1. What is Aubagio (teriflunomide)?
Aubagio is the brand name for teriflunomide, an oral medication taken once per day to treat relapsing forms of multiple sclerosis (MS). It is available in strengths of 7 mg and 14 mg as film-coated tablets.
When Aubagio was approved by the FDA in 2012, it became the 9th disease-modifying therapy (DMT) available to treat MS and the second that is taken by mouth (after Gilenya, which contains the active ingredient fingolimod). Other oral medications for MS, such as Tecfidera (dimethyl fumarate), have since been approved.
Aubagio is typically considered a first-line treatment, particularly for people who prefer to take an oral medication rather than receive injections/infusions. Although it has a well-defined safety profile, it has two black-box warnings (the most serious warnings issued by the FDA) regarding hepatotoxicity (which can cause severe liver problems) and embryo-fetal toxicity (meaning it can cause fetal harm in pregnant women). You can read more about these warnings and other side effects in question 5: What are the side effects of Aubagio (teriflunomide) and how long do they last? and question 6: Why does Aubagio (teriflunomide) have black box warnings?
2. What does Aubagio (teriflunomide) do for MS?
Aubagio (teriflunomide) is a disease-modifying therapy (DMT) for multiple sclerosis (MS), meaning it can help slow down disease progression and minimize damage rather than simply treat symptoms.
Specifically, Aubagio is used to treat relapsing forms of MS. It is taken orally once per day, with or without food, at a strength of either 7 mg or 14 mg.
The relapsing forms of MS that Aubagio is approved to treat are:
Clinically isolated syndrome
Clinically isolated syndrome (CIS) refers to a single episode of neurological symptoms that lasts at least 24 hours. Because CIS is a single episode of symptoms, it is sometimes considered to be a different condition from MS; others consider it to be the earliest form of relapsing-remitting MS (RRMS).
Regardless, the purpose of Aubagio therapy is to prevent or slow down the progression to RRMS.
Whereas a single episode of neurological symptoms is called clinically isolated syndrome, the second episode of symptoms means the condition has progressed to relapsing-remitting MS (or relapsing-remitting disease).
The purpose of Aubagio therapy in people living with RRMS is to slow down disease progression and reduce the number of relapses, reduce brain lesions, and prevent disability progression.
Active secondary progressive disease
Secondary progressive MS (SPMS) or secondary progressive disease is characterized by a steady worsening of symptoms rather than distinct relapses (although relapses can also occur). SPMS is considered ‘active’ when either relapses occur or there is MRI evidence of new legions.
As is the case with CIS and RRMS, Aubagio is intended to slow down disease progression.
3. Aubagio 7 mg vs 14 mg – which is better?
Over the course of three clinical trials, Aubagio 14 mg was found to be effective compared to a placebo in three key measures: relapses, brain lesions, and disability progression. Aubagio 7 mg was shown to be effective compared to a placebo in two of the three key measures: relapses and brain lesions.
Over the course of the trials, Aubagio 14 mg was more effective than Aubagio 7 mg at reducing relapse rates, increasing the number of people who remained relapse-free, reducing new lesions, and reducing total lesion volume.
You can read more about the clinical studies here: Aubagio website: Clinical Studies
Despite the superior efficacy of Aubagio 14 mg, however, your doctor may prescribe Aubagio 7 mg depending on your personal circumstances. For example, if your disease is less severe the 7 mg dosage may have the desired therapeutic effect while reducing the risk of side effects such as hair thinning or loss, nausea, and diarrhea.
4. How does Aubagio (teriflunomide) work?
Aubagio (teriflunomide) is considered a ‘pyrimidine synthesis inhibitor’. Although the exact way Aubagio helps people living with multiple sclerosis is not known, it is believed to be related to teriflunomide blocking an enzyme called dihydroorotate dehydrogenase (DHODH). This is believed to prevent the synthesis of a compound called pyrimidine (hence the name ‘pyrimidine synthesis inhibitor’), which is necessary for the rapid division of T and B cells. It is possible that this mechanism of action, which makes Aubagio an immunomodulator (meaning it modulates the immune system), reduces the number of immune cells — specifically, T and B cells — that attack myelin.
Teriflunomide’s mechanism of action can also help with other autoimmune diseases; leflunomide, a drug that is metabolized to teriflunomide in the body, is approved to treat rheumatoid arthritis.
Regardless of Aubagio’s exact mechanism of action, it is different from any other MS treatment currently approved. This can make it an attractive choice for people who have tried other treatments but have found them ineffective or to cause side effects.
5. What are the side effects of Aubagio (teriflunomide) and how long do they last?
Aubagio (teriflunomide) has two black box warnings, which are the most serious warnings issued by the FDA. The warnings are that Aubagio can lead to serious liver damage and can cause harm to unborn babies. You can read more about these warnings in the following question: Why does Aubagio (teriflunomide) have black box warnings?
Aside from the risk of liver damage and the risk to unborn babies, Aubagio can cause the following serious side effects:
Reducing white blood cell count (which can increase your risk of infections). Your doctor will check your white blood cell count and perform a skin test for tuberculosis (TB). Nonetheless, Aubagio may make you more susceptible to infections, signs of which include:
◦ Body aches
Peripheral neuropathy, signs of which include:
◦ New or worsening numbness or tingling in your hand or feet (that is different from your MS symptoms)
New or worsening breathing problems, such as shortness of breath (with or without fever)
Kidney problems, signs of which include pain in your side
High blood pressure (you doctor should check your blood pressure before you begin Aubagio treatment and monitor it throughout your treatment)
High potassium levels, signs of which include nausea or racing heartbeat
If you have any of these symptoms, you should contact your doctor immediately.
More common side effects include:
- Hair thinning or loss
- Prickling feeling in your skin
These side effects are more likely to occur at the beginning of your treatment and often ease off as your body adjusts to the medication. Hair thinning or loss often occurs after around 3 months (although it can be earlier or later) and, in clinical trials, was reported in 13% of people taking Aubagio 14 mg and in 10% of people taking Aubagio 7 mg. However, hair thinning or loss is usually temporary and will usually grow back as your hair returns to its usual cycle.
These common side effects often do not require medical attention. However, if they are severe, bothersome, persistent, or worsen, you should contact your doctor.
Although rare, Aubagio can cause a serious allergic reaction. Signs of a serious allergic reaction should be treated as a medical emergency. They include:
- Skin rash – for example itchy, red, or swollen skin
- Tightness in the chest or throat
- Trouble breathing or talking
- Swollen mouth, face, lips, tongue, or throat
This is not a complete list of the possible side effects of Aubagio. It is important to speak to your healthcare professional to gain information about the risk of side effects and steps you can take to help prevent or control them.
6. Why does Aubagio (teriflunomide) have black box warnings?
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.
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:
- Stomach pain
- Loss of appetite
- Yellowing of your skin or white of your eyes
- Dark urine
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.
7. How much does Aubagio (teriflunomide) cost?
The list price of Aubagio in the US, as of January 2020, is $7,668.14 for a 30-day supply (7 mg or 14 mg). However, the amount you will have to pay depends on factors such as whether you have prescription drug insurance, the type of insurance you have, and whether you have met your deductible.
According to the Aubagio website, most commercially insured people pay between $0 and $110.87 per month. More information about costs, including for people with Medicare or Medicaid coverage, can be found here: Aubagio pricing information. This also provides contact details for Sanofi’s Patient Assistance Program for people who are not insured or whose insurance does not cover Aubagio.
If you live outside of the US, the amount you will pay will also depend on your insurance coverage or whether Aubagio is made available by your public health body (as it is by the NHS in the UK, for example).
8. What happens if I miss a dose of Aubagio (teriflunomide)?
If you miss a dose of Aubagio, you can skip the missed dose and take your next dose as planned. Do not double your next dose to make up for the one you missed.
If you find yourself missing doses regularly, you should speak to your healthcare provider about finding the best solution.
9. Can I drink alcohol while taking Aubagio (teriflunomide)?
One of the most serious risks associated with Aubagio (teriflunomide) is related to liver damage and drinking alcohol may increase this risk. It is usually recommended that you should limit your alcohol consumption or avoid drinking altogether.
Your doctor will perform liver enzyme tests before you start taking Aubagio and periodically throughout the first six months of treatment. You should speak to your doctor about your personal risk of liver problems and whether it is safe to drink alcohol. If you do drink alcohol while taking Aubagio and have signs of liver problems, you should contact your doctor immediately. These signs include:
- Stomach pain
- Loss of appetite
- Yellowing of your skin or white of your eyes
- Dark urine
The content on this page is provided for informational purposes only. If you have any questions or concerns about your treatment, you should talk to your doctor, pharmacist, or healthcare professional. This is particularly important if you are taking multiple medications or have any existing medical conditions.
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