Aubagio

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Aubagio

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Treatment option: Multiple Sclerosis

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Aubagio

Property Description
Active ingredient Teriflunomide
Form Oral Tablet
Pharmacological class Disease-Modifying Antirheumatic Drug (DMARD)
Common Use Management of chronic autoimmune conditions
Origin Synthetic compound

What is Teriflunomide (Aubagio)?

Aubagio is the trade name for the active ingredient Teriflunomide, a medicine used as a foundational, long-term oral therapy. As a synthetic compound, it is precisely manufactured and presented as a single-ingredient product in a simple oral tablet form. A key differentiating factor is its origin: Teriflunomide is the main active metabolite of the older immunosuppressant drug, leflunomide, ensuring a consistent and established chemical lineage. The drug is utilized to help manage and stabilize specific chronic autoimmune conditions over time.


What Type of Medicine is Aubagio?

Teriflunomide is functionally categorized as a Disease-Modifying Antirheumatic Drug (DMARD) and an immunomodulatory agent. This classification means its primary role is to alter the underlying disease process rather than merely treating temporary symptoms. It acts as a selective immunosuppressant that focuses on key immune pathways. The drug moderates the immune response by selectively targeting immune cells.


What is the General Purpose of Aubagio Therapy?

The general purpose of Aubagio therapy is to dampen the excessive immune response and stabilize the chronic condition. This benefit is achieved through selective cell growth control, where the drug limits the rapid multiplication of overactive T- and B-lymphocytes—the specific immune cells involved in driving chronic inflammation. By selectively blocking the mitochondrial enzyme dihydroorotate dehydrogenase (DHODH), the medication places an energetic blockade on the proliferation of these destructive immune cells. This targeted action is clinically recognized for its efficacy in a typical neutral use scenario: helping to manage the frequency of active disease periods, thereby mitigating ongoing tissue damage and maintaining its role as a key foundational treatment.

Regulatory References

  1. U.S. National Library of Medicine (NIH) confirms

What side effects are possible with Aubagio?

Possible Side Effects and Safety Information

The official safety profile for teriflunomide (Aubagio) is organized by regulatory agencies (such as the FDA and EMA) into categories based on the frequency and the physiological systems affected. This framework distinguishes between commonly reported events and serious, low-incidence risks.

Frequency-Classified Adverse Reactions

Adverse reactions documented in official labeling that affect a significant portion of treated individuals include events classified as very common (occurring in more than 1 in 10 patients) and common (occurring in 1 to 10 in 100 patients).

Classification Examples of Documented Effects
Very Common Diarrhea, Nausea, Alopecia (hair thinning), Alanine Aminotransferase (ALT) increase
Common Headache, Paresthesia, Hypertension, Vomiting, Neutropenia

Systemic Safety Concerns

The most significant safety focus in regulatory documents relates to Hepatobiliary disorders. Increases in liver enzymes (ALT and GGT) are common, with more serious, but rare, events involving the risk of severe hepatotoxicity, including acute liver failure, documented in the labeling. Other serious reactions explicitly listed include the potential for Interstitial Lung Disease (ILD) and severe skin reactions (such as Stevens-Johnson syndrome).

Population-Specific Constraints

Teriflunomide is subject to specific constraints based on population. The drug is contraindicated in pregnancy due to the recognized risk of fetal harm (teratogenicity) and in patients with severe hepatic impairment. Certain effects, such as ALT elevations, are noted to occur more frequently during the first six months of treatment. Regulatory constraints also recommend screening for latent tuberculosis prior to initiation of therapy and prohibit the concurrent use of live virus vaccines.

Overdose and Emergency Response

The official regulatory profile for Aubagio (teriflunomide) overdose reports limited clinical experience with acute symptomatic overdose. The primary concern is the potential for severe systemic toxicity associated with high drug exposure. Regulator-documented severe outcomes requiring immediate intervention include potentially life-threatening liver injury, such as acute liver failure, and serious skin reactions, including Stevens-Johnson syndrome and Toxic Epidermal Necrolysis. Severe hepatic impairment is noted in official labeling as a condition increasing the risk of toxicity.

Immediate medical help must be sought for signs of severe hepatic dysfunction, such as unexplained jaundice, dark urine, or persistent nausea and vomiting, or for life-threatening symptoms like collapse or seizure. Patients should contact poison control immediately.

No specific pharmaceutical antidote is known for teriflunomide overdose. The mandated management is the accelerated elimination procedure, which involves administering cholestyramine or activated charcoal for eleven days to rapidly reduce the drug's plasma concentration. Following discontinuation due to toxicity, regulatory instructions require weekly monitoring of serum transaminase and bilirubin levels until they are normalized.

Therapeutic Uses of Aubagio

Aubagio (teriflunomide) is an oral medication designed to address the clinical course of relapsing forms of multiple sclerosis (RMS) in adults. Its therapeutic use encompasses several related conditions: clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The primary benefit of this treatment is its role in helping to reduce the frequency of relapses, which are characteristic episodes of new or worsening neurological symptoms.


Quick Fact: Relief for Disease Activity and Relapse Frequency


By moderating disease activity, Aubagio may also support the slowing of physical disability progression. This can be an important factor in maintaining everyday function for patients managing a chronic condition. Clinical data suggests that this therapy may provide a long-term approach to management, focusing on reducing the visible signs of disease activity observed on imaging scans, such as new or enlarging brain lesions. This supports the overall goal of long-term disease control, providing a supportive element within a comprehensive treatment plan approved by a healthcare provider.

Eligibility and Restrictions for Use

Aubagio (teriflunomide) is officially approved for use in adults and pediatric patients 10 years of age and older with relapsing forms of multiple sclerosis. Regulatory labeling establishes clear contraindications and limitations based on patient health status.

The medicine is contraindicated and must not be used in pregnant women or women who are breastfeeding. It is also contraindicated for patients with severe hepatic impairment or a known hypersensitivity to teriflunomide or leflunomide.


Contraindications and Use Restrictions

Status Population/Condition
Contraindicated Pregnant women, breastfeeding women, severe hepatic impairment, known hypersensitivity.
Not Recommended Severe immunodeficiency states, severe renal impairment on dialysis, impaired bone marrow function, severe hypoproteinemia.

Regulatory documents state that use is not established in children under 10 years of age. Treatment should be used with caution in patients over 65 years of age due to limited data. Furthermore, patients must be screened for latent tuberculosis prior to treatment initiation, and treatment should not be started in the presence of a severe uncontrolled infection.

What should I know about interactions with other medicines?

Aubagio Interactions with other medicines and products

Official regulatory information describes specific interaction patterns for Aubagio (teriflunomide) involving metabolic enzymes, drug transporters, and agents with similar toxicity profiles.

Pharmacokinetic and Exposure Effects

Teriflunomide is documented as a moderate inhibitor of the CYP2C8 enzyme and a weak inducer of CYP1A2, altering the plasma concentrations of medicines metabolized by these pathways. It also inhibits the drug transporters OATP1B1/B3 and BCRP, leading to increased exposure for their substrates. Consequently, the dose of Rosuvastatin is restricted to 10 mg once daily when co-administered, and exposure to Ethinylestradiol and Levonorgestrel (oral contraceptives) is increased. Exposure to drugs metabolized by CYP1A2, such as Theophylline or Caffeine, may be decreased.

Interaction-Related Restrictions and Constraints

Co-administration with Leflunomide is strictly contraindicated. The label notes that concomitant use with other potentially hepatotoxic agents (including alcohol) may increase the risk of severe liver injury. Furthermore, Live Vaccines are not recommended during treatment due to potential immunosuppressive effects. In cases where accelerated elimination is required, substances like Cholestyramine or Activated Charcoal are used to rapidly decrease teriflunomide plasma concentration. The drug is also contraindicated in patients with severe hepatic impairment.

Mechanism of Action

How Aubagio Works: Targeted Mechanisms

Teriflunomide functions as a reversible inhibitor that affects the metabolic machinery of specific immune cells. The resulting physiological effect is the modulation of immune cell proliferation, achieved via a precise causal chain from the molecular target.


Inhibition of the Key Mitochondrial Enzyme DHODH

This domain covers the drug's core action: the reversible inhibition of the enzyme Dihydroorotate Dehydrogenase (DHODH). This molecular blockade stops a critical step in the de novo pyrimidine synthesis pathway, which is essential for creating the DNA and RNA building blocks (nucleotides) necessary for cell replication.


Selective Blockade of T- and B-Lymphocyte Proliferation

  • The resulting shortage of pyrimidine nucleotides causes a metabolic arrest in cells attempting to divide rapidly. This mechanism selectively targets and prevents the clonal expansion of activated T- and B-lymphocytes, which are characterized by high metabolic demands.

  • This action results in the reduction of proliferating immune cell populations, preserving the function of non-dividing (resting) cells, which utilize an unaffected metabolic salvage pathway.


Gradual Modulation of Systemic Immune Activity

The physiological consequence of this antiproliferative effect is the modulation of the overall immune cell population size. Because the mechanism limits the growth of new immune cells, the systemic effect is time-dependent, emerging as the existing activated cell pool naturally declines, leading to an alteration in immune cell composition.

Dosage and Administration Information

How Aubagio is Used: Official Administration Guidelines

Aubagio (teriflunomide) is an oral therapy administered once daily. The drug is taken as a single-ingredient, film-coated tablet and is intended for long-term, continuous use.


Standard Dosing and Administration

Usage Component Official Instruction
Route of Administration Oral
Available Strengths 7 mg and 14 mg film-coated tablets
Adult Dosing Regimen 7 mg or 14 mg once daily.
Frequency Pattern Once daily (qDay).
Administration Context May be taken with or without food. The tablet must be swallowed whole with water.
Missed Dose Protocol If a dose is missed, skip that dose and take the next scheduled dose. Dosing must not be doubled

Population-Specific Usage

Specific population guidelines describe the dosing rules for various groups.

Population Group Official Dosing Rule
Pediatric (10+ years) Weight-based: Patients le 40 kg receive 7 mg once daily; patients > 40 kg receive 14 mg once daily.
Hepatic/Renal Impairment No dose adjustment is required for mild/moderate hepatic impairment or for non-dialysis-dependent renal impairment.

This medication protocol establishes a standardized, flexible, long-term approach to therapy, ensuring consistent daily exposure within defined clinical parameters.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Aubagio

Evidence for Relapsing Forms of Multiple Sclerosis (RMS)

The evidence base for teriflunomide relies on large, international Phase 3 Randomized Controlled Trials (RCTs) involving adults with relapsing forms of MS and those with a first clinical episode (Clinically Isolated Syndrome - CIS). These studies were typically double-blind and placebo-controlled, lasting around two years.

Researchers focused on measuring the annual rate of relapses and the time to confirmed accumulation of disability using the Expanded Disability Status Scale (EDSS). Studies monitored disease activity using MRI scans. Findings describe patterns indicating that groups receiving the active drug had lower rates of clinical relapse activity and patterns related to fewer new or enlarging lesions when compared to placebo groups. In CIS studies, measurements of the time to conversion to clinically definite MS were compared across studied populations.

Long-Term Follow-up, Special Populations, and Research Gaps

Longer-term data are available from open-label extension studies, which have observed cohorts for seven to nine years. These observations describe patterns related to monitored relapse activity and changes in disability scores over these extended intervals. However, continuous, double-blind, placebo-controlled data are not available for these long durations, which represents a research gap.

A dedicated Phase 3 trial was conducted for pediatric patients (aged 10 to 17 years). While some secondary outcomes related to imaging were observed, the study's primary outcome (time to the first confirmed clinical relapse) was inconclusive. For other specific patient subgroups, such as those switching from multiple prior therapies, the available data remain insufficient for high-certainty conclusions. Research highlights what is known, but the results apply only to the populations studied and provide context, not individual predictions.

Key Studies & References Teriflunomide in multiple sclerosis: a randomized controlled trial (TOWER)

Frequently Asked Questions (FAQ)

Common questions about Aubagio (FAQ)

Q: Is Aubagio safe for people with pre-existing kidney issues?

A: Official product information states that no dose adjustment is typically needed for people with non-dialysis-dependent kidney impairment. However, monitoring for signs of hyperkalemia (high potassium levels) or acute kidney failure is typically advised, as this medication can affect the renal system.


Q: What happens if you miss a dose of Aubagio?

A: Official labeling states that if a dose is missed, it should be skipped, and the patient should resume the normal dosing schedule the following day. It is important that the dose is never doubled to compensate for the one that was missed.


Q: Is there a generic version of Aubagio available?

A: Yes, the active ingredient, teriflunomide, is available in generic versions approved by regulatory bodies. These are available in the same 7 mg and 14 mg strengths as the brand-name medication.


Q: Are there any known interactions between Aubagio and supplements like Vitamin D?

A: While official labeling does not specifically name Vitamin D, it describes drug interactions with substances that affect specific metabolic enzymes (like CYP) and transporters. Patients should discuss all supplements with a healthcare provider, as potential interactions with metabolic pathways are described in the drug label.


Q: Does Aubagio have a known connection to weight changes?

A: Weight loss has been reported as a side effect in some of the clinical trial data. However, it is not classified as one of the most common adverse reactions listed in the primary regulatory labeling.


Q: What are the signs of a serious allergic reaction to Aubagio?

A: Serious allergic reactions, including anaphylaxis and angioedema (severe swelling), have been reported with this medication. Signs can include swelling of the face, lips, tongue, or throat, hives, blistering skin, or difficulty breathing. Seek immediate medical attention if these symptoms develop.


Q: Can taking Aubagio cause an increase in infections?

A: Yes. Because Aubagio acts as an immunomodulatory agent, it can sometimes cause a reduction in white blood cell count (neutropenia), which is listed as a common effect. This reduction is associated with an increased risk of infections. Treatment should not begin if an active infection is present.


Q: Is Aubagio safe for older adults with MS?

A: Official information states that use in patients over 65 years of age should be approached with caution. This is because there is limited clinical data available for this specific age group, and the full safety and efficacy profile has not been established for this group.


Q: How often do people experience elevated liver enzymes while on Aubagio?

A: Clinical trials reported that serum ALT, a measure of liver enzymes, was elevated in approximately 13% to 15% of patients taking Aubagio, compared to 9% of those on placebo. A smaller fraction, about 6% of patients, experienced elevations greater than three times the upper limit of normal.


Q: Are headaches a common side effect of Aubagio?

A: Yes, official clinical trial summaries list headache as a Common side effect. This means it was frequently reported in clinical trials.


Q: What kind of impact does Aubagio have on the immune system?

A: Aubagio is an immunomodulatory agent that functions as a selective immunosuppressant. Its action is to reduce the proliferation and numbers of activated T- and B-lymphocytes by inhibiting a key enzyme, dihydroorotate dehydrogenase (DHODH). This selective targeting helps modulate the overall immune response.


Q: Is it typical for blood pressure to increase after starting Aubagio?

A: High blood pressure (Hypertension) is listed as a Common side effect. Official guidance recommends that blood pressure be measured and monitored at the start of treatment and throughout the course of therapy.


Q: Does Aubagio have a risk evaluation and mitigation strategy (REMS)?

A: Yes. Due to the potential for serious safety risks, such as liver damage and fetal harm, Aubagio has restricted distribution under a Risk Evaluation and Mitigation Strategy (REMS) program in the U.S. This limits its dispensing to registered prescribers and pharmacies.


Q: Is Aubagio used for primary progressive MS?

A: No. Aubagio is officially approved for treating relapsing forms of multiple sclerosis in adults and certain pediatric patients. This includes clinically isolated syndrome, relapsing-remitting MS, and active secondary-progressive MS, but not primary progressive MS.

How should Aubagio be stored and disposed of?

How to Store and Dispose of Aubagio?

The storage and disposal requirements for Aubagio (teriflunomide) tablets are strictly defined by regulatory guidelines to maintain product integrity and ensure safety.

Official Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, between 20 C to 25 C (68 F to 77 F).
Environment Must be protected from excess heat, moisture, and direct light. Do not freeze.
Container Keep the medication in the original container, and ensure the container is tightly closed.
Safety Keep the product out of the sight and reach of children.

Official Disposal Instructions

Unused or expired Aubagio must not be disposed of in household garbage or flushed down a toilet or drain, as required by environmental protection guidelines. Patients must consult a healthcare professional or pharmacist to determine the appropriate local method for disposing of the medicine.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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