达依泊汀皮下注射剂ARANESP 40mcg(Darbepoetin Alfa)

药店国别:

产地国家:美国

处方药:

所属类别: 40微克/1毫升/瓶 4瓶/盒

包装规格: 40微克/1毫升/瓶 4瓶/盒

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Amgen

原产地英文商品名:ARANESP 40mcg/1ml 4vials/Box

原产地英文药品名:Darbepoetin Alfa

中文参考商品译名:ARANESP 40微克/1毫升/瓶 4瓶/盒

中文参考药品译名:达依泊汀

曾用名:

简介:Aranesp®(阿法达贝泊汀)注射,静脉内或皮下使用可以改善癌症生存美国首次批准:2001

警告:

欧空局增加死亡,心肌梗死,中风,静脉血栓栓塞,血管通路血栓形成和肿瘤进展或复发的查看完整的黑框警告完整的处方信息的风险。慢性肾脏病:在对照试验中,患者出现死亡,严重不良反应心血管疾病和中风的风险更大时,给予红细胞生成刺激剂(ESAs的)目标的大于11克/分升血红蛋白水平。没有试验已经确定了血红蛋白目标水平,Aranesp的剂量,给药策略,不增加这些风险。使用最低的Aranesp剂量足以减少对红血细胞(RBC)的输血。巨蟹座:ESAs的缩短总体存活和/或增加患者的乳房,非小细胞肺癌,头颈癌,淋巴,和子宫颈癌临床研究肿瘤进展或复发的危险。处方医师和医院必须参加,并符合欧空局通报肿瘤项目规定和/或免除Aranesp的癌症患者。使用最低剂量,避免红细胞输血。使用欧空局只从骨髓抑制性化疗贫血。欧空局都没有表示接受骨髓抑制性化疗的患者,当预期的结果是治愈。中止完成化疗过程之后。目前的主要变化用法与用量:在癌症化疗患者适应症和用法Aranesp的是红血球生成刺激剂(ESA)的指示为贫血症是由于治疗:•慢性肾脏病(CKD)患者在透析患者和非透析。•伴随骨髓抑制性化疗的效果,并且开始时,有一个最小的计划化疗的两个附加月。使用限制Aranesp的还没有被证明可以改善生活,疲劳,或患者福祉的质量。Aranesp的未标明使用说明:•在癌症患者接受激素剂,生物制品,或放射治疗,除非也同时接受骨髓抑制性化疗。•在癌症患者接受骨髓抑制性化疗时的预期结果是固化。•作为红细胞输注在谁需要贫血立即纠正患者的替代品。

【用法用量】

推荐起始剂量为慢性肾病透析患者:0.45微克/千克静脉注射或皮下注射每周,或0.75微克/公斤静脉内或皮下,每2周静脉内途径被推荐用于血液透析病人推荐起始剂量与CKD患者不透析0.45微克/千克静脉注射或皮下注射,4周的间隔推荐起始剂量为癌症化疗患者:2.25微克/kg皮下注射每周或500微克皮下注射,每3周剂型和规格单剂量小瓶:25,40,60,100,200,300,和500微克/ 1毫升,和150微克/0.75毫升单剂量预充式注射器:10微克/ 0.4毫升,25微克/毫升0.42,40微克/ 0.4mL的,60微克/毫升0.3,100微克/0.5mL的,150微克/毫升0.3,200微克/ 0.4mL的,300微克/ 0.6毫升和500微克/1毫升禁忌未控制的高血压纯红细胞再生障碍(PRCA)开头的Aranesp或其他促红细胞生成素蛋白的药物治疗后严重过敏反应的Aranesp

警告和注意事项

增加的死亡率,心肌梗塞,中风和血栓栓塞:使用的Aranesp目标的大于11克血红蛋白水平/dL的增加的严重有害的心血管反应的风险,并没有被示出,以提供额外的好处。患者的共存心血管疾病和中风谨慎使用。死亡率增加和/或增加肿瘤进展或复发的风险癌症患者。

高血压:之前开始和治疗期间与Aranesp的控制高血压。癫痫发作:Aranesp的增加癫痫发作的慢性肾病患者的风险。加大监测这些病人的变化发作频率或前驱症状。

PRCA:如果在治疗Aranesp的严重贫血和低网织红细胞计数发展,扣压Aranesp和评估PRCA。

不良反应

慢性肾脏病患者:在Aranesp的治疗的患者在临床研究中≥10%的不良反应是高血压,呼吸困难,血管神经性水肿,咳嗽,和程序低血压。癌症患者在接受化疗:不良反应中的Aranesp治疗的患者在临床研究中的≥1%为腹痛,水肿,血栓性血管事件。

特殊人群中使用

妊娠:根据动物实验数据,可能会对胎儿造成伤害。妊娠监察计划可用。

哺乳母亲:请务必小心时的Aranesp被给予哺乳妇女。

儿童用药:安全性和有效性尚未建立贫血CKD患者的初步治疗,从另一个促红细胞生成素的慢性肾脏病患者谁是不到1岁,或小儿癌症患者的过渡。

达依泊汀皮下注射剂英文版说明书

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.

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