奥贝胆酸薄膜片Obeticholsäure(Ocaliva 5mg Filmtabletten)说明书

产地国家:德国

处方药:是

所属类别: 5毫克/片 30片/瓶

包装规格: 5毫克/片 30片/瓶

计价单位:瓶

生产厂家英文名:Intercept Pharmaceuticals

原产地英文商品名:OCALIVA film-coated 5mg/tablets 30tablets/bottle

原产地英文药品名:Obeticholsäure

中文参考商品译名:Ocaliva薄膜片 5毫克/片 30片/瓶

中文参考药品译名:奥贝胆酸

简介

2016年12月,肝病新药Ocaliva获欧盟批准用于慢性肝病原发性胆汁性胆管炎(PBC)患者常规治疗药物,这也欧盟国内的患者20年来获得了一种新的治疗方案。Ocaliva(obeticholic acid,OCA)是Intercept开发的一款创新药物法尼酯X受体(FXR)激动剂,这是一种人类胆汁酸模拟物,目前正开发用于多种慢性肝脏疾病的治疗,包括原发性胆汁性胆管炎(PBC)、非酒精性脂肪性肝炎(NASH)、原发性硬化性胆管炎(PSC)、胆道闭锁。

作用机理

Obeticholic酸是FXR,在肝脏和小肠中表达的核受体的激动剂。 FXR是胆汁酸,炎性,纤维化,和代谢途径的关键调节。FXR活化由胆固醇以及由胆汁酸增加了运输出肝细胞的抑制从头合成降低的肝胆汁酸的细胞内浓度。这些机制限制了循环的胆汁酸池的整体尺寸,同时促进胆汁分泌,从而肝减少暴露于胆汁酸。

适应症和用法

OCALIVA具有法尼醇X受体(FXR)激动剂,表示在成人与熊去氧胆酸(UDCA)组合原发性胆汁性胆管炎(PBC)的治疗反应不足到的UDCA,或者作为成人无法容忍的UDCA单一疗法。此指示下基于在碱性磷酸酶(ALP)的减少加速审批批准。成立于生存或疾病相关症状的改善有没有过时的名著。这个指示继续批准可不经审核的临床获益描述验证试验队伍。

用法用量

开始用量:推荐的起始剂量为5毫克口服OCALIVA每日一次成人穷国实现充分的反应UDCA的适当剂量至少1年或不能耐受UDCA。剂量滴定:如果在ALP和/或总胆红素充分减少一直没有后豆类每日一次取得3个月OCALIVA 5毫克和患者耐受OCALIVA,每日一次增加剂量至10毫克。

最大用量:每天一次10毫克瘙痒难耐的患者的管理:参见管理选项的完整处方信息。

肝损伤:参见剂量调整患者的中度或重度肝功能不全(Child-Pugh分级B级或C)的完整处方信息。行政指导带或不带食物同时服用。为病人服用胆汁酸结合树脂,OCALIVA采取之前至少4小时或4小时以后,胆汁酸结合树脂,或作为大的间隔尽可能。

剂型和规格

片5毫克,10毫克

禁忌症

胆道梗阻患者

完成包装规格

[采购以咨询为准]OCALIVA 5mg film-coated tablets, 30 EU/1/16/1139/001OCALIVA 5mg film-coated tablets, 100 EU/1/16/1139/003OCALIVA 10mg film-coated tablets, 30 EU/1/16/1139/002OCALIVA 10mg film-coated tablets, 100 EU/1/16/1139/004

英文版说明书

Intercept Pharma UK & Ireland Contact detailsOCALIVA (obeticholic acid)Important Safety InformationWho should not take OCALIVA® (obeticholic acid)?Do not take OCALIVA if you have been told by a healthcare provider that you have complete biliary obstruction. Report to your healthcare provider immediately if you develop symptoms of complete biliary obstruction.What are the possible side effects of OCALIVA?OCALIVA may cause serious side effects, including:•Liver-Related Adverse Reactions. Liver-related adverse reactions including jaundice (yellow pigmentation of skin and whites of the eyes), worsening ascites (accumulation of fluid in the stomach) and primary biliary cholangitis flare (sudden worsening of PBC symptoms) have been observed in clinical trials, as early as one month after starting treatment with OCALIVA 10 mg once-daily up to 50 mg once-daily (up to 5-times the highest recommended dosage). Your healthcare provider may do blood tests periodically during your treatment with OCALIVA to check how well your liver is working. Report to your healthcare provider immediately if you develop any symptoms of worsening liver disease.•Severe Pruritus. Cases of severe pruritus have occurred in patients being treated with OCALIVA. Severe pruritus consists of intense or widespread itching, interfering with activities of daily living, or causing severe difficulty in staying asleep, or intolerable discomfort, and typically requiring medical interventions. Your healthcare provider may recommend taking bile acid resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing to help manage the symptoms of severe pruritus. Be sure to tell your healthcare provider if pruritus develops or worsens during treatment with OCALIVA.•Decreases in HDL-C Cholesterol. Decreases in HDL-C (good cholesterol) have been observed in patients taking OCALIVA. Your healthcare provider may check your lipid levels periodically during your treatment with OCALIVA.The most common side effects of OCALIVA include: pruritus (severe itching of the skin), fatigue (feeling tired all over), stomach pain and discomfort, rash, arthralgia (joint pain), oropharyngeal pain (pain in the middle part of the throat), dizziness, constipation, abnormal thyroid function and eczema (inflammation of the skin).These are not all the possible side effects associated with OCALIVA. Tell your healthcare provider if you have any side effect that bothers you or does not go away.What should I tell my healthcare provider before taking OCALIVA?Before taking OCALIVA, tell your healthcare provider about:•all of your medical conditions•all of the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins and herbal supplements. OCALIVA and other medicines may affect each other, so be sure to tell your healthcare provider if you start a new medicine.OCALIVA may affect the way other medicines work, and other medicines may affect how OCALIVA works.Especially tell your healthcare provider if you take:•Bile Acid Resins, such as cholestyramine, colestipol or colesevelam. Some medicines used to lower blood cholesterol levels, so-called bile acid resins may reduce the effectiveness of OCALIVA. If you take any of these medicines, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid resin, or at as great an interval as possible.•Warfarin. Your International Normalized Ratio (INR) (which measures how your blood clots) is decreased when warfarin is taken along with OCALIVA. Your physician may need to monitor your INR and/or adjust your dosage of warfarin to keep your INR in a target range while you are taking both warfarin and OCALIVA. Your healthcare provider may need to monitor the co-administration of OCALIVA and warfarin.•CYP1A2 Substrates with Narrow Therapeutic Index. Obeticholic acid, the active ingredient in OCALIVA, may increase the exposure to certain drugs that are CYP1A2 substrates, such as theophylline and tizanidine. Your healthcare provider may, as needed, monitor CYP1A2 Substrates with Narrow Therapeutic Index when they are taken along with OCALIVA.Please see the full Prescribing Information for OCALIVA (obeticholic acid) 5mg and 10mg tablets.https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cdfbe0cd-eb15-45a1-ac17-531bcda21aec

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