AUBAGIO: Uses, Dosage & Side Effects
An oral immunomodulatory agent for the treatment of relapsing-remitting multiple sclerosis in adults and children aged 10 years and older
AUBAGIO (teriflunomide) is a prescription immunomodulatory medication used for the treatment of relapsing forms of multiple sclerosis (MS) in adults and in children and adolescents aged 10 years and older. It works by selectively and reversibly inhibiting dihydroorotate dehydrogenase (DHODH), a mitochondrial enzyme essential for the de novo synthesis of pyrimidines. This inhibition reduces the proliferation of activated T and B lymphocytes that drive the autoimmune inflammatory process responsible for demyelination and nerve damage in MS. AUBAGIO is taken orally as a once-daily tablet, making it a convenient first-line treatment option that has been shown in pivotal clinical trials to significantly reduce relapse rates and slow the progression of physical disability.
Quick Facts: AUBAGIO
Key Takeaways
- AUBAGIO (teriflunomide) is an oral immunomodulatory medication approved for relapsing-remitting multiple sclerosis in adults and children aged 10 years and older, taken as a convenient once-daily tablet.
- It works by inhibiting dihydroorotate dehydrogenase (DHODH), reducing the proliferation of activated lymphocytes responsible for the autoimmune attack on myelin in the central nervous system.
- Pivotal clinical trials (TEMSO and TOWER) demonstrated that AUBAGIO 14 mg significantly reduced annualized relapse rates by approximately 31–36% compared to placebo and slowed disability progression.
- AUBAGIO must not be used during pregnancy due to the risk of birth defects. Because of its very long half-life (approximately 18–19 days), an accelerated elimination procedure is required before conception.
- Regular monitoring of liver function and blood counts is essential during treatment, as hepatotoxicity and immunosuppressive effects are known risks that require clinical oversight.
What Is AUBAGIO and What Is It Used For?
AUBAGIO contains the active substance teriflunomide, the principal active metabolite of leflunomide (a drug used in rheumatoid arthritis). Teriflunomide is classified as an immunomodulatory agent, meaning it modifies the function of the immune system rather than broadly suppressing it. This distinction is clinically important because it allows AUBAGIO to reduce the pathological immune responses that damage the nervous system in MS while preserving a degree of overall immune competence necessary for fighting infections and maintaining normal physiological functions.
Multiple sclerosis is a chronic autoimmune disease of the central nervous system (CNS), which comprises the brain and spinal cord. In MS, the immune system mistakenly attacks the protective myelin sheath that insulates nerve fibers (axons) within the CNS. This process, known as demyelination, disrupts the normal transmission of electrical signals along the nerves. The resulting damage leads to a wide range of neurological symptoms depending on which areas of the CNS are affected. Over time, repeated episodes of inflammation and demyelination can cause progressive and often irreversible nerve damage and neurological disability.
Relapsing-remitting multiple sclerosis (RRMS), the most common form of the disease at diagnosis, is characterized by clearly defined episodes of new or worsening neurological symptoms (called relapses or exacerbations), followed by periods of partial or complete recovery (remissions). Common symptoms experienced during relapses include difficulty walking, visual disturbances (such as optic neuritis), problems with balance and coordination, numbness or tingling in the limbs, fatigue, and cognitive difficulties. While symptoms may resolve completely after a relapse, over time some patients develop residual deficits that can accumulate and lead to progressive physical disability.
How AUBAGIO Works
Teriflunomide exerts its therapeutic effect primarily by selectively and reversibly inhibiting the mitochondrial enzyme dihydroorotate dehydrogenase (DHODH). This enzyme plays a critical role in the de novo biosynthesis of pyrimidines, which are essential building blocks for DNA and RNA synthesis. Rapidly dividing cells, such as activated T lymphocytes and B lymphocytes involved in the autoimmune attack on myelin, have a high demand for pyrimidines and depend heavily on the de novo synthesis pathway. By blocking DHODH, teriflunomide restricts the availability of pyrimidines needed for these cells to proliferate, thereby reducing the number of activated immune cells that enter the CNS and cause inflammation and demyelination.
Importantly, resting (non-activated) lymphocytes and other slowly dividing cells can meet their pyrimidine requirements through an alternative metabolic route known as the salvage pathway, which recycles pyrimidines from degraded DNA and RNA. Because teriflunomide does not significantly affect this salvage pathway, the drug selectively targets the rapidly expanding pool of activated immune cells while largely sparing the resting immune cell population. This mechanism underlies the immunomodulatory (rather than broadly immunosuppressive) nature of AUBAGIO and contributes to its favorable safety profile.
Beyond DHODH inhibition, teriflunomide has been shown in preclinical studies to have additional immunomodulatory properties, including effects on cytokine production, protein tyrosine kinases, and nuclear factor-kappa B (NF-κB) signaling pathways. However, the clinical relevance of these additional mechanisms at the therapeutic doses used in MS has not been fully established, and DHODH inhibition is considered the primary mechanism of action.
Clinical Evidence
The efficacy and safety of AUBAGIO in relapsing MS have been established through a robust clinical trial program, including two pivotal phase III randomized, double-blind, placebo-controlled trials:
- TEMSO (Teriflunomide Multiple Sclerosis Oral): This landmark trial enrolled 1,088 patients with relapsing MS. Over a 108-week treatment period, teriflunomide 14 mg demonstrated a 31.5% relative reduction in annualized relapse rate (ARR) compared to placebo (0.37 vs. 0.54, p < 0.001). Additionally, teriflunomide 14 mg significantly reduced the risk of sustained disability progression (confirmed at 12 weeks) by 29.8% compared to placebo. MRI outcomes also showed significant reductions in lesion activity, including a 67% reduction in T1 gadolinium-enhancing lesions.
- TOWER: This confirmatory trial enrolled 1,169 patients with relapsing MS. Over a variable treatment period (minimum 48 weeks), teriflunomide 14 mg reduced the ARR by 36.3% compared to placebo (0.32 vs. 0.50, p < 0.001) and reduced the risk of sustained disability progression (confirmed at 12 weeks) by 31.5% compared to placebo.
Long-term extension studies following the pivotal trials have demonstrated sustained efficacy over more than 12 years of continuous treatment, with maintained reductions in relapse rates and stable or slowly progressing disability scores in many patients. The long-term safety profile has remained consistent with that observed in the controlled trial periods, without new safety signals emerging.
AUBAGIO was first approved by the U.S. Food and Drug Administration (FDA) in September 2012 and by the European Medicines Agency (EMA) in August 2013 for the treatment of relapsing forms of MS in adults. In 2021, the EMA extended the indication to include children and adolescents aged 10 years and older based on data from the TERIKIDS pediatric trial, making AUBAGIO one of the few oral disease-modifying therapies approved for pediatric MS. It is now approved in more than 80 countries worldwide and is recommended in international treatment guidelines as a first-line option for relapsing MS.
AUBAGIO is widely regarded as an effective first-line oral disease-modifying therapy for relapsing-remitting MS. International guidelines, including those from the American Academy of Neurology (AAN) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), recommend teriflunomide as one of several appropriate initial treatment options for patients with active relapsing MS, particularly for those who prefer oral administration over injectable therapies.
What Should You Know Before Taking AUBAGIO?
Contraindications
There are several absolute contraindications to the use of AUBAGIO. You must not take this medication if any of the following apply to you:
- Allergy: Hypersensitivity to teriflunomide or any of the excipients in the formulation. If you have had severe skin reactions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis), blistering, or mouth ulcers after taking teriflunomide or leflunomide, you must not use AUBAGIO.
- Pregnancy and breastfeeding: AUBAGIO is contraindicated during pregnancy due to the risk of birth defects (teratogenicity). It must also not be used while breastfeeding, as teriflunomide is excreted in breast milk.
- Severe liver disease: Patients with severe hepatic impairment (Child-Pugh class C) must not take AUBAGIO due to the risk of worsening liver function and hepatotoxicity.
- Severe immunodeficiency: Conditions such as AIDS or other states of severely compromised immune function contraindicate the use of AUBAGIO.
- Severe bone marrow dysfunction: Significantly impaired bone marrow function or low blood cell counts (severe anemia, leukopenia, or thrombocytopenia) are contraindications.
- Severe active infection: AUBAGIO must not be initiated during an ongoing severe infection, as the drug reduces the number of white blood cells and may impair the ability to fight infections.
- Severe renal impairment requiring dialysis: Patients with kidney disease requiring dialysis must not use AUBAGIO, as the drug is highly protein-bound and cannot be effectively removed by dialysis.
- Severe hypoproteinemia: Very low blood protein levels can increase the free (unbound) fraction of teriflunomide, potentially leading to increased toxicity.
Warnings and Precautions
AUBAGIO can cause serious liver injury, including fatal cases. Your doctor must check your liver function (ALT levels) before starting treatment, every two weeks during the first six months, and periodically thereafter. If your liver enzymes rise significantly (more than 3 times the upper limit of normal), treatment may need to be discontinued and an accelerated elimination procedure may be initiated. Seek immediate medical attention if you develop symptoms such as unexplained nausea, vomiting, abdominal pain, fatigue, dark urine, or yellowing of the skin or eyes.
Before and during treatment with AUBAGIO, the following precautions are important:
- Liver function: Your doctor will perform blood tests to monitor liver enzymes (particularly ALT) before starting treatment, every two weeks for the first six months, and every 8 weeks thereafter. If you have pre-existing liver disease or consume significant amounts of alcohol, the risk of hepatotoxicity may be increased. Symptoms of liver problems include nausea, vomiting, abdominal pain, unusual fatigue, dark urine, and jaundice (yellowing of the skin or eyes).
- Blood pressure: AUBAGIO may cause a slight increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly during treatment, regardless of whether you are already taking antihypertensive medication. If elevated blood pressure develops, appropriate treatment should be initiated.
- Infections: Because AUBAGIO reduces white blood cell counts (particularly lymphocytes), your ability to fight infections may be impaired. Your doctor will check a complete blood count before starting treatment and periodically during treatment. If you develop signs of infection (fever, sore throat, prolonged cough, or unusual weakness), contact your doctor promptly. Herpesvirus infections, including oral herpes and herpes zoster (shingles), have been reported during treatment. In rare cases, serious complications from herpesvirus infections have occurred.
- Respiratory symptoms: Cases of interstitial lung disease (ILD) have been reported with teriflunomide. If you develop unexplained cough or dyspnea (shortness of breath) during treatment, inform your doctor immediately, as additional investigations may be needed.
- Peripheral neuropathy: Numbness, tingling, weakness, or pain in the hands and feet (peripheral neuropathy) has been reported. If you experience these symptoms, consult your doctor, as treatment discontinuation and an accelerated elimination procedure may be considered.
- Skin reactions: Serious skin reactions, including rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. If you develop severe skin rash with blistering or peeling, seek immediate medical attention.
- Wound healing: AUBAGIO may impair wound healing. If you are planning surgery or have an unhealed surgical wound, discuss with your doctor whether treatment should be temporarily suspended with an accelerated elimination procedure.
- Vaccinations: Live vaccines should be avoided during AUBAGIO treatment and for a period after discontinuation until teriflunomide has been eliminated from the body. Inactivated vaccines may be administered, although the immune response may be reduced.
Pregnancy and Breastfeeding
AUBAGIO must not be taken during pregnancy. Teriflunomide has been shown to cause birth defects in animal studies, and the potential risk to human fetuses is considered significant. Women of childbearing potential must use effective contraception during treatment and until plasma teriflunomide levels are confirmed to be below 0.02 mg/L. Due to the very long elimination half-life, this may take up to 2 years without an accelerated elimination procedure.
If you are a woman of childbearing potential, your doctor will confirm that you are not pregnant before starting AUBAGIO treatment. You must use reliable contraception throughout the entire duration of treatment and continue using contraception after stopping AUBAGIO until your doctor confirms through blood tests that teriflunomide levels have fallen below the clinically relevant threshold of 0.02 mg/L. Without an accelerated elimination procedure, the natural elimination of teriflunomide from the body can take up to 2 years due to its long half-life and extensive protein binding.
An accelerated elimination procedure can shorten this waiting period to approximately 11 days. The procedure involves taking either cholestyramine 8 g three times daily or activated charcoal 50 g twice daily for 11 consecutive days. Both agents bind teriflunomide in the gastrointestinal tract and interrupt its enterohepatic recirculation, dramatically accelerating its clearance. After completing the elimination procedure, blood tests on two separate occasions at least 14 days apart must confirm that plasma teriflunomide levels are below 0.02 mg/L before pregnancy may be attempted.
If you become pregnant while taking AUBAGIO, or if you suspect pregnancy within 2 years of stopping treatment without having completed the elimination procedure, you must immediately stop taking the medication and contact your doctor. An accelerated elimination procedure should be initiated promptly, and pregnancy testing should be performed. Your doctor will discuss the potential risks and options with you.
AUBAGIO must not be used while breastfeeding, as teriflunomide has been detected in the breast milk of animals at concentrations similar to those in plasma. The potential for serious adverse effects in the breastfed infant is considered significant.
Driving and Operating Machinery
AUBAGIO may cause dizziness, which can impair your ability to concentrate and react. If you experience dizziness or other symptoms that could affect your ability to drive or operate machinery safely, refrain from these activities until the symptoms resolve. Discuss with your doctor if dizziness persists.
Important Information About Ingredients
AUBAGIO tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medication. AUBAGIO also contains less than 1 mmol (23 mg) of sodium per tablet, making it essentially sodium-free.
How Does AUBAGIO Interact with Other Drugs?
Teriflunomide has a complex pharmacokinetic profile that leads to several clinically significant drug interactions. Unlike many biological therapies used in MS, teriflunomide is a small molecule that is metabolized and can interact with hepatic drug-metabolizing enzymes and drug transporters. Understanding these interactions is essential for safe prescribing, particularly since MS patients may take multiple medications concurrently.
Always inform your doctor and pharmacist about all medications you are taking, including prescription drugs, over-the-counter medications, herbal supplements, and vitamins. This is especially important for the following categories of drugs:
Major Interactions
| Drug/Class | Interaction Mechanism | Clinical Recommendation |
|---|---|---|
| Leflunomide | Teriflunomide is the active metabolite of leflunomide; combined use increases immunosuppressive risk | Do not combine; not recommended |
| Methotrexate, other immunosuppressants | Additive immunosuppression increases infection risk and hematological toxicity | Avoid combination; if switching, use elimination procedure |
| Warfarin | Teriflunomide inhibits CYP2C9, potentially increasing warfarin exposure and INR | Monitor INR closely; dose adjustments may be needed |
| Repaglinide | OATP1B1/B3 and CYP2C8 inhibition by teriflunomide increases repaglinide levels | Use with caution; consider switching to another antidiabetic |
| Rosuvastatin | Inhibition of BCRP and OATP1B1/B3 transporters increases rosuvastatin exposure by 2–3 fold | Reduce rosuvastatin dose; do not exceed 10 mg daily |
| Live vaccines | Immunomodulatory effects may increase risk of infection from live vaccine strains | Avoid during treatment; wait until elimination confirmed |
Other Notable Interactions
| Drug/Class | Interaction Mechanism | Clinical Recommendation |
|---|---|---|
| Rifampicin | Repeated doses of rifampicin increase teriflunomide exposure by approximately 40% via CYP/transporter induction effects | Use with caution; monitor for increased side effects |
| Carbamazepine, phenobarbital, phenytoin | Strong CYP3A4/PXR inducers; effect on teriflunomide not fully characterized | Monitor carefully; clinical effect uncertain |
| Duloxetine | Teriflunomide is a mild inducer of CYP1A2 and inhibitor of OAT3; duloxetine is a CYP1A2 substrate | Monitor for changes in duloxetine efficacy |
| Oral contraceptives (ethinylestradiol/levonorgestrel) | Teriflunomide increases ethinylestradiol (by ~50%) and levonorgestrel exposure | Consider low-dose hormonal contraceptive; contraception remains effective |
| Theophylline | CYP1A2 induction by teriflunomide may decrease theophylline levels | Monitor theophylline levels; dose increase may be needed |
| Cholestyramine, activated charcoal | Dramatically reduces teriflunomide plasma levels by interrupting enterohepatic recirculation | Used therapeutically in accelerated elimination procedure; avoid during active treatment |
| St. John’s Wort | Potent CYP inducer; may affect teriflunomide or co-prescribed drug levels | Avoid concomitant use |
The pharmacokinetic interactions of teriflunomide are primarily driven by its ability to inhibit the drug transporter breast cancer resistance protein (BCRP) and the organic anion transporter polypeptides OATP1B1 and OATP1B3. Drugs that are substrates of these transporters, such as rosuvastatin, may have significantly increased plasma concentrations when co-administered with AUBAGIO. Teriflunomide also inhibits CYP2C8, which metabolizes drugs like repaglinide and pioglitazone, and is a mild inducer of CYP1A2, which metabolizes drugs such as theophylline, tizanidine, and caffeine.
It is particularly important to note that if you are switching from AUBAGIO to another MS medication (or vice versa), an accelerated elimination procedure may be recommended to avoid overlapping immunosuppressive effects. Discuss the transition plan with your neurologist to ensure a safe switch.
Teriflunomide can interfere with laboratory calcium measurements, potentially giving falsely low ionized calcium results. If a blood test suggests unusually low calcium levels while you are taking AUBAGIO, inform your doctor and laboratory that you are on teriflunomide, as the result may need to be re-evaluated.
What Is the Correct Dosage of AUBAGIO?
AUBAGIO treatment should be initiated and supervised by a neurologist experienced in the management of multiple sclerosis. Before starting treatment, your doctor will perform baseline assessments including liver function tests, a complete blood count, blood pressure measurement, and a pregnancy test (for women of childbearing potential). These assessments help ensure that you can safely begin treatment and establish baseline values for ongoing monitoring.
Adults
Adult Dosage
The recommended dose is one 14 mg film-coated tablet taken once daily. The tablet should be swallowed whole with a little water and can be taken at any time of day, with or without food. Consistent timing of the daily dose is recommended to maintain stable drug levels.
In the pivotal clinical trials, the 14 mg dose demonstrated superior efficacy compared to the 7 mg dose, with a favorable benefit-risk balance. The 14 mg dose is therefore the recommended adult dose in most countries. Some regulatory authorities have also approved the 7 mg dose for adults, although this lower dose is generally reserved for patients who do not tolerate the 14 mg dose.
Children and Adolescents (10 Years and Older)
| Body Weight | Recommended Dose | Tablet Strength | Frequency |
|---|---|---|---|
| More than 40 kg | 14 mg | 14 mg tablet | Once daily |
| 40 kg or less | 7 mg | 7 mg tablet | Once daily |
The approval of AUBAGIO for pediatric use was based on the TERIKIDS trial, a phase III study in children and adolescents aged 10 to 17 years with relapsing MS. Children whose body weight reaches and stabilizes above 40 kg during treatment should be switched from the 7 mg to the 14 mg dose as directed by their doctor. AUBAGIO has not been studied in children under 10 years of age, and its use in this group is not recommended.
For pediatric patients, the same monitoring schedule for liver function, blood counts, and blood pressure applies as for adults. Additionally, pancreatitis has been observed more frequently in pediatric patients receiving teriflunomide compared to adults. If pancreatitis is suspected, your child’s doctor may order blood tests to check pancreatic enzyme levels (amylase and lipase).
Elderly Patients
No dose adjustment is required for elderly patients. Clinical experience in patients aged 65 and older is limited, but the available data do not suggest a need for dose modification. However, as with any medication in elderly patients, careful monitoring of liver function, blood counts, and overall clinical status is advisable, particularly given the higher prevalence of comorbidities and polypharmacy in this age group.
Missed Dose
If you forget to take a dose of AUBAGIO, do not take a double dose to make up for the missed one. Simply take your next dose at the usual scheduled time. The long elimination half-life of teriflunomide (approximately 18–19 days) means that missing a single dose will not significantly affect the overall drug levels in your blood. However, try to take your medication consistently each day to maintain optimal therapeutic levels.
Overdose
If you take more AUBAGIO than prescribed, contact your doctor or go to the nearest hospital emergency department immediately. You may experience side effects similar to those described in the side effects section, but potentially at greater severity. In the event of significant overdose or severe toxicity, your doctor may initiate an accelerated elimination procedure using cholestyramine or activated charcoal to rapidly clear teriflunomide from your body. There is no specific antidote for teriflunomide.
Stopping Treatment
Do not stop taking AUBAGIO or change your dose without first consulting your doctor. If your doctor decides to discontinue treatment, they may recommend an accelerated elimination procedure. This is particularly important if you are planning to become pregnant, if you are switching to another MS medication, or if you experience a serious adverse effect. Without the elimination procedure, teriflunomide can remain in the body at potentially relevant levels for up to 2 years after the last dose.
What Are the Side Effects of AUBAGIO?
Like all medicines, AUBAGIO can cause side effects, although not everyone who takes it will experience them. The side effects listed below have been observed during clinical trials and post-marketing surveillance. Many of the common side effects tend to be most prominent during the first few months of treatment and may diminish over time. However, some effects, particularly hepatotoxicity and hematological changes, require ongoing monitoring throughout the course of treatment.
Serious Side Effects
Some side effects can be serious and require immediate medical attention. Contact your doctor right away if you experience any of the following:
Common Serious Effects
May affect up to 1 in 10 people
- Pancreatitis (inflammation of the pancreas) – symptoms include abdominal pain, nausea, vomiting (more common in children and adolescents than in adults)
Uncommon Serious Effects
May affect up to 1 in 100 people
- Allergic reactions (rash, hives, swollen lips, tongue or face, sudden difficulty breathing)
- Severe skin reactions (skin rash with blistering, fever, mouth ulcers)
- Serious infections or sepsis (high fever, chills, confusion, decreased urine output)
- Interstitial lung disease (unexplained shortness of breath, persistent cough)
Frequency Not Known
Cannot be estimated from available data
- Serious liver disease (yellowing of skin or eyes, dark urine, unexplained nausea and vomiting, abdominal pain)
Other Side Effects by Frequency
Very Common
May affect more than 1 in 10 people
- Headache
- Diarrhea, nausea
- Elevated ALT (liver enzyme changes seen in blood tests)
- Hair thinning (alopecia)
Common
May affect up to 1 in 10 people
- Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat, cystitis, viral gastroenteritis, dental infection, laryngitis, fungal foot infection
- Herpesvirus infections (oral herpes, herpes zoster/shingles with blisters, burning, itching, numbness or pain)
- Anemia (decreased red blood cells), changes in white blood cell counts, elevated creatine phosphokinase
- Mild allergic reactions, anxiety
- Tingling, weakness, numbness (paraesthesia), sciatica, carpal tunnel syndrome
- Palpitations, increased blood pressure
- Vomiting, toothache, upper abdominal pain
- Skin rash, acne
- Tendon pain, joint pain, bone pain, muscle pain (musculoskeletal pain)
- Frequent urination, heavy menstrual periods
- Pain, lack of energy or weakness (asthenia), weight loss
Uncommon
May affect up to 1 in 100 people
- Mild thrombocytopenia (decreased platelet count)
- Increased sensitivity, peripheral neuropathy (nerve problems in arms or legs)
- Nail disorders, severe skin reactions
- Psoriasis, inflammation of mouth/lips (stomatitis)
- Abnormal blood lipid levels, colitis (inflammation of the colon)
Rare
May affect up to 1 in 1,000 people
- Hepatitis (liver inflammation) or liver damage
Frequency Not Known
Cannot be estimated from available data
- Pulmonary hypertension (elevated blood pressure in the blood vessels of the lungs)
Additional Information for Children and Adolescents
The side effect profile in children and adolescents aged 10 years and older is generally similar to that observed in adults. However, pancreatitis (inflammation of the pancreas) has been reported more frequently in pediatric patients and is classified as a common side effect in this age group, compared to an uncommon occurrence in adults. Parents and caregivers should be aware of symptoms of pancreatitis, including abdominal pain, nausea, and vomiting, and should seek prompt medical attention if these occur.
Hair thinning (alopecia) is one of the most common side effects of AUBAGIO, reported in approximately 10–15% of patients taking the 14 mg dose. This hair loss is typically diffuse, mild to moderate, and most often occurs during the first 6 months of treatment. In most cases, hair thinning resolves spontaneously while continuing treatment, and does not require dose adjustment or treatment discontinuation. Complete hair loss (alopecia totalis) has not been reported with AUBAGIO.
How Should You Store AUBAGIO?
AUBAGIO does not require any special storage conditions, which is a practical advantage for patients. The film-coated tablets are stable at room temperature and do not need refrigeration. Follow these storage guidelines:
- Room temperature storage: Store AUBAGIO at room temperature. No special temperature range is specified, as the tablets are stable under normal household conditions.
- Keep in original packaging: Keep the tablets in the original blister pack or wallet until ready to take them. This protects the tablets from moisture and light.
- Keep out of reach of children: Store AUBAGIO in a secure location that is out of sight and reach of children.
- Check expiration date: Do not use AUBAGIO after the expiration date (“EXP”) printed on the carton and blister pack. The expiration date refers to the last day of that month.
- Proper disposal: Do not dispose of unused medications via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. These measures help protect the environment.
When traveling with AUBAGIO, keep the medication in your carry-on luggage in its original packaging. There are no restrictions on carrying AUBAGIO through airport security or customs, but it is advisable to carry a copy of your prescription or a letter from your doctor confirming the medication is prescribed to you. Store the medication in a cool, dry place and avoid exposure to excessive heat or humidity during transit.
What Does AUBAGIO Contain?
Active Ingredient
The active substance is teriflunomide, a selective inhibitor of dihydroorotate dehydrogenase (DHODH). Each film-coated tablet contains either 7 mg or 14 mg of teriflunomide.
Inactive Ingredients (Excipients)
| Ingredient | Role | Notes |
|---|---|---|
| Teriflunomide | Active substance | 7 mg or 14 mg per tablet |
| Lactose monohydrate | Filler / diluent | May affect patients with lactose intolerance |
| Corn starch | Disintegrant / binder | Aids tablet dissolution |
| Microcrystalline cellulose | Filler / binder | Provides tablet structure |
| Sodium starch glycolate (Type A) | Disintegrant | Facilitates tablet breakup |
| Hydroxypropylcellulose | Binder | Maintains tablet integrity |
| Magnesium stearate | Lubricant | Prevents sticking during manufacturing |
| Hypromellose, titanium dioxide (E171), talc, macrogol 8000, indigo carmine aluminum lake (E132) | Film coating | Provides color and protects the tablet |
The 7 mg tablet also contains yellow iron oxide (E172) in the film coating, giving it a pale blue-green color. The 14 mg tablet does not contain this colorant and appears pale blue to pastel blue.
Appearance and Pack Sizes
AUBAGIO 7 mg: Very pale blue-green to pale blue-green, hexagonal (six-sided) film-coated tablets, debossed with “7” on one side and the company logo on the other. Available in cartons of 28 tablets in integrated blister packs.
AUBAGIO 14 mg: Pale blue to pastel blue, pentagonal (five-sided) film-coated tablets, debossed with “14” on one side and the company logo on the other. Available in cartons of 14, 28, 84, or 98 tablets in integrated blister packs, or 10 x 1 tablets in unit-dose blisters. Not all pack sizes may be marketed in every country.
Marketing Authorization Holder and Manufacturer
AUBAGIO is developed and marketed by Sanofi. The marketing authorization holder is Sanofi Winthrop Industrie (Gentilly, France). The tablets are manufactured at Sanofi facilities in Compiègne and Tours, France. Multiple generic versions of teriflunomide are also available from other manufacturers, including Teriflunomide Sandoz, Teriflunomide STADA, Teriflunomide Viatris, Teriflunomide Krka, Teriflunomide Vivanta, and Teriflunomide Zentiva.
Frequently Asked Questions About AUBAGIO
AUBAGIO (teriflunomide) is a prescription immunomodulatory medication used for the treatment of relapsing-remitting multiple sclerosis (RRMS) in adults and in children and adolescents aged 10 years and older. Multiple sclerosis is a chronic autoimmune disease where the immune system attacks the protective myelin sheath surrounding nerves in the brain and spinal cord, causing inflammation and nerve damage. AUBAGIO helps reduce the frequency of relapses (flare-ups of symptoms) and slows the progression of physical disability associated with MS.
AUBAGIO reaches therapeutic plasma concentrations relatively quickly, with steady-state levels typically achieved within 3 months of starting daily dosing. In clinical trials, reductions in MRI lesion activity were observed within the first few months of treatment. However, the full clinical benefit of AUBAGIO in reducing relapse rates and slowing disability progression is typically assessed over a period of at least 6 to 12 months. Your neurologist will monitor your response to treatment through regular clinical assessments and may order MRI scans to evaluate disease activity.
Hair thinning (not complete hair loss) is one of the more common side effects of AUBAGIO, affecting approximately 10–15% of patients on the 14 mg dose. The thinning is typically diffuse and mild to moderate in severity, usually occurring during the first 6 months of treatment. Importantly, in the majority of patients, hair thinning resolves spontaneously while continuing treatment, without needing to stop or reduce the dose. Complete hair loss (alopecia totalis) has not been reported with AUBAGIO. If hair thinning is bothersome, discuss it with your neurologist.
Because AUBAGIO can affect the liver and elevated liver enzymes (ALT) are a common side effect, excessive alcohol consumption is not recommended during treatment. Alcohol also places stress on the liver, and combining it with teriflunomide may increase the risk of liver damage. Occasional moderate alcohol consumption may be acceptable for many patients, but you should discuss your individual alcohol intake with your doctor, particularly if you have any pre-existing liver conditions. Your doctor will monitor your liver function through regular blood tests during treatment.
AUBAGIO is one of several oral disease-modifying therapies available for relapsing MS, alongside drugs like dimethyl fumarate (Tecfidera), fingolimod (Gilenya), siponimod (Mayzent), and cladribine (Mavenclad). What distinguishes AUBAGIO is its specific mechanism of action (DHODH inhibition), its well-established long-term safety profile with over a decade of clinical experience, and its simple once-daily oral dosing without the need for first-dose observation or specialized monitoring protocols required by some other MS therapies. However, it is generally considered a moderate-efficacy therapy compared to high-efficacy agents like natalizumab, ocrelizumab, or alemtuzumab, which may be more appropriate for patients with highly active disease.
Because teriflunomide has a very long elimination half-life (approximately 18–19 days), it can remain in the body for up to 2 years after the last dose through natural elimination. To safely plan a pregnancy, your doctor will initiate an accelerated elimination procedure using either cholestyramine (8 g three times daily for 11 days) or activated charcoal (50 g twice daily for 11 days). After completing this procedure, two separate blood tests taken at least 14 days apart must confirm that your plasma teriflunomide level has fallen below 0.02 mg/L before you attempt to conceive. This is essential to minimize the risk of birth defects.
References
- European Medicines Agency (EMA). AUBAGIO (teriflunomide) – Summary of Product Characteristics. Last updated 2025. Available at: EMA AUBAGIO EPAR.
- U.S. Food and Drug Administration (FDA). AUBAGIO (teriflunomide) – Prescribing Information. Sanofi Genzyme. Revised 2024.
- O’Connor P, Wolinsky JS, Confavreux C, et al. Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis (TEMSO). N Engl J Med. 2011;365(14):1293–1303. doi:10.1056/NEJMoa1014656.
- Confavreux C, O’Connor P, Comi G, et al. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(3):247–256. doi:10.1016/S1474-4422(13)70308-9.
- Chitnis T, Banwell B, Engmann NJ, et al. Teriflunomide in pediatric multiple sclerosis: Results of the TERIKIDS study. Neurology. 2021;96(8):e1170–e1187.
- Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Neurology. 2018;90(17):777–788. doi:10.1212/WNL.0000000000005347.
- Montalban X, Gold R, Thompson AJ, et al. ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis. Mult Scler. 2018;24(2):96–120.
- Bar-Or A, Pachner A, Menguy-Vacheron F, et al. Teriflunomide and its mechanism of action in multiple sclerosis. Drugs. 2014;74(6):659–674. doi:10.1007/s40265-014-0212-x.
- World Health Organization (WHO). Multiple Sclerosis. Fact Sheet. 2023. Available at: WHO Multiple Sclerosis.
- British National Formulary (BNF). Teriflunomide. National Institute for Health and Care Excellence (NICE). 2025.
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