他唑来膦胶囊Talzenna capsules 1mg(talazoparib)

产地国家:美国 处方药:是 所属类别: 1毫克/粒 30粒/瓶 包装规格: 1毫克/粒 30粒/瓶 计价单位:瓶 生产厂家中文参考译名: 生产厂家英文名:Pfizer 原产地英文商品名:Talzenna 1mg/capsules 30capsules/Bottles 原产地英文药品名:talazoparib 中文参考商品译名:Talzenna胶囊 1毫克/粒 30粒/瓶 中文参考药品译名:他唑来膦

简介

近日,美国食品和药物管理局(FDA)已批准Talzenna(talazoparib 中文名:他唑来膦)胶囊上市,Talzenna是一种聚(ADP-核糖)聚合酶(PARP)抑制剂,用于有害或疑似有害生殖系BRCA突变(gBRCAm),HER2阴性局部晚期或转移的患者乳腺癌。必须根据FDA批准的伴随诊断选择患者进行治疗。 作用机制:Talazoparib是聚(ADP-核糖)聚合酶(PARP)酶的抑制剂,包括PARP1和PARP2,它们在DNA修复中起作用。含有BRCA 1和2等DNA修复基因缺陷的癌细胞系的体外研究表明,塔拉唑巴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,细胞增殖减少。 和细胞凋亡。 在表达突变或野生型BRCA1和2的人类患者衍生的异种移植乳腺癌肿瘤模型中观察到他唑巴肽抗肿瘤活性。 适应症和用法:TALZENNA是一种聚(ADP-核糖)聚合酶(PARP)抑制剂,用于治疗成人患有有害或疑似有害的线粒体BRCA-突变(gBRCAm)HER2阴性的局部晚期转移性乳腺癌。根据FDA批准的TALZENNA伴随诊断选择患者进行治疗。 剂量和给药:TALZENNA的推荐剂量为1mg,每日口服一次,含或不含食物。•应对患者进行治疗,直至疾病进展或出现不可接受的毒性。•对于不良反应,考虑给药中断或减少剂量。•对于中度肾功能不全(CLcr 30-59mL/min)的患者,推荐的TALZENNA剂量为每日一次0.75mg。 剂量形式和强度胶囊:0.25mg,1mg 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):在临床研究中,用TALZENNA治疗的584例(0.3%)实体瘤患者中有2例报告了MDS/AML。为Talzenna监测患者将提供0.25毫克和1毫克强度胶囊30计数瓶。基线时和之后每月一次的血液学毒性。如果确认MDS/AML,则停止使用。•骨髓抑制:TALZENNA可能影响造血功能,可引起贫血,中性粒细胞减少和/或血小板减少症。•胚胎-胎儿毒性:TALZENNA可能导致胎儿伤害。建议胎儿的潜在风险并使用有效的避孕措施。 不良反应:任何等级的最常见(≥20%)不良反应为:疲劳,贫血,恶心,中性粒细胞减少,头痛,血小板减少,呕吐,脱发,腹泻,食欲减退。•最常见的实验室异常(≥25%)是:血红蛋白,血小板,中性粒细胞,淋巴细胞,白细胞和钙减少。葡萄糖,丙氨酸氨基转移酶,天冬氨酸氨基转移酶和碱性磷酸酶增加。药物相互作用•P-gp抑制剂:降低某些P-gp抑制剂的TALZENNA剂量,并监测适当时可能增加的不良反应。•BCRP抑制剂:监测可能增加的不良反应。 用于特定人群哺乳期:建议女性不要母乳喂养。包装提供/存储和处理TALZENNA提供强度和封装配置:TALZENNA胶囊包组态 胶囊强度(mg) NDC瓶装30粒 0.25 NDC:0069-0296-30瓶装30粒 1 NDC:0069-1195-30存储储存在20°C至25°C(68°F至77°F); 允许的偏差在15°C至30°C(59°F至86°F)之间。

英文版说明书

Approved for Germline BRCA-Mutated, HER2-Negative Breast CancerThe Food and Drug Administration (FDA) has approved Talzenna (talazoparib; Pfizer) for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Concurrently, the FDA has approved Myriad Genetic Laboratories' BRACAnalysis CDx test as a diagnostic companion to identify patients with breast cancer who are eligible for treatment with Talzenna.Talzenna, a poly (ADP-ribose) polymerase (PARP) inhibitor, was eva luated in EMBRACA, an open-label trial that randomized patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer (N=431) to receive talazoparib 1mg or physician's choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). Patients received no more than 3 prior cytotoxic chemotherapy regimens for their metastatic or locally advanced disease. In addition, patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.The major efficacy outcome measure was progression-free survival (PFS) eva luated according to Response eva luation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by blinded independent central review. The estimated median PFS was 8.6 months in the talazoparib arm vs.5.6 months in the chemotherapy arm (hazard ratio [HR] 0.54, 95% CI, 0.41, 0.71; P <.0001). Fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite were the most common adverse reactions associated with therapy.
用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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