Teriflunomide Orion (Teriflunomide 14 mg)
Oral disease-modifying therapy for relapsing-remitting multiple sclerosis
Quick Facts About Teriflunomide Orion
Key Takeaways About Teriflunomide Orion
- Once-daily oral MS therapy: Teriflunomide Orion is taken as a single 14 mg tablet each day, offering a convenient alternative to injectable MS treatments
- Reduces relapses: Clinical trials show teriflunomide reduces the annualized relapse rate by roughly 30% and slows disability progression compared to placebo
- Strict pregnancy warning: Teriflunomide can cause serious birth defects and is contraindicated during pregnancy — effective contraception is essential for both women and men of reproductive potential
- Regular liver monitoring required: Liver enzyme tests (ALT) are needed before starting, every two weeks for the first six months, then every eight weeks to detect potential liver injury
- Very long half-life: Teriflunomide can remain in the body for up to two years after stopping; an accelerated elimination procedure is available when rapid removal is needed
What Is Teriflunomide Orion and What Is It Used For?
Teriflunomide Orion is an oral, once-daily disease-modifying therapy used to treat relapsing forms of multiple sclerosis (MS) in adults. Its active ingredient, teriflunomide, modulates the immune system to reduce the frequency of relapses and slow the accumulation of neurological disability.
Teriflunomide Orion is a generic version of teriflunomide that contains the same active ingredient and delivers the same therapeutic effect as the originator brand (Aubagio). As a generic product, it has been developed to meet stringent bioequivalence standards, meaning it is absorbed into the bloodstream at the same rate and to the same extent as the reference medicine. Orion Corporation is a Finnish pharmaceutical company recognized for producing a broad range of prescription generics across the European Economic Area.
Multiple sclerosis is a chronic autoimmune disease of the central nervous system (CNS) in which the body's own immune cells mistakenly attack the myelin sheath — the protective layer surrounding nerve fibers in the brain and spinal cord. This damage disrupts the normal transmission of nerve impulses, leading to symptoms such as fatigue, vision problems, muscle weakness, numbness, poor coordination, and cognitive difficulties. According to the World Health Organization (WHO) and MS International Federation, approximately 2.9 million people live with MS worldwide, and the disease most commonly presents between the ages of 20 and 40, affecting women about two to three times more often than men.
The relapsing-remitting course is the most common form of MS, characterized by distinct episodes of new or worsening neurological symptoms (relapses) followed by periods of partial or complete recovery (remissions). Teriflunomide Orion is specifically approved for patients with this relapsing form of the disease. In some jurisdictions, it is also authorized for active secondary progressive MS with evidence of relapses or new inflammatory activity on MRI scans.
How Teriflunomide Works
Teriflunomide is the active metabolite of leflunomide, a related disease-modifying drug used in rheumatoid arthritis. In MS, teriflunomide's primary mechanism is the selective and reversible inhibition of the mitochondrial enzyme dihydroorotate dehydrogenase (DHODH). This enzyme is essential for the de novo synthesis of pyrimidines — the building blocks of DNA and RNA needed for cell division.
Most resting cells in the body meet their pyrimidine needs through a salvage pathway, recycling existing nucleotides. However, rapidly dividing immune cells such as activated T and B lymphocytes depend heavily on de novo synthesis when they are stimulated. By inhibiting DHODH, teriflunomide preferentially reduces the proliferation of these activated lymphocytes without broadly suppressing the entire immune system. This targeted effect lowers the number of autoreactive immune cells reaching the CNS and reduces the autoimmune attack on myelin.
Clinical trials, including the pivotal TEMSO, TOWER, and TENERE studies, have demonstrated that teriflunomide 14 mg once daily significantly reduces the annualized relapse rate (by approximately 31–36% versus placebo) and slows the progression of sustained physical disability. Magnetic resonance imaging (MRI) outcomes also show meaningful reductions in gadolinium-enhancing lesions and new or enlarging T2 lesions, reflecting reduced CNS inflammation.
Who Is Teriflunomide Orion For?
Teriflunomide Orion is indicated for adult patients with active relapsing forms of multiple sclerosis. The definition of "active" disease varies slightly between regulatory agencies but generally includes recent clinical relapses, new or enlarging MRI lesions, or both. A neurologist typically considers teriflunomide as a first- or second-line oral option for patients with mild-to-moderate disease activity who prefer an oral tablet over injectable or infused therapies.
Teriflunomide Orion does not cure multiple sclerosis. It is a long-term maintenance therapy designed to reduce disease activity and slow progression. Patients typically remain on treatment for years as long as it is tolerated and continues to control the disease effectively.
What Should You Know Before Taking Teriflunomide Orion?
Before starting Teriflunomide Orion, your doctor will check your liver function, blood pressure, blood counts, and rule out pregnancy and serious infections. Teriflunomide is contraindicated in pregnancy, severe liver disease, severe immunodeficiency, significant bone marrow suppression, and severe active infection. Effective contraception is required for both women and men of reproductive potential.
Teriflunomide is a powerful long-term immunomodulator, and proper patient selection is essential for safety. Your neurologist or MS nurse will take a detailed medical history, review your current medicines, and order baseline tests before deciding whether Teriflunomide Orion is appropriate for you. Understanding the contraindications, warnings, and monitoring requirements will help you participate actively in your own care and recognize early signs of problems.
Contraindications
You must not take Teriflunomide Orion if any of the following apply:
- You are allergic (hypersensitive) to teriflunomide, leflunomide, or any of the other ingredients listed in the composition section
- You have severe liver disease (hepatic impairment Child-Pugh class C)
- You are pregnant or could become pregnant and are not using effective contraception
- You are breastfeeding
- You have a severely weakened immune system (for example, AIDS or severe primary immunodeficiency)
- You have significantly reduced bone marrow function or severe anemia, leukopenia, neutropenia, or thrombocytopenia from any cause
- You have a serious active infection that has not resolved
- You have severely reduced kidney function requiring dialysis
- You have severely low blood protein levels (hypoproteinemia), such as in nephrotic syndrome
If you are uncertain about any of these, discuss your medical history in detail with your prescribing physician before beginning treatment.
Warnings and Precautions
Talk to your doctor before taking Teriflunomide Orion if any of the following apply to you:
- Liver problems: Even mild liver enzyme elevations require close monitoring. Your doctor will order baseline and regular ALT tests
- High blood pressure: Teriflunomide can cause or worsen hypertension, so blood pressure should be measured before starting and monitored regularly
- Severe skin reactions: Rare but serious reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. Stop the drug and seek medical advice if a new rash appears
- Respiratory symptoms: New or worsening cough and shortness of breath may indicate interstitial lung disease, which has been reported in association with teriflunomide and leflunomide
- Peripheral neuropathy: Tingling, numbness, or weakness in the hands or feet should be reported, as these can be signs of nerve damage
- Pancreatitis: Severe upper abdominal pain that may radiate to the back could indicate inflammation of the pancreas
- Recent infections: Any unresolved or recurrent infection should be addressed before starting treatment
- Latent tuberculosis: Patients with a history of TB exposure should be screened and treated if necessary before starting teriflunomide
- Recent use of other immunosuppressants or MS therapies: A washout period and additional monitoring may be needed when switching from natalizumab, fingolimod, alemtuzumab, or ocrelizumab
Serious and sometimes fatal liver injury has been reported in patients treated with teriflunomide and with leflunomide, its parent compound. ALT levels must be checked before treatment, every two weeks for the first six months, and then every eight weeks. If ALT exceeds three times the upper limit of normal on confirmed testing, treatment must be stopped and an accelerated elimination procedure initiated. Seek immediate medical attention for jaundice (yellow skin or eyes), dark urine, severe fatigue, nausea, or unexplained abdominal pain.
Pregnancy, Breastfeeding, and Contraception
Teriflunomide is teratogenic in animal studies at doses comparable to human therapeutic doses. Women who are pregnant or could become pregnant must not take teriflunomide. A negative pregnancy test is required before starting therapy, and effective contraception must be used during treatment and until plasma concentrations drop below 0.02 mg/L after stopping the medicine (which can take up to two years without intervention).
- Women of childbearing potential: Use a reliable method of contraception (such as an IUD, combined oral contraceptive, implant, or correctly used barrier methods) throughout treatment
- Planning pregnancy: Inform your neurologist. An accelerated elimination procedure with cholestyramine 8 g three times daily (or 4 g three times daily if not tolerated) or activated charcoal 50 g twice daily for 11 days must be performed
- Before conceiving, two separate blood tests at least 14 days apart must confirm teriflunomide plasma concentration below 0.02 mg/L
- Men planning to father a child: Theoretical risk exists from teriflunomide in semen; men should discuss accelerated elimination with their doctor. Current guidance considers paternal exposure to be low risk, but individual counseling is recommended
- Breastfeeding: Teriflunomide is excreted in animal milk, and human data are limited. It should not be used while breastfeeding
Vaccinations
Live attenuated vaccines (for example, MMR, varicella, oral polio, yellow fever, BCG) are not recommended during teriflunomide treatment because of a theoretical risk of infection in an immunomodulated patient. Inactivated vaccines (for example, influenza, pneumococcal, tetanus, and COVID-19 mRNA or protein-based vaccines) can generally be given, although the immune response may be somewhat reduced. Ideally, complete required vaccinations before starting teriflunomide. Your healthcare team can tailor advice based on local immunization schedules and your travel plans.
Because of the long elimination half-life of teriflunomide and potential risk to recipients, you should not donate blood during treatment and until plasma concentrations have fallen below 0.02 mg/L following an accelerated elimination procedure. Inform any blood donation service about your current or recent use of the medication.
Driving and Operating Machinery
Teriflunomide Orion has no or negligible influence on the ability to drive or use machines in most patients. However, if you experience dizziness, significant fatigue, or changes in vision, do not drive or operate heavy equipment until the symptoms have resolved and your doctor confirms it is safe.
Use in Children and Adolescents
The safety and efficacy of teriflunomide in children and adolescents under 18 years of age have been studied in the TERIKIDS trial, and some regulatory agencies have approved use in pediatric MS patients aged 10 to 17 years. The 14 mg Orion formulation is intended for adults; pediatric dosing may differ. Treatment in children should only be initiated and supervised by a specialist experienced in pediatric MS.
Use in Elderly Patients
No specific dose adjustment is needed for patients over 65, but caution is advised because older adults are more likely to have reduced kidney or liver function and multiple comorbidities. Clinical trials included relatively few patients over 65, so individual risk-benefit assessment is important.
How Does Teriflunomide Orion Interact with Other Drugs?
Teriflunomide can interact with anticoagulants (notably warfarin), some statins, oral contraceptives, and other MS or immunosuppressive medicines. It is a moderate inhibitor of CYP2C8 and an inducer of CYP1A2, and it affects drug transporters such as OAT3, BCRP, and OATP1B1/1B3. Always inform every clinician and pharmacist about your use of Teriflunomide Orion.
Because teriflunomide has a long half-life and influences several drug-metabolizing enzymes and transporters, interactions can persist for weeks or months after stopping. Provide a complete and current list of all prescription medicines, over-the-counter remedies, herbal products, and supplements you use to your prescribing physician, pharmacist, and any clinician you consult.
Major Interactions
| Interacting Drug/Class | Effect | Recommendation |
|---|---|---|
| Warfarin | Teriflunomide may decrease the anticoagulant effect; INR can drop | Monitor INR closely when starting, stopping, or changing dose; adjust warfarin as needed |
| Rosuvastatin | Rosuvastatin plasma exposure increases approximately 2.5-fold (via BCRP/OATP inhibition) | Reduce rosuvastatin dose by 50% when co-administered; consider alternative statin |
| Oral contraceptives (ethinyl estradiol, levonorgestrel) | Teriflunomide modestly increases hormone exposure | Usually not clinically significant; consider when selecting contraceptive options |
| Repaglinide, paclitaxel, pioglitazone (CYP2C8 substrates) | Teriflunomide can increase exposure via CYP2C8 inhibition | Use with caution; monitor for side effects and consider dose adjustment |
| Duloxetine, theophylline, tizanidine (CYP1A2 substrates) | Teriflunomide may reduce plasma levels via CYP1A2 induction | Monitor clinical response; dose adjustment may be required |
| Leflunomide | Teriflunomide is the active metabolite of leflunomide; combined use leads to excessive exposure | Do not use concomitantly |
| Methotrexate and other hepatotoxic drugs | Additive risk of liver injury | Use with caution; more frequent liver monitoring advised |
| Live attenuated vaccines | Risk of infection from attenuated pathogens | Avoid during treatment and for six months after accelerated elimination |
| Other immunosuppressants and MS therapies (natalizumab, fingolimod, alemtuzumab) | Additive immunosuppression and potential infection risk | Concomitant use not generally recommended; specialist supervision required when switching |
Minor Interactions
Teriflunomide also interacts with several other drugs to a lesser degree, usually without requiring dose adjustment but warranting awareness:
- Caffeine and melatonin (CYP1A2 substrates): Effects may be slightly reduced
- NSAIDs and ACE inhibitors: No direct pharmacokinetic interaction, but combined effects on blood pressure and renal function may occur in susceptible patients
- Cholestyramine and activated charcoal: These accelerate teriflunomide elimination and should only be used intentionally under medical supervision — accidental concomitant use can reduce efficacy
- Food: Teriflunomide can be taken with or without food; a high-fat meal does not meaningfully affect absorption
Always tell a physician, pharmacist, or dentist that you are taking Teriflunomide Orion. Because of its 18–19 day half-life, interactions can still matter for several weeks after you stop the medicine unless accelerated elimination is performed.
What Is the Correct Dosage of Teriflunomide Orion?
The recommended dose of Teriflunomide Orion in adults is one 14 mg tablet taken once daily by mouth, with or without food. The tablet should be swallowed whole with a glass of water. Do not crush or chew the tablet. Dosing is the same for all adults regardless of weight, and no routine dose adjustment is required for age or mild-to-moderate kidney or liver impairment.
Teriflunomide Orion is designed for long-term, continuous daily dosing. Because of its slow elimination, a loading dose is not required — steady-state plasma concentrations are achieved after approximately three months of daily dosing. Consistency in timing helps maintain stable blood levels and supports medication adherence.
Adults
Standard adult dose: 14 mg once daily
Take one 14 mg film-coated tablet every day at approximately the same time. The tablet should be swallowed whole with water. Food does not meaningfully affect absorption, so Teriflunomide Orion can be taken with or without meals according to personal preference. Establishing a fixed routine — for example, with breakfast or bedtime — improves adherence.
Children and Adolescents
Pediatric use (10–17 years)
In regions where teriflunomide is approved for pediatric MS, the dose is weight-based: 7 mg once daily for patients weighing 40 kg or less, and 14 mg once daily for patients weighing more than 40 kg. The Teriflunomide Orion 14 mg tablet is not suitable for children requiring the 7 mg dose, and those patients should receive an appropriate alternative strength. Treatment in children must be initiated by a neurologist experienced in managing pediatric MS.
Elderly Patients
Patients over 65 years
No specific dose adjustment is required based on age alone. However, elderly patients often have reduced renal or hepatic function and may take more concomitant medications, so individualized assessment is important. Monitor blood pressure, liver enzymes, and renal function more frequently if clinically indicated.
Patients with Kidney or Liver Impairment
Renal or hepatic impairment
No dose adjustment is needed for patients with mild or moderate kidney impairment or mild to moderate hepatic impairment. However, teriflunomide is contraindicated in severe hepatic impairment (Child-Pugh class C) and has not been studied adequately in severe renal impairment requiring dialysis.
Missed Dose
What to do if you miss a dose
If you forget to take a dose, take it as soon as you remember on the same day. If it is already close to the time of the next dose, skip the missed dose and continue with your normal schedule. Do not take two doses to make up for a missed one. Because teriflunomide has a long half-life, a single missed dose has minimal impact on overall therapy, but chronic non-adherence can reduce efficacy.
Overdose
If too much is taken
There is limited experience with teriflunomide overdose in humans. Doses up to 70 mg daily for 14 days were generally well tolerated in healthy volunteers. In case of suspected overdose, contact a poison control center or emergency services immediately. Treatment may include an accelerated elimination procedure with cholestyramine or activated charcoal to remove the drug more quickly from the body. Symptomatic and supportive care should be provided as needed.
Monitoring During Treatment
| Test | Baseline | First 6 Months | After 6 Months |
|---|---|---|---|
| ALT (liver enzymes) | Required | Every 2 weeks | Every 8 weeks |
| Complete blood count | Required | As clinically indicated | Periodically |
| Blood pressure | Required | Periodically | Periodically |
| Pregnancy test (women) | Required | If pregnancy suspected | If pregnancy suspected |
| TB screening | Consider in high-risk patients | If new exposure | If new exposure |
Accelerated Elimination Procedure
In certain circumstances — such as serious side effects, planned pregnancy, or a need to switch to a treatment that requires low teriflunomide levels — it is important to remove the drug from the body quickly. The standard accelerated elimination procedures are:
- Cholestyramine 8 g three times daily for 11 days (or 4 g three times daily if the higher dose is not tolerated); or
- Activated charcoal powder 50 g twice daily for 11 days
After completing either regimen, two separate blood tests at least 14 days apart are required to confirm plasma teriflunomide concentration below 0.02 mg/L. The procedure is highly effective and typically reduces levels from the steady-state range (approximately 2–3 mg/L) to below the target within 11 days.
What Are the Side Effects of Teriflunomide Orion?
The most common side effects of Teriflunomide Orion include headache, diarrhea, nausea, hair thinning (alopecia), elevated liver enzymes, increased blood pressure, and upper respiratory infections. Serious but less common side effects include significant liver injury, interstitial lung disease, peripheral neuropathy, pancreatitis, and severe skin reactions. Seek urgent medical advice for jaundice, unusual rash, new breathing problems, or numbness in hands and feet.
Like all medicines, Teriflunomide Orion can cause side effects, although not everyone experiences them. Most adverse effects are mild to moderate and tend to improve or stabilize with continued treatment. However, some side effects — particularly those involving the liver, lungs, skin, or nerves — can be serious and require prompt recognition and action. Understanding the frequency and nature of possible side effects helps you participate in your own monitoring and reporting.
Contact your doctor or emergency services immediately if you experience: yellowing of the skin or eyes (jaundice); dark urine; severe or persistent abdominal pain; unexplained nausea or vomiting; new or worsening shortness of breath or persistent cough; widespread skin rash, especially with blisters or peeling; swelling of the face, lips, tongue, or throat; high fever with sore throat; or signs of serious infection. These may indicate severe liver injury, interstitial lung disease, severe cutaneous reactions, or other medical emergencies.
Frequency of Side Effects
Very Common (affects more than 1 in 10 patients)
- Headache — typically mild to moderate and often improves over time
- Diarrhea — usually mild; rarely leads to discontinuation
- Nausea — often transient, improves within the first few weeks
- Alopecia (hair thinning) — typically diffuse thinning, usually resolves or stabilizes within 6 months
- Elevated alanine aminotransferase (ALT) — mild liver enzyme rises are common and usually transient
- Influenza and upper respiratory tract infections — including the common cold, sinusitis, and bronchitis
Common (affects up to 1 in 10 patients)
- Hypertension — new-onset or worsening high blood pressure
- Paresthesia (tingling, pins and needles)
- Abdominal pain, dyspepsia, vomiting
- Muscle or joint pain (myalgia, arthralgia)
- Urinary tract infection, gastroenteritis, oral herpes
- Neutropenia and lymphopenia — reduced white blood cell counts
- Anxiety
- Peripheral neuropathy (sensory or motor)
- Acne
- Weight loss
- Elevated gamma-glutamyl transferase (GGT) or aspartate aminotransferase (AST)
- Elevated creatine phosphokinase (CK)
Uncommon (affects up to 1 in 100 patients)
- Hypokalemia (low blood potassium)
- Mild hyperlipidemia
- Hyperesthesia, post-herpetic neuralgia
- Palpitations
- Stomatitis (mouth inflammation)
- Thrombocytopenia (reduced platelet counts)
- Psoriasis or nail disorders
- Severe rash or pruritus
- Mild allergic reactions
Rare or Very Rare (fewer than 1 in 1,000 patients)
- Severe hepatic injury and hepatitis, including rare cases of acute liver failure
- Interstitial lung disease — presenting as cough, dyspnea, and fever
- Pancreatitis — severe abdominal pain radiating to the back
- Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) — life-threatening skin reactions
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Anaphylactic or anaphylactoid reactions
- Serious opportunistic infections, including TB reactivation
- Progressive multifocal leukoencephalopathy (PML) has been reported very rarely, particularly after switching from other immunosuppressive therapies
- Colitis
Hair Thinning (Alopecia)
One of the most noticeable cosmetic side effects is diffuse hair thinning, sometimes described as "telogen effluvium." This typically begins within the first 3 to 6 months of treatment and usually affects the scalp diffusely rather than causing patchy hair loss. Most patients find that hair thinning stabilizes or improves over time, and it rarely leads to discontinuation. If hair loss is distressing or severe, discuss options with your healthcare team, including topical treatments or consultation with a dermatologist.
Liver Injury
ALT elevation occurs in many patients early in treatment and is usually mild and transient. However, clinically significant liver injury — sometimes requiring treatment discontinuation and accelerated elimination — has been reported. Severe liver failure is very rare but can be fatal. Adherence to the monitoring schedule is essential. Symptoms such as new-onset fatigue, loss of appetite, right upper abdominal pain, dark urine, pale stools, or jaundice should prompt immediate medical review and liver function testing.
Interstitial Lung Disease
Interstitial lung disease (ILD), including fatal cases, has been reported with both teriflunomide and leflunomide. New or worsening respiratory symptoms such as cough and breathlessness — with or without fever — should prompt pulmonary evaluation. If ILD is suspected or confirmed, the drug should be discontinued and accelerated elimination considered.
Managing and Reporting Side Effects
It is important to report any suspected side effects to your healthcare team, even if you are not sure whether they are related to the medicine. Prompt reporting helps your clinical team intervene early and also contributes to ongoing pharmacovigilance. In most countries, patients and family members can also report adverse drug reactions directly to national medicines agencies through their yellow-card or MedWatch systems.
How Should You Store Teriflunomide Orion?
Store Teriflunomide Orion tablets in their original blister pack at room temperature, typically below 30°C, in a dry place away from direct sunlight. Keep out of the sight and reach of children. Do not use the medicine after the expiry date printed on the packaging, and return any unused tablets to a pharmacy for safe disposal.
Correct storage preserves the potency and safety of the medicine throughout its shelf life. Teriflunomide is a relatively stable compound and does not require refrigeration, but it should be protected from extreme temperatures, humidity, and direct light. The standard storage conditions described on the product packaging are similar across most European and international markets.
Storage Conditions
- Temperature: Store below 30°C (86°F). Do not refrigerate or freeze
- Humidity and light: Keep tablets in the original blister pack to protect from moisture and light. Do not transfer to a different container unless instructed by a pharmacist
- Child safety: Keep out of reach and sight of children. Consider a locked cabinet if young children or vulnerable adults live in the household
- Shelf life: Do not use Teriflunomide Orion after the expiry date shown on the blister and outer carton. The expiry date refers to the last day of that month
Disposal of Unused Medicines
Do not dispose of unused or expired Teriflunomide Orion via household waste, toilets, or sinks. Because it contains an immunomodulator with environmental and safety concerns, return unused tablets to your pharmacy for proper disposal. Most countries operate medicine take-back programs, which ensure safe incineration and prevent environmental contamination and accidental exposure.
Keep the medicine in its original container with the pharmacist's label when traveling. Carry it in your hand luggage when flying, along with a copy of the prescription or a letter from your prescriber, especially for international travel. Temperatures above 30°C in checked baggage or in a hot car can degrade the tablets.
What Does Teriflunomide Orion Contain?
Each Teriflunomide Orion film-coated tablet contains 14 mg of teriflunomide as the active ingredient, along with lactose, other standard tablet excipients, and a film coating. The tablets are gluten-free, but patients with galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should avoid them due to lactose content.
The full qualitative and quantitative composition of Teriflunomide Orion is specified in the official Summary of Product Characteristics (SmPC) approved in your region. The information below reflects the typical composition of teriflunomide 14 mg tablet formulations. Always confirm the exact composition with your current pack insert, because excipients can vary slightly between generic manufacturers and batches.
Active Ingredient
- Teriflunomide 14 mg per film-coated tablet
Tablet Core (Excipients / Inactive Ingredients)
Typical excipients in the tablet core include:
- Lactose monohydrate — a filler and diluent
- Maize starch (corn starch) — a disintegrant
- Microcrystalline cellulose — a filler and binder
- Hydroxypropylcellulose — a binder
- Sodium starch glycolate — a disintegrant
- Magnesium stearate — a lubricant
- Colloidal anhydrous silica — a glidant
Film Coating
The film coating typically contains:
- Hypromellose
- Titanium dioxide (E171)
- Talc
- Macrogol
- Colorants such as indigo carmine aluminium lake (E132) to give the tablet its characteristic color
Important Composition Notes
- Lactose content: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take Teriflunomide Orion
- Sodium content: Each tablet contains less than 1 mmol (23 mg) of sodium, and is essentially "sodium-free"
- Gluten: Teriflunomide Orion tablets are gluten-free and suitable for patients with celiac disease
- Animal-derived ingredients: None of the listed excipients contain animal products; the tablets are generally suitable for vegetarian and vegan patients
Appearance and Packaging
Teriflunomide Orion 14 mg film-coated tablets are typically pale blue, round or pentagonal, with an imprint such as "14" or a manufacturer's code on one side. They are supplied in blister packs containing 14, 28, 84, or 98 tablets, although pack sizes may vary by country. The exact appearance, shape, and pack size for your market is described in the product information leaflet included in the carton.
Frequently Asked Questions About Teriflunomide Orion
Teriflunomide Orion is an oral prescription medicine used to treat adult patients with relapsing forms of multiple sclerosis (MS), most commonly relapsing-remitting MS. It is a disease-modifying therapy (DMT) that reduces the frequency of clinical relapses and slows the accumulation of physical disability by reducing the activity of the immune cells that attack the myelin sheath in the central nervous system. In some regions, it is also approved for pediatric MS patients aged 10 to 17 years.
Teriflunomide has a very long elimination half-life of approximately 18 to 19 days. Without intervention, it can take up to two years for blood levels to drop below the detection limit after discontinuation. If faster elimination is required — for example, because of pregnancy, serious side effects, or a planned switch to another treatment — an accelerated elimination procedure using cholestyramine 8 g three times daily for 11 days, or activated charcoal powder 50 g twice daily for 11 days, can bring plasma concentrations below 0.02 mg/L within about 11 days. Two separate blood tests at least 14 days apart are then used to confirm adequate elimination.
No. Teriflunomide is contraindicated during pregnancy because animal studies and case reports indicate that it can cause serious birth defects. Women of childbearing potential must use effective contraception during treatment and until plasma concentrations fall below 0.02 mg/L after stopping the drug. If pregnancy is planned or occurs, an accelerated elimination procedure must be carried out and pregnancy delayed until teriflunomide levels are confirmed to be sufficiently low on two tests at least 14 days apart.
The most common side effects include headache, diarrhea, nausea, hair thinning (alopecia), elevated liver enzymes (raised ALT), increased blood pressure, and influenza or other upper respiratory tract infections. Most side effects are mild to moderate in severity and tend to improve over time. Hair thinning typically occurs during the first 6 months and usually resolves or stabilizes with continued therapy. Serious but less common side effects include significant liver injury, interstitial lung disease, peripheral neuropathy, pancreatitis, and severe skin reactions.
Yes. Liver function tests (ALT) must be checked before starting treatment, then every two weeks for the first six months, and every eight weeks thereafter or as clinically indicated. Teriflunomide has been associated with elevated liver enzymes and, in rare cases, serious liver injury, so regular monitoring is essential. The medicine should be stopped and an accelerated elimination procedure initiated if ALT exceeds three times the upper limit of normal on confirmed testing. Blood pressure and complete blood counts should also be monitored periodically.
There is no absolute prohibition, but because both alcohol and teriflunomide can stress the liver, it is generally recommended to limit or avoid alcohol during treatment. Patients with any history of liver disease, elevated liver enzymes, or heavy alcohol use should discuss this carefully with their neurologist or pharmacist. Occasional light drinking is usually tolerated by most patients, but regular heavy consumption should be avoided due to cumulative hepatotoxicity risk.
Yes. Teriflunomide Orion is a generic medicine that contains the same active ingredient, strength, dosage form, and route of administration as the originator brand Aubagio. It has been shown to be bioequivalent, meaning it delivers the same active drug to the bloodstream at the same rate and extent. A switch between brands is generally safe and clinically equivalent, but it is best to discuss any change with your neurologist, who may recommend continued monitoring of liver enzymes and blood pressure as a precaution.
Store Teriflunomide Orion tablets in their original blister pack at room temperature, typically below 30°C, away from moisture and direct sunlight. Keep out of the sight and reach of children. Do not use the medicine after the expiry date printed on the packaging. Do not dispose of medicines via wastewater or household waste; return any unused tablets to a pharmacy for safe disposal.
References
- European Medicines Agency (EMA). Teriflunomide — Summary of Product Characteristics (Aubagio and generics). Available at: ema.europa.eu/en/medicines. Accessed January 2026.
- U.S. Food and Drug Administration (FDA). AUBAGIO (teriflunomide) — Prescribing Information. Original approval 2012, updated periodically through 2025.
- 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.
- Vermersch P, Czlonkowska A, Grimaldi LME, et al. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis (TENERE). Mult Scler. 2014;20(6):705-716.
- Chitnis T, Banwell B, Kappos L, et al. Safety and efficacy of teriflunomide in paediatric multiple sclerosis (TERIKIDS): a multicentre, double-blind, phase 3, randomised, placebo-controlled trial. Lancet Neurol. 2021;20(12):1001-1011.
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