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[心脑血管类] 诺欣妥片 (慢性心衰)

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华夏 发表于 2019-7-2 13:33:51 | 显示全部楼层 |阅读模式 打印 上一主题 下一主题
 
俄罗斯医药,天天都介绍:
诺欣妥片 (慢性心衰)

诺欣妥(Entresto)
英文名称:SacubitrilValsartanSodiumTablets

成份

本品活性成份:沙库巴曲缬沙坦钠
化学名称:十八钠六(4-{[(1S,3R)-1-([1,1’-联苯基)-4-基甲基)-4-乙 氧基-3-甲基-4-氧代丁基]氨基}-4-氧代丁酸)六(N-戊酰基-N-{[2’-(1H- 四氮唑-5-基)联苯-4-基]甲基}-L-缬氨酸)-水(1/15)

适应症

用于射血分数降低的慢性心力衰竭(NYHAⅡ-Ⅳ级,LVEF≤40%)成人患者,降低心血管死亡和心力衰竭住院的风险。 沙库巴曲缬沙坦钠片可代替血管紧张素转化酶抑制剂(ACEI)或血管紧张素Ⅱ受体拮抗剂(ARB),与其他心力衰竭治疗药物(例如:β受体阻断剂、利尿剂和盐皮质激素拮抗剂)合用。

用法用量

本品可以与食物同服,或空腹服用。 由于与ACE抑制剂合用时存在血管性水肿的潜在风险,禁止本品与ACEI合用。如果从ACEI转换成本品,必须在停止ACE抑制剂治疗至少36小时之后才能开始应用本品。 推荐本品起始剂量为每次100mg,每天两次。在目前未服用ACEI或血管紧张素II受体拮抗剂(ARB)的患者或服用低剂量上述药物的患者中,用药经验有限,推荐本品的起始剂量为50mg,每天两次。根据患者耐受情况,本品剂量应该每2至4周倍增一次,直至达到每次200mg每天两次的目标维持剂量。 血钾水平>5.4mmol/l的患者不可开始给予本品治疗。SBP<100mmHg的患者,开始给予本品治疗时需慎重,注意监测血压变化。对于100mmHg≤SBP至110mmHg的患者,应考虑起始剂量为50mg,每天两次。 如果患者出现不耐受本品的情况(收缩压≤95mmHg、症状性低血压、高钾血症、肾功能损害),建议调整合并用药,暂时降低本品剂量或停用本品。 本品具有拮抗血管紧张素Ⅱ受体的活性,故不应与ARB合用。 特殊人群 肾功能损害患者: 轻度肾功能损害(eGFR60~90mL/min/1.73m2)患者不需要调整起始剂量。 中度肾功能损害(eGFR30~60mL/min/1.73m2)患者应考虑起始剂量为每次50mg,每天两次。由于在重度肾功能损害患者(eGFR<30ml/min/1.73m2)中的用药经验非常有限,因此这类患者应慎用本 品,推荐起始剂量为每次50mg,每天两次。 没有在终末期肾病患者中的使用经验,因此不建议此类患者使用本品。 肝功能损害: 轻度肝功能损害(Child-PughA级)患者不需要调整起始剂量。 中度肝功能损害(Child-PughB级)患者的推荐起始剂量为每次50mg,每天两次。在患者能够耐受的情况下,可以每2-4周倍增一次本品剂量,直至达到目标维持剂量200mg每天两次。 不推荐重度肝功能损害(Child-PughC级)患者应用本品。 老年患者(65岁以上): 65岁以上患者无需进行剂量调整。

不良反应

本品可导致以下具有临床意义的不良反应:血管性水肿、低血压、肾功能损害、高钾血症,详见注意事项。 临床试验经验: 由于临床试验是在不同条件下开展的,一种药物在临床试验中观察到的不良反应发生率不能与另一种药物在其他临床试验中观察到的不良反应发生率进行直接比较,并且在临床试验中观察到的这种药物的不良反应发生率可能无法反映实际应用中观察到的发生率。 试验PARADIGM-HF中,在进入比较沙库巴曲缬沙坦钠片(诺欣妥)和依那普利的随机双盲阶段之前,要求受试者完成分别为期15天和29天(中位值)序贯的依那普利导入期和诺欣妥导入期。依那普利导入期有1102名患者(10.5%)永久终止研究,5.6%是由于不良事件,最常见的是肾功能损害(1.7%)、高钾血症(1.7%)和低血压(1.4%)。诺欣妥导入期,另外10.4%的患者永久终止治疗,5.9%是由于不良事件,最常见的是肾功能损害(1.8%)、低血压(1.7%)和高钾血症(1.3%)。由于这一导入期设计,下面描述的不良反应发生率低于预期的实际应用中的发生率。 双盲阶段评价了4203名诺欣妥治疗患者、4229名依那普利治疗患者的安全性。PARADIGM-HF研究中,随机至诺欣妥组的患者接受长达4.3年的治疗,中位暴露持续时间为24个月;3271名患者接受了一年以上的治疗。450名(10.7%)诺欣妥治疗患者、516名(12.2%)依那普利治疗患者在双盲阶段因不良事件终止治疗。 双盲阶段≥5%诺欣妥治疗患者发生的不良反应如表1所示。 1.双盲阶段≥5%诺欣妥治疗患者报告的不良反应 低血压诺欣妥(n=4,203)18%依那普利(n=4,229)12% 高钾血症诺欣妥(n=4,203)12%依那普利(n=4,229)14% 咳嗽诺欣妥(n=4,203)9%依那普利(n=4,229)13% 头晕诺欣妥(n=4,203)6%依那普利(n=4,229)5% 肾功能衰竭/急性肾功能衰竭诺欣妥(n=4,203)5%依那普利(n=4,229)5% 试验PARADIGM-HF中,依那普利导入期和诺欣妥导入期的血管性水肿发生率均为0.1%。双盲阶段,诺欣妥治疗患者血管性水肿发生率高于依那普利治疗患者(分别为0.5%和0.2%)。诺欣妥治疗的黑人患者和依那普利治疗的黑人患者中血管性水肿发生率分别为2.4%和0.5%(参见[注意事项])。 在PARADIGM-HF研究的双盲阶段,依那普利组、诺欣妥组的Orthostasis发生率分别为1.1%、2.1%。与依那普利治疗患者相比(1.3%),1.9%的诺欣妥治疗患者报告了跌倒。 实验室异常: 血红蛋白和红细胞压积在PARADIGM-HF研究的双盲阶段,诺欣妥组和依那普利组均有大约5%的治疗患者观察到血红蛋白/红细胞压积降低>20%。 血清肌酐 依那普利导入期1.4%的患者、诺欣妥导入期2.2%的患者观察到血清肌酐升高>50%。双盲治疗阶段,诺欣妥组和依那普利组均有大约16%的患者血清肌酐升高>50%。 血清钾 依那普利和诺欣妥导入期,均观察到大约4%患者的钾浓度>5.5mEq/L。双盲治疗阶段,诺欣妥组和依那普利组均有大约16%的患者钾浓度>5.5mEq/L。

禁忌

禁用于对本品活性成份(沙库巴曲、缬沙坦)或任何辅料过敏者。 禁止与ACEI合用。必须在停止ACEI治疗36小时之后才能服用本品。 禁用于存在ACEI或ARB治疗相关的血管性水肿既往病史的患者。 禁用于遗传性或特发性血管性水肿患者。 在2型糖尿病患者中,禁止诺欣妥与阿利吉仑合用。 禁用于重度肝功能损害、胆汁性肝硬化和胆汁淤积。 禁用于中期和晚期妊娠患者。

注意事项

警告:胚胎毒性 怀孕妇女应用本品可能造成胎儿损害。孕中期和孕晚期应用作用于肾素-血管紧张素系统的药物,可降低胎儿肾脏功能并增加胎儿和新生儿发病率和死亡率。发现怀孕时要考虑替代药物治疗并停用本品。但是,如果没有合适的替代治疗(替代影响肾素-血管紧张素系统的药物),并且认为本品可挽救母亲生命,则告知怀孕妇女本品对胎儿的潜在风险。 血管性水肿: 诺欣妥可能导致血管性水肿。在研究PARADIGM-HF的双盲阶段,0.5%的诺欣妥治疗患者和0.2%的依那普利治疗患者发生了血管性水。如果发生血管性水肿,立即停用诺欣妥,给予适当的治疗并监测呼吸道受累情况。禁止再次应用诺欣妥。对于已确认的局限于面部和唇部的血管性水肿病例,一般无需治疗便可缓解,虽然应用抗组胺药有助于缓解症状。 伴有喉头水肿的血管性水肿可能是致命性的。如果水肿累及舌、声门或喉,可能会导致气道阻塞,要给予适当的治疗,例如皮下注射肾上腺素溶液1:1000(0.3mL-0.5mL)以及采取必要措施以确保患者气道通畅。 应用诺欣妥时黑人中血管性水肿发生率高于非黑人患者。 有血管性水肿既往史的患者应用诺欣妥时血管性水肿风险可能增加。已知有与ACEI或ARB治疗相关的血管性水肿既往病史的患者不应该使用诺欣妥。 肾素-血管紧张素-醛固酮系统(RAAS)的双重阻滞: 因有发生血管性水肿的风险,诺欣妥不得与ACEI合用。必须在ACEI末次给药36小时之后才能开始应用诺欣妥。如果停止诺欣妥治疗,必须在诺欣妥末次给药36小时之后才能开始应用ACEI。 诺欣妥与直接肾素抑制剂(如阿利吉仑)合用需警慎。在2型糖尿病患者中禁止诺欣妥与阿利吉仑合用。 因具有拮抗血管紧张素II受体的活性,诺欣妥不应与ARB合用。 低血压: 诺欣妥可降低血压并可能造成症状性低血压。肾素-血管紧张素系统被激活的患者(例如血容量不足或电解质不足的患者,如正接受高剂量利尿剂治疗患者)风险更大。研究PARADIGM-HF双盲阶段,18%的诺欣妥治疗患者和12%的依那普利治疗患者报告了低血压不良事件,两个治疗组大约1.5%的患者报告了低血压严重不良事件。在给予诺欣妥之前应纠正血容量不足或电解质不足的状况,或是以较低剂量开始给药。如果发生低血压,应考虑调整利尿剂、合用的降压药的剂量,并治疗导致低血压的其他病因(如血容量不足)。如果在采取了这些措施之后低血压仍持续存在,则降低诺欣妥剂量或暂时停用。通常不需要永久停止治疗。 肾功能损害: 由于抑制肾素-血管紧张素-醛固酮系统(RAAS),预期易感个体应用诺欣妥治疗可能出现肾功能减退。在PARADIGM-HF研究双盲阶段,诺欣妥组和依那普利组均有5%的患者报告了肾功能衰竭不良事件。在肾功能取决于肾素-血管紧张素-醛固酮系统活性的患者中(例如,严重充血性心力衰竭患者),应用ACEI和ARB治疗可伴发少尿、进行性氮质血症、罕见急性肾功能衰竭和死亡。如果患者出现具有临床意义的肾功能减退,则密切监测血清肌酐并降低诺欣妥剂量或暂停给药。 与影响肾素-血管紧张素-醛固酮系统的其他药物一样,在双侧或单侧肾动脉狭窄患者中,诺欣妥可能引起血尿素和血清肌酐水平升高。肾动脉狭窄患者需慎用诺欣妥并建议进行肾功能监测。 高钾血症: 通过作用于RAAS,应用诺欣妥治疗时可能发生高钾血症。在PARADIGM-HF研究双盲阶段,12%的诺欣妥治疗患者和14%的依那普利治疗患者报告了高钾血症不良事件。要定期监测血清钾水平并进行适当治疗,尤其是对存在高钾血症风险因素的患者(如重度肾功能损害、糖尿病、低醛固酮血症或正在接受高钾饮食),可能需要降低诺欣妥剂量或暂停给药。 NYHA功能分级IV级患者: 由于在NYHA功能分级Ⅳ级的患者中的临床经验有限,此类患者开始诺欣妥治疗时应慎重。 B型利钠肽(BNP): B型利钠肽(BNP)是脑啡肽酶的底物。对于接受诺欣妥治疗的患者而言,B型利钠肽(BNP)并不是心力衰竭的合适的生物标志物。 肝功能损害患者: 在中度肝功能损害(Child-PughB级)或AST/ALT值高于正常上限两倍的患者中的临床用药经验有限。在这些患者中,暴露量可能增高,且未确立安全性特征。因此建议此类患者慎用本品。本品禁用于重度肝功能损害、胆汁性肝硬化或胆汁淤积患者(Child-PughC级)

孕妇及哺乳期妇女用药

妊娠: 动物数据: 器官形成期间,大鼠给药剂量≥沙库巴曲缬沙坦100mg/kg/日(以AUC计,≤最大推荐人体剂量[MRHD]200mg每天两次的0.14倍[LBQ657,活性代谢产物]和1.5倍[缬沙坦]),兔给药剂量≥沙库巴曲缬沙坦10mg/kg日(以缬沙坦和LBQ657AUC计,分别为MRHD的4倍和0.06倍),诺欣妥使胚胎-胎儿致死率增加。根据兔给药诺欣妥剂量≥沙库巴曲缬沙坦10mg/kg/日观察到的与母体毒性剂量相关的胎儿脑积水的低发生率,认为诺欣妥具有致畸性。诺欣妥的胚胎-胎儿不良影响是因其血管紧张素受体拮抗剂活性所致。 大鼠出生前后发育研究显示(应用沙库巴曲剂量高达750mg/kg/日(以LBQ657AUC计,4.5倍的MRHD)和缬沙坦剂量高达600mg/kg/日(以AUC计,为0.86倍的MRHD))显示,器官形成期、妊娠期和哺乳期应用沙库巴曲缬沙坦可能会影响幼仔的发育和存活。 风险总结: 怀孕妇女应用诺欣妥可对胎儿造成损害。孕中期和孕晚期应用作用于肾素-血管紧张素系统的药物可降低胎儿肾脏功能,增加胎儿和新生儿的患病情况和死亡率。大多数流行病学研究(评估孕早期应用降压药后的胎儿异常)尚未将影响肾素-血管紧张素系统药物与其他降压药物相区别。动物生殖研究中,大鼠和兔器官形成期间应用诺欣妥导致胚胎-胎儿致死率升高,在兔中具有致畸性。发现怀孕时,应考虑停用诺欣妥并改用替代药物治疗。但是,如果没有作用于肾素-血管紧张素系统的 适当的替代药物治疗,且如果认为本品可挽救母亲生命,要告知怀孕妇女本品对胎儿的潜在风险。 临床考虑: 胎儿/新生儿不良反应:孕中期和孕晚期应用影响肾素-血管紧张素系统药物的怀孕妇女出现羊水过少可导致以下情况:胎儿肾功能减退导致无尿和肾功能衰竭、胎儿肺发育不全、骨骼变形(包括颅骨发育不全)、低血压和死亡。 进行系列超声检查以评估羊膜腔内环境。根据妊娠周数进行胎儿检测可能是合适的。但患者和医生应该了解,有可能在胎儿已经出现了持续的不可逆性损害之后才出现羊水过少。如果观察到羊水过少,要考虑替代药物治疗。有诺欣妥宫内暴露史的新生儿要密切观察是否出现低血压、少尿和高钾血症。有诺欣妥宫内暴露史的新生儿如果发生少尿或低血压,要升高血压和增加肾脏灌注。可能需要换血疗法或透析疗法作为逆转低血压和替代肾功能的手段。 哺乳: 哺乳大鼠口服给药[14C]沙库巴曲缬沙坦钠(沙库巴曲15mg/缬沙坦15mg/kg)之后观察到LBQ657转移到乳汁中。哺乳大鼠单次口服给药[14C]缬沙坦3mg/kg后观察到缬沙坦转移到乳汁中。 风险总结:没有人乳汁中出现沙库巴曲/缬沙坦的信息、没有对母乳喂养的婴儿或乳汁生成的影响作用的信息。由于母乳喂养的婴儿暴露于沙库巴曲/缬沙坦存在发生严重不良反应的可能性,要告知哺乳妇女在本品治疗期间不推荐哺乳。

儿童用药

尚未确定诺欣妥在18岁以下儿童患者中的安全性和有效性。

老年用药

尚未观察到老年(≥65岁)或高龄(≥75岁)患者与总体人群之间存在有临床相关性的药代动力学差异(参见[药代动力学])。

药物相互作用

禁忌合用: ACEI:诺欣妥禁忌合用ACEI,因为在抑制脑啡肽酶(NEP)的同时应用ACEI可能会增加发生血管性水肿的风险。必须在应用最后一剂ACEI36小时之后才能开始应用诺欣妥。必须在应用最后一剂诺欣妥36小时之后才能开始应用ACEI。 阿利吉仑:在2型糖尿病患者中,诺欣妥禁忌合用阿利吉仑。肾功能损害(eGFR
诺欣妥片 (慢性心衰)80 作者:华夏 帖子ID:7636
诺欣妥片 (慢性心衰)387 作者:华夏 帖子ID:7636
诺欣妥片 (慢性心衰)3136 作者:华夏 帖子ID:7636
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