尼拉帕尼胶囊Zejula capsules 30x100mg(niraparib)

药店国别： 产地国家：美国 处方药：是 所属类别： 100毫克/胶囊 30胶囊/瓶 包装规格： 100毫克/胶囊 30胶囊/瓶 计价单位：瓶 生产厂家中文参考译名： 生产厂家英文名：Tesaro, Inc 原产地英文商品名：Zejula 100mg/Caps 30Caps/bottle 原产地英文药品名：niraparib 中文参考商品译名：Zejula胶囊 100毫克/胶囊 30胶囊/瓶 中文参考药品译名：尼拉帕尼 曾用名：奈拉帕里 Niraparib, MK-4827 简介：近日，美国FDA批准Zejula(niraparib)用于复发性上皮性卵巢，输卵管或原发性腹膜癌的成年患者的维持治疗(旨在延缓癌症生长)，相对于铂类化疗其肿瘤完全或部分收缩(完全或部分反应)。FDA的药物评估和研究中心血液和肿瘤学产品办公室主任Richard Pazdur博士说：“维持治疗是对初次治疗积极响应的患者的癌症治疗方案的重要组成部分，FDA肿瘤学卓越中心主任。“Zejula为患者提供了一种新的治疗方案，可能有助于延缓这些癌症的未来发展，无论它们是否具有特定的基因突变。”Zejula是一种多聚ADP-核糖聚合酶(PARP)抑制剂，可阻断涉及修复受损DNA的酶。通过阻断该酶，癌细胞内的DNA可能不太可能被修复，导致细胞死亡，并可能导致肿瘤生长的减慢或停止。ZEJULA(尼拉帕尼[niraparib])胶囊，用于口服美国最初批准：2017年 作用机制: Niraparib是聚(ADP-核糖)聚合酶(PARP)酶PARP-1和PARP-2的抑制剂，它在DNA修复中起作用。 体外研究表明，尼拉巴尼诱导的细胞毒性可能涉及抑制PARP酶活性和增加PARP-DNA复合物的形成，导致DNA损伤，细胞凋亡和细胞死亡。在具有或不具有BRCA1/2缺陷的肿瘤细胞系中观察到增加的镍吡啶诱导的细胞毒性。Niraparib在具有BRCA1/2缺陷的人癌细胞系的小鼠异种移植模型中和在具有突变或野生型BRCA1/2的同源重组缺陷的人患者衍生的异种移植肿瘤模型中减少肿瘤生长。 适应症和用法: ZEJULA是一种聚(ADP-核糖)聚合酶(PARP)抑制剂，适用于对复发性上皮性卵巢癌，输卵管癌或原发性腹膜癌患者进行维持治疗，这些患者对铂类化疗有完全或部分反应。 剂量和给药: 推荐剂量为300毫克，每日一次，有或没有食物。继续治疗直至疾病进展或不可接受的不良反应。对于不良反应，考虑中断治疗，减少剂量或停止剂量。 剂量形式和强度胶囊： 100毫克 禁忌症: 没有。 警告和注意事项: 骨髓增生异常综合征/急性髓细胞白血病(MDS/AML)：接触ZEJULA的患者发生MDS/ AML，有些病例是致命的。监测患者的血液毒性，如果确诊MDS/AML则停药。骨髓抑制：第一个月每周测试全血细胞计数，接下来的11个月每月测试一次血液计数，之后定期测试临床显着变化。心血管效应：第一年每月监测血压和心率，之后在ZEJULA治疗期间定期监测。如有必要，使用抗高血压药物管理以及调整ZEJULA剂量。胚胎 - 胎儿毒性：ZEJULA会导致胎儿受到伤害。告知女性有可能对胎儿造成潜在风险的生殖潜力并使用有效的避孕措施。 不良反应: 最常见的不良反应(发生率≥10%)是血小板减少，贫血，中性粒细胞减少，白细胞减少，心悸，恶心，便秘，呕吐，腹痛/腹胀，粘膜炎/口腔炎，腹泻，消化不良，口干，疲劳/虚弱，食欲减退，尿路感染，AST/ALT升高，肌痛，背痛，关节痛，头痛，头晕，味觉障碍，失眠，焦虑，鼻咽炎，呼吸困难，咳嗽，皮疹和高血压。 用于特定人群哺乳期： 建议女性在治疗期间和接受最终剂量后1个月不进行母乳喂养。 包装提供/存储和处理 ZEJULA可用作胶囊，其白色主体用黑色墨水印刷“100mg”，紫色帽用白色墨水印刷“Niraparib”。每粒胶囊含有100毫克尼拉巴尼游离碱。ZEJULA胶囊包装为90粒/瓶 NDC 69656-103-9030粒/瓶 NDC 69656-103-30储存在20°C至25°C(68°F至77°F); 允许偏差在15°C至30°C(59°F至86°F)之间[参见USP受控室温]。 尼拉帕尼胶囊英文版说明书 polymerase (PARP) inhibitor.Zejula is specifically indicated for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.Zejula is supplied as a capsule for oral administration. The recommended dose of Zejua as monotherapy is 300 mg (three 100 mg capsules) taken orally once daily. Zejula should be administered at approximately the same time each day. Each capsule should be swallowed whole and may be taken with or without food.Patients should start treatment with Zejula no later than 8 weeks after their most recent platinum-containing regimen.Zejula treatment should be continued until disease progression or unacceptable toxicity. In the case of a missed dose, the next dose should be administered at its regularly scheduled time. If a patient vomits or misses a dose of Zejula, an additional dose should not be taken.Please see drug label for additional modifications.Clinical ResultsFDA ApprovalThe FDA approval of Zejula was based on NOVA, a double-blind, placebo-controlled trial in which 553 patients with platinum sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer were randomized 2:1 to Zejula 300 mg orally daily or matched placebo within 8 weeks of the last therapy.All patients had received at least two prior platinum-containing regimens and were in response (complete or partial) to their most recent platinum-based regimen. The major efficacy outcome measure, PFS (progression-free survival), was determined primarily by central independent assessment per RECIST. Among patients who were germline BRCA mutation carriers, the niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS.The median PFS for patients treated with niraparib was 21.0 months, compared to 5.5 months for control (p < 0.0001). For patients who were not germline BRCA mutation carriers but whose tumors were determined to be HRD positive, the niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS. The median PFS for patients with HRD-positive tumors who were treated with niraparib was 12.9 months, compared to 3.8 months for control (p < 0.0001).Niraparib also showed statistical significance in the overall non-germline BRCA mutant cohort, which included patients with both HRD-positive and HRD-negative tumors. The niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS. The median PFS for patients treated with niraparib was 9.3 months, compared to 3.9 months for control (p < 0.0001).Mechanism of ActionZejula (niraparib) is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair. In vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis and cell death.Increased niraparib-induced cytotoxicity was observed in tumor cell lines with or without deficiencies in BRCA1/2.Niraparib decreased tumor growth in mouse xenograft models of human cancer cell lines with deficiencies in BRCA1/2 and in human patient-derived xenograft tumor models with homologous recombination deficiency that had either mutated or wild type BRCA1/2.Zejula will be available as 100mg strength capsules in 90-count bottles.