The information in this medication sheet has been adapted from the FDA-approved prescribing information for Aubagio (teriflunomide).
Aubagio® (teriflunomide), a pyrimidine synthesis inhibitor, is an oral compound that inhibits the function of specific immune cells that have been implicated in MS. It is related to leflunomide, a drug used to treat rheumatoid arthritis. Aubagio can inhibit a key enzyme required by white blood cells (lymphocytes) – which in turn reduces the proliferation of T and B immune cells that are active in MS and also inhibits the production of immune messenger chemicals by T cells.
Approval by the U.S. Food and Drug Administration (FDA)
Aubagio was approved by the U.S. Food and Drug Administration (FDA) in September, 2012 for patients with relapsing forms of multiple sclerosis. In one phase III study (http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=5577) involving 1088 people with relapsing MS (796 completed the trial), oral Aubagio reduced relapses compared with placebo over at least 108weeks. Of two different doses tested during the TEMSO trial (7 mg and 14 mg), the higher dose also slowed progression of disability. Both doses also had a favorable effect on several MRI measures, including a smaller increase in total lesion volume and fewer new and actives lesions compared with placebo.
- Aubagio (7mg or 14mg) is a tablet taken once per day by mouth, with or without food.
Prior to starting this medication, the prescribing information for Aubagio recommends that your doctor do the following tests:
- A new or recent (within six months) blood test to detect levels of liver enzymes and a Complete Blood Count (CBC) to determine levels of blood cells.
- Blood pressure check
- Screening test for tuberculosis (tuberculin skin test)
- A pregnancy test in women of childbearing age
After starting treatment with Aubagio, the following monitoring steps should be taken:
- A monthly blood test for the first six months to detect liver enzymes, followed by additional testing if symptoms of liver problems occur (for example, nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellowing of the skin or whites of the eyes).
- Monitoring for signs of infection
- Periodic monitoring of blood pressure
- Monitoring of renal function and potassium levels in patients with symptoms of renal failure or elevated potassium levels
Warnings and Precautions
- The prescribing information contains a boxed warning about the potential for liver damage (hepatotoxicity). Severe liver injury, including fatal liver failure has been reported in patients taking leflunomide to treat rheumatoid arthritis, and a similar risk would be expected with Aubagio (teriflunomide) because of the similarities between the two medications.
- Based on data in animal studies, the prescribing information also contains a boxed warning indicating that Aubagio may cause significant birth defects if used during pregnancy. Aubagio should not be taken by women who are pregnant or by women of childbearing age who are not using effective birth control. Women taking Aubagio who wish to become pregnant should stop taking the medication and undergo an accelerated elimination procedure to decrease the level of Aubagio in the blood to a safe level (less than 0.02 mg/L). See Use in Specific Populations below.
- Aubagio can cause peripheral neuropathy (numbness and/or pain in the hands or feet).
- Aubagio can cause transient acute renal failure and high levels of potassium in the blood.
- Severe skin reactions have occurred in post marketing surveillance of leflunomide and could occur with Aubagio.
Note: Aubagio remains in the blood for an average of eight months after a person stops taking the medication, but may remain in the blood for up to two years after the last dose. If necessary, for medical reasons or because a woman has become pregnant or a woman or man wishes to conceive a child, the medication can be eliminated from the body in 11 days with the use of cholestyramine or active charcoal
Use in Specific Populations
- To minimize any possible risk, men taking Aubagio and their partners who do not wish to have a child should use reliable birth control. Men taking Aubagio who wish to father a child should stop taking the medication and undergo an accelerated elimination procedure to decrease the level of Aubagio in the blood to a safe level (less than 0.02 mg/L).
- Women who are planning to get pregnant, or are pregnant or breastfeeding should not take Aubagio (See Warnings and Precautions). A pregnancy registry has been established to monitor outcomes in women who accidently become pregnant while taking Aubagio. Enrollment in the registry is available by calling 1-800-745-4447, option 2.
- The safety and effectiveness of Aubagio in pediatric patients has not been studied.
- The safety and effectiveness of Aubagio in patients over the age of 65 has not been studied.
Possible Side Effects
- The most common side effects in the clinical trials of Aubagio were diarrhea, abnormal liver tests, nausea, influenza, and hair thinning (alopecia).
For information about Aubagio and Genzyme’s patient support program, call 1-855-676-6326, or visit the company’s Website at www.MSOnetoOne.com.