Key Points
- Aubagio (teriflunomide) can stay in your blood for up to two years after you stop taking it. For some side effects or pregnancy, you may need an accelerated removal process to fully remove Aubagio from your blood. This accelerated process involves taking a special medicine (cholestyramine or activated charcoal) to remove the medicine out of your body more quickly.
- Aubagio can harm an unborn baby. Do not take Aubagio if you are pregnant or considering having a baby (for women and men). Aubagio is also found in a man’s semen.
- In general, most of the common side effects with Aubagio are short-lived and will go away within a few weeks or months. However, all patients react differently to Aubagio and can have a different set of side effects. Some patients will have few or no side effects at all. See Table 1 and Table 2 for the most common side effects.
- Call your doctor or 911 for emergency care right away if you are experiencing any serious side effects.
Aubagio (teriflunomide) is a prescription medicine approved by the FDA in 2012 for the treatment of adults patients with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Aubagio has a Boxed Warning, the most stringent FDA warning, about the risk for liver toxicity and harm to an unborn baby.
You should NOT take Aubagio if:
- you have severe liver problems are pregnant or of childbearing potential and not using effective birth control
- have had an allergic reaction to Aubagio or leflunomide (brand: Arava)
- are taking a medicine called leflunomide (brand: Arava) for rheumatoid arthritis
The most common side effects with Aubagio include increased liver enzymes (which may signal liver disease), hair thinning or loss, diarrhea, influenza, nausea, low phosphate levels, and numbness or burning sensation in legs, hands, arms, or feet.
Does Aubagio have a long-half-life?
Yes, Aubagio has a long half-life of roughly 18-19 days and is eliminated slowly from your body. The half-life is the amount of time it takes for half of a drug’s concentration to be eliminated from your body.
Because of the long half-life, it can potentially take several months for many side effects to dissipate. It takes on average 8 months to eliminate the drug (to reach a plasma concentration less 0.02 mg/L), but this is variable and may take up to 2 years based on differences between patients.
Your doctor may need to do an accelerated removal process using a specific medicine if you have any serious side effects, are pregnant or are considering having a baby (both men and women).
Table 1: Percent of Patients With Most Common Side Effects in Aubagio Clinical Trials
| Side Effect | Aubagio 7 mg | Aubagio 14 mg | Placebo (inactive) |
| Headache | 18% | 16% | 15% |
| Abnormal liver tests | 13% | 15% | 9% |
| Diarrhea | 13% | 14% | 8% |
| Hair thinning or loss (alopecia) | 10% | 13% | 5% |
| Nausea | 8% | 11% | 7% |
Table from Aubagio (teriflunomide) Product Information.
It can be helpful to understand how well a patient tolerates a medication by looking at the number of people who stopped taking the drug in clinical studies because of a certain side effect.
In studies compared to a placebo (inactive drug), the number of people who stopped treatment due to common side effects was low (Table 2).
Table 2: Percent Who Stopped Aubagio Due to Common Side Effects
| Side Effect | Aubagio 7 mg (1045 people) | Aubagio 14 mg (1002 people) | Placebo (997 people; inactive treatment) |
| Diarrhea | 0.5% = 5 people | 0.4% = 4 people | 0.1% = 1 person |
| Nausea | 0.1% = 1 person | 0.3% = 3 people | 0.0% = 0 people |
| Hair thinning or loss | 0.2% = 2 people | 1.3% = 13 people | 0.1% = 1 person |
| Abnormal liver tests | 3.3% = 34 people | 2.6% = 26 people | 2.3% = 23 people |
| Headache | 0.0% = 0 people | 0.0% = 0 people | 0.3% = 3 people |
Table from Aubagio (teriflunomide) Product Information.
What are some of the most important side effects with Aubagio?
Harm to unborn baby
Do NOT take Aubagio if you are pregnant. Aubagio can stay in your blood for up to 2 years after you stop taking it, and this is especially important in pregnancy. Aubagio can harm an unborn baby. Your doctor can prescribe a medicine to help lower your blood levels of Aubagio more quickly.
Both men and women should talk to your doctor if you want more information about this. The risk of harm to an unborn baby due to Aubagio treatment may require both men and women to undergo an accelerated removal of Aubagio from their body, or wait two years before attempting to get pregnant.
Women
- Do not take Aubagio if you are pregnant or not using effective birth control.
- Have a pregnancy test before starting Aubagio treatment.
- When you stop Aubagio treatment, continue your effective birth control until you have blood tests to be sure your levels of Aubagio are low enough to safely become pregnant.
- If you become pregnant while taking Aubagio or within 2 years after you stop taking it, tell your doctor right away.
Men
- Men also need to have accelerated removal of Aubagio from their body if their female partner decides to become pregnant.
- Talk to your doctor about this before attempting pregnancy. Aubagio is found in a man’s semen.
- If your female partner does not plan to become pregnant, you and your female partner should use effective birth control during your treatment with Aubagio. Continue using effective birth control until Aubagio blood levels have been checked and they are low enough.
Elevated liver enzymes
Elevated liver enzymes (called ALT) can signal that liver toxicity may be occurring. Most people who had elevated liver enzymes during clinical trials had them in the first year, and 50% of cases returned to normal over time without patients having to stop treatment. Your doctor will check your liver with a blood test before treatment with Aubagio, and for the first 6 months while taking treatment. If liver injury is suspected, you will undergo accelerated drug removal.
In studies conducted by the manufacturer, elevated liver enzymes 3 times greater than the upper limit of normal occurred in 5.8% and 6.2% of patients receiving Aubagio, compared to 3.8% of those receiving placebo. Elevated liver enzymes were the top reason why people stopped treatment in studies. You should not use Aubagio if you have severe liver disease.
Of the patients who stopped Aubagio due to elevated liver enzymes and underwent accelerated elimination in controlled trials, half of patients returned to normal or near normal values within 2 months.
Hair thinning or hair loss
Hair-thinning or loss can be a concern for many patients, but is usually temporary with Aubagio treatment. In studies, 10 to 13 out of every 100 patients reported hair thinning or loss, so this effect does not happen to everyone.
In clinical studies, most patients did not stop treatment due to hair thinning. Hair thinning or loss is usually mild to moderate, temporary and may occur around 3 months after starting treatment. Hair thinning associated with Aubagio is similar to the hair thinning that may happen with childbirth, stress, or iron deficiency.
Diarrhea
According to the manufacturer, most cases of diarrhea were mild to moderate and not persistent.
Decreased white blood cells
Aubagio may lower your white blood cell (WBC) count. White blood cells are used to fight infection. You may be more likely to get an infection while taking Aubagio. Contact your doctor if you develop an infection or fever.
In studies, the decrease in mean WBC count occurred during the first 6 weeks of treatment and remained low during treatment.
Peripheral Neuropathy
Tell your doctor if you should develop numbness or tingling of your hands or feet.
You can develop peripheral neuropathy with Aubagio, although it was not a frequent side effect in clinical trials.
- Roughly 1.4% to 1.9% (13 to 17 patients) compared to 0.4% (4 patients) taking the inactive placebo developed peripheral neuropathy.
- Five cases recovered when Aubagio was stopped, but not all patients recovered with continued treatment.
Other serious side effects
If you should experience any of these serious side effects or circumstances, speak with your doctor immediately:
- reduced white blood cell count which may increase your infections, fever; reduced platelets
- numbness or tingling in your hands or feet that is different from your MS symptoms
- allergic reactions, including serious skin reactions (hypersensitivity); sores in your mouth, eyes or genitals
- trouble breathing (new or worsening), lung problems
- liver disease, a history of liver disease, or elevated liver enzymes
- high blood pressure
- certain vaccinations should be avoided during treatment with Aubagio and for at least 6 months after discontinuation
- Aubagio can harm an unborn baby, women should tell their doctor if they are pregnant or planning a pregnancy before starting treatment
- Men taking Aubagio, whose partners are planning a pregnancy, should also talk to their doctor before attempting a pregnancy.
You should NOT take Aubagio if:
- you have severe liver problems are pregnant or of childbearing potential and not using effective birth control
- have had an allergic reaction to Aubagio or leflunomide (brand: Arava), or are taking leflunomide for rheumatoid arthritis. Teriflunomide is the active metabolite of leflunomide.
Ask your doctor how to recognize symptoms of serious side effects if you are taking Aubagio. Talk to your health care provider if you’re concerned about any potential side effects.
You can also speak to Genzymes’s MS One to One Nurses at 1‑855‑676‑6326.
Bottom Line
- Most common side effects with Aubagio treatment for MS are temporary and go away within a few weeks to a few months.
- However, Aubagio can stay in your blood for up to 2 years after stopping treatment. For some serious side effects, or pregnancy, an accelerated removal process may be needed to clear the drug out of the body more quickly.
- There are side effects with Aubagio that can be serious or long-lasting and you should review the FDA-approved patient information (Medication Guide) and speak with your doctor to learn more.
This is not all the information you need to know about Aubagio (teriflunomide) for safe and effective use. Review the full Aubagio information here, and discuss this information with your doctor or other health care provider.