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PMS-TERIFLUNOMIDE is a brand name for Teriflunomide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-TERIFLUNOMIDE (teriflunomide) is indicated for: • monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. pms-TERIFLUNOMIDE should only be prescribed by clinicians who are…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Monitoring recommended prior to initiating and during treatment: Obtain transaminase and bilirubin levels within 6 months before initiation of pms-TERIFLUNOMIDE therapy. Monitor ALT levels at least monthly for at least six months after starting pms-TERIFLUNOMIDE (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with pms-TERIFLUNOMIDE and periodically during treatment. Further monitoring should be based on signs and symptoms of infection (see 7 WARNINGS AND PRECAUTIONS, Hematologic).
Prior to initiating pms-TERIFLUNOMIDE, screen patients for latent tuberculosis infection (see 7 WARNINGS AND PRECAUTIONS, Immune-Infections). pms-TERIFLUNOMIDE (Teriflunomide tablets) Page 6 of 45 Check blood pressure before start of pms-TERIFLUNOMIDE treatment and periodically throughout treatment (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
1 Pregnant Women). 2 Recommended Dose and Dosage Adjustment The recommended dose of pms-TERIFLUNOMIDE is 14 mg orally once daily which can be taken with or without food. Pediatric Patients The safety and efficacy of teriflunomide have not been established in pediatric patients and pms-TERIFLUNOMIDE is not recommended in this patient population.
Geriatric Patients Clinical studies of teriflunomide did not include patients over 65 years old. 3 Pharmacokinetics, Special Populations and Conditions). Hepatic Impairment No dosage adjustment is necessary for patients with mild and moderate hepatic impairment.
Teriflunomide is contraindicated in patients with severe hepatic impairment (see 2 CONTRAINDICATIONS; 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). Renal Impairment No dosage adjustment is necessary for patients with severe renal impairment (see 7 WARNINGS AND PRECAUTIONS, Renal).
Patients with severe renal impairment undergoing dialysis were not evaluated. Teriflunomide is not recommended in this population. 5 Missed Dose If a dose is missed, treatment should be continued with the next dose as planned.
). The majority of patients recovered from decreased neutrophils and/or lymphocyte cell counts in less than 8 weeks, whether continuing on teriflunomide or after discontinuation. Rare cases of pancytopenia, agranulocytosis and thrombocytopenia have been reported in the post-marketing setting with leflunomide.
A similar risk is expected for teriflunomide. Obtain a complete blood cell count (CBC) within 6 months before initiating treatment with pms- TERIFLUNOMIDE and periodically during treatment. Further monitoring should be based on signs and symptoms suggestive of infection.
, natalizumab, fingolimod). 3 Pharmacokinetics; 7 WARNINGS AND PRECAUTIONS, Accelerated Elimination Procedure). In patients with pre-existing anemia, leucopenia, and/or thrombocytopenia as well as in patients with impaired bone marrow function or those at risk of bone marrow suppression, the risk of hematological disorders is increased.
If such effects occur, the accelerated elimination procedure should be considered. Hepatic/Biliary/Pancreatic Hepatic Liver function abnormalities have been reported in some patients treated with teriflunomide in clinical trials. Severe liver injury including fatal liver failure occurred rarely in the post-marketing setting.
Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking teriflunomide. 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.
pms-TERIFLUNOMIDE is contraindicated in patients with severe hepatic impairment (see 2 CONTRAINDICATIONS). Elevations of liver enzymes have been observed in patients receiving teriflunomide. 7%) of patients on placebo, during the treatment period of up to 2 years.
2 Drug Interactions Overview ....................................................................................... 4 Drug-Drug Interactions ..............................................................................................
5 Drug-Food Interactions.............................................................................................. 6 Drug-Herb Interactions ..............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................ 25 10 CLINICAL PHARMACOLOGY .............................................................................................
1 Mechanism of Action................................................................................................. 2 Pharmacodynamics ...................................................................................................
3 Pharmacokinetics ...................................................................................................... 26 11 STORAGE, STABILITY AND DISPOSAL ................................................................................
28 PART II: SCIENTIFIC INFORMATION ........................................................................................ 29 13 PHARMACEUTICAL INFORMATION...................................................................................
29 14 CLINICAL TRIALS ............................................................................................................... 1 Clinical Trials by Indication .........................................................................................
2 Comparative Bioavailability Study ............................................................................. 35 15 MICROBIOLOGY ...............................................................................................................
pms-TERIFLUNOMIDE (teriflunomide) is contraindicated in patients: • with known hypersensitivity to teriflunomide, leflunomide (the parent compound) or to any of the nonmedicinal ingredients in the formulation. • who are currently treated with leflunomide.
Co-administration of teriflunomide with leflunomide is contraindicated. • with severe hepatic impairment (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). • who are pregnant or women of childbearing potential not using reliable contraception (see 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential).
Teriflunomide may cause fetal harm when administered to a pregnant woman. Pregnancy must be excluded before start of treatment. , AIDS). • with impaired bone marrow function or significant anemias, leucopenia, neutropenia or thrombocytopenia.
pms-TERIFLUNOMIDE (Teriflunomide tablets) Page 5 of 45 • with serious active infections.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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These elevations occurred mostly within the first 6 months of treatment. Half of the cases returned to normal without drug discontinuation. In clinical trials, teriflunomide was discontinued if the ALT elevation exceeded 3 times the ULN on two consecutive tests.
Of the patients who underwent discontinuation of teriflunomide and accelerated elimination in controlled trials, serum transaminase levels returned to normal within approximately 2 months. In controlled clinical trials, one serious case of “toxic hepatitis” was reported in a 35-year-old female patient.
The patient developed ALT 32 times the ULN and jaundice 5 months after initiation of teriflunomide 14 mg treatment. The patient was hospitalized for 5 weeks and recovered after plasmapheresis and cholestyramine accelerated elimination procedure.
Although the etiology of the hepatic event remained unclear, a causal role of teriflunomide in this case is possible. 5Post-Market Adverse Reactions). The time to onset of DILI ranged from days to years after initiating treatment with teriflunomide.
Drug-induced liver injury events were reported in patients with and without relevant risk factors, such as a history of drug-induced hepatotoxicity or concomitant use of other hepatotoxic drugs, including some drugs used for managing multiple sclerosis.
Due to the potential for severe liver injury, exercise caution and closely monitor patients if other known or potentially hepatotoxic drugs are used in combination with teriflunomide or if there is a history of drug-induced hepatotoxicity (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Hepatotoxicity and Risk of Teratogenicity).
For all patients, obtain serum transaminase and bilirubin levels within 6 months before initiating treatment with teriflunomide. Monitor ALT levels at least monthly for at least six months after starting pms-TERIFLUNOMIDE. Additional monitoring is recommended if pms-TERIFLUNOMIDE is used with other potentially hepatotoxic drugs or if there is a history of drug-induced hepatotoxicity.
Consider discontinuing pms-TERIFLUNOMIDE if serum transaminase increase (greater than three times the ULN) is confirmed. Monitor serum transaminase and bilirubin on pms-TERIFLUNOMIDE 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.
Patients should be advised to immediately report signs or symptoms of hepatotoxicity. If liver injury is suspected to be teriflunomide-induced, discontinue pms-TERIFLUNOMIDE and start an accelerated elimination procedure (see 7 WARNINGS AND PRECAUTIONS, General, Accelerated Elimination Procedure) and monitor liver tests weekly until normalized.
If teriflunomide-induced liver injury is unlikely because some other probable cause has been found, resumption of teriflunomide therapy may be considered. Due to a potential for additive hepatotoxic effects, alcohol consumption should be avoided pms-TERIFLUNOMIDE (Teriflunomide tablets) Page 11 of 45 during treatment with pms-TERIFLUNOMIDE.
Hypoproteinemia […]
35 16 NON-CLINICAL TOXICOLOGY ............................................................................................ 35 17 SUPPORTING PRODUCT MONOGRAPHS...........................................................................
37 PATIENT MEDICATION INFORMATION ................................................................................... 38 pms-TERIFLUNOMIDE (Teriflunomide tablets) Page 4 of 45 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS pms-TERIFLUNOMIDE (teriflunomide) is indicated for: • monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
pms-TERIFLUNOMIDE should only be prescribed by clinicians who are experienced in the diagnosis and management of multiple sclerosis. 1 Pediatrics Pediatrics (< 18 years of age):The safety and efficacy of teriflunomide have not been established in pediatric patients and pms-TERIFLUNOMIDE is not recommended in this patient population.
2 Geriatrics Clinical studies of teriflunomide did not include patients over 65 years old. pms-TERIFLUNOMIDE should be used with caution in patients aged 65 years and over. 4 Geriatrics). 2 CONTRAINDICATIONS pms-TERIFLUNOMIDE (teriflunomide) is contraindicated in patients: • with known hypersensitivity to teriflunomide, leflunomide (the parent compound) or to any of the nonmedicinal ingredients in the formulation.
• who are currently treated with leflunomide. Co-administration of teriflunomide with leflunomide is contraindicated. • with severe hepatic impairment (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). • who are pregnant or women of childbearing potential not using reliable contraception (see 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential).
Teriflunomide may cause fetal harm when administered to a pregnant woman. Pregnancy must be excluded before start of treatment. , AIDS). • with impaired bone marrow function or significant anemias, leucopenia, neutropenia or thrombocytopenia.
pms-TERIFLUNOMIDE (Teriflunomide tablets) Page 5 of 45 • with serious active infections. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Hepatotoxicity Severe liver injury including fatal liver failure occurred rarely in the post-marketing setting.
Concomitant use of pms-TERIFLUNOMIDE with other potentially hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of pms-TERIFLUNOMIDE therapy. Monitor ALT levels at least monthly for at least six months after starting pms-TERIFLUNOMIDE (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
If drug induced liver injury is suspected, discontinue pms-TERIFLUNOMIDE and start an accelerated elimination procedure with cholestyramine or charcoal (see 7 WARNINGS AND PRECAUTIONS, Accelerated Elimination Procedure). pms-TERIFLUNOMIDE is contraindicated in patients with severe hepatic impairment.
Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking pms-TERIFLUNOMIDE. Risk of Teratogenicity Based on animal data, teriflunomide may cause major birth defects if used during pregnancy.
Pregnancy must be […]