Aubagio® (Teriflunomide) is a prescription medication approved by the Food and Drug Administration (FDA) in 2012 for treating adults with relapsing forms of multiple sclerosis (MS). It is also known by its drug name, Teriflunomide. Aubagio has been shown to reduce rates of relapse, reduce new brain lesions, and to slow the progression of disability. Aubagio is not a cure for MS.
Aubagio is an immunomodulatory drug, which means that it modulates the immune system. It is thought that Aubagio works by inhibiting T and B lymphocytes (also called T cells and B cells, types of white blood cell that are part of the immune system. T and B cells are responsible for causing the inflammatory process seen in MS.
Aubagio is approved in more than 50 countries, with additional marketing applications under review by regulatory authorities globally.
Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). Aubagio is supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries.
Aubagio is not suitable for people with liver problems. Aubagio should not be taken by pregnant women, or women who are not on effective birth control, or by men whose partners are pregnant or not on effective birth control. If you are taking a related drug called Leflunomide, you should not take Aubagio.
Aubagio is a tablet taken orally once a day, with or without food. Dosage may be 7mg or 14mg.
Before starting Aubagio, your doctor will perform tests including a skin-prick or blood test for tuberculosis, a blood test to check your liver enzymes and white blood cell levels, and, if you are female, possibly a pregnancy test.
While you are taking Aubagio, your doctor may order a blood test once a month to check liver enzyme levels and kidney function. Your doctor may also periodically check your blood pressure and ask you about any signs of infection. This is to ensure that you are not developing serious side effects.
You should not receive certain vaccinations while taking Aubagio or for six months after you stop taking it.
Whether you are a man or a woman, you should use effective birth control while taking Aubagio. If you or your partner become pregnant while taking Aubagio, notify your doctor immediately. They can prescribe certain medications that will quickly reduce the levels of Aubagio in your body. Since Aubagio remains in your system for eight months to two years after you stop taking it, you should ask your doctor for these medications if you decide to try to become pregnant within this time period.
Always follow your doctor’s instructions exactly when taking Aubagio.
Aubagio was approved by the FDA in 2012 based on two clinical trials. A third clinical trial was also performed and completed in October of 2014.
1,088 patients were studied in the first clinical trial called TEMSO. Aubagio 14 mg was shown to be effective vs placebo in 3 key measures of disease activity—relapses, brain lesions, and disability progression—in this clinical trial. Aubagio 7 mg was shown to be effective vs placebo in 2 of those 3 key measures—relapses and brain lesions—in this clinical trial.
- Patients taking AUBAGIO 7 mg showed a 31% reduction in relapse rate vs placebo. 54% of patients remained relapse-free with AUBAGIO 7 mg vs 46% with placebo over 108 weeks.
- Patients taking AUBAGIO 14 mg showed a 31% reduction in relapse rate vs placebo. 54% of patients remained relapse-free with AUBAGIO 14 mg vs 57% with placebo over 108 weeks.
Some 1,165 patients were studied in the second clinical trial called TOWER. In this trial 2 key measures of MS disease activity were studied. AUBAGIO 14 mg was shown to be effective in both key measures of MS disease activity—relapses and disability progression. Patients taking AUBAGIO 7 mg experienced improvement in relapses vs placebo.
- Patients taking AUBAGIO 7 mg showed a 22% reduction in relapse rate vs placebo. 58% of patients remained relapse-free with AUBAGIO 7 mg vs 47% with placebo over 108 weeks.
- Patients taking AUBAGIO 14 mg showed a 36% reduction in relapse rate vs placebo. 57% of patients remained relapse-free with AUBAGIO 14 mg vs 47% with placebo over 108 weeks.
In October 2014, Aubagio updated its prescribing label with a third clinical trial. This trial (TOPIC) showed similar results to the above trial. 614 patients were studied in this clinical trial called TOPIC. Genzyme conducted a trial to measure how AUBAGIO would work in patients recently diagnosed with relapsing MS who had 2 or more lesions on MRI and who had their first symptoms within 90 days before the trial.
- 72% of patients with a first clinical event remained relapse-free with AUBAGIO 14 mg vs 62% with placebo.
The most serious potential side effect of Aubagio is liver damage. A closely related drug, Leflunomide, has caused severe liver damage and fatal liver failure, and it is thought that Aubagio can cause similar problems. Aubagio may also cause kidney problems, numbness or pain in the hands or feet (peripheral neuropathy), severe skin reactions, elevated potassium levels, breathing problems, and worsening of existing breathing problems.
The most common side effects for Aubagio are diarrhea, nausea, abnormal liver test results, hair thinning, burning or prickling sensations in the skin, and influenza. You may also bleed or bruise more easily.
Most common side effects dissipate within several months.
Aubagio may cause major birth defects whether taken by either parent, so pregnancy should be avoided while taking it and for up to two years after you stop taking it.
Seek medical help immediately if you experience symptoms of liver failure such as yellowing of skin or whites of eyes, loss of appetite and vomiting.
Also seek emergency medical help if you experience symptoms of an allergic reaction such as trouble breathing, severe dizziness, a rash, or itching or swelling of the face, tongue and throat.
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients.
Aubagio Prescription Assistance Program Information
Program name: MS One to One
Phone: (855) 676-6326
MS One to One will assist qualifying patients:
- Individuals lacking medical insurance or individuals with only Medicare part A and B may register for the assistance program
- Individuals must reside in The United States of America and posses a Social Security number.
- Household income must be less than or equal to $100,000 annually.
- Individuals who have Part D Medicare are not eligible for Aubagio prescription assistance.
- Aubagio prescription assistance must be reapplied for each year annually.
- Individuals with private insurance may be eligible for co-pay assistance if available.
- With co-payment eligible individuals, the applicant will receive the medication for the first three months at no cost.
- Each following month, the co-payment is $35 for the rest of the year.
- Co-Payment assistance must be reapplied for annually.
- For co-payment assistance no financial limit is placed on income.
- Only individuals with private insurance may apply.
Individuals covered by Federal and State Healthcare Programs are not eligible for assistance (excluding individuals on Medicare without part D who are otherwise eligible under the patient assistance program).
Aubagio FDA Fact Guide: