Teriflunomid Devatis: Uses, Dosage & Side Effects
A generic oral immunomodulatory agent containing teriflunomide 7 mg for the treatment of relapsing forms of multiple sclerosis
Teriflunomid Devatis is a prescription immunomodulatory medication containing the active substance teriflunomide 7 mg. It is a generic equivalent of the originator product Aubagio and is indicated for the treatment of relapsing forms of multiple sclerosis (MS). Teriflunomide selectively and reversibly inhibits dihydroorotate dehydrogenase (DHODH), a mitochondrial enzyme essential for de novo pyrimidine synthesis in rapidly dividing immune cells. By limiting the proliferation of activated T and B lymphocytes that drive the autoimmune attack on myelin, teriflunomide reduces relapse rates and slows disability progression. Taken orally as a once-daily film-coated tablet, Teriflunomid Devatis offers a convenient disease-modifying therapy with over a decade of accumulated clinical experience through the reference product.
Quick Facts: Teriflunomid Devatis
Key Takeaways
- Teriflunomid Devatis 7 mg is a generic teriflunomide product indicated for relapsing-remitting multiple sclerosis, taken as a once-daily oral film-coated tablet.
- As a generic equivalent of the originator Aubagio, it contains the same active substance (teriflunomide) and must demonstrate pharmaceutical and bioequivalence to the reference product to be approved by the EMA or competent authorities.
- Teriflunomide works by reversibly inhibiting dihydroorotate dehydrogenase (DHODH), reducing the proliferation of activated lymphocytes responsible for myelin damage while largely sparing resting immune cells.
- The drug is contraindicated in pregnancy due to a risk of birth defects. Its very long elimination half-life (approximately 18–19 days) requires an accelerated elimination procedure before conception or when switching to another immunosuppressive therapy.
- Regular monitoring of liver function (ALT), complete blood count, and blood pressure is essential during treatment because hepatotoxicity, infection risk, and hypertension are recognised adverse effects of teriflunomide.
What Is Teriflunomid Devatis and What Is It Used For?
Teriflunomid Devatis contains the active substance teriflunomide, the principal active metabolite of leflunomide (a disease-modifying antirheumatic 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 the drug to reduce the pathological immune responses that damage the central nervous system in multiple sclerosis while preserving a degree of overall immune competence needed for fighting infections and maintaining normal physiological function.
Multiple sclerosis is a chronic autoimmune disease of the central nervous system (CNS), which comprises the brain, spinal cord, and optic nerves. In MS, the immune system mistakenly attacks the protective myelin sheath that insulates nerve fibres (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 initial diagnosis, is characterised 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 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 after a relapse, some patients accumulate residual deficits that can progress to permanent physical disability.
Generic Equivalence to the Reference Product
Teriflunomid Devatis is a generic medicine. A generic medicine contains the same active substance and is used at the same dose(s) to treat the same disease(s) as the originator (reference) product. In the case of teriflunomide, the reference product is Aubagio, developed by Sanofi and first authorised in the United States in 2012 and in the European Union in 2013. Because the patent protection on teriflunomide has expired in many jurisdictions, multiple generic versions are now available, including Teriflunomid Devatis and products from other manufacturers such as Sandoz, STADA, Viatris, Krka, Accord, Vivanta, Ashcure, and Zentiva.
Before a generic teriflunomide product can be approved, the manufacturer must demonstrate that it is pharmaceutically and biologically equivalent to the reference product. Pharmaceutical equivalence requires that the generic contains the same active substance, at the same strength, in the same dosage form, and via the same route of administration. Bioequivalence studies in healthy volunteers must show that the rate and extent of absorption of the generic product fall within accepted regulatory limits (typically a 90% confidence interval for AUC and Cmax between 80% and 125% relative to the reference product). Because teriflunomide is a small-molecule drug with well-characterised pharmacokinetics, these studies give a high degree of confidence that the therapeutic effect, dosing, and safety profile of generic teriflunomide are equivalent to those of Aubagio.
The clinical experience with teriflunomide underlying the approval of Teriflunomid Devatis is therefore the same evidence base that supports Aubagio: more than a decade of randomised trial data, long-term extension studies, and real-world observational data covering tens of thousands of patient-years of exposure. Switching between brand-name and generic teriflunomide products, or between different generics, is generally considered safe and is routinely practised in clinical neurology, though consistent use of a single product may simplify patient understanding and adherence.
How Teriflunomide 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, 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 teriflunomide and contributes to its favourable long-term 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) signalling pathways. However, the clinical relevance of these additional mechanisms at the therapeutic doses used in multiple sclerosis has not been fully established, and DHODH inhibition is considered the primary mechanism of action.
Clinical Evidence
The efficacy and safety of teriflunomide in relapsing MS have been established through a robust clinical trial programme, including two pivotal phase III randomised, 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 annualised relapse rate (ARR) compared to placebo (0.37 vs. 0.54, p < 0.001). Teriflunomide 14 mg also significantly reduced the risk of sustained disability progression (confirmed at 12 weeks) by 29.8% compared to placebo, and MRI outcomes showed a 67% reduction in T1 gadolinium-enhancing lesions.
- TOWER: This confirmatory trial enrolled 1,169 patients with relapsing MS. 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.
- TERIKIDS: A phase III pediatric study in children and adolescents aged 10–17 years with relapsing MS demonstrated a favourable benefit-risk profile in this younger population, leading to the extension of the indication to pediatric patients in 2021.
Long-term extension studies following the pivotal trials have demonstrated sustained efficacy over more than 12 years of continuous teriflunomide 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. Because Teriflunomid Devatis contains the same active substance as the reference product, it is expected to share this efficacy and long-term safety profile.
Teriflunomide 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 or infusion-based therapies.
What Should You Know Before Taking Teriflunomid Devatis?
Contraindications
There are several absolute contraindications to the use of Teriflunomid Devatis. You must not take this medication if any of the following apply to you:
- Hypersensitivity: Allergy to teriflunomide, leflunomide, or any of the excipients in the tablet. 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 Teriflunomid Devatis.
- Pregnancy: Teriflunomide is contraindicated during pregnancy due to the risk of birth defects (teratogenicity). It must not be initiated or continued if you are pregnant or planning pregnancy without first completing an accelerated elimination procedure.
- Breastfeeding: Teriflunomide is excreted in breast milk in animal studies, and the potential for serious adverse effects in the nursing infant is considered significant. Breastfeeding must be discontinued before starting treatment.
- Severe hepatic impairment: Patients with severe liver disease (Child-Pugh class C) must not take teriflunomide 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 teriflunomide.
- Severe bone marrow dysfunction: Significantly impaired bone marrow function or low blood cell counts (severe anaemia, leukopenia, or thrombocytopenia) are contraindications.
- Severe active infection: Teriflunomide must not be initiated during an ongoing severe infection, as the drug reduces lymphocyte counts and may impair the body’s ability to fight infections.
- Severe renal impairment requiring dialysis: Because teriflunomide is more than 99% protein-bound, it cannot be effectively removed by dialysis. Patients with end-stage kidney disease requiring dialysis should not use this medication.
- Severe hypoproteinaemia: Very low blood protein levels, such as those seen in nephrotic syndrome, can increase the free (unbound) fraction of teriflunomide and potentially lead to increased toxicity.
Warnings and Precautions
Teriflunomide can cause serious liver injury, including rare 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 (jaundice).
Before and during treatment with Teriflunomid Devatis, 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.
- Blood pressure: Teriflunomide may cause an 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 teriflunomide 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 dyspnoea (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, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported. If you develop severe skin rash with blistering or peeling, seek immediate medical attention.
- Wound healing: Teriflunomide 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 teriflunomide treatment and for a period after discontinuation until the drug has been eliminated from the body. Inactivated vaccines may be administered, although the immune response may be somewhat reduced.
- Pancreatitis risk (children): Acute pancreatitis has been observed more frequently in pediatric patients receiving teriflunomide than in adults. Parents and carers should seek prompt medical attention if a child on teriflunomide develops abdominal pain, nausea, or vomiting.
Pregnancy and Breastfeeding
Teriflunomid Devatis 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 on two separate tests at least 14 days apart. 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 Teriflunomid Devatis. You must use reliable contraception throughout the entire duration of treatment and continue using contraception after stopping the drug until blood tests confirm 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 enterohepatic recirculation.
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 Teriflunomid Devatis, or if you suspect pregnancy within 2 years of stopping treatment without having completed the elimination procedure, you must immediately stop 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.
Teriflunomid Devatis must not be used while breastfeeding. Teriflunomide has been detected in the breast milk of animals at concentrations similar to those in maternal plasma, and the potential for serious adverse effects in the breastfed infant is considered significant.
Male patients should be aware that teriflunomide is present in semen. The risk of male-mediated fetotoxicity through seminal transfer is considered low, and currently available data do not suggest a clinically significant risk. Nevertheless, if a male patient’s partner is planning a pregnancy, a discussion with the treating physician regarding individualised risk-benefit considerations is advisable.
Driving and Operating Machinery
Teriflunomid Devatis 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
Teriflunomid Devatis tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars (such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption), consult your doctor before taking this medication. The tablets also contain less than 1 mmol (23 mg) of sodium per tablet, and can therefore be considered essentially “sodium-free”.
How Does Teriflunomid Devatis 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 metabolised and can interact with hepatic drug-metabolising enzymes and drug transporters. Understanding these interactions is essential for safe prescribing, particularly since patients with multiple sclerosis often take several medications concurrently for symptomatic management or comorbid conditions.
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 causes additive exposure and increases immunosuppressive risk | Do not combine; contraindicated co-administration |
| Methotrexate and other immunosuppressants | Additive immunosuppression increases infection risk and haematological toxicity | Avoid combination; if switching therapies, use accelerated elimination procedure |
| Warfarin | Teriflunomide inhibits CYP2C9, potentially increasing warfarin exposure and INR | Monitor INR closely; dose adjustments may be needed |
| Repaglinide, pioglitazone | CYP2C8 inhibition by teriflunomide increases repaglinide and pioglitazone plasma levels | Use with caution; consider dose reduction or switching antidiabetic agent |
| 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 attenuated 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 combined CYP/transporter induction effects | Use with caution; monitor for increased side effects |
| Carbamazepine, phenobarbital, phenytoin | Strong CYP3A4/PXR inducers; overall effect on teriflunomide not fully characterised | Monitor clinical response carefully; adjust as needed |
| 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; contraceptive efficacy is maintained |
| Theophylline, tizanidine, caffeine | CYP1A2 induction by teriflunomide may decrease plasma levels of CYP1A2 substrates | Monitor levels and clinical response; 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/PXR 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 Teriflunomid Devatis. Teriflunomide also inhibits CYP2C8, which metabolises drugs such as repaglinide and pioglitazone, and is a mild inducer of CYP1A2, which metabolises drugs such as theophylline, tizanidine, and caffeine.
It is particularly important to note that if you are switching from Teriflunomid Devatis 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. For patients transitioning to highly immunosuppressive therapies (such as natalizumab, ocrelizumab, alemtuzumab, or cladribine), careful planning is essential to minimise the window of combined immunological effect.
Teriflunomide can interfere with some laboratory calcium assays, potentially giving falsely low ionised calcium results. If a blood test suggests unusually low calcium levels while you are taking Teriflunomid Devatis, inform your doctor and the laboratory that you are on teriflunomide, as the result may need to be re-evaluated using an alternative method.
What Is the Correct Dosage of Teriflunomid Devatis?
Teriflunomid Devatis 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 (ALT), a complete blood count, tuberculosis screening (if indicated), 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 during therapy.
Adults
Adult Dosage (Teriflunomide)
The recommended adult dose of teriflunomide for relapsing MS is 14 mg once daily. Because Teriflunomid Devatis is marketed as a 7 mg tablet, adults on the 14 mg regimen require a 14 mg formulation (available under other brands and generic names). The 7 mg strength of Teriflunomid Devatis may be used in adults only when specifically directed by the treating physician, for example, during tolerance assessment, in selected special populations, or in pediatric dose titration.
In the pivotal clinical trials, the 14 mg dose demonstrated superior efficacy compared to the 7 mg dose in adults, with a favourable benefit-risk balance. The 14 mg dose is therefore the recommended adult dose in most countries. The 7 mg dose was approved in some jurisdictions but generally produced smaller effects on disability progression and MRI outcomes in adults; its routine use in adults is limited.
Children and Adolescents (10 Years and Older)
The approval of teriflunomide 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. For pediatric patients, the recommended dose depends on body weight. The 7 mg strength of Teriflunomid Devatis is the preferred formulation for children and adolescents weighing 40 kg or less.
| Body Weight | Recommended Dose | Tablet Strength | Frequency |
|---|---|---|---|
| 40 kg or less | 7 mg | Teriflunomid Devatis 7 mg | Once daily |
| More than 40 kg | 14 mg | 14 mg tablet (alternative brand/generic) | Once daily |
Children whose body weight reaches and stabilises above 40 kg during treatment should be switched from the 7 mg to the 14 mg dose as directed by their doctor. Teriflunomide 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. Pancreatitis has been observed more frequently in pediatric patients receiving teriflunomide than in adults; therefore, clinical vigilance for symptoms such as abdominal pain, nausea, and vomiting is especially important in this age group, and amylase/lipase testing may be considered if clinical concern arises.
Elderly Patients
No dose adjustment is required specifically for elderly patients. Clinical experience in patients aged 65 years and older is limited, but the available data do not suggest a need for dose modification. 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. Drug interactions are also more likely in older patients taking multiple medications, and each new co-prescription should be reviewed carefully.
Renal and Hepatic Impairment
No dose adjustment is required in patients with mild to moderate renal impairment. Teriflunomide is contraindicated in patients with severe renal impairment requiring dialysis, because the drug is highly protein-bound and cannot be effectively removed by dialysis. For patients with mild to moderate hepatic impairment, no dose adjustment is required, but these patients should be monitored particularly carefully. Teriflunomide is contraindicated in patients with severe hepatic impairment (Child-Pugh class C).
Missed Dose
If you forget to take a dose of Teriflunomid Devatis, 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. Nevertheless, try to take your medication consistently each day to maintain optimal therapeutic adherence.
Overdose
If you take more Teriflunomid Devatis 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, potentially at greater severity, including diarrhea, nausea, elevated liver enzymes, and haematological changes. 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 Teriflunomid Devatis or change your dose without first consulting your doctor. If your doctor decides to discontinue treatment, an accelerated elimination procedure may be recommended depending on the reason for stopping. 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 Teriflunomid Devatis?
Like all medicines, Teriflunomid Devatis can cause side effects, although not everyone who takes it will experience them. The side effects listed below have been observed during the teriflunomide clinical trial programme and post-marketing surveillance. Because Teriflunomid Devatis is bioequivalent to the reference product, its safety profile is considered equivalent to that of the originator. 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 haematological changes, require ongoing monitoring throughout the course of treatment.
Serious Side Effects Requiring Medical Attention
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 severe abdominal pain, nausea, and vomiting (more common in children and adolescents than in adults)
- Herpesvirus infections including oral herpes and shingles (herpes zoster)
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)
- Post-treatment peripheral neuropathy
Rare Serious Effects
May affect up to 1 in 1,000 people
- Hepatitis (liver inflammation) and acute liver injury
- Stevens-Johnson syndrome and toxic epidermal necrolysis
- DRESS syndrome (drug reaction with eosinophilia and systemic symptoms)
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)
- Pulmonary hypertension
Side Effects by Frequency
Very Common
May affect more than 1 in 10 people
- Headache
- Diarrhea
- Nausea
- Elevated ALT (liver enzyme increase 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, pharyngitis (sore throat), cystitis, viral gastroenteritis, dental infection, laryngitis, tinea pedis (fungal foot infection)
- Herpesvirus infections (oral herpes, herpes zoster/shingles)
- Anaemia (decreased red blood cells), changes in white blood cell counts, elevated creatine phosphokinase
- Mild allergic reactions, anxiety
- Paraesthesia (tingling, numbness), sciatica, carpal tunnel syndrome
- Palpitations, hypertension (increased blood pressure)
- Vomiting, toothache, upper abdominal pain
- Skin rash, acne
- Tendon pain, arthralgia (joint pain), bone pain, myalgia (muscle pain)
- Pollakiuria (frequent urination), menorrhagia (heavy menstrual periods)
- Pain, asthenia (weakness), weight loss
Uncommon
May affect up to 1 in 100 people
- Mild thrombocytopenia (decreased platelet count)
- Hyperesthesia (increased sensitivity), peripheral neuropathy (nerve problems in arms or legs)
- Nail disorders, severe skin reactions
- Psoriasis, stomatitis (inflammation of mouth/lips)
- Abnormal blood lipid levels (dyslipidemia)
- Colitis (inflammation of the colon)
- Post-infectious glomerulonephritis
Rare
May affect up to 1 in 1,000 people
- Hepatitis and acute liver injury
- Severe hypersensitivity reactions
Frequency Not Known
Cannot be estimated from available data
- Pulmonary hypertension (elevated blood pressure in the pulmonary arteries)
- Serious hepatic events, including very rare fatal cases
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 carers should be aware of symptoms of pancreatitis, including severe upper abdominal pain, persistent nausea, and vomiting, and should seek prompt medical attention if these occur. In the TERIKIDS trial, upper respiratory tract infections, nasopharyngitis, headache, and alopecia were the most commonly reported adverse events in pediatric patients.
Hair thinning (alopecia) is one of the most common side effects of teriflunomide, reported in approximately 10–15% of patients. 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 teriflunomide.
Reporting of Side Effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this article or in the package leaflet. You can also report side effects directly via your national pharmacovigilance system (such as the EMA, the FDA MedWatch programme, the UK Yellow Card Scheme, or equivalent systems in your country). By reporting side effects, you can help provide more information on the safety of this medicine.
How Should You Store Teriflunomid Devatis?
Teriflunomid Devatis 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 Teriflunomid Devatis at room temperature. No special temperature range is specified in the product information, as the tablets are stable under normal household conditions.
- Keep in original packaging: Keep the tablets in the original blister pack or container until ready to take them. This protects the tablets from moisture and light.
- Keep out of reach of children: Store Teriflunomid Devatis in a secure location that is out of sight and reach of children. Accidental ingestion by a child or a pregnant person could be harmful.
- Check expiration date: Do not use Teriflunomid Devatis 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 and prevent accidental exposure.
When travelling with Teriflunomid Devatis, keep the medication in your carry-on luggage in its original packaging. There are no specific restrictions on carrying teriflunomide 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, particularly for international travel. Store the medication in a cool, dry place and avoid exposure to excessive heat, direct sunlight, or humidity during transit.
If you need to temporarily store the medication in an environment with extreme temperatures (for example, in a hot car or a cold suitcase at high altitude), this should be avoided where possible. Do not use tablets that show signs of damage, discoloration, or unusual appearance compared with previous supplies, and consult your pharmacist if you are unsure.
What Does Teriflunomid Devatis Contain?
Active Ingredient
The active substance is teriflunomide, a selective and reversible inhibitor of dihydroorotate dehydrogenase (DHODH). Each film-coated tablet of Teriflunomid Devatis contains 7 mg of teriflunomide.
Inactive Ingredients (Excipients)
As a generic teriflunomide product, Teriflunomid Devatis uses standard pharmaceutical excipients similar to those of the reference product. The exact excipient list is specified in the product’s official Summary of Product Characteristics and package leaflet. Typical excipients for teriflunomide 7 mg film-coated tablets include the following:
| Ingredient | Role | Notes |
|---|---|---|
| Teriflunomide | Active substance | 7 mg per tablet |
| Lactose monohydrate | Filler / diluent | May affect patients with lactose intolerance or galactose intolerance |
| Corn (maize) 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, indigo carmine aluminium lake (E132) and/or yellow iron oxide (E172) | Film coating | Provides colour, identification, and protection of the tablet |
Because excipient lists for generic products can vary slightly between manufacturers and manufacturing sites, patients with known allergies or intolerances should always consult the specific package leaflet accompanying their supply of Teriflunomid Devatis and check the label for batch-specific information. Notify your pharmacist or prescribing neurologist if you have previously had an allergic reaction to any tablet excipient.
Appearance and Pack Sizes
Teriflunomid Devatis 7 mg is supplied as a film-coated tablet. The precise appearance (colour, shape, embossing) is described in the product’s package leaflet and may differ from the originator tablet. Tablets are packaged in blister packs within cartons. Pack sizes are typically aligned with monthly or quarterly dispensing schedules (for example, 28 or 84 tablets), though specific pack sizes may vary by country and may not all be marketed in every market.
Marketing Authorisation Holder and Manufacturer
Teriflunomid Devatis is marketed by Devatis, a generic pharmaceutical company, under an appropriate marketing authorisation. As with other generic teriflunomide products, the manufacturer has demonstrated pharmaceutical equivalence and bioequivalence to the reference product Aubagio to obtain approval. Detailed information about the marketing authorisation holder, manufacturing site, and local distributor can be found on the product packaging and in the package leaflet supplied with the medicine, as well as on the websites of the relevant national medicines agencies.
Frequently Asked Questions About Teriflunomid Devatis
Teriflunomid Devatis is a prescription immunomodulatory medication containing teriflunomide, used for the treatment of relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS. Multiple sclerosis is a chronic autoimmune disease in which the immune system attacks the protective myelin sheath surrounding nerves in the brain and spinal cord, causing inflammation and nerve damage. Teriflunomid Devatis helps reduce the frequency of relapses (flare-ups of symptoms) and slows the progression of physical disability associated with MS. The 7 mg strength is primarily indicated for children and adolescents aged 10 years or older who weigh 40 kg or less.
Teriflunomid Devatis is a generic version of teriflunomide, the same active substance as in Aubagio (the originator brand developed by Sanofi). Generic medicines contain the same active ingredient, at the same strength, in the same dosage form and route of administration as the reference product, and must demonstrate pharmaceutical and biological equivalence to be approved by regulatory authorities such as the European Medicines Agency. The clinical efficacy and safety profile of Teriflunomid Devatis are therefore expected to be equivalent to those of Aubagio. Excipients, tablet appearance, and pack sizes may differ between brands, but the therapeutic effect is the same.
Teriflunomide reaches therapeutic plasma concentrations relatively quickly, with steady-state levels typically achieved within 3 months of starting daily dosing. In clinical trials with the reference product, reductions in MRI lesion activity were observed within the first few months of treatment. However, the full clinical benefit in terms of reducing relapse rates and slowing disability progression is typically assessed over 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 over time.
Hair thinning (not complete hair loss) is one of the more common side effects of teriflunomide, affecting approximately 10–15% of patients. The thinning is typically diffuse and mild to moderate in severity, usually occurring during the first 6 months of treatment. In most 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 teriflunomide. If hair thinning is significantly bothersome, discuss it with your neurologist; options such as topical treatments or psychological support may be available.
Because teriflunomide can affect the liver and elevated liver enzymes (ALT) are a very common laboratory finding, excessive alcohol consumption is not recommended during treatment with Teriflunomid Devatis. 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.
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 usually 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 minimise the risk of birth defects.
In adults, the standard dose of teriflunomide for relapsing MS is 14 mg once daily, because this dose demonstrated superior efficacy compared to 7 mg in the pivotal clinical trials. The 7 mg strength, including Teriflunomid Devatis 7 mg, is primarily used for children and adolescents aged 10 years and older who weigh 40 kg or less, based on weight-based dosing established in the TERIKIDS pediatric trial. In some regulatory settings, the 7 mg dose is also approved as an option for adults who do not tolerate the 14 mg dose. Your neurologist will determine the appropriate strength and regimen based on age, body weight, tolerance, and local prescribing guidelines.
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.
- European Medicines Agency. Generic and hybrid medicines: authorisation of generics – Guideline on the Investigation of Bioequivalence. 2024.
- 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.
About Our Medical Team
All content on iMedic is created and reviewed by qualified medical professionals following international evidence-based guidelines. Our editorial process ensures accuracy, currency, and clinical relevance for patients, carers, and healthcare professionals.
Medical Content Team
Specialists in neurology, neuroimmunology, and clinical pharmacology with extensive experience in multiple sclerosis management and disease-modifying therapies.
Medical Review Board
Independent panel of board-certified physicians who verify all medical claims against current evidence and international guidelines (WHO, EMA, FDA, AAN, ECTRIMS).
Editorial Standards
All content follows the GRADE evidence framework and is based on Level 1A evidence from systematic reviews and randomised controlled trials where available.
Independence
iMedic receives no pharmaceutical company funding or sponsorship. All content is editorially independent, ensuring unbiased medical information for patients and caregivers.