Black box warnings are the most serious warning issued by the FDA. They are used to highlight risks that can cause very serious and potentially life-threatening adverse effects. Aubagio (teriflunomide) contains two black box warnings. Hepatotoxicity
The active ingredient in Aubagio, teriflunomide, is also the active metabolite of a drug used to treat rheumatoid arthritis called leflunomide. Leflunomide can cause severe and sometimes life-threatening liver damage, particularly in people with pre-existing liver problems, and the same risk is believed to exist for Aubagio. The black box warning reads: Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Concomitant use of AUBAGIO with other potentially hepatotoxic drugs may increase the risk of severe liver injury. Your healthcare provider will test your liver function before you start Aubagio therapy and will monitor liver enzymes for the first six months of treatment. Additionally, you should contact your doctor straight away if you have symptoms of liver problems, including: Nausea Vomiting Stomach pain Loss of appetite Tiredness Yellowing of your skin or white of your eyes Dark urine Embryo-fetal toxicity
The active ingredient in Aubagio, teriflunomide, can cause fetal harm. It is, therefore, not prescribed to pregnant women or to women of reproductive potential who are not using contraception. Furthermore, teriflunomide stays in your system for many months after stopping treatment, so you should continue using effective birth control until a blood test confirms that levels are low enough to be safe. If you do get pregnant while taking Aubagio or within two years of stopping treatment, you should contact your doctor immediately. Medications (cholestyramine or activated charcoal) can be used to help eliminate Aubagio from your body faster and reduce the risk to your baby. Similarly, if you plan to get pregnant while taking Aubagio or within two years of stopping treatment, these medications can be used to help you do so safely. There is also evidence that teriflunomide can transfer through semen, so men taking Aubagio should take the same precautions regarding contraception.