阿法依泊汀注射剂ARANESP PFS Injection 500mcg

药店国别： 产地国家：加拿大 处方药：是 所属类别： 500微克/毫升 1單位 包装规格： 500微克/毫升 1單位 计价单位：瓶 生产厂家中文参考译名： 生产厂家英文名：AMGEN INC 原产地英文商品名：ARANESP PFS Injection 500mcg/ml 1 unit 原产地英文药品名：darbepoetin alfa POLYSORBAT 中文参考商品译名：ARANESP PFS注射剂 500微克/毫升 1單位 中文参考药品译名：阿法依泊汀 alfa POLYSORBAT 曾用名： 简介：部份阿法依泊汀中文资料(仅供参考)Amgen有限公司(安进公司)2007年9月28日宣布，欧盟委员会已批准扩展其达贝阿法依泊汀(darbepoetinalfa/Aranesp)适用对象至所有已在或尚未接受透析治疗之儿科慢性肾病或称慢性肾衰相关贫血个体治疗。达贝阿法依泊汀最早是于2001年在欧盟获准上市的，它至今已用于270万肾病学和肿瘤学患者。但在治疗慢性肾病相关贫血方面，达贝阿法依泊汀原仅被批准用于11岁及以上人群。阿法达贝泊汀(darbepoetinal—fa)，在美国和欧洲的商标名分别为Aranesp和Nespo。阿法达贝泊汀实是阿法依泊汀的改进型产品，其结构较之阿法依泊汀的重要差异在于它带有两个含烃链唾液酸，故半衰期无论是静脉、抑或皮下注射都延长了2倍，十分有利于简化给药方案，临床上可每2周、甚或每3周用药1次。慢性肾病属进行性和不可逆疾病，它以肾损害和肾功能下降为特征。慢性肾病的最常见症状之一即为贫血，后者是因衰竭了的肾脏不再能够生产足量的促红细胞生成素、由此使得红血细胞生产和血红蛋白水平减少所致。贫血会严重影响患者的日常健康和生活质量，其具体表现包括疲劳、虚弱、呼吸短促、注意力分散、精神混乱、头晕或晕厥、皮肤苍白、心跳加快和反复感冒等。贫血还可致使发展潜在致死性的心血管疾病，此在全部慢性肾病人群中的流行率高至35～40%。达贝阿法依泊汀于2001年首次获得欧盟批准用于治疗11岁及以上儿童至成人的慢性肾病相关贫血。2002年，达贝阿法依泊汀又获准治疗正接受化疗之成人实体瘤患者贫血。2003年 适应证 适用对象获准扩展至正接受化疗之成人非骨髓性恶性肿瘤癌症人群的有症状贫血治疗。2004年，达贝阿法依泊汀又获准可以每3周1次给药频率治疗正接受化疗之成人非骨髓性恶性肿瘤癌症患者贫血及能以每月1次剂量间隔方案治疗尚未进行透析之慢性肾病人群贫血。2006年，达贝阿法依泊汀标签再被更新至允许正进行透析之慢性肾病个体自每周1～3次给药重组人DNA促红细胞生成素类药物切换到每2周1次给药达贝阿法依泊汀疗法。美国FDA发布警告,阿法达贝泊汀(darbepoetinalfa,商品名Aranesp)对非化疗引起的癌症病人的贫血无效,不能减少其需要的红细胞输注率及改善疲乏症状,且增加死亡率。阿法达贝泊汀是一种蛋白,与肾脏分泌的促红细胞生成素作用相似,通过刺激骨髓,促进红细胞生成。2001年被FDA批准用于治疗慢性肾功能衰竭引起的贫血,2002年获准用于非骨髓性恶性肿瘤化疗所致贫血患者。临床上,阿法达贝泊汀有时被用于非化疗引起的贫血患者,为了验证其有效性和安全性,一项大型、多中心、随机、安慰剂对照的研究被进行,该研究共纳入989例未接受化疗或放疗的活动期恶性肿瘤患者,60%的患者为疾病晚期。结果显示,阿法达贝泊汀组16周内红细胞输注率为18%,而安慰组剂为24%,两组比较无统计学差异(P=0.15;危险比0.89);治疗组绝对死亡率高于安慰剂组(49%对46%;风险比1.25)。因此,FDA告诫医务人员,阿法达贝泊汀的适应人群为因化疗所致贫血及产品说明书的适应证,而不应标签外用药。 阿法依泊汀注射剂英文版说明书 INDICATIONAranesp® is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.LIMITATIONS OF USEAranesp® has not been shown to improve quality of life, fatigue, or patient well-being.Aranesp® is not indicated for use:•In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.•In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.•As a substitute for RBC transfusions in patients who require immediate correction of anemia.ARANESP® (DARBEPOETIN ALFA) INDICATIONAranesp® is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.LIMITATIONS OF USEAranesp® has not been shown to improve quality of life, fatigue, or patient well-being.Aranesp® is not indicated for use:In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.As a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia.IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNINGSWARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCEChronic Kidney Disease:In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.No trial has identified a hemoglobin target level, Aranesp® dose, or dosing strategy that does not increase these risks.Use the lowest Aranesp® dose sufficient to reduce the need for red blood cell (RBC) transfusions.Cancer:ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Aranesp® to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.Use ESAs only for anemia from myelosuppressive chemotherapy.ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.Discontinue following the completion of a chemotherapy course.Aranesp® is contraindicated in patients with:Uncontrolled hypertensionPure red cell aplasia (PRCA) that begins after treatment with Aranesp® or other erythropoietin protein drugsSerious allergic reactions to Aranesp®In controlled clinical trials of patients with cancer, Aranesp® and other ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke.In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.Control hypertension prior to initiating and during treatment with Aranesp®.For lack or loss of hemoglobin response to Aranesp®, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, eva luate for PRCA.Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp®.This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration.PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp® is not approved).If severe anemia and low reticulocyte count develop during treatment with Aranesp®, withhold Aranesp® and eva luate patients for neutralizing antibodies to erythropoietin.Permanently discontinue Aranesp® in patients who develop PRCA following treatment with Aranesp® or other erythropoietin protein drugs. Do not switch patients to other ESAs.Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp®. Immediately and permanently discontinue Aranesp® if a serious allergic reaction occurs.Adverse reactions (≥ 1%) in clinical studies in cancer patients receiving chemotherapy were abdominal pain, edema, and thrombovascular events.