete baldness has not been reported. If hair thinning is bothersome, discuss it with your neurologist.

Yes. Generic teriflunomide became available in 2023, offering a lower-cost alternative to branded Aubagio. Generic versions contain the same active ingredient and must meet FDA bioequivalence standards. The availability of generics makes teriflunomide one of the more affordable oral MS treatment options.