维耐托克，维耐托克薄膜片Venclyxto filmcoated tablets 100mg(venetoclax)

药店国别：无 产地国家：英国 处方药：是 所属类别： 100毫克/片 112片/盒 包装规格： 100毫克/片 112片/盒 计价单位：盒 生产厂家中文参考译名：无 生产厂家英文名：AbbVie Ltd 原产地英文商品名：Venclyxto filmcoated 100mg/tablets 112tablets/box 原产地英文药品名：venetoclax 中文参考商品译名：Venclyxto薄膜片 100毫克/片 112片/盒 中文参考药品译名：venetoclax 曾用名：无

简介

部份中文VENCLYXTO处方资料（仅供参考） 商品名：VENCLYXTO 英文名：VENETOCLAX 生产商：艾伯维 适应症: venclyxto单独用于治疗慢性淋巴细胞白血病（慢性淋巴细胞白血病（CLL）的存在或在17p缺失TP53突变或不适当的成人患者的治疗失败的一个受体的细胞通路抑制剂。 用法用量 venetoclax治疗应由具有抗癌药物使用经验的医生发起和监督。起始剂量为每天一次20毫克的venetoclax，持续7天。 剂量必须在5周内逐渐增加至建议的每日剂量400mg。第1星期（14粒X10MG）每天2粒每日20MG第2星期（7粒X50MG）每天1粒每日50MG第3星期（7粒X100MG）每天1粒每日100MG第4星期（14粒X100MG）每天2粒每曰200MG第5星期起（14粒X100MG）每天4粒每日400MG5 周剂量：滴定计划旨在逐步减少肿瘤负荷（减压）并降低肿瘤溶解综合征的风险。应继续治疗直至疾病进展或患者不再耐受。应整片口服，可配饭或水。不要咀嚼，压碎或破裂。 不良反应 感染常见-上呼吸道感染共同-肺炎、尿路感染血液和淋巴系统紊乱常见-中性粒细胞减少症、贫血共同-发热性中性粒细胞减少症、淋巴细胞减少代谢和和营养障碍常见-高磷酸盐血症共同-肿瘤溶解综合征、高钾血症、高尿酸血症、低钙血症胃肠道疾病常见-腹泻呕吐恶心便秘一般情况常见-疲劳研究显示常见-血肌酐增加 包装规格： 薄膜包衣片10mg ×5、7、10、14、112片盒50mg ×5、7、10、14、112片盒100mg ×5、7、10、14、112片盒 生产厂家：艾伯维（英国 AbbVie Ltd） 白血病新药Venclyxto被欧盟批准用于难治性慢性淋巴细胞白血病（CLL）venetoclax是一种口服的B细胞淋巴瘤因子-2（BCL-2）抑制剂，BCL-2在细胞凋亡（程序性细胞死亡）中发挥重要作用，可阻止一些细胞（包括淋巴细胞）的凋亡，并且在某些类型癌症中过度表达，与耐药性的形成相关。venetoclax旨在选择性抑制BCL-2的功能，恢复细胞的通讯系统，让癌细胞自我毁灭，达到治疗肿瘤的目的。

英文版说明

Venclyxto 10mg, 50mg and 100mg Film-coated TabletsEuropean Commission Grants Conditional Marketing Approval for AbbVie’s VENCLYXTO™ (venetoclax) Monotherapy for Appropriate Patients with Difficult-To-Treat Chronic Lymphocytic Leukaemia– VENCLYXTO monotherapy is also indicated for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor1– In a Phase 2 clinical trial of VENCLYXTO in 107 patients with previously treated CLL with 17p deletion, overall response rate (ORR) was 79 percent1– In a second Phase 2 clinical trial of VENCLYXTO in 64 patients with CLL who had been previously treated with and failed ibrutinib or idelalisib, combined ORR was 64 percent1Important EU Safety InformationContraindicationsConcomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase due to increased risk for tumour lysis syndrome (TLS). Concomitant use of preparations containing St. John’s wort as VENCLYXTO efficacy may be reduced. Hypersensitivity to the active substance or to any of the excipients is contraindicated.Special Warnings & Precautions for UseTumour lysis syndrome (TLS), including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with VENCLYXTO. VENCLYXTO poses a risk for TLS in the initial 5-week ramp-up phase. Changes in blood chemistries consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLYXTO and at each dose increase. Patients should be assessed for risk and should receive appropriate prophylaxis for TLS. Blood chemistries should be monitored and abnormalities managed promptly. More intensive measures (including hospitalization) should be employed as overall risk increases.Neutropenia (grade 3 or 4) has been reported and complete blood counts should be monitored throughout the treatment period.Live vaccines should not be administered during treatment or thereafter until B-cell recovery.Drug InteractionsCYP3A inhibitors may increase VENCLYXTO plasma concentrations. At initiation and dose-titration phase: Strong CYP3A inhibitors are contraindicated and moderate CYP3A inhibitors should be avoided. If moderate CYP3A inhibitors must be used, physicians should refer to the SmPC for dose adjustment recommendations. At steady daily dose: If moderate or strong CYP3A inhibitors must be used, physicians should refer to the SmPC for dose adjustment recommendations.Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase.CYP3A4 inducers may decrease VENCLYXTO plasma concentrations. Avoid coadministration with strong or moderate CYP3A inducers.Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO.Adverse ReactionsThe most commonly occurring adverse reactions (>=20%) of any grade were neutropenia/neutrophil count decreased, diarrhoea, nausea, anemia, upper respiratory tract infection, fatigue, hyperphosphatemia, vomiting and constipation.The most frequently occurring adverse reactions (>=2%) were pneumonia, febrile neutropenia and TLS.Discontinuations due to adverse reactions occurred in 9.1% of patients and dosage adjustments due to adverse reactions occurred in 11.8% of patients.Specific PopulationsVENCLYXTO may cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid pregnancy during treatment. Advise nursing women to discontinue breastfeeding during treatment.This is not a complete summary of all safety information. See VENCLYXTO full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.https://www.medicines.org.uk/emc/product/2267/smpc