Teriflunomid SUN (Teriflunomide 14 mg): Uses, Dosage & Side Effects
A once-daily oral disease-modifying therapy for relapsing-remitting multiple sclerosis (RRMS) in adults and children aged 10 years and older — generic version of the reference product AUBAGIO
Teriflunomid SUN is a generic formulation of teriflunomide 14 mg, a once-daily oral immunomodulatory medicine used to treat relapsing-remitting multiple sclerosis (RRMS) in adults and in children aged 10 years and older. Teriflunomide reduces relapse rates, slows progression of physical disability, and decreases the number of active lesions seen on magnetic resonance imaging (MRI). Unlike first-line injectable beta-interferons and glatiramer acetate, teriflunomide offers the convenience of oral dosing. The active substance works by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH), which reduces the proliferation of activated lymphocytes driving autoimmune injury to the myelin sheaths of the central nervous system. Teriflunomid SUN is marketed as a generic equivalent of the reference product AUBAGIO and has been authorised on the basis of bioequivalence to the reference product.
Quick Facts: Teriflunomid SUN (Teriflunomide)
Key Takeaways
- Teriflunomid SUN is a generic teriflunomide 14 mg film-coated tablet taken once daily for the treatment of relapsing-remitting multiple sclerosis (RRMS) in adults and children aged 10 years and older, with the same efficacy and safety profile as the reference product AUBAGIO.
- Teriflunomide reduces annualised relapse rates by approximately 30–36% and decreases the risk of sustained disability progression compared with placebo, as established in the pivotal TEMSO and TOWER phase III trials and confirmed in the paediatric TERIKIDS study.
- Teriflunomide is strictly contraindicated in pregnancy and in women of childbearing potential who are not using reliable contraception; the drug has a long half-life of approximately 18–19 days and can be accelerated out of the body with cholestyramine or activated charcoal over 11 days if needed.
- Regular monitoring of liver function (at least monthly ALT during the first 6 months), blood pressure, complete blood count, and vigilance for signs of infection are mandatory; rare but serious adverse events include hepatotoxicity, interstitial lung disease, severe skin reactions, and pancreatitis.
- Common side effects include headache, diarrhoea, nausea, hair thinning, elevated liver enzymes, upper respiratory infections, and mild increases in blood pressure; most are manageable and do not require treatment discontinuation.
What Is Teriflunomid SUN and What Is It Used For?
Teriflunomid SUN contains the active substance teriflunomide, a selective and reversible inhibitor of the mitochondrial enzyme dihydroorotate dehydrogenase (DHODH). It belongs to a class of medicines known as selective immunosuppressants (ATC code L04AA31) and is categorised by regulators and clinicians as an oral disease-modifying therapy (DMT) for multiple sclerosis. The medicine is supplied as a 14 mg film-coated tablet taken by mouth once daily. As a generic product, Teriflunomid SUN is authorised on the basis that it is bioequivalent to the originator brand AUBAGIO, meaning it delivers the same amount of active drug to the bloodstream at the same rate and produces the same clinical effect.
Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system in which the body’s own immune cells cross the blood–brain barrier and attack the myelin sheaths that insulate nerve fibres in the brain, spinal cord, and optic nerves. This demyelination disrupts the electrical signals that travel along neurons, producing the characteristic clinical manifestations of MS: visual disturbances, numbness or weakness in the limbs, balance and coordination problems, bladder and bowel dysfunction, cognitive symptoms, and overwhelming fatigue. The relapsing-remitting form of MS (RRMS) is the most common clinical course, affecting roughly 85% of people at the time of diagnosis. It is characterised by discrete relapses (flares of new neurological symptoms) separated by periods of partial or complete remission. Over time, many patients transition to a secondary progressive form in which disability accumulates more steadily.
Teriflunomide exerts its therapeutic effect by blocking the de novo synthesis of pyrimidines, a class of nucleotides required to build DNA and RNA. Activated lymphocytes — especially the autoreactive T and B cells that drive MS attacks — depend heavily on this de novo pathway to support their rapid proliferation during an immune response. Resting lymphocytes, by contrast, rely on the pyrimidine salvage pathway and are far less sensitive to DHODH inhibition. By selectively dampening the expansion of activated immune cells without causing broad immunosuppression, teriflunomide produces an immunomodulatory rather than a cytotoxic effect. This mechanism is entirely reversible: when the drug is cleared from the body, DHODH function and lymphocyte proliferation return to normal.
The clinical efficacy of teriflunomide 14 mg has been established in several large, placebo-controlled and active-comparator randomised trials. The pivotal TEMSO study (2011) showed that once-daily teriflunomide 14 mg reduced the annualised relapse rate by approximately 31% compared with placebo over 2 years, and lowered the risk of sustained disability progression at 12 weeks by roughly 30%. The TOWER trial (2014) confirmed a 36% reduction in annualised relapse rate and a significant reduction in disability progression. The head-to-head TENERE trial compared teriflunomide 14 mg with subcutaneous interferon beta-1a and showed broadly comparable efficacy, with a favourable oral administration profile. In paediatric MS, the TERIKIDS study (published in 2021) demonstrated a meaningful benefit in children and adolescents aged 10–17 years and supported the extension of the indication to this age group.
International treatment guidelines, including the 2018 American Academy of Neurology (AAN) practice guideline and the 2024 ECTRIMS/EAN clinical practice recommendations on MS, consider teriflunomide a reasonable first-line oral disease-modifying therapy for people with mild-to-moderate RRMS. It is particularly suitable for patients who prefer an oral route of administration, who wish to avoid injections, or for whom other therapies are not appropriate. Teriflunomid SUN, as a generic formulation, provides the same treatment option at a lower cost to healthcare systems and patients without compromising clinical outcomes.
What Should You Know Before Taking Teriflunomid SUN?
Contraindications
Teriflunomide is a potent immunomodulatory drug with several absolute contraindications. Understanding these is essential to the safe use of Teriflunomid SUN and to prevent life-threatening complications. Do not take Teriflunomid SUN if any of the following apply to you:
- Hypersensitivity: A known allergy to teriflunomide, leflunomide (the parent drug used for rheumatoid arthritis), or any of the excipients listed in the product information. Previous severe cutaneous adverse reactions — Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS — are also a contraindication.
- Severe liver impairment: Child-Pugh class C hepatic impairment or any active liver disease. Teriflunomide is metabolised primarily in the liver and has been associated with rare but fatal hepatotoxic events.
- Pregnancy: Women who are pregnant, or women of childbearing potential who are not using effective contraception, must not take teriflunomide because of documented teratogenic effects in animal species.
- Breastfeeding: Teriflunomide is excreted into animal milk and is expected to be excreted into human breast milk; breastfeeding is contraindicated.
- Severe immunodeficiency: Any condition that causes severe immunosuppression, including acquired immunodeficiency syndrome (AIDS).
- Impaired bone marrow function or significant anaemia, leukopenia, neutropenia, or thrombocytopenia: Pre-existing bone marrow suppression can be worsened by teriflunomide.
- Severe active infection: Any uncontrolled serious bacterial, viral, fungal, or opportunistic infection until resolved.
- Severe renal impairment: In patients receiving dialysis, because clinical data are limited.
- Severe hypoproteinaemia: For example, in nephrotic syndrome; because teriflunomide is more than 99% protein-bound, marked hypoalbuminaemia can increase free drug concentrations and toxicity.
Warnings and Precautions
Severe liver injury, including cases of acute liver failure leading to liver transplantation or death, has been reported with teriflunomide. Your doctor will measure alanine aminotransferase (ALT) before you start treatment and at least every month for the first 6 months, and every 8 weeks thereafter. If ALT rises to more than 3 times the upper limit of normal, Teriflunomid SUN should be stopped and the accelerated elimination procedure considered. Stop the drug and seek urgent medical advice if you develop unexplained nausea, vomiting, abdominal pain, profound fatigue, loss of appetite, dark urine, or yellowing of the skin or whites of the eyes (jaundice).
Before starting Teriflunomid SUN, your doctor will check your blood pressure, perform a complete blood count including differential white blood cell count and platelet count, screen you for tuberculosis (either with a tuberculin skin test or an interferon-gamma release assay), and review your vaccination history. Baseline liver function tests are essential, as are a pregnancy test in women of childbearing potential and a discussion of effective contraceptive measures. Any uncontrolled hypertension, untreated latent tuberculosis, or unresolved infection should be addressed before treatment begins.
Teriflunomide can cause a modest but clinically meaningful rise in blood pressure. Blood pressure should be checked at baseline and then at regular intervals during treatment. Existing hypertension must be controlled before starting the drug and during therapy. If blood pressure rises significantly, lifestyle advice and antihypertensive treatment should be initiated, and the risk-benefit balance of continuing Teriflunomid SUN should be reviewed.
Haematological effects are a further concern. Reductions in white blood cell count, particularly lymphocytes and neutrophils, are relatively common. Rarely, severe reductions in platelets, neutrophils, or all blood cell lines (pancytopenia) can occur. Tell your doctor promptly if you develop unusual bruising, bleeding, pallor, persistent fatigue, or signs of infection. Your doctor may wish to repeat blood counts when clinical symptoms arise.
Because teriflunomide modestly suppresses the immune response, you may be more susceptible to infections. Serious, and in rare cases fatal, infections have been reported including sepsis and opportunistic infections. Contact your doctor promptly if you develop fever, persistent cough, sore throat, painful urination, or any other symptoms suggestive of infection. Latent infections such as tuberculosis or hepatitis B may reactivate. Men and women should also be aware of progressive multifocal leukoencephalopathy (PML), an extremely rare brain infection associated with other MS drugs; although PML has not been clearly linked to teriflunomide monotherapy, any new or worsening neurological symptoms should be reported immediately.
Severe cutaneous adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These are rare but potentially life-threatening. If you develop a widespread rash, blistering or peeling skin, painful mouth or eye sores, facial swelling, swollen lymph nodes, or high fever, stop Teriflunomid SUN immediately and seek urgent medical care. The accelerated elimination procedure should be used to clear the drug as quickly as possible.
Interstitial lung disease (ILD), a rare inflammatory disorder of the lung tissue, has been reported, sometimes with a fatal outcome. Report any new or worsening cough, shortness of breath, or reduced exercise tolerance to your doctor without delay. Teriflunomide should be discontinued and a thorough respiratory evaluation undertaken if ILD is suspected. Similarly, peripheral neuropathy (manifesting as numbness, tingling, burning, or weakness in the hands or feet) has been described and usually improves on treatment discontinuation and an accelerated washout procedure.
Live attenuated vaccines should not be administered during treatment with Teriflunomid SUN and for a period after discontinuation to avoid the risk of infection from the vaccine strain. Inactivated (killed) vaccines are considered safe but may produce a slightly reduced antibody response. The response to seasonal influenza vaccination has been studied and is generally adequate. Complete all recommended vaccinations, particularly varicella (chickenpox) if you are seronegative, before starting teriflunomide.
Children and Adolescents
Teriflunomide is authorised in the European Union for the treatment of relapsing-remitting multiple sclerosis in paediatric patients aged 10 years and older, based on the results of the TERIKIDS phase III study. The recommended dose in children weighing more than 40 kg is the same as in adults (14 mg once daily). Children weighing 40 kg or less receive 7 mg once daily, which may require an alternative strength not available as Teriflunomid SUN; in such cases the reference product or another generic with 7 mg tablets must be used. Teriflunomide has not been studied in children younger than 10 years, and its use in this age group is not recommended.
Pregnancy, Breastfeeding, and Fertility
Teriflunomid SUN is strictly contraindicated during pregnancy. Teriflunomide has been shown to cause major birth defects and fetal death in animal studies at doses comparable to human therapeutic exposure. Women of childbearing potential must have a negative pregnancy test before starting treatment and must use reliable contraception throughout treatment and until the plasma concentration of teriflunomide is confirmed to be below 0.02 mg/L. Without intervention, this can take up to 2 years after the last dose.
If pregnancy is planned after treatment, an accelerated elimination procedure should be performed. This involves 11 days of cholestyramine 8 g three times a day (or 4 g three times a day if 8 g is not tolerated), or alternatively 50 g of activated charcoal powder twice a day for 11 days. After the washout, plasma teriflunomide should be measured on two occasions at least 14 days apart, and both results must be below 0.02 mg/L. Once this has been confirmed, conception can be attempted; an additional waiting period of at least 1.5 months is recommended to allow time for the full washout of residual drug. If an unplanned pregnancy is discovered during treatment, the accelerated elimination procedure should be started immediately and a specialist obstetric review arranged.
For men, although the potential risk from paternal exposure is considered low based on animal data, it cannot be entirely excluded. Men wishing to father a child may consider discontinuing teriflunomide and undergoing an accelerated elimination procedure to minimise the theoretical risk to the foetus. Discuss family planning with your neurologist well in advance.
Teriflunomide passes into milk in animal studies and should be presumed to pass into human breast milk. Breastfeeding is therefore contraindicated during treatment with Teriflunomid SUN.
Driving and Operating Machinery
Teriflunomide has no or negligible direct influence on the ability to drive or use machines. However, dizziness has been reported, which may temporarily impair the ability to concentrate and to react. If you experience dizziness or any other neurological symptoms that could affect driving or the safe operation of machinery, refrain from these activities until the symptoms resolve.
How Does Teriflunomid SUN Interact with Other Drugs?
Teriflunomide has a rich interaction profile. As an inhibitor of cytochrome P450 2C8 (CYP2C8), CYP1A2, the organic anion transporter 3 (OAT3), and the efflux transporters BCRP and OATP1B1, it can raise plasma concentrations of substrates of these pathways and thereby increase their therapeutic and adverse effects. Simultaneously, potent inducers of hepatic metabolism can accelerate teriflunomide clearance and reduce its efficacy. A careful medication review is therefore essential before starting Teriflunomid SUN and whenever a new medicine is added to your regimen.
Major Interactions
| Interacting Drug | Effect | Action Required |
|---|---|---|
| Leflunomide | Leflunomide is converted in the body to teriflunomide; concurrent use leads to excessive, potentially toxic plasma concentrations | Do not use together |
| Warfarin and other vitamin K antagonists | A clinically meaningful decrease in INR (approximately 25%) has been reported; anticoagulant effect may be reduced | Close INR monitoring; dose adjustment of warfarin may be needed |
| Rifampicin, carbamazepine, phenobarbital, phenytoin, St John’s wort | Potent inducers of CYP and transporters may decrease teriflunomide exposure by approximately 30%, potentially reducing efficacy | Use with caution; monitor clinical response; avoid if possible |
| Repaglinide, paclitaxel, pioglitazone, rosiglitazone | Teriflunomide inhibits CYP2C8, raising plasma levels of these substrates | Use with caution; monitor blood glucose (repaglinide, pioglitazone) or adverse effects; dose reduction may be needed |
| Cholestyramine or activated charcoal | Rapidly reduces plasma teriflunomide by interrupting enterohepatic recirculation | Do not combine during active treatment unless accelerated elimination is intended (e.g., pregnancy, severe adverse event) |
| Methotrexate and other immunosuppressants | Increased risk of additive hepatotoxicity and myelosuppression | Avoid combination or use only under close specialist supervision with frequent monitoring |
Other Notable Interactions
| Interacting Drug | Effect | Action Required |
|---|---|---|
| Rosuvastatin | Teriflunomide inhibits BCRP, increasing rosuvastatin exposure up to 2.5-fold | Limit rosuvastatin dose to half of the usual maximum; monitor for muscle pain and weakness |
| Simvastatin, atorvastatin, pravastatin, pitavastatin | Increased statin exposure due to OATP1B1 inhibition, raising risk of myopathy | Monitor for symptoms of myopathy; consider dose reduction |
| Duloxetine, alosetron, theophylline, tizanidine | CYP1A2 inhibition may modestly increase plasma levels of these drugs | Monitor for adverse effects; dose adjustment may be required |
| Oral contraceptives (ethinylestradiol, levonorgestrel) | Teriflunomide increases exposure to these hormones, which is not expected to reduce contraceptive efficacy but could alter side-effect profile | Consider this when selecting a contraceptive; reliable contraception is mandatory regardless |
| Cefaclor, benzylpenicillin, ciprofloxacin, indometacin, ketoprofen, furosemide, cimetidine, zidovudine | OAT3 inhibition by teriflunomide may increase plasma levels of these drugs | Monitor for adverse effects; dose adjustment may be needed |
| Live attenuated vaccines (yellow fever, oral polio, MMR, BCG, varicella, rotavirus) | Risk of infection from the vaccine strain during immunosuppression | Avoid during treatment and for a period after discontinuation; plan vaccinations before starting |
Food, Drink, and Alcohol
Teriflunomid SUN can be taken with or without food and does not have clinically significant interactions with common foods. However, alcohol should be used cautiously or avoided during treatment because both alcohol and teriflunomide are metabolised in the liver; combined use may increase the risk of hepatotoxicity. If you drink alcohol, keep intake moderate, avoid binge drinking, and ensure your doctor is aware. Grapefruit juice does not significantly affect teriflunomide metabolism and is not contraindicated.
This list of interactions is not exhaustive. Always tell your doctor, nurse, or pharmacist about every prescription medicine, over-the-counter product, vitamin, herbal remedy, or recreational drug you are using or plan to start using while on Teriflunomid SUN.
What Is the Correct Dosage of Teriflunomid SUN?
Always take Teriflunomid SUN exactly as prescribed by your neurologist or a physician experienced in the treatment of multiple sclerosis. Swallow the tablet whole with a glass of water. It may be taken at any time of day, but taking it at the same time each day helps maintain steady plasma concentrations and makes it easier to remember. Teriflunomide is administered continuously; there is no loading dose, and there are no planned drug holidays.
Adults
Adult Dose for Relapsing-Remitting MS
- Standard dose: 14 mg once daily
- Route: Oral, swallowed whole with water
- With food: May be taken with or without food
- Onset of clinical effect: Reduction in relapse rate and MRI activity observed from approximately 12 weeks of continuous treatment
- Duration: Continuous long-term treatment while benefit outweighs risk
Steady-state plasma concentrations are typically reached within 3–4 months of continuous daily dosing. Because teriflunomide has a long half-life, missed single doses have only a modest impact on overall exposure, but maintaining consistent daily dosing remains the best way to control disease activity and simplify monitoring.
Children and Adolescents (aged 10–17 years)
Paediatric Dose for Relapsing-Remitting MS
- Weight greater than 40 kg: 14 mg once daily
- Weight 40 kg or less: 7 mg once daily (not available as Teriflunomid SUN 14 mg; alternative strength required)
- Age: 10 years and older
- Duration: Continuous long-term treatment as directed
In children and adolescents, the dose is determined by body weight. Monitoring requirements are the same as in adults, with particular attention to growth, development, and vaccination status. Teriflunomide is not recommended in children younger than 10 years because its safety and efficacy have not been established in this age group.
Elderly Patients
No specific dose adjustment is required on the basis of age alone. However, clinical data in patients 65 years and older are limited, and older patients may have age-related reductions in hepatic or renal function, together with a higher burden of concomitant medication. More careful monitoring of liver function, blood pressure, and general health is therefore advisable in this population.
Patients with Kidney or Liver Problems
In patients with mild or moderate renal impairment, no dose adjustment is needed. Teriflunomide is contraindicated in patients with severe renal impairment on dialysis because clinical experience is limited and pharmacokinetic data are insufficient. In mild or moderate hepatic impairment, no dose adjustment is required, although liver function monitoring should be intensified. Teriflunomide is contraindicated in severe hepatic impairment (Child-Pugh C).
Missed Dose
If you forget to take a dose, take it as soon as you remember on the same day. If it is almost time for your next scheduled dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the one you missed. Because teriflunomide has a long half-life, occasional missed doses are unlikely to lead to a sudden loss of efficacy.
Overdose
If you take more Teriflunomid SUN than prescribed, contact your doctor, poison control centre, or emergency department immediately. There is no specific antidote, but the accelerated elimination procedure with cholestyramine or activated charcoal significantly reduces plasma levels and should be started without delay. Because teriflunomide is more than 99% protein-bound, haemodialysis and continuous venovenous haemofiltration are not effective. Bring the medication packaging with you to the healthcare facility.
In clinical studies, healthy volunteers receiving up to 70 times the standard 14 mg dose did not experience clinically significant toxicity. Nevertheless, exaggerated pharmacological effects including diarrhoea, nausea, elevated liver enzymes, reduced blood cell counts, or increased infection risk may occur. Supportive care, close haematological and biochemical monitoring, and expedited drug elimination form the mainstay of overdose management.
Stopping Treatment and Switching Therapy
Do not stop Teriflunomid SUN without first consulting your neurologist, even if you feel well. Stopping abruptly does not usually cause withdrawal symptoms, but MS disease activity may return over time. If you are switching to another disease-modifying therapy — particularly a potent immunosuppressant such as natalizumab, fingolimod, ocrelizumab, or alemtuzumab — your doctor may recommend an accelerated elimination procedure to shorten the overlap period and reduce the risk of additive immunosuppression. The same procedure is used if an unplanned pregnancy occurs or if a serious adverse reaction develops.
What Are the Side Effects of Teriflunomid SUN?
Like all medicines, Teriflunomid SUN can cause side effects, although not everyone experiences them. Most adverse effects are mild to moderate and either self-limiting or easily managed with symptomatic treatment or temporary dose adjustment. A minority of side effects are serious and require immediate medical attention. The frequency categories listed below are drawn directly from the regulatory Summary of Product Characteristics for teriflunomide and apply equally to Teriflunomid SUN as a bioequivalent generic product.
Stop Teriflunomid SUN and contact your doctor or emergency services immediately if you experience: yellowing of the skin or eyes, dark urine, or severe upper-right abdominal pain (possible liver failure); a widespread rash with blistering or peeling skin, mouth or eye sores, or high fever (possible Stevens-Johnson syndrome, TEN, or DRESS); sudden breathing difficulty, persistent cough, or progressively reduced exercise tolerance (possible interstitial lung disease); severe abdominal pain radiating to the back with vomiting (possible pancreatitis); persistent numbness, tingling, or weakness in the hands or feet (possible peripheral neuropathy); high fever, chills, or other signs of serious infection; or any sign of a severe allergic reaction such as swelling of the face, tongue, or throat.
Very Common
May affect more than 1 in 10 people
- Headache
- Diarrhoea
- Nausea
- Hair thinning or mild hair loss (alopecia)
- Increased alanine aminotransferase (ALT) on blood tests
Common
May affect up to 1 in 10 people
- Influenza, upper respiratory tract infection, urinary tract infection, sinusitis, bronchitis, gastroenteritis, oral herpes, tooth infection
- Neutropenia, lymphopenia, mild anaemia
- Mild allergic reactions
- Anxiety
- Paraesthesia (tingling), sciatica, carpal tunnel syndrome
- Increased blood pressure
- Vomiting, abdominal pain, upper abdominal pain, dyspepsia
- Increased gamma-glutamyl transferase (GGT) and aspartate aminotransferase (AST)
- Rash, acne
- Musculoskeletal pain, myalgia, arthralgia
- Pollakiuria (urinary frequency)
- Menorrhagia (heavy menstrual bleeding)
- Pain, feeling weak, fatigue
- Weight loss
Uncommon
May affect up to 1 in 100 people
- Mild thrombocytopenia (platelet count below 100×10&sup9;/L)
- Hyperaesthesia (heightened skin sensation), neuralgia
- Peripheral neuropathy
- Palpitations
- Post-traumatic pain
- Increased creatine phosphokinase (CPK)
Rare
May affect up to 1 in 1,000 people
- Severe infections including sepsis, which can be life-threatening
- Significantly elevated liver enzymes progressing to hepatitis, jaundice, or acute liver failure
- Pancreatitis
- Stomatitis
- Interstitial lung disease
- Pulmonary hypertension
- Nail disorders
Very Rare and Frequency Not Known
Fewer than 1 in 10,000 people, or cannot be estimated
- Severe cutaneous adverse reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Anaphylactic reactions, severe hypersensitivity reactions
- Angioedema
- Severe thrombocytopenia
- Colitis
- Cutaneous lupus erythematosus, psoriasis (new onset or worsening)
Laboratory Abnormalities
Blood tests frequently show mild and reversible abnormalities during treatment. Elevated ALT is the most common laboratory finding, typically a mild elevation of up to 3 times the upper limit of normal, and usually resolves without intervention. A mild reduction in white blood cell count (mean decrease of approximately 15%) occurs during the first weeks of treatment and then stabilises. Small, usually clinically insignificant changes in phosphate, potassium, and neutrophil counts may also be observed. Your doctor will explain which changes are significant enough to warrant dose adjustment, closer monitoring, or discontinuation of the drug.
Reporting Side Effects
If you notice any side effects not listed here, or if any of the listed side effects become severe, contact your doctor, pharmacist, or nurse. You can also report suspected side effects to your national drug regulatory authority, such as the FDA MedWatch programme in the United States, the Yellow Card Scheme (MHRA) in the United Kingdom, the EMA pharmacovigilance network in the European Union, or the equivalent regulator in your country. Reporting side effects helps provide more safety information about the medicine.
How Should You Store Teriflunomid SUN?
Store Teriflunomid SUN film-coated tablets at a temperature below 30°C (86°F) in a dry location away from direct sunlight. The blister pack protects the tablets from moisture, so keep the tablets in the original blister until you are ready to take them. Protect the carton from extreme heat, such as that inside a parked car in summer, and do not refrigerate or freeze the tablets. The shelf life is printed on the outer packaging and refers to the last day of the stated month.
Keep Teriflunomid SUN out of the sight and reach of children. The 14 mg tablets can cause serious harm, including birth defects in unborn babies, if taken accidentally by a pregnant woman or child. If a child or another person has inadvertently taken the medicine, contact your poison control centre or emergency department immediately, and consider requesting an accelerated elimination procedure with cholestyramine or activated charcoal under medical supervision.
Do not dispose of medications via wastewater or household waste. Return unused or expired tablets to your pharmacist, hospital pharmacy, or designated medicine take-back programme for safe disposal. These measures protect the environment from pharmaceutical contamination and prevent accidental exposure in the community. If the tablets appear damaged, discoloured, or otherwise altered in appearance, do not use them and discuss replacement with your pharmacist.
What Does Teriflunomid SUN Contain?
Each Teriflunomid SUN film-coated tablet contains the active substance teriflunomide. The strength available in this generic is 14 mg, matching the maintenance dose of the reference product AUBAGIO used in adult and paediatric relapsing-remitting multiple sclerosis.
| Component | Content | Role |
|---|---|---|
| Teriflunomide | 14 mg | Active pharmaceutical ingredient |
| Lactose monohydrate | Tablet core | Diluent and filler |
| Maize starch | Tablet core | Diluent and disintegrant |
| Microcrystalline cellulose | Tablet core | Binder and filler |
| Sodium starch glycolate | Tablet core | Disintegrant |
| Hydroxypropyl cellulose, magnesium stearate, colloidal anhydrous silica | Tablet core | Binder, lubricant, glidant |
| Hypromellose, titanium dioxide (E171), talc, macrogol, indigo carmine aluminium lake (E132) | Film coating | Protection, ease of swallowing, identification colour |
Teriflunomid SUN tablets contain lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, or if you have the rare hereditary conditions of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption, speak to your doctor before taking this medicine. The amount of lactose per 14 mg tablet is generally well below the threshold that causes symptoms in most lactose-intolerant individuals, but sensitivity varies.
Teriflunomid SUN is manufactured by Sun Pharmaceutical Industries, a large international manufacturer of generic and specialty medicines. The exact list of excipients and the appearance of the film-coated tablet may differ from other teriflunomide generics and from the originator AUBAGIO, but the active substance, the 14 mg dose, and the therapeutic effect are equivalent by virtue of the stringent bioequivalence standards applied by regulatory authorities. The precise composition and tablet identification for your specific pack can be confirmed from the Patient Information Leaflet supplied with the medicine and from the local Summary of Product Characteristics published by your national regulator.
Frequently Asked Questions About Teriflunomid SUN
Teriflunomid SUN is a generic formulation of teriflunomide 14 mg, a once-daily oral disease-modifying therapy (DMT) used to treat adult and paediatric patients (aged 10 years and older) with relapsing-remitting multiple sclerosis (RRMS). It reduces the frequency of clinical relapses, slows the accumulation of physical disability, and decreases the number of new or enlarging lesions on MRI. Teriflunomide is a selective and reversible inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH) and is classified as an immunomodulatory agent.
No. Teriflunomid SUN is contraindicated during pregnancy because teriflunomide has shown teratogenic effects in animal studies. Women of childbearing potential must use effective contraception throughout treatment and until plasma teriflunomide concentration is confirmed below 0.02 mg/L on two blood tests at least 14 days apart. Without intervention this may take up to 2 years; an 11-day accelerated elimination procedure using cholestyramine (8 g three times a day) or activated charcoal (50 g twice a day) dramatically shortens this period. Men who wish to father a child should also discuss risks and options with their doctor before and during treatment.
Teriflunomide has a median elimination half-life of approximately 18 to 19 days at the 14 mg dose because of extensive enterohepatic recirculation. Without intervention, it typically takes about 8 months, and in some cases up to 2 years, for plasma concentrations to fall below 0.02 mg/L after stopping treatment. If rapid elimination is required — for example, to prepare for pregnancy, to manage a serious adverse reaction, or to switch quickly to another disease-modifying therapy — an 11-day course of cholestyramine or activated charcoal can reduce plasma levels to negligible concentrations within weeks.
Before starting treatment, your neurologist will check alanine aminotransferase (ALT) and other liver function tests, bilirubin, complete blood count including white blood cell differential and platelets, blood pressure, a pregnancy test in women of childbearing potential, and a tuberculosis screening test. During treatment, ALT must be monitored at least every month for the first 6 months and every 8 weeks thereafter. Blood counts are repeated based on clinical symptoms, and blood pressure is measured regularly. Elevated liver enzymes above 3 times the upper limit of normal typically prompt discontinuation and consideration of the accelerated elimination procedure.
The most common side effects are headache, diarrhoea, nausea, hair thinning or mild hair loss, and elevated liver enzymes on blood tests. Other frequent effects include flu-like illness, upper respiratory tract infections, urinary tract infections, mild blood pressure elevation, and reduced white blood cell counts. Serious but less common adverse events include severe liver injury, pancreatitis, interstitial lung disease, peripheral neuropathy, serious infections, and severe skin reactions. Seek urgent medical care for jaundice, persistent fever, shortness of breath, numbness or tingling in the hands or feet, or a widespread rash with blistering or skin peeling.
Teriflunomid SUN contains the same active substance — teriflunomide 14 mg — as the reference product AUBAGIO manufactured by Sanofi. As an EMA-approved generic, it has been authorised on the basis of bioequivalence to the reference product, meaning it delivers the same amount of active drug to the bloodstream within the strict limits required by regulators. The inactive ingredients and tablet appearance may differ, but the clinical effect, indications, contraindications, warnings, interactions, and adverse-event profile are identical to those of the originator. Generics offer a lower-cost alternative without compromising quality or safety.
Alcohol should be used cautiously during treatment with Teriflunomid SUN because both alcohol and teriflunomide can stress the liver. Regular or heavy alcohol consumption increases the risk of hepatotoxicity, particularly during the first months of treatment when liver enzyme elevations are most common. Light-to-moderate, occasional drinking is usually tolerated, but your doctor may advise complete avoidance if you have any other risk factors for liver disease such as viral hepatitis, fatty liver, or concurrent hepatotoxic medication. Always disclose your alcohol intake honestly to your neurologist so that they can interpret liver function results correctly.
References
This article is based on current international medical guidelines and peer-reviewed scientific literature. All medical claims are supported by evidence level 1A, the highest quality of evidence based on systematic reviews and randomized controlled trials.
- European Medicines Agency (EMA). AUBAGIO (teriflunomide) — Summary of Product Characteristics. Updated 2024. Official European regulatory document for teriflunomide, applicable to all generic products including Teriflunomid SUN.
- U.S. Food and Drug Administration (FDA). AUBAGIO (teriflunomide) Prescribing Information. Genzyme/Sanofi. Official U.S. prescribing information for teriflunomide.
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