United States - English - NLM (National Library of Medicine)

dispensing solutions, inc. - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 20 mg - leflunomide tablets are indicated in adults for the treatment of active rheumatoid arthritis (ra): - to reduce signs and symptoms - to inhibit structural damage as evidenced by x-ray erosions and joint space narrowing - to improve physical function (see clinical studies). aspirin, nonsteroidal anti-inflammatory agents and/or low dose corticosteroids may be continued during treatment with leflunomide tablets (see precautions - drug interactions – nsaids). the combined use of leflunomide tablets with antimalarials, intramuscular or oral gold, d penicillamine, azathioprine, or methotrexate has not been adequately studied. (see warnings - immunosuppression potential/bone marrow suppression). leflunomide tablets are contraindicated in patients with known hypersensitivity to leflunomide or any of the other components of leflunomide tablets. leflunomide tablets can cause fetal harm when administered to a pregnant woman. leflunomide, when administered orally to rats during organogenesis at a dose of 15 mg/kg, was ter

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 10 mg - leflunomide is indicated in adults for the treatment of active rheumatoid arthritis (ra): - to reduce signs and symptoms - to inhibit structural damage as evidenced by x-ray erosions and joint space narrowing - to improve physical function (see clinical studies ). aspirin, nonsteroidal anti-inflammatory agents and/or low dose corticosteroids may be continued during treatment with leflunomide (see precautions: drug interactions: nsaids ). the combined use of leflunomide with antimalarials, intramuscular or oral gold, d penicillamine, azathioprine, or methotrexate has not been adequately studied (see warnings: immunosuppression potential/bone marrow suppression ). leflunomide is contraindicated in patients with known hypersensitivity to leflunomide or any of the other components of leflunomide. leflunomide can cause fetal harm when administered to a pregnant woman. leflunomide, when administered orally to rats during organogenesis at a dose of 15 mg/kg, was teratogenic (most notably anophthalmia or microophth

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 10 mg - leflunomide tablets usp are indicated for the treatment of adults with active rheumatoid arthritis (ra).  leflunomide is contraindicated in: ·            pregnant women. leflunomide may cause fetal harm. if a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1 and 5.3) and use in specific populations (8.1)].   ·            patients with severe hepatic impairment [see warnings and precautions (5.2)]. ·            patients with known hypersensitivity to leflunomide or any of the other components of leflunomide. known reactions include anaphylaxis [see adverse reactions (6.1)]. ·             patients being treated with teriflunomide [see drug interactions (7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy. health care providers and patients are encouraged to report pr

United States - English - NLM (National Library of Medicine)

trigen laboratories, llc - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 10 mg - leflunomide tablets usp are indicated for the treatment of adults with active rheumatoid arthritis (ra).  leflunomide is contraindicated in: ·            pregnant women. leflunomide may cause fetal harm. if a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1 and 5.3) and use in specific populations (8.1)].   ·            patients with severe hepatic impairment [see warnings and precautions (5.2)]. ·            patients with known hypersensitivity to leflunomide or any of the other components of leflunomide. known reactions include anaphylaxis [see adverse reactions (6.1)]. ·             patients being treated with teriflunomide [see drug interactions (7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy. health care providers and patients are encouraged to report pr

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals limited - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 10 mg - leflunomide tablets usp are indicated for the treatment of adults with active rheumatoid arthritis (ra).  leflunomide is contraindicated in: ·            pregnant women. leflunomide may cause fetal harm. if a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1 and 5.3) and use in specific populations (8.1)].   ·            patients with severe hepatic impairment [see warnings and precautions (5.2)]. ·            patients with known hypersensitivity to leflunomide or any of the other components of leflunomide. known reactions include anaphylaxis [see adverse reactions (6.1)]. ·             patients being treated with teriflunomide [see drug interactions (7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy. health care providers and patients are encouraged to report pr

United States - English - NLM (National Library of Medicine)

winthrop u.s, a business of sanofi-aventis u.s. llc - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 10 mg - leflunomide is indicated for the treatment of adults with active rheumatoid arthritis (ra). leflunomide is contraindicated in: - pregnant women. leflunomide may cause fetal harm. if a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1,5.3)and use in specific populations (8.1)]. - patients with severe hepatic impairment [see warnings and precautions (5.2)]. - patients with known hypersensitivity to leflunomide or any of the other components of leflunomide. known reactions include anaphylaxis [see adverse reactions (6.1)]. - patients being treated with teriflunomide [see drug interactions (7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy. health care providers and patients are encouraged to report pregnancies by calling 1-877-311-8972 or visit http://www.pregnancystudies.org/participate-in-a-study/. risk summary leflunomide is contraindicated for use in pregnant women because of the potential for fetal harm. in animal reproduction studies, oral administration of leflunomide during organogenesis at a dose of 1/10 of, and equivalent to, the maximum recommended human dose (mrhd) based on auc, respectively, in rats and rabbits, caused teratogenicity (rats and rabbits), and embryo-lethality (rats) [see data] . pregnancy exposure registry data are not available at this time to inform the presence or absence of drug-associated risk with the use of leflunomide during pregnancy. the background risk of major birth defects and miscarriage for the indicated populations is unknown. the background risk in the u.s. general population of major birth defects is 2%–4% and of miscarriage is 15%–20% of clinically recognized pregnancies. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, stop treatment with leflunomide, apprise the patient of the potential hazard to a fetus, and perform the accelerated drug elimination procedure to achieve teriflunomide concentrations of less than 0.02 mg/l (0.02 mcg/ml) [see warnings and precautions (5.3)] . clinical considerations fetal/neonatal adverse reactions lowering the plasma concentration of the active metabolite, teriflunomide, by instituting an accelerated drug elimination procedure as soon as pregnancy is detected may decrease the risk to the fetus from leflunomide. the accelerated drug elimination procedure includes verification that the plasma teriflunomide concentration is less than 0.02 mg/l [see warnings and precautions (5.3)and clinical pharmacology (12.3)] . data animal data in an embryo-fetal development study, pregnant rats administered leflunomide during organogenesis from gestation days 7 to 19 at a dose approximately 1/10 of the mrhd (on an auc basis at a maternal oral dose of 15 mg/kg), teratogenic effects, most notably anophthalmia or microphthalmia and internal hydrocephalus, were observed. under these exposure conditions, leflunomide also caused a decrease in the maternal body weight and an increase in embryolethality with a decrease in fetal body weight for surviving fetuses. in an embryo-fetal development study, pregnant rabbits administered leflunomide during organogenesis from gestation days 6 to 18 at a dose approximately equivalent to the mrhd (on an auc basis at a maternal oral dose of 10 mg/kg), a teratogenic finding of fused, dysplastic sternebrae was observed. leflunomide was not teratogenic in rats and rabbits at doses approximately 1/150 and 1/10 of the mrhd, respectively (on an auc basis at maternal oral dose of 1 mg/kg in both rats and rabbits). in a pre and postnatal development study, when female rats were treated with leflunomide at a dose that was approximately 1/100 of the mrhd (on an auc basis at a maternal dose of 1.25 mg/kg) beginning 14 days before mating and continuing until the end of lactation, the offspring exhibited marked (greater than 90%) decreases in postnatal survival. risk summary clinical lactation studies have not been conducted to assess the presence of leflunomide in human milk, the effects of leflunomide on the breastfed child, or the effects of leflunomide on milk production. because of the potential for serious adverse reactions in a breastfed infant from leflunomide, advise a nursing woman to discontinue breastfeeding during treatment with leflunomide. leflunomide may cause fetal harm when administered during pregnancy. advise females of the potential risk to the fetus. advise females to notify their healthcare provider immediately if pregnancy occurs or is suspected during treatment [see use in specific populations (8.1)] . women receiving leflunomide treatment who wish to become pregnant should discontinue leflunomide and undergo an accelerated drug elimination procedure to achieve plasma teriflunomide concentrations of less than 0.02 mg/l (0.02 mcg/ml) [see warnings and precautions (5.3)] . pregnancy testing exclude pregnancy in females of reproductive potential before starting treatment with leflunomide. contraception females advise females of reproductive potential to use effective contraception during treatment with leflunomide and while undergoing a drug elimination procedure until verification that the plasma teriflunomide concentration is less than 0.02 mg/l [see warnings and precautions (5.3)] . the safety and effectiveness of leflunomide in pediatric patients have not been established. the safety and effectiveness of leflunomide in the treatment of polyarticular course juvenile idiopathic arthritis (jia) was evaluated in a single multicenter, double-blind, active-controlled trial in 94 pediatric patients (1:1 randomization) with polyarticular course juvenile idiopathic arthritis (jia) as defined by the american college of rheumatology (acr). in this population, leflunomide treatment was found not to be effective. the safety of leflunomide was studied in 74 patients with polyarticular course jia ranging in age from 3–17 years (47 patients from the active-controlled study and 27 from an open-label safety and pharmacokinetic study). the most common adverse events included abdominal pain, diarrhea, nausea, vomiting, oral ulcers, upper respiratory tract infections, alopecia, rash, headache, and dizziness. less common adverse events included anemia, hypertension, and weight loss. fourteen pediatric patients experienced alt and/or ast elevations, nine between 1.2 and 3-fold the upper limit of normal, and five between 3 and 8-fold the upper limit of normal. of the total number of subjects in controlled clinical trials (trials 1, 2, and 3) of leflunomide, 234 subjects were 65 years and over [see clinical studies (14)] . no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dosage adjustment is needed in patients over 65. dedicated studies of the effect of hepatic impairment on leflunomide pharmacokinetics have not been conducted. given the need to metabolize leflunomide into the active species, the role of the liver in drug elimination/recycling, and the possible risk of increased hepatic toxicity, the use of leflunomide in patients with hepatic impairment is not recommended. dedicated studies of the effect of renal impairment on leflunomide pharmacokinetics have not been conducted. given that the kidney plays an important role in drug elimination, caution should be used when leflunomide is administered to these patients.

United States - English - NLM (National Library of Medicine)

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 10 mg - leflunomide tablets, usp are indicated for the treatment of adults with active rheumatoid arthritis (ra). leflunomide tablets are contraindicated in: •pregnant women.  leflunomide may cause fetal harm.  if a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1and 5.3) and use in specific populations (8.1)]. •patients with severe hepatic impairment [see warnings and precautions (5.2)] . •patients with known hypersensitivity to leflunomide or any of the other components of leflunomide tablets. known reactions include anaphylaxis [see adverse reactions (6.1)] . •patients being treated with teriflunomide [see drug interactions (7)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy.  health care providers and patients are encouraged to report pregnancies by calling 1-877-3

United States - English - NLM (National Library of Medicine)

apotex corp. - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 10 mg - leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (ra). leflunomide is contraindicated in: - pregnant women. leflunomide may cause fetal harm. if a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1 and 5.3) and use in specific populations (8.1)]. - patients with severe hepatic impairment [see warnings and precautions (5.2)]. - patients with known hypersensitivity to leflunomide or any of the other components of leflunomide. known reactions include anaphylaxis [see adverse reactions (6.1)]. - patients being treated with teriflunomide [see drug interactions (7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy. health care providers and patients are encouraged to report pregnancies by calling 1-877-311-8972 or visit http://www.pregnancystudies.org/participate-in­-a-study/. risk summary leflunomide is contraindicated for use in pregnant women because of the potential for fetal harm. in animal reproduction studies, oral administration of leflunomide during organogenesis at a dose of 1/10 of and equivalent to the maximum recommended human dose (mrhd) based on auc, respectively in rats and rabbits, caused teratogenicity (rats and rabbits) and embryo-lethality (rats) [see data] . pregnancy exposure registry data are not available at this time to inform the presence or absence of drug-associated risk with the use of leflunomide during pregnancy. the background risk of major birth defects and miscarriage for the indicated populations is unknown. the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, stop treatment with leflunomide, apprise the patient of the potential hazard to a fetus, and perform the accelerated drug elimination procedure to achieve teriflunomide concentrations of less than 0.02 mg/l (0.02 mcg/ml) [see warnings and precautions (5.3)]. clinical considerations fetal/neonatal adverse reactions lowering the plasma concentration of the active metabolite, teriflunomide, by instituting an accelerated drug elimination procedure as soon as pregnancy is detected may decrease the risk to the fetus from leflunomide. the accelerated drug elimination procedure includes verification that the plasma teriflunomide concentration is less than 0.02 mg/l [see warnings and precautions (5.3) and clinical pharmacology (12.3)]. data animal data in an embryofetal development study, pregnant rats administered leflunomide during organogenesis from gestation days 7 to 19 at a dose approximately 1/10 of the mrhd (on an auc basis at a maternal oral dose of 15 mg/kg), teratogenic effects, most notably anophthalmia or microophthalmia and internal hydrocephalus, were observed. under these exposure conditions, leflunomide also caused a decrease in the maternal body weight and an increase in embryolethality with a decrease in fetal body weight for surviving fetuses. in an embryofetal development study, pregnant rabbits administered leflunomide during organogenesis from gestation days 6 to 18 at a dose approximately equivalent to the mrhd (on an auc basis at a maternal oral dose of 10 mg/kg), a teratogenic finding of fused, dysplastic sternebrae was observed. leflunomide was not teratogenic in rats and rabbits at doses approximately 1/150 and 1/10 of the mrhd, respectively (on an auc basis at maternal oral dose of 1 mg/kg in both rats and rabbits). in a pre- and post-natal development study, when female rats were treated leflunomide at a dose that was approximately 1/100 of the mrhd (on an auc basis at a maternal dose of 1.25 mg/kg) beginning 14 days before mating and continuing until the end of lactation, the offspring exhibited marked (greater than 90%) decreases in postnatal survival. risk summary clinical lactation studies have not been conducted to assess the presence of leflunomide in human milk, the effects of leflunomide on the breastfed child, or the effects of leflunomide on milk production. because of the potential for serious adverse reactions in a breastfed infant from leflunomide, advise a nursing woman to discontinue breastfeeding during treatment with leflunomide. leflunomide may cause fetal harm when administered during pregnancy. advise females of the potential risk to the fetus. advise females to notify their healthcare provider immediately if pregnancy occurs or is suspected during treatment [see use in specific populations (8.1)] . women receiving leflunomide treatment who wish to become pregnant should discontinue leflunomide and undergo an accelerated drug elimination procedure to achieve plasma teriflunomide concentrations of less than 0.02 mg/l (0.02 mcg/ml) [see warnings and precautions (5.3)]. pregnancy testing exclude pregnancy in females of reproductive potential before starting treatment with leflunomide. contraception females advise females of reproductive potential to use effective contraception during treatment with leflunomide and while undergoing a drug elimination procedure until verification that the plasma teriflunomide concentration is less than 0.02 mg/l [see warnings and precautions (5.3)]. the safety and effectiveness of leflunomide in pediatric patients have not been established. the safety and effectiveness of leflunomide in the treatment of polyarticular course juvenile idiopathic arthritis (jia) was evaluated in a single multicenter, double-blind, active-controlled trial in 94 pediatric patients (1:1 randomization) with polyarticular course juvenile idiopathic arthritis (jia) as defined by the american college of rheumatology (acr). in this population, leflunomide treatment was found not to be effective. the safety of leflunomide was studied in 74 patients with polyarticular course jia ranging in age from 3 to 17 years (47 patients from the active-controlled study and 27 from an open-label safety and pharmacokinetic study). the most common adverse events included abdominal pain, diarrhea, nausea, vomiting, oral ulcers, upper respiratory tract infections, alopecia, rash, headache, and dizziness. less common adverse events included anemia, hypertension, and weight loss. fourteen pediatric patients experienced alt and/or ast elevations, nine between 1.2 and 3-fold the upper limit of normal, five between 3 and 8-fold the upper limit of normal. of the total number of subjects in controlled clinical trials (trials 1, 2, and 3) of leflunomide, 234 subjects were 65 years and over [see clinical studies (14)] . no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dosage adjustment is needed in patients over 65. dedicated studies of the effect of hepatic impairment on leflunomide pharmacokinetics have not been conducted. given the need to metabolize leflunomide into the active species, the role of the liver in drug elimination/recycling, and the possible risk of increased hepatic toxicity, the use of leflunomide in patients with hepatic impairment is not recommended. dedicated studies of the effect of renal impairment on leflunomide pharmacokinetics have not been conducted. given that the kidney plays an important role in drug elimination, caution should be used when leflunomide is administered to these patients.

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - leflunomide 10mg - tablet - 10 mg - active: leflunomide 10mg excipient: colloidal silicon dioxide crospovidone lactose magnesium stearate - apo-leflunomide is indicated for the treatment of: · rheumatoid arthritis, to improve signs and symptoms to retard joint destruction and to improve functional ability and quality of life. leflunomide may be used in patients who have failed to respond to other treatments or as a first line of treatment in patients who have a contraindication to other treatments. · active psoriatic arthritis. leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - leflunomide 20mg - tablet - 20 mg - active: leflunomide 20mg excipient: colloidal silicon dioxide crospovidone lactose magnesium stearate - apo-leflunomide is indicated for the treatment of: · rheumatoid arthritis, to improve signs and symptoms to retard joint destruction and to improve functional ability and quality of life. leflunomide may be used in patients who have failed to respond to other treatments or as a first line of treatment in patients who have a contraindication to other treatments. · active psoriatic arthritis. leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.