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Medicine guide

Teriflunomide

7 mg · Tablet, Film Coated

  • Prescription only
  • Pyrimidine Synthesis Inhibitor
Active substance
Teriflunomide
Made by
Alembic Pharmaceuticals Limited

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2023-02-08

What it is

Pyrimidine Synthesis Inhibitor

Used for
  • Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis. Teriflunomide tablet is a pyrimidine synthesis inhibitor indicated for the treatment of patients…
The label’s usual adult dose

The recommended dose of teriflunomide tablet is 7 mg or 14 mg orally once daily. Teriflunomide tablets can be taken with or without food. Monitoring to assess safety

Full directions ↓
Serious warning

HEPATOTOXICITY and RISK OF TERATOGENICITY

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
31other products contain Teriflunomide — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis. Teriflunomide tablet is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis (1)

From the official label · 2023-02-08 · DailyMed

How it works

From this product’s own US prescribing label.

Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis.

The exact mechanism by which teriflunomide exerts its therapeutic effect in multiple sclerosis is unknown but may involve a reduction in the number of activated lymphocytes in CNS.

Peak level after1–4 h
How the body breaks it down

Drug Interaction Studies Teriflunomide is not metabolized by Cytochrome P450 or flavin monoamine oxidase enzymes.

How it leaves the body

Teriflunomide is eliminated mainly through direct biliary excretion of unchanged drug as well as renal excretion of metabolites.

With food

Food does not have a clinically relevant effect on teriflunomide pharmacokinetics.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-02-08

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

  • HEPATOTOXICITY and RISK OF TERATOGENICITY
  • Hepatotoxicity Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Concomitant use of teriflunomide tablets with other potentially hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets therapy. Monitor ALT levels at least monthly for six months after starting teriflunomide tablets [see Warnings and Precautions (5.1)]. If drug induced liver injury is suspected, discontinue teriflunomide tablets and start an accelerated elimination procedure with cholestyramine or charcoal [see Warnings and Precautions (5.3)]. Teriflunomide tablets are contraindicated in patients with severe hepatic impairment [see Contraindications (4)]. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking teriflunomide tablets.
  • Risk of Teratogenicity Teriflunomide tablets are contraindicated for use in pregnant women and in women of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposures lower than that in humans. Exclude pregnancy before the start of treatment with teriflunomide tablets in females of reproductive potential. Advise females of reproductive potential to use effective contraception during teriflunomide tablets treatment and during an accelerated drug elimination procedure after teriflunomide tablets treatment. Stop teriflunomide tablets and use an accelerated drug elimination procedure if the patient becomes pregnant [see Contraindications (4), Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.1), and Clinical Pharmacology (12.3)]. WARNING:
  • HEPATOTOXICITY and RISK OF TERATOGENICITY See full prescribing information for complete boxed warning
  • Hepatotoxicity Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets and monitor ALT levels at least monthly for six months (5.1). If drug induced liver injury is suspected, discontinue teriflunomide tablets and start accelerated elimination procedure (5.3).
  • Risk of Teratogenicity Teratogenicity and embryolethality occurred in animals administered teriflunomide (5.2, 8.1). Exclude pregnancy prior to initiating teriflunomide tablets therapy (4, 5.2, 8.1). Advise use of effective contraception in females of reproductive potential during treatment and during an accelerated drug elimination procedure (4, 5.2, 5.3, 8.1). Stop teriflunomide tablets and use an accelerated drug elimination procedure if the patient becomes pregnant (5.2, 5.3, 8.1).

Quoted from the official label, section “Boxed Warning”.

Do not take it if

  • Teriflunomide tablet is contraindicated in/with:
  • Patients with severe hepatic impairment [see Warnings and Precautions (5.1)] . · Pregnant women and females of reproductive potential not using effective contraception. Teriflunomide tablet may cause fetal harm [see Warnings and Precautions (5.2, and 5.3) and Use in Specific Populations (8.1)] . · Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablet. Reactions have included anaphylaxis, angioedema, and serious skin reactions [see Warnings and Precautions (5.5)]. · Coadministration with leflunomide [see Clinical Pharmacology (12.3)].
  • Severe hepatic impairment (4, 5.1)
  • Pregnancy (4, 5.2, 8.1)
  • Hypersensitivity (4, 5.5)
  • Current leflunomide treatment (4)

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • The recommended dose of teriflunomide tablet is 7 mg or 14 mg orally once daily. Teriflunomide tablets can be taken with or without food. Monitoring to assess safety
  • Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets therapy. Monitor ALT levels at least monthly for six months after starting teriflunomide tablets [see Warnings and Precautions (5.1)].
  • Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with teriflunomide tablets. Further monitoring should be based on signs and symptoms of infection [see Warnings and Precautions (5.4)].
  • Prior to initiating teriflunomide tablets, screen patients for latent tuberculosis infection with a tuberculin skin test or blood test for mycobacterium tuberculosis infection [see Warnings and Precautions (5.4)].
  • Exclude pregnancy prior to initiation of treatment with teriflunomide tablets in females of reproductive potential [see Warnings and Precautions (5.2)].
  • Check blood pressure before start of teriflunomide tablets treatment and periodically thereafter [see Warnings and Precautions (5.7)]. 7 mg or 14 mg orally once daily, with or without food. (2)

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Elimination of teriflunomide tablets can be accelerated by administration of cholestyramine or activated charcoal for 11 days (5.3)
  • Teriflunomide tablets may decrease WBC. A recent CBC should be available before starting teriflunomide tablets. Monitor for signs and symptoms of infection. Consider suspending treatment with teriflunomide tablets in case of serious infection. Do not start teriflunomide tablets in patients with active infections (5.4)
  • Stop teriflunomide tablets if patient has anaphylaxis, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis; initiate rapid elimination (5.3, 5.5)
  • If patient develops symptoms consistent with peripheral neuropathy, evaluate patient and consider discontinuing teriflunomide tablets (5.6)
  • Teriflunomide tablets may increase blood pressure. Measure blood pressure at treatment initiation and monitor blood pressure during treatment (5.7) 5.1 Hepatotoxicity Severe liver injury including fatal liver failure and dysfunction has been reported in some patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking teriflunomide tablets. Patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than two times the upper limit of normal (ULN) before initiating treatment, should not normally be treated with teriflunomide tablets. Teriflunomide tablets are contraindicated in patients with severe hepatic impairment [see Contraindications (4)] . In placebo-controlled trials, ALT greater than three times the ULN occurred in 61/1,045 (5.8%) and 62/1,002 (6.2%) of patients receiving teriflunomide tablets 7 mg and 14 mg, respectively, and 38/997 (3.8%) of patients receiving placebo, during the treatment period. These elevations occurred mostly within the first year of treatment. Half of the cases returned to normal without drug discontinuation. In clinical trials, if ALT elevation was greater than three times the ULN on two consecutive tests, teriflunomide tablet was discontinued and patients underwent an accelerated elimination procedure [see Warnings and Precautions (5.3)] . Of the patients who underwent discontinuation and accelerated elimination in controlled trials, half returned to normal or near normal values within 2 months. One patient in the controlled trials developed ALT 32 times the ULN and jaundice 5 months after initiation of teriflunomide tablets 14 mg treatment. The patient was hospitalized for 5 weeks and recovered after plasmapheresis and cholestyramine accelerated elimination procedure. Teriflunomide tablets-induced liver injury in this patient could not be ruled out. Obtain serum transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets therapy. Monitor ALT levels at least monthly for six months after starting teriflunomide tablets. Consider additional monitoring when teriflunomide tablets are given with other potentially hepatotoxic drugs. Consider discontinuing teriflunomide tablets if serum transaminase increase (greater than three times the ULN) is confirmed. Monitor serum transaminase and bilirubin on teriflunomide tablets therapy, particularly in patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine. If liver injury is suspected to be teriflunomide tablets-induced, discontinue teriflunomide tablets and start an accelerated elimination procedure [see Warnings and Precautions (5.3)] and monitor liver tests weekly until normalized. If teriflunomide tablets-induced liver injury is unlikely because some other probable cause has been found, resumption of teriflunomide tablets therapy may be considered. 5.2 Teratogenecity Teriflunomide tablets may cause fetal harm when administered to a pregnant woman. Teratogenicity and embryo-fetal lethality occurred in animal reproduction studies in multiple animal species at plasma teriflunomide exposures similar to or lower than that in humans at the maximum human recommended dose (MHRD) of 14 mg/day [see Use in Specific Populations (8.1)]. Teriflunomide tablets are contraindicated for use in pregnant women and females of reproductive potential not using effective contraception [see Contraindications (4) and Warnings and Precautions (5.3)] . 5.3 Procedure for Accelerated Elimination of Teriflunomide Teriflunomide is eliminated slowly from the plasma [see Clinical Pharmacology (12.3)]. Without an accelerated elimination procedure, it takes on average 8 months to reach plasma concentrations less than 0.02 mg/L, although because of individual variations in drug clearance it may take as long as 2 years. An accelerated elimination procedure could be used at any time after discontinuation of teriflunomide tablets. Elimination can be accelerated by either of the following procedures:
  • Administration of cholestyramine 8 g every 8 hours for 11 days. If cholestyramine 8 g three times a day is not well tolerated, cholestyramine 4 g three times a day can be used.
  • Administration of 50 g oral activated charcoal powder every 12 hours for 11 days. If either elimination procedure is poorly tolerated, treatment days do not need to be consecutive unless there is a need to lower teriflunomide plasma concentration rapidly. At the end of 11 days, both regimens successfully accelerated teriflunomide elimination, leading to more than 98% decrease in teriflunomide plasma concentrations. Use of the accelerated elimination procedure may potentially result in return of disease activity if the patient had been responding to teriflunomide tablets treatment. 5.4 Bone Marrow Effects/Immunosuppression Potential/Infections Bone Marrow Effects A mean decrease compared to baseline in white blood cell (WBC) count of approximately 15% (mainly neutrophils and lymphocytes) and in platelet count of approximately 10% was observed in placebo-controlled trials with 7 mg and 14 mg of teriflunomide tablets. The decrease in mean WBC count occurred during the first 6 weeks and WBC count remained low during treatment. In placebo-controlled studies, neutrophil count < 1.5x109/L was observed in 12% and 16% of patients receiving teriflunomide tablets 7 mg and 14 mg, respectively, compared with 7% of patients receiving placebo; lymphocyte count <0.8x109/L was observed in 10% and 12% of patients receiving teriflunomide tablets 7 mg and 14 mg, respectively, compared with 6% of patients receiving placebo. No cases of serious pancytopenia were reported in premarketing clinical trials of teriflunomide tablets but rare cases of pancytopenia and agranulocytosis, have been reported in the postmarketing setting with leflunomide. A similar risk would be expected for teriflunomide tablets [see Clinical Pharmacology (12.3)]. Cases of thrombocytopenia with teriflunomide tablets, including rare cases with platelet counts less than 50,000/mm 3 , have been reported in the postmarketing setting. Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with teriflunomide tablets. Further monitoring should be based on signs and symptoms suggestive of bone marrow suppression. Risk of Infection / Tuberculosis Screening Patients with active acute or chronic infections should not start treatment until the infection(s) is resolved. If a patient develops a serious infection consider suspending treatment with teriflunomide tablets and using an accelerated elimination procedure. Reassess the benefits and risks prior to resumption of therapy. Instruct patients receiving teriflunomide tablets to report symptoms of infections to a physician. Teriflunomide tablets are not recommended for patients with severe immunodeficiency, bone marrow disease, or severe, uncontrolled infections. Medications like teriflunomide tablets that have immunosuppression potential may cause patients to be more susceptible to infections, including opportunistic infections. In placebo-controlled studies of teriflunomide tablets, no overall increase in the risk of serious infections was observed with teriflunomide tablets 7 mg (2.2%) or 14 mg (2.7%) compared to placebo (2.2%). However, one fatal case of klebsiella pneumonia sepsis occurred in a patient taking teriflunomide tablets 14 mg for 1.7 years. Fatal infections have been reported in the postmarketing setting in patients receiving leflunomide, especially Pneumocystis jiroveci pneumonia and aspergillosis. Most of the reports were confounded by concomitant immunosuppressant therapy and/or comorbid illness which, in addition to rheumatoid disease, may predispose patients to infection. In clinical studies with teriflunomide tablets, cytomegalovirus hepatitis reactivation has been observed. In clinical studies with teriflunomide tablets, cases of tuberculosis have been observed. Prior to initiating teriflunomide tablets, screen patients for latent tuberculosis infection with a tuberculin skin test or with a blood test for mycobacterium tuberculosis infection. Teriflunomide tablet has not been studied in patients with a positive tuberculosis screen, and the safety of teriflunomide tablets in individuals with latent tuberculosis infection is unknown. For patients testing positive in tuberculosis screening, treat by standard medical practice prior to therapy with teriflunomide tablets. Vaccination No clinical data are available on the efficacy and safety of live vaccinations in patients taking teriflunomide tablets. Vaccination with live vaccines is not recommended. The long half-life of teriflunomide tablets should be considered when contemplating administration of a live vaccine after stopping teriflunomide tablets. Malignancy The risk of malignancy, particularly lymphoproliferative disorders, is increased with the use of some immunosuppressive medications. There is a potential for immunosuppression with teriflunomide tablets. No apparent increase in the incidence of malignancies and lymphoproliferative disorders was reported in the teriflunomide tablets clinical trials, but larger and longer-term studies would be needed to determine whether there is an increased risk of malignancy or lymphoproliferative disorders with teriflunomide tablets. 5.5 Hypersensitivity and Serious Skin Reactions Teriflunomide tablets can cause anaphylaxis and severe allergic reactions [see Contraindications (4)]. Signs and symptoms have included dyspnea, urticaria, and angioedema including lips, eyes, throat, and tongue. Cases of serious skin reactions, including cases of Stevens-Johnson syndrome (SJS) and a fatal case of toxic epidermal necrolysis (TEN), have been reported with teriflunomide tablets. In patients treated with leflunomide, the parent compound, very rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported. Inform patients of the signs and symptoms of anaphylaxis and angioedema and signs and symptoms that may signal a serious skin reaction. Inform patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, or hepatic dysfunction) may be drug-related. Instruct patients to discontinue teriflunomide tablets and seek immediate medical care should these signs and symptoms occur. Discontinue teriflunomide tablets, unless the reactions are clearly not drug-related, and begin an accelerated elimination procedure immediately [see Warnings and Precautions (5.3)]. In such cases, patients should not be re-exposed to teriflunomide [see Contraindications (4)]. 5.6 Peripheral Neuropathy In placebo-controlled studies, peripheral neuropathy, including both polyneuropathy and mononeuropathy (e.g., carpal tunnel syndrome), occurred more frequently in patients taking teriflunomide tablets than in patients taking placebo. The incidence of peripheral neuropathy confirmed by nerve conduction studies was 1.4% (13 patients) and 1.9% (17 patients) of patients receiving 7 mg and 14 mg of teriflunomide tablets, respectively, compared with 0.4% receiving placebo (4 patients). Treatment was discontinued in 0.7% (8 patients) with confirmed peripheral neuropathy (3 patients receiving teriflunomide tablets 7 mg and 5 patients receiving teriflunomide tablets 14 mg). Five of them recovered following treatment discontinuation. Not all cases of peripheral neuropathy resolved with continued treatment. Peripheral neuropathy also occurred in patients receiving leflunomide. Age older than 60 years, concomitant neurotoxic medications, and diabetes may increase the risk for peripheral neuropathy . If a patient taking teriflunomide tablets develops symptoms consistent with peripheral neuropathy, such as bilateral numbness or tingling of hands or feet, consider discontinuing teriflunomide tablets therapy and performing an accelerated elimination procedure [see Warnings and Precautions (5.3)] . 5.7 Increased Blood Pressure In placebo-controlled studies, the mean change from baseline to the end of study in systolic blood pressure was +2.3 mmHg and +2.7 mmHg for teriflunomide tablets 7 mg and 14 mg, respectively, and -0.6 mmHg for placebo. The change from baseline in diastolic blood pressure was +1.4 mmHg and +1.9 mmHg for teriflunomide tablets 7 mg and 14 mg, respectively, and -0.3 mmHg for placebo. Hypertension was an adverse reaction in 3.1% and 4.3% of patients treated with 7 mg or 14 mg of teriflunomide tablets compared with 1.8% for placebo. Check blood pressure before start of teriflunomide tablets treatment and periodically thereafter. Elevated blood pressure should be appropriately managed during treatment with teriflunomide tablets. 5.8 Respiratory Effects Interstitial lung disease, including acute interstitial pneumonitis, has been reported with teriflunomide tablets in the postmarketing setting. Interstitial lung disease and worsening of pre-existing interstitial lung disease have been reported during treatment with leflunomide. Interstitial lung disease may be fatal and may occur acutely at any time during therapy with a variable clinical presentation. New onset or worsening pulmonary symptoms, such as cough and dyspnea, with or without associated fever, may be a reason for discontinuation of therapy and for further investigation as appropriate. If discontinuation of the drug is necessary, consider initiation of an accelerated elimination procedure [see Warnings and Precautions (5.3)]. 5.9 Concomitant Use with Immunosuppressive or Immunomodulating Therapies Coadministration with antineoplastic, or immunosuppressive therapies used for treatment of multiple sclerosis has not been evaluated. Safety studies in which teriflunomide tablets was concomitantly administered with other immune modulating therapies for up to one year (interferon beta, glatiramer acetate) did not reveal any specific safety concerns. The long term safety of these combinations in the treatment of multiple sclerosis has not been established. In any situation in which the decision is made to switch from teriflunomide tablets to another agent with a known potential for hematologic suppression, it would be prudent to monitor for hematologic toxicity, because there will be overlap of systemic exposure to both compounds. Use of an accelerated elimination procedure may decrease this risk, but may also potentially result in return of disease activity if the patient had been responding to teriflunomide tablets treatment [see Warnings and Precautions (5.3)] .

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary Teriflunomide tablets are contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data.
  • Human data are not available at this time to inform the presence or absence of drug-associated risk with the use of teriflunomide tablets during pregnancy.
  • In animal reproduction studies in rat and rabbits, oral administration of teriflunomide during organogenesis caused teratogenicity and embryolethality at plasma exposures (AUC) lower than that at the maximum human recommended dose (MHRD) of 14 mg/day [see Data].
  • In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
  • The background risk of major birth defects and miscarriage in the indicated population is unknown.
  • Clinical Considerations Women who wish to become pregnant should discontinue use of teriflunomide tablets and undergo an accelerated elimination procedure to decrease the plasma concentration of teriflunomide to less than 0.02 mg/L (0.02 mcg/mL).
  • Effective contraception should be used until is it verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)] .
  • Human plasma concentrations of teriflunomide less than 0.02 mg/L (0.02 mcg/mL) are expected to have minimal embryofetal risk [see Contraindications (4) and Warnings and Precautions (5.3)] .
  • If the patient becomes pregnant while taking this drug, stop treatment with teriflunomide tablets, inform the patient of the potential risk to the fetus, and perform the accelerated drug elimination procedure to achieve plasma concentrations of less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].
  • Refer the patient to an obstetrician/gynecologist, preferably experienced in reproductive toxicity, for further evaluation and counseling [see Warnings and Precautions (5.2, 5.3)].
  • Data Animal Data When teriflunomide (oral doses of 1, 3, or 10 mg/kg/day) was administered to pregnant rats throughout the period of organogenesis, high incidences of fetal malformation (primarily craniofacial, and axial and appendicular skeletal defects) and embryofetal death were observed at doses not associated with maternal toxicity.
  • Adverse effects on embryofetal development were observed following dosing at various stages throughout organogenesis.
  • Maternal plasma exposure at the no-effect level (1 mg/kg/day) for embryofetal developmental toxicity in rats was less than that in humans at the maximum recommended human dose (MRHD, 14 mg/day).
  • Administration of teriflunomide (oral doses of 1, 3.5, or 12 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in high incidences of fetal malformation (primarily craniofacial, and axial and appendicular skeletal defects) and embryofetal death at doses associated with minimal maternal toxicity.
  • Maternal plasma exposure at the no-effect dose (1 mg/kg/day) for embryofetal developmental toxicity in rabbits was less than that in humans at the MRHD.
  • In studies in which teriflunomide (oral doses of 0.05, 0.1, 0.3, 0.6, or 1 mg/kg/day) was administered to rats during gestation and lactation, decreased growth, eye and skin abnormalities, and high incidences of malformation (limb defects) and postnatal death were observed in the offspring at doses not associated with maternal toxicity.
  • Maternal plasma exposure at the no-effect dose for pre-and postnatal developmental toxicity in rats (0.1 mg/kg/day) was less than that in humans at the MRHD.
  • In animal reproduction studies of leflunomide, embryolethality and teratogenic effects were observed in pregnant rat and rabbit at or below clinically relevant plasma teriflunomide exposures (AUC).
  • In published reproduction studies in pregnant mice, leflunomide was embryolethal and increased the incidence of malformations (craniofacial, axial skeletal, heart and great vessel).
  • Supplementation with exogenous uridine reduced the teratogenic effects in pregnant mice, suggesting that the mode of action (inhibition of mitochondrial enzyme dihydroorotate dehydrogenase) is the same for therapeutic efficacy and developmental toxicity.
  • At recommended doses in humans, teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide.
  • 8.3 Females and Males of Reproductive Potential Pregnancy Testing Exclude pregnancy prior to initiation of treatment with teriflunomide tablets in females of reproductive potential.
  • Advise females to notify their healthcare provider immediately if pregnancy occurs or is suspected during treatment [see Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.1)].
  • Contraception Females Females of reproductive potential should use effective contraception while taking teriflunomide tablets.
  • If teriflunomide tablet is discontinued, use of contraception should be continued until is it verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL).
  • Females of reproductive potential who wish to become pregnant should undergo an accelerated elimination procedure.
  • Effective contraception should be used until it is verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)] .
  • Males Teriflunomide is detected in human semen.
  • Animal studies to specifically evaluate the risk of male-mediated fetal toxicity have not been conducted.
  • To minimize any possible risk, men not wishing to father a child and their female partners should use effective contraception.
  • Men wishing to father a child should discontinue use of teriflunomide tablets and either undergo an accelerated elimination procedure or wait until verification that the plasma teriflunomide concentration is less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)].
  • Infertility Administration of teriflunomide to male rats resulted in no adverse effects on fertility.
  • However, reduced epididymal sperm count was observed [see Nonclinical Toxicology (13.1)].
  • Effects of teriflunomide tablets on fertility in humans have not been evaluated.
  • IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy Risk Summary Teriflunomide tablets are contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data.
  • Human data are not available at this time to inform the presence or absence of drug-associated risk with the use of teriflunomide tablets during pregnancy.
  • In animal reproduction studies in rat and rabbits, oral administration of teriflunomide during organogenesis caused teratogenicity and embryolethality at plasma exposures (AUC) lower than that at the maximum human recommended dose (MHRD) of 14 mg/day [see Data].
  • In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
  • The background risk of major birth defects and miscarriage in the indicated population is unknown.
  • Clinical Considerations Women who wish to become pregnant should discontinue use of teriflunomide tablets and undergo an accelerated elimination procedure to decrease the plasma concentration of teriflunomide to less than 0.02 mg/L (0.02 mcg/mL).
  • Effective contraception should be used until is it verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)] .
  • Human plasma concentrations of teriflunomide less than 0.02 mg/L (0.02 mcg/mL) are expected to have minimal embryofetal risk [see Contraindications (4) and Warnings and Precautions (5.3)] .
  • If the patient becomes pregnant while taking this drug, stop treatment with teriflunomide tablets, inform the patient of the potential risk to the fetus, and perform the accelerated drug elimination procedure to achieve plasma concentrations of less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].
  • Refer the patient to an obstetrician/gynecologist, preferably experienced in reproductive toxicity, for further evaluation and counseling [see Warnings and Precautions (5.2, 5.3)].
  • Data Animal Data When teriflunomide (oral doses of 1, 3, or 10 mg/kg/day) was administered to pregnant rats throughout the period of organogenesis, high incidences of fetal malformation (primarily craniofacial, and axial and appendicular skeletal defects) and embryofetal death were observed at doses not associated with maternal toxicity.
  • Adverse effects on embryofetal development were observed following dosing at various stages throughout organogenesis.
  • Maternal plasma exposure at the no-effect level (1 mg/kg/day) for embryofetal developmental toxicity in rats was less than that in humans at the maximum recommended human dose (MRHD, 14 mg/day).
  • Administration of teriflunomide (oral doses of 1, 3.5, or 12 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in high incidences of fetal malformation (primarily craniofacial, and axial and appendicular skeletal defects) and embryofetal death at doses associated with minimal maternal toxicity.
  • Maternal plasma exposure at the no-effect dose (1 mg/kg/day) for embryofetal developmental toxicity in rabbits was less than that in humans at the MRHD.
  • In studies in which teriflunomide (oral doses of 0.05, 0.1, 0.3, 0.6, or 1 mg/kg/day) was administered to rats during gestation and lactation, decreased growth, eye and skin abnormalities, and high incidences of malformation (limb defects) and postnatal death were observed in the offspring at doses not associated with maternal toxicity.
  • Maternal plasma exposure at the no-effect dose for pre-and postnatal developmental toxicity in rats (0.1 mg/kg/day) was less than that in humans at the MRHD.
  • In animal reproduction studies of leflunomide, embryolethality and teratogenic effects were observed in pregnant rat and rabbit at or below clinically relevant plasma teriflunomide exposures (AUC).
  • In published reproduction studies in pregnant mice, leflunomide was embryolethal and increased the incidence of malformations (craniofacial, axial skeletal, heart and great vessel).
  • Supplementation with exogenous uridine reduced the teratogenic effects in pregnant mice, suggesting that the mode of action (inhibition of mitochondrial enzyme dihydroorotate dehydrogenase) is the same for therapeutic efficacy and developmental toxicity.
  • At recommended doses in humans, teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide.
  • 8.2 Lactation Risk Summary It is not known whether this drug is excreted in human milk.
  • Teriflunomide was detected in rat milk following a single oral dose.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for teriflunomide tablets and any potential adverse effects on the breastfed infant from teriflunomide tablets or from the underlying maternal condition.
  • 8.3 Females and Males of Reproductive Potential Pregnancy Testing Exclude pregnancy prior to initiation of treatment with teriflunomide tablets in females of reproductive potential.
  • Advise females to notify their healthcare provider immediately if pregnancy occurs or is suspected during treatment [see Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.1)].
  • Contraception Females Females of reproductive potential should use effective contraception while taking teriflunomide tablets.
  • If teriflunomide tablet is discontinued, use of contraception should be continued until is it verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL).
  • Females of reproductive potential who wish to become pregnant should undergo an accelerated elimination procedure.
  • Effective contraception should be used until it is verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)] .
  • Males Teriflunomide is detected in human semen.
  • Animal studies to specifically evaluate the risk of male-mediated fetal toxicity have not been conducted.
  • To minimize any possible risk, men not wishing to father a child and their female partners should use effective contraception.
  • Men wishing to father a child should discontinue use of teriflunomide tablets and either undergo an accelerated elimination procedure or wait until verification that the plasma teriflunomide concentration is less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)].
  • Infertility Administration of teriflunomide to male rats resulted in no adverse effects on fertility.
  • However, reduced epididymal sperm count was observed [see Nonclinical Toxicology (13.1)].
  • Effects of teriflunomide tablets on fertility in humans have not been evaluated.
  • 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
  • 8.5 Geriatric Use Clinical studies of teriflunomide tablets did not include patients over 65 years old.
  • 8.6 Hepatic Impairment No dosage adjustment is necessary for patients with mild and moderate hepatic impairment.
  • The pharmacokinetics of teriflunomide in severe hepatic impairment has not been evaluated.
  • Teriflunomide tablets are contraindicated in patients with severe hepatic impairment [see Contraindications (4), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)] .
  • 8.7 Renal Impairment No dosage adjustment is necessary for patients with mild, moderate, and severe renal impairment [see Clinical Pharmacology (12.3)] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • Effect of teriflunomide tablets on CYP2C8 substrates Teriflunomide is an inhibitor of CYP2C8 in vivo . In patients taking teriflunomide tablets, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP2C8 as required [see Clinical Pharmacology (12.3)] . Effect of teriflunomide tablets on warfarin Coadministration of teriflunomide tablets with warfarin requires close monitoring of the international normalized ratio (INR) because teriflunomide tablets may decrease peak INR by approximately 25%. Effect of teriflunomide tablets on oral contraceptives Teriflunomide tablets may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with teriflunomide tablets [see Clinical Pharmacology (12.3)] . Effect of teriflunomide tablets on CYP1A2 substrates Teriflunomide may be a weak inducer of CYP1A2 in vivo . In patients taking teriflunomide tablets, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP1A2 as required [see Clinical Pharmacology (12.3)] . Effect of teriflunomide tablets on organic anion transporter 3 (OAT3) substrates Teriflunomide inhibits the activity of OAT3 in vivo . In patients taking teriflunomide tablets, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) which are OAT3 substrates as required [see Clinical Pharmacology (12.3)] . Effect of teriflunomide tablets on BCRP and organic anion transporting polypeptide B1 and B3 (OATP1B1/1B3) substrates Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo . For a patient taking teriflunomide tablets, the dose of rosuvastatin should not exceed 10 mg once daily. For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased exposures to the drugs while patients are taking teriflunomide tablets [see Clinical Pharmacology (12.3)] .
  • Drugs metabolized by CYP2C8 and OAT3 transporters:
  • Monitor patients because teriflunomide may increase exposure of these drugs (7)
  • Teriflunomide may increase exposure of ethinylestradiol and levonorgestrel. Choose an appropriate oral contraceptive (7)
  • Drugs metabolized by CYP1A2:
  • Monitor patients because teriflunomide may decrease exposure of these drugs (7)
  • Warfarin: Monitor INR as teriflunomide may decrease INR (7)
  • Drugs metabolized by BCRP and OATP1B1/B3 transporters:
  • Monitor patients because teriflunomide may increase exposure of these drugs (7)
  • Rosuvastatin:
  • The dose of rosuvastatin should not exceed 10 mg once daily in patients taking teriflunomide tablets (7)

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • There is no experience regarding teriflunomide overdose or intoxication in humans.
  • Teriflunomide 70 mg daily up to 14 days was well tolerated by healthy subjects.
  • In the event of clinically significant overdose or toxicity, cholestyramine or activated charcoal is recommended to accelerate elimination [see Warnings and Precautions (5.3)] .

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of teriflunomide tablets did not include patients over 65 years old.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • The following serious adverse reactions are described elsewhere in the prescribing information:
  • Hepatotoxicity [see Contraindications (4) and Warnings and Precautions (5.1)]
  • Bone Marrow Effects/Immunosuppression Potential/Infections [see Warnings and Precautions (5.4)]
  • Hypersensitivity and Serious Skin Reactions [see Contraindications (4) and Warnings and Precautions (5.5)]
  • Peripheral Neuropathy [see Warnings and Precautions (5.6)]
  • Increased Blood Pressure [see Warnings and Precautions (5.7)]
  • Respiratory Effects [see Warnings and Precautions (5.8)] Most common adverse reactions (≥10% and ≥2% greater than placebo):
  • headache, diarrhea, nausea, alopecia, increase in ALT (6) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A total of 2,047 patients receiving teriflunomide tablets (7 mg or 14 mg once daily) constituted the safety population in the pooled analysis of placebo controlled studies in patients with relapsing forms of multiple sclerosis; of these, 71% were female. The average age was 37 years. Table 1 lists adverse reactions in placebo-controlled trials with rates that were at least 2% for teriflunomide tablets patients and also at least 2% above the rate in placebo patients. The most common were headache, an increase in ALT, diarrhea, alopecia, and nausea. The adverse reaction most commonly associated with discontinuation was an increase in ALT (3.3%, 2.6%, and 2.3% of all patients in the teriflunomide tablets 7 mg, teriflunomide tablets 14 mg, and placebo treatment arms, respectively). Table 1. Adverse Reactions in Pooled Placebo-Controlled Studies in Patients with Relapsing Forms of Multiple Sclerosis Adverse Reaction Teriflunomide Tablets 7 mg (N=1,045) Teriflunomide Tablets 14 mg (N=1,002) Placebo (N=997) Headache 18% 16% 15% Increase in Alanine aminotransferase 13% 15% 9% Diarrhea 13% 14% 8% Alopecia 10% 13% 5% Nausea 8% 11% 7% Paresthesia 8% 9% 7% Arthralgia 8% 6% 5% Neutropenia 4% 6% 2% Hypertension 3% 4% 2% Cardiovascular Deaths Four cardiovascular deaths, including three sudden deaths, and one myocardial infarction in a patient with a history of hyperlipidemia and hypertension were reported among approximately 2,600 patients exposed to teriflunomide tablets in the premarketing database. These cardiovascular deaths occurred during uncontrolled extension studies, one to nine years after initiation of treatment. A relationship between teriflunomide tablets and cardiovascular death has not been established. Acute Renal Failure In placebo-controlled studies, creatinine values increased more than 100% over baseline in 8/1,045 (0.8%) patients in the 7 mg teriflunomide tablets group and 6/1,002 (0.6%) patients in the 14 mg teriflunomide tablets group versus 4/997 (0.4%) patients in the placebo group. These elevations were transient. Some elevations were accompanied by hyperkalemia. Teriflunomide tablets may cause acute uric acid nephropathy with transient acute renal failure because teriflunomide tablets increases renal uric acid clearance. Hypophosphatemia In clinical trials, 18% of teriflunomide tablets-treated patients had hypophosphatemia with serum phosphorus levels of at least 0.6 mmol/L, compared to 7% of placebo-treated patients; 4% of teriflunomide tablets-treated patients had hypophosphatemia with serum phosphorus levels at least 0.3 mmol/L but less than 0.6 mmol/L, compared to 0.8% of placebo-treated patients. No patient in any treatment group had a serum phosphorus below 0.3 mmol/L. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of teriflunomide tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Hypersensitivity reactions, some of which were severe, such as anaphylaxis and angioedema [see Warnings and Precautions (5.5)]
  • Severe skin reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome [see Warnings and Precautions (5.5)]
  • Thrombocytopenia [see Warnings and Precautions (5.4)]
  • Interstitial lung disease [see Warnings and Precautions (5.8)]
  • Pancreatitis

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • A Medication Guide is required for distribution with teriflunomide tablets.
  • Hepatotoxicity Inform patients that teriflunomide tablets may increase liver enzymes and that their liver enzymes will be checked before starting teriflunomide tablets and for at least 6 months while they are taking teriflunomide tablets.
  • Advise patients that they should contact their physician if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
  • Importance of Preventing Pregnancy · Inform patients that based on animal studies, teriflunomide tablets may cause fetal harm. · Advise females of reproductive potential of the need for effective contraception during teriflunomide tablets treatment and until completion of an accelerated elimination procedure.
  • Advise them that an accelerated elimination procedure can be used at any time after the discontinuation of teriflunomide tablets. · Instruct the patient that if she suspects or confirms pregnancy, she should immediately inform her physician. · Instruct men taking teriflunomide tablets and not wishing to father a child to use effective contraception to minimize any possible risk to the fetus; their female partners should also use effective contraception. · Advise men wishing to father a child to discontinue use of teriflunomide tablets and undergo an accelerated elimination procedure.
  • Availability of an Accelerated Elimination Procedure Advise patients that teriflunomide tablets may stay in the blood for up to 2 years after the last dose and that an accelerated elimination procedure may be used if needed.
  • Risk of Infections Inform patients that they may develop a lowering of their white blood cell counts and that their blood counts will be checked before starting teriflunomide tablets.
  • Inform patients that they may be more likely to get infections when taking teriflunomide tablets and that they should contact their physician if they develop symptoms of infection, particularly in case of fever.
  • Advise patients that the use of some vaccines should be avoided during treatment with teriflunomide tablets and for at least 6 months after discontinuation.
  • Serious Allergic Reactions Advise patients to discontinue teriflunomide tablets and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur [see Contraindications (4) and Warnings and Precautions (5.5)].
  • Signs and symptoms include dyspnea, urticaria, and angioedema including lips, eyes, throat, and tongue or skin rash.
  • Peripheral Neuropathy Inform patients that they may develop peripheral neuropathy.
  • Advise patients that they should contact their physician if they develop symptoms of peripheral neuropathy, such as numbness or tingling of hands or feet.
  • Increased Blood Pressure Inform patients that teriflunomide tablets may increase blood pressure.
  • Lactation Inform patients that it is not known whether this drug is present in human milk.
  • Advise patients, if they are considering breastfeeding, to discuss this with their healthcare provider to decide if they will take teriflunomide tablets or breastfeed.
  • Advise patients that they should not do both.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS Teriflunomide tablets are available as 7 mg and 14 mg tablets.
  • The 7 mg tablet is very light greenish-bluish grey to pale greenish-blue, hexagonal film-coated tablet debossed with “L” on one side and “597” on other side.
  • Each tablet contains 7 mg of teriflunomide.
  • The 14 mg tablet is pale blue to pastel blue, pentagonal film-coated tablet debossed with “L” on one side and “598” on other side.
  • Each tablet contains 14 mg of teriflunomide. 7 mg and 14 mg film-coated tablets (3)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • Teriflunomide tablets are available as 7 mg and 14 mg tablets.
  • The 7 mg tablet is pale blue to pastel blue, hexagonal film-coated tablet debossed with “L” on one side and “597” on other side.
  • Each tablet contains 7 mg of teriflunomide.
  • Teriflunomide tablets 7 mg are supplied as:
  • NDC 46708-313-14 Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card NDC 46708-313-30 Bottle of 30 tablets with child-resistant closure The 14 mg tablet is pale blue to pastel blue, pentagonal film-coated tablet debossed with “L” on one side and “598” on other side.
  • Each tablet contains 14 mg of teriflunomide.
  • Teriflunomide tablets 14 mg are supplied as:
  • NDC 46708-314-14 Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card NDC 46708-314-30 Bottle of 30 tablets with child-resistant closure NDC 46708-314-91 Bottle of 1,000 tablets
  • Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

  • Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide.
  • Its molecular weight is 270.21, and the empirical formula is C 12 H 9 F 3 N 2 O 2 with the following chemical structure:
  • Teriflunomide is a white to off-white powder that is soluble in N, N – Dimethyl formamide and practically insoluble in water.
  • Teriflunomide is formulated as film-coated tablets for oral administration.
  • Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients:
  • lactose monohydrate, corn starch, sodium starch glycolate, hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.
  • The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol 8000, talc, and FD&C Blue#2 Aluminium Lake.
  • In addition to these, the 7 mg tablet film coating includes iron oxide yellow.
  • Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (16)

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Details

Made byAlembic Pharmaceuticals Limited
Active substanceTeriflunomide
Strength7 mg
FormTablet, Film Coated
RouteOral
Packs2 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK · 30 TABLET, FILM COATED in 1 BOTTLE
NDC46708-313

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

30 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Aubagio14 mgPrescription onlyTablet, Film Coated Genzyme Corporation · TeriflunomideAubagio7 mgPrescription onlyTablet, Film Coated Genzyme Corporation · TeriflunomideTeriflunomide7 mgPrescription onlyTablet, Film Coated Mylan Pharmaceuticals Inc. · TeriflunomideTeriflunomide14 mgPrescription onlyTablet, Film Coated Mylan Pharmaceuticals Inc. · TeriflunomideTeriflunomide14 mgPrescription onlyTablet, Film Coated Teva Pharmaceuticals, Inc. · TeriflunomideTeriflunomide7 mgPrescription onlyTablet, Film Coated Teva Pharmaceuticals, Inc. · Teriflunomide

See every product with Teriflunomide