近日，复发性多发性硬化症新药Aubagio(Teriflunomide 中文译名：特立氟胺)口服片获美国及欧盟批准上市，特立氟胺片为一种新的药物，为每日1片,用于复发型多发性硬化症患者的治疗。 批准日期：September 12，2012；公司：Sanofi AUBAGIO（特立氟胺 teriflunomide）片剂，用于口服使用 美国初步批准：2012年 警告： 致命性和致畸风险查看完整的盒装警告的完整处方信息 肝毒性 在用来氟米特治疗的患者中已经报道了严重的肝损伤，包括致死性肝衰竭，这被指示用于类风湿性关节炎。预期特立氟胺具有类似的风险，因为推荐剂量的特立氟胺和来氟米特导致特立氟胺的血浆浓度范围相似。在开始AUBAGIO前6个月内获得转氨酶和胆红素水平，并至少每月监测ALT水平六个月。 如果怀疑药物诱导的肝损伤，停止AUBAGIO并开始加速消除程序。 致畸性危险 致畸性和胚胎率发生在给予特立氟胺的动物中。在开始AUBAGIO治疗之前排除妊娠。建议在治疗期间和加速药物消除程序期间在生殖潜能女性中使用有效避孕方法。停止AUBAGIO并使用加速药物消除程序，如果患者怀孕最近主要更改 作用机制 特立氟胺（具有抗炎性质的免疫调节剂）抑制二氢乳清酸脱氢酶，参与从头嘧啶合成的线粒体酶。 特立氟胺在多发性硬化中发挥其治疗作用的确切机制是未知的，但可能涉及CNS中活化淋巴细胞数目的减少。 适应症和用法 AUBAGIO是一种嘧啶合成抑制剂，用于治疗复发型多发性硬化患者 剂量和给药 7mg或14mg，每天一次，含或不含食物。 剂量形式和强度 7mg和14mg膜包衣片 禁忌症 严重肝损害 怀孕 超敏性 当前来氟米特治疗 警告和注意事项 通过施用消胆胺或活性炭11天可以加速AUBAG10的消除 AUBAGIO可能会减少WBC。在启动AUBAGIO之前应该有最新的CBC。监测感染的体征和症状。考虑在严重感染的情况下暂停使用AUBAGIO治疗。不要在活动性感染患者中启动AUBAGIO 停止AUBAGIO如果患者有过敏反应，血管性水肿，史蒂文斯 - 约翰逊综合征，中毒性表皮坏死松解症;启动快速消除 如果患者出现与周围神经病变一致的症状，评估患者并考虑停止AUBAGIO AUBAGIO可能会增加血压。在治疗开始时测量血压并在治疗期间监测血压 不良反应 最常见的不良反应（≥10％，≥2％，大于安慰剂）：头痛，腹泻，恶心，脱发，ALT增加 药物相互作用 由CYP2C8和OAT3转运体代谢的药物：监测患者，因为特立氟胺可能增加这些药物的暴露 特立氟胺可增加乙炔雌二醇和左炔诺孕酮的暴露。选择合适的口服避孕药 由CYP1A2代谢的药物：监测患者，因为特立氟胺可减少这些药物的暴露 华法林：监测INR为特立氟胺可能降低INR 通过BCRP和OATP1B1/B3转运体代谢的药物：监测患者，因为特立氟胺可能增加这些药物的暴露 在服用AUBAGIO的患者中，剂量不应超过每日一次10mg 参见17关于患者咨询信息和药物治疗指南。 修订：11/2016 完整处方资料附件： https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4650d12c-b9c8-4525-b07f-a2d773eca155 Aubagio(Teriflunomide Tablets) AUBAGIO® (teriflunomide) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. IMPORTANT SAFETY INFORMATION WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY  •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. AUBAGIO is contraindicated in patients with severe hepatic impairment and in patients taking leflunomide. •Concomitant use of AUBAGIO with other potentially hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for 6 months after starting AUBAGIO. If drug-induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or charcoal. AUBAGIO 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 AUBAGIO. •Based on animal data, AUBAGIO may cause major birth defects if used during pregnancy. Pregnancy must be excluded before starting AUBAGIO. AUBAGIO is contraindicated in pregnant women or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during AUBAGIO treatment or prior to the completion of an accelerated elimination procedure after AUBAGIO treatment. CONTRAINDICATIONS  •AUBAGIO is contraindicated in patients with severe hepatic impairment, in pregnant women, in women of childbearing potential who are not using reliable contraception, in patients with a history of hypersensitivity to teriflunomide, its inactive ingredients, or leflunomide, or who are currently taking leflunomide. WARNINGS AND PRECAUTIONS  •Hepatotoxicity: Patients with pre-existing acute or chronic liver disease, or those with serum ALT >2 times the upper limit of normal (ULN) before initiating treatment, should not normally be treated with AUBAGIO. In clinical trials, if ALT elevation was >3 times the ULN on 2 consecutive tests, patients discontinued AUBAGIO and underwent accelerated elimination. Consider additional monitoring if co-administering AUBAGIO with other potentially hepatotoxic drugs; monitor patients who develop symptoms suggestive of hepatic dysfunction (eg, unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine). •Use in Women of Childbearing Potential: Before starting therapy, use of reliable contraception must be confirmed, and the patient counseled on risks to the fetus. Patients with delayed onset of menses or other reason to suspect pregnancy should immediately see their physician for pregnancy testing. Patients who become pregnant or wish to become pregnant should discontinue treatment, followed by accelerated elimination until plasma concentrations of <0.02 mcg/mL are verified, a level expected to pose minimal risk to the fetus. Women who become pregnant while taking AUBAGIO may enroll in the AUBAGIO pregnancy registry by calling 1-800-745-4447, option 2. •Procedure for Accelerated Elimination of Teriflunomide: Teriflunomide is eliminated slowly from the plasma—it takes an average of 8 months, or up to 2 years, to reach plasma concentrations <0.02 mcg/mL. Elimination may be accelerated by administration of cholestyramine or charcoal, but this may cause disease activity to return in patients who were responding to AUBAGIO. •Bone Marrow Effects/Immunosuppression Potential/Infections: Decreases in white blood cell counts, mainly of neutrophils and lymphocytes, and platelets have been reported with AUBAGIO. Thrombocytopenia, including rare cases with platelet counts less than 50,000/mm3, have been reported in the postmarketing setting. Obtain a complete blood cell count within 6 months before starting treatment, with further monitoring based on signs and symptoms of bone marrow suppression. AUBAGIO is not recommended for patients with severe immunodeficiency, bone marrow disease, or severe uncontrolled infections. Tuberculosis (TB) has been observed in clinical studies of AUBAGIO. Before starting treatment, screen patients for latent TB infection with a tuberculin test. Treatment in patients with acute or chronic infections should not be started until the infection(s) is resolved. Administration of live vaccines is not recommended. The risk of malignancy, particularly lymphoproliferative disorders, or infection may be increased with the use of some medications with immunosuppressive potential, including teriflunomide. •Hypersensitivity and Serious Skin Reactions: AUBAGIO can cause anaphylaxis and severe allergic reactions. Signs and symptoms have included dyspnea ---------------------------------------- 注：以下产品不同规格和不同价格，采购在线咨询为准！ ---------------------------------------- 产地国家：德国 原产地英文商品名: Aubagio 14mg/Tablet 28Tablets/box 原产地英文药品名: Teriflunomide 中文参考商品译名: Aubagio 14毫克／片 28片/盒 中文参考药品译名: 特立氟胺 生产厂家中文参考译名: 健赞制药 生产厂家英文名: Genzyme ---------------------------------------- 产地国家：德国 原产地英文商品名: Aubagio 14mg/Tablet 84Tablets/box 原产地英文药品名: Teriflunomide 中文参考商品译名: Aubagio 14毫克／片 84片/盒 中文参考药品译名: 特立氟胺 生产厂家中文参考译名: 健赞制药 生产厂家英文名: Genzyme ---------------------------------------- 产地国家：美国 原产地英文商品名: Aubagio 7mg/Tablet 5Tablets/box 原产地英文药品名: Teriflunomide 中文参考商品译名: Aubagio 7毫克／片 5片/盒 中文参考药品译名: 特立氟胺 生产厂家中文参考译名: 健赞制药 生产厂家英文名: Genzyme ---------------------------------------- 产地国家：美国 原产地英文商品名: Aubagio 7mg/Tablet 28Tablets/box 原产地英文药品名: Teriflunomide 中文参考商品译名: Aubagio 7毫克／片 28片/盒 中文参考药品译名: 特立氟胺 生产厂家中文参考译名: 健赞制药 生产厂家英文名: Genzyme ---------------------------------------- 产地国家：美国 原产地英文商品名: Aubagio 14mg/Tablet 5Tablets/box 原产地英文药品名: Teriflunomide 中文参考商品译名: Aubagio 14毫克／片 5片/盒 中文参考药品译名: 特立氟胺 生产厂家中文参考译名: 健赞制药 生产厂家英文名: Genzyme ---------------------------------------- 产地国家：美国 原产地英文商品名: Aubagio 14mg/Tablet 28Tablets/box 原产地英文药品名: Teriflunomide 中文参考商品译名: Aubagio 14毫克／片 28片/盒 中文参考药品译名: 特立氟胺 生产厂家中文参考译名: 健赞制药 生产厂家英文名: Genzyme