——美国批准一种治疗Ⅱ型糖尿病口服药片Tradjenta上市 2012年8月17日，Boehringer Ingelheim Pharmaceuticals，Inc.和Eli Lilly和公司今天宣布美国食品和药品监督管理局(FDA)已批准Tradjenta(linagliptin)片的一个补充新药申请(sNDA)作为添加对胰岛素治疗。Tradjenta是一种处方药 在2型糖尿病成年中与膳食和运动一起使用降血糖，和可为2型糖尿病用作单药治疗或与其他常用处方药联用，例如二甲双胍[metformin]，磺酰脲类，吡格列酮[pioglitazone]或胰岛素。Tradjenta不应在1型糖尿病患者中使用或为治疗糖尿病酮症酸中毒(血或尿中酮体增加)。 FDA的决定是根据来自一项52-周，3期试验证实Tradjenta与胰岛素(有或无二甲双胍和/或吡格列酮)联用的疗效的数据。试验结果显示增添 Tradjenta至胰岛素比单用胰岛素产生更佳血糖控制，两治疗组低血糖发生率相似(1)。Tradjenta属于一类处方药被称为二肽肽酶 -4(DPP-4)抑制剂和是这类中被批准的第一个成员在剂量强度 (5 mg，每天1次)。 另外，FDA-批准说明书包括一项有严重慢性肾受损人们的临床研究。来自一项52-周，双盲，随机，安慰剂对照试验数据显示使用Tradjenta 5 mg加其他降糖治疗与安慰剂比较在这个患者群提供糖化血红蛋白(HbA1c或A1C)统计显著改善(安慰剂-调整减低0.7 %)。(1 ) Boehringer Ingelheim Pharmaceuticals，Inc.公司临床发展和医疗事务高级副总裁John Smith，M.D.，Ph.D.说：“许多2型糖尿病人们用胰岛素还需要增加药物。用今天FDA决定，Tradjenta可被有效添加治疗显示安全性图形有助于成年患者用胰岛素改善其血糖控制，”“不管肾功能或肝受损，Tradjenta只要每天1次，在这类药物中1剂量无需调整剂量。” Tradjenta通过增加肠促胰岛素水平，和整天自始至终增加餐后胰岛素水平，以葡萄糖依赖方式降血糖。许多考虑中当治疗2型糖尿病患者，约40 %个体有某些程度的肾受损。(2) 用Tradjenta不管肾功能或肝受损，无需剂量调整。(1) 为学习更多关于Tradjenta和对完整处方资料访问：www.Tradjenta.com,或电话Boehringer Ingelheim Pharmaceuticals，Inc.电话1-800-542-6257. 在一项52-周随机，双盲，安慰剂对照试验24周后测量用主要终点评价Tradjenta添加至基础胰岛素治疗的疗效。在这个试验中，总共1,261例用甘精胰岛素，地特胰岛素，或NPH 胰岛素控制不佳有2型糖尿病患者被随机接受或Tradjenta 5 mg每天1次或安慰剂。试验纳入患者有基线A1C大于或等于7 %和小于或等于10 %，和包括709例有肾受损患者，大多数为有轻度肾受损(估计肾小球滤过率[eGFR]60至<90 ml/min)。在糖尿病患者测量A1C提供既往2至3个月血糖控制指。试验头24周前和期间患者保持稳定的胰岛素剂量。另外背景治疗联用包括基础胰岛素加二甲双胍(75.5 %)，基础胰岛素加二甲双胍和吡格列酮(7.4 %)，和基础胰岛素加吡格列酮(1 %)。(1 ) 本试验主要终点是治疗24周后 A1C变化。在24周时，Tradjenta加基础胰岛素显示in 血红蛋白A1C安慰剂-调整从基线A1C的8.3 %减低0.65 %。对Tradjenta在24周后基础胰岛素剂量平均变化为 +0.6 IU/day相比对安慰剂+1.3 IU/day。(1) 对有或无肾受损患者Tradjenta和安慰剂间见到A1C差别有可比性，而不管损伤的严重程度。至第24周两个治疗组体重从基线的总体平均变化相似。在研究的头24周两组低血糖率也相似(Tradjenta21.4 %，和安慰剂22.9 %)。(1) 严重肾受损患者中Tradjenta与胰岛素联用伴低血糖较高率。 52-周试验在有2型糖尿病和严重慢性肾受损，定义为eGFR小于30 ml/min，患者(n=133)中评价Tradjenta的疗效和安全性。除了研究药物，患者还接收背景抗高血糖治疗，其中包括胰岛素或与胰岛素任何联用；磺酰脲类或格列奈类药物[glinides]作为单药治疗；和吡格列酮或任何其他降血糖药物除其他DPP-4抑制剂。对研究的初始12周，降血糖药背景剂量保持稳定。随后40-周期时，如不符合血糖目标降血糖药治疗背景剂量可调整。在基线时62.5 %患者单独接受胰岛素作为背景糖尿病治疗，而12.5 %单独接受磺酰脲类。(3) 本研究主要终点是12周治疗后A1C从基线变化。12周治疗后，与安慰剂比较Tradjenta 5 mg提供A1C统计显著改善与校正平均变化-0.6 %。与安慰剂比较疗效维持52周A1C从基线校正平均变化-0.7 %。(1 ) 严重低血糖事件，定义为一个事件需要另外人协助积极给予碳水化合物，胰高血糖素或其他抢救行动，被报道在三例(4.4 %)Tradjena治疗患者和三例(4.6 %)安慰剂-治疗患者。 请报告任何非期望效应或产品问题至Boehringer Ingelheim药物资料单位提供电话1-800-542-6257 (选择4). Tradjenta是一种处方药在有2型糖尿病成年中与膳食和运动一起使用降血糖。 Tradjenta不是为1型糖尿病人们或为有糖尿病酮症酸中毒人们(血或尿中酮体增加)。 如患者对linagliptin或Tradjenta 中任何无效成分过敏不要用Tradjenta。 对Tradjenta严重过敏反应的症状是皮疹，皮肤增高红色斑块(麻疹)，面，唇，和喉肿胀可能引起呼吸或吞咽困难。如患者有任何严重过敏反应症状，停止用Tradjenta和马上叫患者医生。 如果用其它药物可能减低血糖，例如一种磺酰脲类或胰岛素告诉患者医生。 Tradjenta可能引起副作用，包括低血糖。如果用Tradjenta 与另一种可能致低血糖药物，例如磺酰脲类或胰岛素，得到低血糖的风险较高。而当用Tradjenta时磺酰脲类或胰岛素剂量可能需要较低。. 低血糖体征和症状可能包括头痛，睡意，无力，眩晕，混乱，易怒，饥饿，心跳过快，出汗，或感觉紧张。 还告诉患者医生如服用利福平[rifampin](Rifadin(R)，Rimactane(R)，Rifater(R)，Rifamate(R))，一种抗生素用于治疗结核。 Tradjenta可能影响其他药物的工作，而其他药物可能影响Tradjenta工作。 如妊娠或计划成为怀孕或正在哺乳或计划哺乳告诉患者医生。 告诉患者医生关于使用所有药物，包括处方和非-处方药，维生素，和草药补充剂。 Tradjenta的最常见副作用包括闷或流鼻涕和喉咙痛。鼓励患者报告处方药物的阴性副作用至FDA 请参阅下文为TRADJENTA的处方资料 美国初始批准：2011 1 适应证和用途 1.1 单药治疗和联合治疗 TRADJENTA片适用于作为膳食和运动的辅助治疗成年2型糖尿病改善血糖控制[见临床研究]。 1.2 重要使用限制 TRADJENTA不应在1型糖尿病患者中使用或为治疗糖尿病酮症酸中毒，因为在这些情况不会有效。 未曾研究TRADJENTA与胰岛素联用。 2 剂量和给药方法 2.1 推荐给药 TRADJENTA的推荐剂量是5 mg每天1次。 TRADJENTA片可与食物或不与食物服用。 2.2 与一种磺酰脲类同时使用 当TRADJENTA与一种胰岛素促分泌素联用时(如，磺酰脲类)，可能需要较低剂量胰岛素促分泌素以减低低血糖症的风险[见警告和注意事项]。 3 剂型和规格 TRADJENTA(利拉利汀) 5 mg片是浅红色，圆，双凸，斜边，薄膜包衣片在一侧凹有“D5”和另一侧凹有 Boehringer Ingelheim标识。 4 禁忌证 对利拉利汀超敏反应史患者禁忌TRADJENTA，例如荨麻疹，血管水肿，或支气管超敏性[见不良反应]。 5 警告和注意事项 5.1 与已知引起低血糖症药物使用 促胰岛素分泌素已知引起低血糖症。在一项临床试验中，TRADJENTA与一种胰岛素促分泌素联用(如，磺酰脲类)与安慰剂比较伴有低血糖症较高发生率[见不良反应(6.1)]。所以，当与TRADJENTA联用时为减低低血糖症风险，可能需要较低剂量的胰岛素促分泌素。 5.2 大血管结局 用TRADJENTA片或任何其它抗糖尿病药，无大血管风险减低临床研究建立结论性证据。 6 不良反应 6.1 临床试验经验 因为临床试验是在广泛不同条件下进行，某药临床试验观察到的不良反应率不能与另一药物临床试验中的发生率直接比较而且可能不反映实践中观察到的发生率。 曾在超过4000例2型糖尿病患者临床试验中评价利拉利汀的安全性, 包括12项安慰剂-对照研究和1项用格列美脲[glimepiride]阳性-对照研究。 在两项18-和24-周时间安慰剂-对照试验TRADJENTA 5 mg每天1次作为单药治疗研究。5项安慰剂-对照试验 研究利拉利汀与其它口服抗-血糖药联用：两项与二甲双胍[metformin](12-和24-周治疗时间)；一项与一种磺酰脲类(18-周治疗时间); 一项与二甲双胍和磺酰脲类(24-周治疗时间)；和一项与匹格列酮[pioglitazone](24-周治疗时间)。在安慰剂-对照临床试验中，接受TRADJENTA患者(n = 2566)发生 ≥5%和比给安慰剂患者(n = 1183)更常见不良反应包括鼻咽炎(5.8%相比5.5%)。在表1中显示用TRADJENTA每天5 mg治疗患者作为单药治疗或与匹格列酮，磺酰脲类，或二甲双胍联用报道≥2%和比用安慰剂治疗患者更常见至少2-倍的不良反应。 在一项对照研究比较利拉利汀与格列美脲其中所有患者还接受二甲双胍，52周治疗后, 用利拉利汀治疗患者(n = 776)报道≥5%和比用一种磺酰脲类治疗患者(n = 775)更频不良反应是关节痛(5.7%相比3.5%)，背痛(6.4%相比5.2%)，和头痛 (5.7%相比4.2%)。 在用TRADJENTA治疗临床研究中报道的其它不良反应是超敏性(如，荨麻疹，血管水肿，局部皮肤脱落，或支气管超敏性)，和肌痛。在临床试验计划中，当正在用TRADJENTA治疗中8/4687例患者(4311例患者年暴露)报道胰腺炎与之比较用安慰剂治疗有0/1183例患者(433例患者年暴露)。利拉利汀末次给药后报道另外三例胰腺炎。 低血糖症 在安慰剂-对照研究中，总数2566例用TRADJENTA 5 mg治疗患者中195例(7.6%)报道低血糖症与之比较1183例安慰剂治疗患者中49患者(4.1%)。当利拉利汀作为被给予单药治疗或与二甲双胍，或与匹格列酮联用低血糖症的发生率与安慰剂相似。当利拉利汀与二甲双胍和一种磺酰脲类联合给药时，181/791例(22.9%)患者报道低血糖症与之比较给予安慰剂与二甲双胍和一种磺酰脲类联用患者有39/263例(14.8%)。 实验室检验 用TRADJENTA 5mg治疗患者与用安慰剂治疗患者比较实验室发现变化相似。在TRADJENTA组中实验室变化值发生更频和比安慰剂组更≥1%是尿酸增加(安慰剂组1.3%，在TRADJENTA组中2.7 %)。 用TRADJENTA治疗患者未观察到临床有意义的生命征象变化。 7 药物相互作用 7.1 P-糖蛋白或CYP3A4酶诱导剂 利福平减低利拉利汀暴露提示当与一种强P-gp或CYP 3A4诱导剂联合给药时TRADJENTA的疗效可能减低。所以，当利拉利汀是将与P-gp或CYP 3A4诱导剂给药时强烈建议用另外治疗[见临床药理学]。 8 特殊人群中使用 8.1妊娠 妊娠类别B 在大鼠和兔中曾进行生殖研究研究。但是在妊娠妇女中无适当和对照良好研究。因为动物生殖研究研究并非总能预测人反应，妊娠期间只有如明确需求时才应使用本药。器官形成期时给予利拉利汀在剂量直至在大鼠中30 mg/kg和在兔中150 mg/kg，或基于AUC暴露接近临床剂量的49和1943倍不是致畸胎性。利拉利汀的剂量在大鼠中引起母体毒性和在兔中也引起在骨骼骨化中发育延迟和大鼠中略微增加胚胎胎鼠丢失(临床剂量1000倍)和在兔中增加胎兔再吸收和内脏和骨骼变异(临床剂量1943倍)。 利拉利汀给予雌性大鼠从怀孕第6天至哺乳第21天在雄性和雌性子代在母体毒性剂量(暴露>临床剂量1000倍)导致体重减轻和身体和行为发育延迟。暴露于临床剂量49倍时，未观察到大鼠子代的功能，行为，或生殖毒性。 在妊娠大鼠和兔中口服给药后，利拉利汀跨越胎盘进入胎畜。 8.3 哺乳母亲 可供利用动物资料曾显示利拉利汀排泄在乳汁，在乳汁-与-血浆比值4:1。不知道本药是否排泄至人乳汁。 因为许多药物排泄至人乳汁，应小心谨慎对待当TRADJENTA给予哺乳妇女。 8.4 儿童使用 尚未确定TRADJENTA在儿童患者中的安全性和有效性。 8.5 老年人使用 在TRADJENTA的临床研究中患者总数(n= 4040)，1085例患者是65岁和以上，而131例患者是75岁和以上。65岁和以上患者和较年轻患者间未观察到安全性和有效性总体差别。而这个和其它临床经验报道没有鉴定老年人和较年轻患者间反应差别，不能除外某些老年个体更大敏感性。在此人群中无需调整剂量。 8.6 肾受损 对有肾受损患者建议无需调整剂量[见临床药理学]。 8.7 肝受损 对有肝受损患者建议无需调整剂量[见临床药理学]。 9 药物过量 在健康受试者对照临床试验期间，用单次给药直至600 mg TRADJENTA(等于推荐每天剂量120倍)无剂量相关临床不良药物反应。在人中没有高于600 mg 以上剂量的经验。 在药物过量事件中，联系中毒控制中心。应用通常支持性措施也是合理的，如，从胃肠道去除未吸收物质，应用临床监视，和通过患者临床状态支配下开始支持治疗。通过血液透析或腹膜内透析预期不能在治疗上显著程度消除利拉利汀。 INDICATION AND IMPORTANT LIMITATIONS OF USE JENTADUETO tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate. JENTADUETO should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, and has not been studied in combination with insulin. IMPORTANT SAFETY INFORMATION WARNING: RISK OF LACTIC ACIDOSIS Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure. The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate. If acidosis is suspected, JENTADUETO should be discontinued and the patient hospitalized immediately. CONTRAINDICATIONS JENTADUETO is contraindicated in patients with: Renal impairment (e.g., serum creatinine ≥1.5 mg/dL for men or ≥1.4 mg/dL for women, or abnormal creatinine clearance). Acute or chronic metabolic acidosis, including diabetic ketoacidosis. History of hypersensitivity reaction to linagliptin (such as urticaria, angioedema, or bronchial hyperreactivity) or metformin. WARNINGS AND PRECAUTIONS Lactic Acidosis Lactic acidosis is a serious, metabolic complication that can occur due to metformin accumulation during treatment with JENTADUETO and is fatal in approximately 50% of cases. The reported incidence of lactic acidosis in patients receiving metformin is approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years. Reported cases have occurred primarily in diabetic patients with significant renal impairment, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, particularly when accompanied by hypoperfusion and hypoxemia due to unstable or acute failure, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal impairment and the patient's age. The risk of lactic acidosis may be significantly decreased by regular monitoring of renal function in patients taking metformin. Treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin treatment should not be initiated in any patients unless measurement of creatinine clearance demonstrates that renal function is not reduced. Metformin should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Monitoring of Renal Function Before initiation of therapy with JENTADUETO and at least annually thereafter, renal function should be assessed and verified as normal. In patients in whom development of renal impairment is anticipated (e.g., elderly), renal function should be assessed more frequently and JENTADUETO discontinued if evidence of renal impairment is present. Radiological studies and surgical procedures: JENTADUETO should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure necessitating restricted intake of food or fluids, and withheld for 48 hours subsequent to the procedure and reinstituted only after renal function has been confirmed to be normal. Impaired Hepatic Function Impaired hepatic function has been associated with cases of lactic acidosis with metformin therapy. JENTADUETO tablets should generally be avoided in patients with clinical or laboratory evidence of hepatic impairment. Hypoglycemia Insulin secretagogues are known to cause hypoglycemia. The use of linagliptin in combination with an insulin secretagogue (e.g., sulfonylurea) was associated with a higher rate of hypoglycemia compared with placebo in a clinical trial. A lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with JENTADUETO. Vitamin B12 Levels Vitamin B12 deficiency: Metformin may lower Vitamin B12 levels. Monitor hematologic parameters annually. Alcohol Intake Alcohol is known to potentiate the effect of metformin on lactate metabolism. Patients should be warned against excessive alcohol intake while receiving JENTADUETO. Hypoxic States Cardiovascular collapse (shock) from whatever cause (e.g., acute congestive heart failure, acute myocardial infarction, and other conditions characterized by hypoxemia) has been associated with lactic acidosis and may also cause prerenal azotemia. When such events occur in patients on JENTADUETO therapy, the drug should be promptly discontinued. Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JENTADUETO or any other antidiabetic drug. ADVERSE REACTIONS In a 24-week factorial design study, adverse reactions reported in ≥5% of patients treated with JENTADUETO and more commonly than in patients treated with placebo were nasopharyngitis and diarrhea. In a 24-week factorial design study, hypoglycemia was reported in 4 (1.4%) of 286 subjects treated with linagliptin + metformin, 6 (2.1%) of 291 subjects treated with metformin and 1 (1.4%) of 72 subjects treated with placebo. In the placebo-controlled studies, hypoglycemia was more commonly reported in patients treated with the combination of linagliptin and metformin with SU (22.9%) compared with those treated with the combination of placeboand metformin with SU (14.8%). Pancreatitis was reported more often in patients randomized to linagliptin (1 per 538 person-years versus 0 in 433 person-years for comparator). DRUG INTERACTIONS Because cationic drugs eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems, careful patient monitoring and dose adjustment of JENTADUETO and/or the interfering drug is recommended in patients who are taking cationic medications that are excreted via the proximal renal tubular secretory system. The efficacy of JENTADUETO may be reduced when administered in combination with a strong P-glycoprotein inducer and CYP3A4 inducer (e.g., rifampin). Use of alternative treatments is strongly recommended The concomitant use of carbonic anhydrase inhibitors (e.g., topiramate) and metformin may induce metabolic acidosis. Use these drugs with caution in patients treated with JENTADUETO, as the risk of lactic acidosis may increase. USE IN SPECIFIC POPULATIONS As there are no adequate and well-controlled studies in pregnant women, the safety of JENTADUETO in pregnant women is not known. JENTADUETO should be used during pregnancy only if clearly needed. It is not known whether linagliptin is excreted in human milk. Metformin is excreted in human milk in low concentrations. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. The safety and effectiveness of JENTADUETO in patients below the age of 18 have not been established. JENTADUETO should be used with caution as age increases, as aging can be associated with reduced renal function. What are Tradjenta® (linagliptin) tablets? TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). Important Safety Information Who should not take TRADJENTA? Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA. Symptoms of a serious allergic reaction to TRADJENTA are rash, raised red patches on your skin (hives), swelling of your face, lips, and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking TRADJENTA and call your doctor right away. What should I tell my doctor before taking TRADJENTA? TelI your doctor if you take other medicines that can lower your blood sugar, such as a sulfonylurea or insulin. TRADJENTA may cause serious side effects, including low blood sugar (hypoglycemia). If you take TRADJENTA with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered while you take TRADJENTA. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery. Also tell your doctor if you take rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®)*, an antibiotic that is used to treat tuberculosis. TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works. Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. What are the possible side effects of TRADJENTA? The most common side effects of TRADJENTA include stuffy or runny nose and sore throat. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For more safety information, please see Patient Information and full Prescribing Information. TJ CONS ISI August 14 2012 *Boehringer Ingelheim Pharmaceuticals, Inc. uses the Tradjenta® registered trademark under license. The other trademarks referenced above are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc. or Lilly USA, LLC. Replacement Card If you are already enrolled in the TRADJENTA Savings Card Program and need a replacement card, please call the TRADJENTA Savings Card Program at 1-877-512-4246. Our customer service representatives are available to assist you. ------------------------------------------------------------ 注：以下产品不同规格和不同价格，购买时以咨询为准！ ------------------------------------------------------------ 原产地英文商品名: TRADJENTA UD 5MG/TAB 100TABS/BOX 原产地英文药品名: LINAGLIPTIN 原产地英文化合物名称:1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7- dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]- 中文参考商品译名: TRADJENTA板装 5毫克/片 100片/盒 中文参考药品译名: 利拉利汀 -------------------------------------------------------------- 原产地英文商品名: TRADJENTA 5MG/TAB 30TABS/BTL 原产地英文药品名: LINAGLIPTIN 原产地英文化合物名称:1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7- dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]- 中文参考商品译名: TRADJENTA 5毫克/片 30片/瓶 中文参考药品译名: 利拉利汀