英文药名: Promacta(Eltrombopag Olamine Tablets) 中文药名: 艾曲波帕片 品牌药生产厂家: Glaxo Smith Kline 药品介绍 美国FDA批准葛兰素史克公司的eltrombopag片(Promacta)上市,用于治疗经糖皮质激素类药物、免疫球蛋白治疗无效或脾切除术后慢性特发性血小板减少性紫癜(ITP)患者的血小板减少。 因本品是首个获准治疗成人慢性ITP患者的口服非肽类血小板生成素受体激动剂,临床前和临床研究显示刺激本品可升高血小板的骨髓巨核细胞的增生和分化。其批准治疗ITP患者是一重要里程碑。 防止血小板被破坏一直是治疗ITP患者的主要方法。像艾曲波帕临床研究的新进展显示,增加血小板的产生来治疗此种疾病也起着重要作用。 对慢性ITP患者随机临床研究的大量数据支持了本品的新药申请获准。此适应证是基于2项关键的短期治疗和1项正在进行长期治疗ITP患者的临床研究数据。 本品还正在进行治疗丙型肝炎病毒、慢性肝病引起的血小板减少症和肿瘤相关的血小板减少症的研究。 近期国外研究,一种新的口服血小板受体激动剂即艾曲波帕薄膜衣片(eltrombopag)可以促血小板生成,对于基线血小板在20×109/L~70×109/L的患者应用艾曲波帕薄膜衣片,可以成功治疗至12周。 严重血小板下降者可输入血小板。 批准日期:2008年11月20日;公司:GlaxoSmithKline 适应证: PROMACTA是一种促血小板生成素受体激动剂适用于治疗慢性免疫性(特发性)血小板减少性紫癜患者的血小板减少,对皮质激素、免疫球蛋白或脾切除反应不佳的患者。 剂量和用法: 对大多数患者PROMACTA的起始剂量是50 mg每天1次;对东方人患者或中度或严重肝功能不全患者,起始剂量为25 mg每天1次。 禁忌证:无。 警告和注意事项: PROMACTA可能引起肝毒性。观察到血清中转氨酶水平和胆红素增加。治疗开始前和治疗期间常规必须测定肝化学。 不良反应:最常见不良反应(发生大于接受PROMACTA1例患者和相比安慰剂PROMACTA发生率较高)是: 恶心、呕吐、月经过多、肌肉痛、感觉异常、白内障、消化不良、瘀斑、血小板减少、ALT/AST增加和结膜出血。 黑框警告:肝毒性风险 PROMACTA可能引起肝毒性: 开始PROMACTA治疗前测定血清丙氨酸转氨酶(AST),和胆红素,调整剂量期每2周1次和确定稳定剂量后每月1次。如胆红素升高,进行分次。 药物相互作用: 艾曲波帕是OATP1B1转运蛋白的抑制剂。紧密监查患者过量暴露于OATP1B1底物(如,罗苏伐他汀(rosuvastatin))药物征象和症状并考虑减低这些药物的剂量。 在特殊人群中的应用: 妊娠:可能引起胎儿伤害。纳入妊娠患者在PROMACTA妊娠注册。 FDA has approved Promacta tablets (eltrombopag, from GlaxoSmithKline) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have been unresponsive to corticosteroids, immunoglobulins or splenectomy. This indication was based on results from two short-term studies and one ongoing long-term study of patients with chronic ITP. In order to assure the safe use of Promacta, healthcare providers and patients must be enrolled in GlaxoSmithKline's Promacta Cares program. Promacta is an oral thrombopoietin (TPO) receptor agonist. What is Promacta? Promacta is a once-daily oral medicine that activates the thrombopoietin (TPO) receptor. Activation of the TPO receptor causes platelets to increase, relieving conditions of low platelets known as thrombocytopenia. Promacta® (eltrombopag) was given accelerated approval by the FDA under the trade name Promacta® in November 2008, for the treatment of chronic ITP in adults who have had an insufficient response to corticosteroids, immunoglobulins or following surgical removal of the spleen. Eltrombopag is authorized for use in all 27 member states of the European Union, as well as India, Australia, Ireland, Japan, Taiwan, Turkey, Singapore, Kuwait, Chile, Russia and Bahrain under the trade name Revolade®. In 2008 Ligand licensed the follow-on thrombopoietin receptor agonist LGD-4665. Thrombocytopenia A reduction in platelet count to a level <150,000/μL is the defining characteristic of any type of thrombocytopenia and diagnosis can be confirmed following a routine blood test. Thrombocytopenia occurs in 5% - 10% of all patients hospitalized for any cause. The severity of thrombocytopenia varies. Mild-to-moderate cases may resolve spontaneously without treatment, but severe thrombocytopenia can be associated with significant morbidity and mortality. The cause of thrombocytopenia associated with hepatitis C is multi-factorial: inadequate thrombopoietin production by damaged liver, bone marrow suppression by interferon or viruses (HCV), sequestration of platelets in the spleen, and increased platelet destruction from an associated autoimmune process. Priority Review In July 2012, GlaxoSmithKline was granted priority review from the US Food and Drug Administration for the supplemental new drug application for Promacta® to treat thrombocytopenia in adult patients with chronic hepatitis C virus (HCV) infection. Priority Review designation is given to drugs that if approved, offer major advances in treatment, or provide a treatment where no adequate therapy exists. Under the Prescription Drugs User Fee Act, the goal for completing a Priority Review is six months. Eltrombopag有望治疗再生障碍性贫血 一项2期临床研究结果显示,eltrombopag,一种血小板生成素类似物,对严重再生障碍性贫血患者有效。 2009至2011年间招募参与者,参与者都被诊断为严重的再生障碍性贫血及严重的持续性血小板减少症,尽管都采用了抗胸腺细胞球蛋白和环孢素治疗。患者服用eltrombopag 50mg,每日1次,若必要可增加剂量。 结果,25例患者接受eltrombopag治疗12周后,44%出现了血液学应答;平均血小板增加44000/mm3;9例患者不再需要血小板输注,其中有3例患者先前依赖红细胞输注,治疗后依赖解除,6例患者平均血红蛋白上升4.4 g/dL,中性粒细胞计数平均增加1350/mm3。此外,患者出现的毒性反应很小,不良反应很少。 研究者指出,Eltrombopag能与c-MPL结合,从而促进巨核细胞生成,以及血小板从成熟巨核细胞的释放。 レボレード錠12.5mg/レボレード錠25mg艾曲波帕片
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艾曲波帕片|Promacta(Eltrombopag)简介:
英文药名: Promacta(Eltrombopag Olamine Tablets)
中文药名: 艾曲波帕片
品牌药生产厂家: Glaxo Smith Kline
药品介绍
美国FDA批准葛兰素史克公司的eltrombopag片(Promacta)上市,用于治疗经糖皮 ... 责任编辑:admin |
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