Brand Name

Aubagio

Generic Name
Teriflunomide
View Brand Information
FDA approval date: May 01, 2013
Classification: Pyrimidine Synthesis Inhibitor
Form: Tablet

What is Aubagio (Teriflunomide)?

Living with multiple sclerosis (MS) often means facing unpredictable fatigue, muscle weakness, and changes in coordination that can disrupt everyday life. For many patients, the uncertainty of when the next relapse will occur can be as challenging as the symptoms themselves. Aubagio (teriflunomide) is a treatment designed to help manage that unpredictability reducing relapses and slowing disease progression so patients can maintain stability and independence. 

Aubagio is an oral medication used to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. It belongs to a class of medications called pyrimidine synthesis inhibitors, which work by controlling certain immune system cells that damage the nervous system. Approved by the U.S. Food and Drug Administration (FDA) in 2012, Aubagio is considered a first-line disease-modifying therapy (DMT), meaning it can be started early in treatment to help manage the disease over time. 

What does Aubagio do? 

Aubagio is prescribed to reduce relapse rates and slow the progression of physical disability in adults with multiple sclerosis. MS is a chronic autoimmune disorder in which the immune system mistakenly attacks the protective covering of nerve fibers, called myelin, in the brain and spinal cord. This leads to communication problems between the brain and the rest of the body. 

By modifying immune system activity, Aubagio helps prevent these attacks and protects nerve function. In large clinical studies, patients taking Aubagio experienced fewer relapses and fewer new or enlarging brain lesions compared to those who received a placebo (NIH, 2024). Many people report greater day-to-day stability, fewer hospitalizations, and improved ability to maintain work or family routines. 

While Aubagio does not cure MS, it helps patients manage the disease long-term by reducing inflammation and preventing future nerve damage, a key factor in maintaining mobility and quality of life. 

How does Aubagio work? 

Aubagio works by selectively blocking an enzyme called dihydroorotate dehydrogenase (DHODH), which is essential for rapidly dividing immune cells known as T and B lymphocytes. These cells play a central role in the autoimmune attack that characterizes multiple sclerosis. 

By inhibiting DHODH, Aubagio slows the growth of these overactive immune cells, reducing their ability to damage the myelin sheath and nerve fibers in the central nervous system. Unlike broad immunosuppressants, Aubagio does not completely shut down the immune system. It helps rebalance it, targeting only the specific overactive cells while allowing the rest of the immune response to function normally. 

Clinically, this mechanism is important because it provides long-term immune regulation with a lower risk of infection than some other immune-modifying treatments. The once-daily oral dosing also makes Aubagio convenient for patients who prefer tablets over injections or infusions. 

Aubagio side effects 

Like any prescription medication, Aubagio can cause side effects, though many are mild and manageable under a doctor’s supervision. 

Common side effects may include: 

  • Hair thinning or mild hair loss 
     
  • Headache 
     
  • Nausea or diarrhea 
     
  • Increased liver enzymes (seen on blood tests) 
     
  • Tingling in hands or feet 

Serious side effects (less common): 

  • Liver problems, which may present as fatigue, yellowing of the skin or eyes (jaundice), or dark urine 
     
  • High blood pressure 
     
  • Decreased white blood cell count 
     
  • Serious skin reactions or allergic responses 
     
  • Nerve damage causing persistent numbness or weakness (rare) 

Because Aubagio can affect the liver, regular blood tests are required especially in the first six months of treatment to monitor liver function and ensure safety. Patients should contact their doctor immediately if they notice signs of liver distress or allergic reactions. 

Avoid Aubagio if you have severe liver disease, are pregnant or planning pregnancy, or are allergic to leflunomide.  

Women of childbearing potential need effective contraception during and after treatment. An “accelerated elimination procedure” can quickly remove the drug if pregnancy is desired. 

Aubagio dosage 

Aubagio is a daily oral tablet, taken with or without food, in strengths tailored to the patient. Consistent daily intake is crucial as the drug remains in the body for a long time. If discontinuation is necessary, for side effects or pregnancy planning, doctors may prescribe specific medications like cholestyramine to accelerate drug elimination. 

Doctors monitor patients’ safety during treatment with blood tests and blood pressure checks, adjusting doses as needed. Closer supervision is required for patients with pre-existing liver disease or high blood pressure.  

Older adults can use Aubagio at the usual dose, but liver and kidney function should be monitored due to potential processing changes. 

Does Aubagio have a generic version? 

Yes. Teriflunomide, the active ingredient in Aubagio, is available as a generic medication in the United States and several other countries. The FDA-approved generic versions contain the same active ingredient, dosage strength, and formulation as the brand-name product, ensuring they are equally effective and safe. 

Generic teriflunomide provides a more affordable, yet equally effective, once-daily oral treatment. Patients should discuss switching with their healthcare provider or pharmacist, particularly if cost is a factor. 

Conclusion 

Aubagio (teriflunomide) is a proven, once-daily oral therapy that helps people living with multiple sclerosis reduce relapses, slow disability progression, and maintain a more stable daily life. By targeting overactive immune cells that damage nerve tissue, it offers effective long-term disease management in a convenient tablet form. 

While requiring monitoring for side effects like liver issues, Aubagio offers hope for MS patients. With consistent use and medical guidance, it can improve quality of life, helping patients breathe easier, move more freely, and feel more confident. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). Aubagio (teriflunomide) prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Teriflunomide (oral route) drug information. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Teriflunomide: Uses, side effects, and precautions. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2024). Disease-modifying therapies for multiple sclerosis. Retrieved from https://www.nih.gov 

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Brand Information

Aubagio (teriflunomide)
WARNING: HEPATOTOXICITY and EMBRYOFETAL TOXICITY
  • Hepatotoxicity
Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with AUBAGIO in the postmarketing setting
Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO
  • Embryofetal Toxicity
AUBAGIO is contraindicated for use in pregnant women and in females of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposures lower than that in humans. Exclude pregnancy before the start of treatment with AUBAGIO in females of reproductive potential. Advise females of reproductive potential to use effective contraception during AUBAGIO treatment and during an accelerated drug elimination procedure after AUBAGIO treatment. Stop AUBAGIO and use an accelerated drug elimination procedure if the patient becomes pregnant
1INDICATIONS AND USAGE
AUBAGIO
2DOSAGE AND ADMINISTRATION
The recommended dose of AUBAGIO is 7 mg or 14 mg orally once daily. AUBAGIO can be taken with or without food.
3DOSAGE FORMS AND STRENGTHS
AUBAGIO is available as 7 mg and 14 mg tablets.
The 14 mg tablet is a pale blue to pastel blue, pentagonal film-coated tablet with the dose strength "14" imprinted on one side and engraved with the corporate logo on the other side. Each tablet contains 14 mg of teriflunomide.
The 7 mg tablet is a very light greenish-bluish grey to pale greenish-blue, hexagonal film-coated tablet with the dose strength "7" imprinted on one side and engraved with the corporate logo on the other side. Each tablet contains 7 mg of teriflunomide.
4ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the prescribing information:
  • Hepatotoxicity
  • Bone Marrow Effects/Immunosuppression Potential/Infections
  • Hypersensitivity Reactions
  • Serious Skin Reactions
  • Drug Reaction with Eosinophilia and Systemic Symptoms
  • Peripheral Neuropathy
  • Increased Blood Pressure
  • Respiratory Effects
  • Pancreatitis in Pediatric Patients
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 2047 patients receiving AUBAGIO (7 mg or 14 mg once daily) constituted the safety population in the pooled analysis of placebo-controlled studies in patients with relapsing forms of multiple sclerosis; of these, 71% were female. The average age was 37 years.
Table 1 lists adverse reactions in placebo-controlled trials with rates that were at least 2% for AUBAGIO patients and also at least 2% above the rate in placebo patients. The most common were headache, an increase in ALT, diarrhea, alopecia, and nausea. The adverse reaction most commonly associated with discontinuation was an increase in ALT (3.3%, 2.6%, and 2.3% of all patients in the AUBAGIO 7 mg, AUBAGIO 14 mg, and placebo treatment arms, respectively).
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of AUBAGIO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Blood and Lymphatic System Disorders: Thrombocytopenia [see
  • Gastrointestinal Disorders: Pancreatitis, colitis
  • Hepatobiliary Disorders: Drug-induced liver injury (DILI) [see
  • Immune System Disorders: Hypersensitivity reactions, some of which were severe, such as anaphylaxis and angioedema [see
  • Respiratory, Thoracic, and Mediastinal Disorders: Interstitial lung disease [see
  • Skin and Subcutaneous Tissue Disorders: Severe skin reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome [see ; drug reaction with eosinophilia and systemic symptoms (DRESS) [see ; psoriasis or worsening of psoriasis (including pustular psoriasis and nail psoriasis); nail disorders
5OVERDOSAGE
There is no experience regarding teriflunomide overdose or intoxication in humans. Teriflunomide 70 mg daily up to 14 days was well tolerated by healthy subjects.
In the event of clinically significant overdose or toxicity, cholestyramine or activated charcoal is recommended to accelerate elimination
6DESCRIPTION
AUBAGIO (teriflunomide) is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C
Chemical Structure
Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water.
Teriflunomide is formulated as film-coated tablets for oral administration. AUBAGIO tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.
7CLINICAL STUDIES
Four randomized, controlled, double-blind clinical trials established the efficacy of AUBAGIO in patients with relapsing forms of multiple sclerosis.
Study 1 was a double-blind, placebo-controlled clinical trial that evaluated once daily doses of AUBAGIO 7 mg and AUBAGIO 14 mg for up to 26 months in patients with relapsing forms of multiple sclerosis. Patients were required to have a diagnosis of multiple sclerosis exhibiting a relapsing clinical course, with or without progression, and to have experienced at least one relapse over the year preceding the trial or at least two relapses over the two years preceding the trial. Patients were required not to have received interferon-beta for at least four months, or any other multiple sclerosis medication for at least six months before entering the study, nor were these medications permitted during the study. Neurological evaluations were to be performed at screening, every 12 weeks until week 108, and after suspected relapses. MRI was to be performed at screening, and at week 24, 48, 72, and 108. The primary endpoint was the annualized relapse rate (ARR).
In Study 1, 1088 patients were randomized to receive AUBAGIO 7 mg (n=366), AUBAGIO 14 mg (n=359), or placebo (n=363). At entry, patients had an Expanded Disability Status Scale (EDSS) score ≤5.5. Patients had a mean age of 38 years, mean disease duration of 5 years, and mean EDSS at baseline of 2.7. A total of 91% of patients had relapsing remitting multiple sclerosis, and 9% had a progressive form of multiple sclerosis with relapses. The mean duration of treatment was 635, 627, and 631 days for AUBAGIO 7 mg, AUBAGIO 14 mg, and placebo, respectively. The percentage of patients who completed the study treatment period was 75%, 73%, and 71% for AUBAGIO 7 mg, AUBAGIO 14 mg, and placebo, respectively.
There was a statistically significant reduction in ARR for patients who received AUBAGIO 7 mg or AUBAGIO 14 mg, compared to patients who received placebo (see
There was a statistically significant reduction in the relative risk of disability progression at week 108 sustained for 12 weeks (as measured by at least a 1-point increase from baseline EDSS ≤5.5 or a 0.5 point increase for those with a baseline EDSS >5.5) in the AUBAGIO 14 mg group compared to placebo (see
The effect of AUBAGIO on several magnetic resonance imaging (MRI) variables, including the total lesion volume of T2 and hypointense T1 lesions, was assessed in Study 1. The change in total lesion volume from baseline was significantly lower in the AUBAGIO 7 mg and AUBAGIO 14 mg groups than in the placebo group. Patients in both AUBAGIO groups had significantly fewer gadolinium-enhancing lesions per T1-weighted scan than those in the placebo group (see
Study 2 was a double-blind, placebo-controlled clinical trial that evaluated once daily doses of AUBAGIO 7 mg and AUBAGIO 14 mg for up to 40 months in patients with relapsing forms of multiple sclerosis. Patients were required to have a diagnosis of multiple sclerosis exhibiting a relapsing clinical course and to have experienced at least one relapse over the year preceding the trial, or at least two relapses over the two years preceding the trial. Patients were required not to have received any multiple sclerosis medication for at least three months before entering the trial, nor were these medications permitted during the trial. Neurological evaluations were to be performed at screening, every 12 weeks until completion, and after every suspected relapse. The primary end point was the ARR.
A total of 1165 patients received AUBAGIO 7 mg (n=407), AUBAGIO 14 mg (n=370), or placebo (n=388). Patients had a mean age of 38 years, a mean disease duration of 5 years, and a mean EDSS at baseline of 2.7. A total of 98% of patients had relapsing remitting multiple sclerosis, and 2% had a progressive form of multiple sclerosis with relapses. The mean duration of treatment was 552, 567, and 571 days for AUBAGIO 7 mg, AUBAGIO 14 mg, and placebo, respectively. The percentage of patients who completed the study treatment period was 67%, 66%, and 68% for AUBAGIO 7 mg, AUBAGIO 14 mg, and placebo, respectively.
There was a statistically significant reduction in the ARR for patients who received AUBAGIO 7 mg or AUBAGIO 14 mg compared to patients who received placebo (see
There was a statistically significant reduction in the relative risk of disability progression at week 108 sustained for 12 weeks (as measured by at least a 1-point increase from baseline EDSS ≤5.5 or a 0.5 point increase for those with a baseline EDSS >5.5) in the AUBAGIO 14 mg group compared to placebo (see
Study 3 was a double-blind, placebo-controlled clinical trial that evaluated once daily doses of AUBAGIO 7 mg and AUBAGIO 14 mg for up to 108 weeks in patients with relapsing multiple sclerosis. Patients were required to have had a first clinical event consistent with acute demyelination occurring within 90 days of randomization with 2 or more T2 lesions at least 3 mm in diameter that were characteristic of multiple sclerosis. A total of 614 patients received AUBAGIO 7 mg (n=203), AUBAGIO 14 mg (n=214), or placebo (n=197). Patients had a mean age of 32 years, EDSS at baseline of 1.7, and mean disease duration of two months. The proportion of patients free of relapse was greater in the AUBAGIO 7 mg (70.5%, p<0.05) and AUBAGIO 14 mg (72.2%, p<0.05) groups than in the placebo group (61.7%).
The effect of AUBAGIO on MRI activity was also demonstrated in Study 4, a randomized, double-blind, placebo-controlled clinical trial of multiple sclerosis patients with relapse. In Study 4, MRI was to be performed at baseline, 6 weeks, 12 weeks, 18 weeks, 24 weeks, 30 weeks, and 36 weeks after treatment initiation. A total of 179 patients were randomized to AUBAGIO 7 mg (n=61), AUBAGIO 14 mg (n=57), or placebo (n=61). Baseline demographics were consistent across treatment groups. The primary endpoint was the average number of unique active lesions/MRI scan during treatment. The mean number of unique active lesions per brain MRI scan during the 36-week treatment period was lower in patients treated with AUBAGIO 7 mg (1.06) and AUBAGIO 14 mg (0.98) as compared to placebo (2.69), the difference being statistically significant for both (p=0.0234 and p=0.0052, respectively).
8HOW SUPPLIED/STORAGE AND HANDLING
AUBAGIO is available as 7 mg and 14 mg tablets.
The 14 mg tablet is pale blue to pastel blue, pentagonal film-coated tablet with dose strength "14" imprinted on one side and engraved with corporate logo on the other side. Each tablet contains 14 mg of teriflunomide.
The 7 mg tablet is very light greenish-bluish grey to pale greenish-blue, hexagonal film-coated tablet with dose strength "7" imprinted on one side and engraved with corporate logo on the other side. Each tablet contains 7 mg of teriflunomide.
AUBAGIO 14 mg tablets are supplied as:
AUBAGIO 7 mg tablets are supplied as:
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
A Medication Guide is required for distribution with AUBAGIO.
10PRINCIPAL DISPLAY PANEL - 7 mg Tablet Bottle Carton
NDC 58468-0211-4
Aubagio
7 mg
Rx only
Dispense with Medication Guide
30 Tablets
sanofi
PRINCIPAL DISPLAY PANEL - 7 mg Tablet Bottle Carton
11PRINCIPAL DISPLAY PANEL - 14 mg Tablet Bottle Carton
NDC 58468-0210-4
Aubagio
14 mg
Rx only
Dispense with Medication Guide
30 Tablets
sanofi
PRINCIPAL DISPLAY PANEL - 14 mg Tablet Bottle Carton