欧盟 - 英文 - EMA (European Medicines Agency)

ratiopharm gmbh - leflunomide - arthritis, rheumatoid - immunosuppressants - leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard);active psoriatic arthritis.recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

以色列 - 英文 - Ministry of Health

sanofi israel ltd - leflunomide - film coated tablets - leflunomide 20 mg - leflunomide - leflunomide - arava is indicated in adults for the treatment of active rheumatoid arthritis (ra) : 1. to reduce signs and symptoms 2. to inhibit structural damage as evidenced by x-ray erosions and joint space narrowing 3. to imptove physical function. arava is indicated for the treatment of adult patients with active psoriatic arthritis.

欧盟 - 英文 - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - leflunomide - arthritis, rheumatoid - selective immunosuppressants - leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard).recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

新西兰 - 英文 - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - leflunomide 20mg;   - film coated tablet - 20 mg - active: leflunomide 20mg   excipient: colloidal silicon dioxide crospovidone lactose monohydrate maize starch opadry yellow 85f12305 povidone purified talc - aft-leflunomide is indicated for treating rheumatoid arthritis, for improving signs and symptoms of the disease, for retarding joint destruction and also for improving functionality and the quality of life. aft-leflunomide can be used with patients who have not responded to alternative treatments or as a first line treatment in patients who have a contraindication to other medicines.

比利时 - 英文 - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - leflunomide 20 mg - film-coated tablet - 20 mg - leflunomide 20 mg - leflunomide

加拿大 - 英文 - Health Canada

teva canada limited - leflunomide - tablet - 10mg - leflunomide 10mg - disease-modifying antirheumatic agents

美国 - 英文 - NLM (National Library of Medicine)

avera mckennan hospital - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 20 mg

美国 - 英文 - NLM (National Library of Medicine)

fosun pharma usa inc. - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - 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 pregnancies by calling 1-877-311-8972 or visit http://www.pregnancystudies.org/participate-ina-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.

新加坡 - 英文 - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - leflunomide - tablet, film coated - 20 mg - leflunomide 20 mg

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - leflunomide, quantity: 20 mg - tablet, uncoated - excipient ingredients: crospovidone; magnesium stearate; colloidal anhydrous silica; lactose - leflunomide apotex is indicated for the treatment of: active rheumatoid arthritis; active psoriatic arthritis. genrx leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. the combined use of genrx leflunomide with other disease modifying antirheumatic drugs (dmards) has not been adequately studied (see precautions).