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Farydak（panobinostat）获准用于多发性骨髓瘤[美国药店]
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　　来源：生物谷　　2015年2月，经历大起大落的抗癌新药Farydak（panobinostat，LBH589）最终获得FDA青睐。FDA已批准Farydak联合Velcade（bortezomib，硼替佐米）和地塞米松（dexamethasone）用于既往接受至少2种治疗方案（包括Velcade和一种免疫调节（IMiD）药物）治疗失败的多发性骨髓瘤（myltiple myeloma，MM）患者群体。FDA批准Farydak时附带有一项风险评估及减灾策略（REMS），用于宣传和教育医疗卫生专业人员了解可能与Farydak治疗相关的风险。此次批准，也标志着Faryda成为用于治疗多发性骨髓瘤（MM）的首个组蛋白脱乙酰酶（HDAC）抑制剂，该药的表观遗传学活性，可能有助于恢复多发性骨髓瘤细胞的功能。目前，Farydak在全球其他地区的监管审查正在进行中。　　Farydak（panobinostat）是一种新型、广谱组蛋白脱乙酰酶（HDAC）抑制剂，具有一种新的作用机制，通过阻断组蛋白脱乙酰酶（HDAC）发挥作用，该药能够对癌细胞施以严重的应激直至其死亡，而健康细胞则不受影响。　　Farydak通过FDA的加速审批程序批准。该药的获批是基于一项全球III期临床研究（PANORAMA-1）中一项预定义亚组分析（n=193）的疗效和安全性数据。数据显示，在既往接受硼替佐米和一种免疫调节（IMiD）药物治疗的多发性骨髓瘤（MM）群体中，联合标准治疗方案（硼替佐米+地塞米松）治疗时，与安慰剂（PFS=5.8个月，n=99）相比，Farydak延长了中位无进展生存期（PFS=10.6个月，n=94）。此外，Farydak治疗组有59%的患者在治疗后肿瘤缩小或消失，而安慰剂组数据为41%。　　不过，值得一提的是，Farydak的监管之路可谓波折。在2014年初，诺华提交panobinostat监管申请时，鉴于其良好的疗效，FDA表示将采用快速审批通道审核该药，使审查周期由通常的12个月缩短至8个月。然而，去年11月底，FDA肿瘤药物顾问委员会（ODAC）以5:2的投票结果建议拒绝批准panobinostat。该委员会表示，panobinostat针对经治多发性骨髓瘤（MM）患者群体确实有效，但该药的副作用过于严重，要求FDA慎重考虑。这一建议也迫使FDA将原定于12月份的最后期限推迟至今年3月。之后，诺华提交了额外的分析数据，同时修改panobinostat适应症，用于既往接受至少2种标准疗法（包括硼替佐米和免疫调节剂）的多发性骨髓瘤（MM）群体。FDA经过仔细审查后，最终批准panobinostat。需要指出的是，Farydak带有黑框警告，提示该药严重的腹泻和严重及致命的心脏事件、心律失常及心电图（ECG）变化。　　多发性骨髓瘤（MM）是一种无法治愈且复发率很高的血液癌症。在过去的11年中，武田的抗癌药Velcade（硼替佐米）作为唯一一种已被证明能够延缓新诊和复发性多发性骨髓瘤（MM）总生存期（OS）的药物，在多发性骨髓瘤（MM）的临床治疗中发挥了重要作用。但该领域仍存在着远未满足的巨大医疗需求。　　好医友美国药店转载　　好医友美国药店（HaoeYou Pharmacy）提供专科药物、处方药物、非处方药物、药物配置、药物注射以及各类非住院患者的药物分发、咨询、配送等各项服务。美国是医药分开的国家，药店全部实行严格的处方药与非处方药分类管理。对处方药的销售，必须凭美国医生（电子/纸质）处方。如今国内患者可以依托科技，实现远程的病历交互，由美国医生根据患者病情开具电子处方，以正规渠道在美国药店购买到处方药。
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Comsenz Inc.帕比司他胶囊|Farydak(panobinostat capsules)-药品说明书与价格-中国新特药网第一医药站
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帕比司他胶囊|Farydak(panobinostat capsules)
帕比司他胶囊|Farydak(panobinostat capsules)
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英文药名：Farydak(panobinostat capsules)
中文药名：帕比司他胶囊
生产厂家：诺华制药药品介绍日，美国食品和药品监管局(FDA)批准Farydak(帕比司他[panobinostat])为多发性骨髓瘤患者的 ...关键字：
英文药名：Farydak(panobinostat capsules)
中文药名：帕比司他胶囊
生产厂家：诺华制药药品介绍日，美国食品和药品监管局(FDA)批准Farydak(帕比司他[panobinostat])为多发性骨髓瘤患者的治疗。多发性骨髓瘤是一种形式对血癌源自浆细胞，骨髓中发现的一种类型白血细胞。按照美国癌症研究所，每年约21,700美国人被诊断有多发性骨髓瘤和10,710 人死于该疾病。主要地影响老年成年，多发性骨髓瘤致浆细胞迅速地倍增和从骨髓排挤其他健康血细胞。当骨髓有太多浆细胞，细胞可能移动到身体其他部分，可能减弱机体的免疫系统，导致贫血和致其他骨和肾脏问题。Farydak通过抑制酶活性起作用，被称为组蛋白去乙酰化酶(HDACs)。这个过程可能减慢在多发性骨髓瘤患者过度-发展的浆细胞或致这些危险细胞死亡。Farydak是第一个HDAC抑制剂被批准治疗多发性骨髓瘤。它意向为患者曾接受至少两个以前标准治疗，包括硼替佐米[bortezomib]和一个免疫调节剂。Farydak是将与硼替佐米，一种类型化疗，和地塞米松，一种抗炎药物联用。FDA的药品评价和研究中心血液学和肿瘤产品室主任Richard Pazdur，M.D.说：“Farydak 有一种新作用机制不同于以前被批准的治疗多发性骨髓瘤药物，使它是一种潜在诱人的为多发性骨髓瘤的治疗备选药，” “Farydak对被批准是特别重要因为它曾减慢多发性骨髓瘤的进展。”2014年11月， FDA的肿瘤药物肿瘤药物咨询委员会建议监管局，根据审评的数据，药物对获益没有胜过它对有复发多发性骨髓瘤患者风险。在会议后，公司递交另一个资料支持 Farydak的对一个不同适应证对使用：有多发性骨髓瘤患者曾接受至少两种以前标准治疗，包括硼替佐米和一种免疫调节剂。在193例临床试验多发性骨髓瘤参加者，接受至少两次以前治疗包括硼替佐米和一种免疫调节剂，证实Farydak与硼替佐米和地塞米松联用的安全性和疗效。参加者被随机地赋予接受一种Farydak，硼替佐米和地塞米松联用，或单独硼替佐米和地塞米松。研究结果显示参加者接受Farydak组合见到其疾病进展延缓(无进展生存)共约10.6个月，与之比较用单独硼替佐米和地塞米松治疗参加者至5.8个月。此外，59 %的Farydak-治疗参加者见到治疗后其癌皱缩或消失(反应率)，相比接受硼替佐米和地塞米松参加者为41%。Farydak带有一个黑框警告警戒患者和卫生保健专业人员，接受Farydak患者中曾发生严重腹泻和严重和致命性心脏事件，心律失常和心电图(ECG)变化。因为这些风险，Farydak正在批准与风险评估和缓解策略(REMS)由一个交流计划告知这些风险卫生保健专业人员和如何缩小风险组成。Farydak的最常见副作用是腹泻，疲劳，恶心，臂或腿肿胀，食欲减低，发热，呕吐和虚弱。最常见实验室异常是低磷血症，低钾血症)，低钠血症，肌酐增加，血小板减少，白细胞减少和低红细胞计数(贫血)。卫生保健专业人员还应告知患者胃肠道和肺中出血风险，和肝损伤 (肝脏毒性)。FDA授权Farydak优先审评和孤儿产品指定。优先审评提供对意向治疗某种严重疾病或情况和可能提供超过可得到治疗显著改善药物加快审评。孤儿产品指定是给予意向治疗罕见疾病药物。FDA 是在监管局的加速批准程序下行动，允许批准治疗某种严重或危及生命疾病根据临床数据显示药物有对一种替代性终点合理地可能预测对患者获益影响。加速批准程序提供患者较早得到鼓舞人有前途新药而公司进行验证性临床试验。尚未对Farydak确定改善生存或疾病-相关症状。公司现在被要求进行验证性试验证明和描述Farydak的临床获益。Farydak由总部新泽西East Hanover的诺华制药上市。
FARYDAK, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. This indication is approved under accelerated approval based on progression free survival [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.Farydak DescriptionFARYDAK (panobinostat lactate) is a histone deacetylase inhibitor.The chemical name of panobinostat lactate is 2-Hydroxypropanoic acid, compd. with 2-(E)-N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2-propenamide (1:1).The structural formula is:Panobinostat lactate anhydrous is a white to slightly yellowish or brownish powder. The molecular formula is C21H23N3O2&#O3 (lactate); its molecular weight is 439.51 (as a lactate), equivalent to 349.43 (free base). Panobinostat lactate anhydrous is light sensitive. Panobinostat lactate anhydrous is both chemically and thermodynamically a stable crystalline form with no polymorphic behavior. Panobinostat free base is not chiral and shows no specific optical rotation. Panobinostat lactate anhydrous is slightly soluble in water. Solubility of panobinostat lactate anhydrous is pH-dependent, with the highest solubility in buffer pH 3.0 (citrate).FARYDAK capsules contain 10 mg, 15 mg, or 20 mg panobinostat free base. The inactive ingredients are magnesium stearate, mannitol, microcrystalline cellulose and pregelatinized starch. The capsules contain gelatin, FD&C Blue 1 (10 mg capsules), yellow iron oxide (10 mg and 15 mg capsules), red iron oxide (15 mg and 20 mg capsules) and titanium dioxide.Dosage Forms & Strengthscapsule10mg15mg20mgMultiple MyelomaIndicated in combination with bortezomib and dexamethasone for multiple myeloma in patients who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent20 mg PO once every other day for 3 doses/week (on Days 1, 3, 5, 8, 10, and 12) of Weeks 1 and 2 of each 21-day cycle for 8 cyclesConsider continuing treatment for an additional 8 cycles for patients with clinical benefit, unless they have unresolved severe or medically
the total duration of treatment may be up to 16 cycles (48 weeks)Recommended dosing schedule with bortezomib and dexamethasone21-day cycleWeeks 1-8Panobinostat on Days 1, 3, 5, 8, 10, and 12, and then rest for 1 weekBortezomib (1.3 mg/m³ IV per scheduled day): Days 1, 4, 8, and 11, and then rest for 1 weekDexamethasone (20 mg PO per scheduled day): Days 1, 2, 4, 5, 8, 9, 11, and 12, and then rest for 1 weekWeeks 9-16Panobinostat on Days 1, 3, 5, 8, 10, and 12, and then rest for 1 weekBortezomib (1.3 mg/m³ IV per scheduled day): Days 1 and 8, and then rest for 1 weekDexamethasone (20 mg PO per scheduled day): Days 1, 2, 8, and 9, and then rest for 1 weekDosage ModificationsManagement of adverse drug reactions may require treatment interruption and/or dose reductionsIf dose reduction is required, reduce panobinostat dose in increments of 5 mg (ie, from 20 mg to 15 mg, or from 15 mg to 10 mg)If the dosing is reduced below 10 mg given 3 times per week, discontinue panobinostatKeep the same treatment schedule (3-week treatment cycle) when reducing doseThrombocytopenia Platelets &50 x 10^9/L: Mainta monitor platelet counts at least weeklyPlatelets &50 x 10^9/L (with grade 3 bleeding): Interrupt monitor platelet counts at least weekly until ≥50 x 10^9/L, then restart at reduced dosePlatelets &25 x 10^9/L: Interrupt monitor platelet counts at least weekly until ≥50 x 10^9/L, then restart at reduced doseBortezomib dosePlatelets &50 x 10^9/L: Maintain dosePlatelets &50 x 10^9/L (with grade 3 bleeding) or platelets &25 x 10^9/L: Interrupt bortezomib dosing until thrombocytopenia resolves to ≥75 x 10^9/LIf only 1 dose was omitted prior to correction to these levels,
if ≥2 doses were omitted consecutively, or within the same cycle, bortezomib should be restarted at a reduced doseNeutropeniaANC 0.75-1 x 10^9/L: Maintain panobinostat doseANC 0.5-0.75 x 10^9/L (≥2 occurrences): Interrupt panobinostat until ANC ≥1 x 10^9/L, then restart at same doseANC &1 x 10^9/L (with febrile neutropenia): Interrupt panobinostat until ANC ≥1 x 10^9/L, then restart at reduced doseANC &0.5 x 10^9/L: Interrupt panobinostat until ANC ≥1 x 10^9/L, then restart at reduced doseBortezomib doseANC 0.75-1 x 10^9/L or ANC 0.5-0.75 x 10^9/L (≥2 occurrences): Maintain doseANC &1 x 10^9/L (with febrile neutropenia) or ANC &0.5 x 10^9/L: Interrupt bortezomib dosing until febrile neutropenia resolves and ANC ≥1 x 10^9/LIf only 1 dose was omitted prior to correction to these levels,
if ≥2 doses were omitted consecutively, or within the same cycle, bortezomib should be restarted at a reduced doseAnemia Hgb &8 g/dL: Interrupt panobinostat until Hgb ≥10 g/dLRestart at reduced doseDiarrheaModerate (4-6 stools/day): Interrupt panobinostat (and bortezomib) d restart each drug at same doseSevere (≥7 stools/day): Interrupt panobinostat (and bortezomib) d restart each drug at reduced doseLife-threatening (grade 4): Permanently discontinue panobinostat (and bortezomib)Nausea or vomitingSevere nausea (grade 3 or 4): Inte restart at reduced doseSevere/life-threatening vomiting (grade 3 or 4): Inte restart at reduced doseMyelosuppressionInterrupt or reduce panobinostat dose for thrombocytopenia, neutropenia, or anemia according to instructions listed aboveFor patients with severe thrombocytopenia, consider platelet transfusionsDiscontinue panobinostat treatment if thrombocytopenia does not improve despite the recommended treatment modifications or if repeated platelet transfusions are requiredIn the event of grade 3 or 4 neutropenia, consider dose reduction and/or the use of growth factors (eg, G-CSF)Discontinue panobinostat if neutropenia does not improve despite dose modifications, colony-stimulating factors, or severe infectionGastrointestinal toxicity Gastrointestinal toxicity is common during treatment with panobinostatPatients who experience diarrhea, nausea, or vomiting may require treatment interruption or dose reduction (see instructions listed above)At the first sign of abdominal cramping, loose stools, or onset of diarrhea, patients should be treated with antidiarrheal medication (eg, loperamide)Consider and administer prophylactic antiemetics as clinically indicatedOther adverse effects For patients experiencing grade 3 or 4 adverse drug reactions other than thrombocytopenia, neutropenia, or gastrointestinal toxicity, the recommendation is the following:Grade 2 toxicity recurrence and grade 3 and 4: Omit the dose until recovery to ≤grade and restart treatment at a reduced doseGrade 3 or 4 toxicity recurrence: A further dose reduction may be considered once the adverse events have resolved to ≤grade 1CYP3A4 inhibitors and inducersStrong CYP3A4 inhibitors: Reduce panobinostat starting dose to 10 mgStrong CYP3A4 inducers: Av reduces systemic exposure of panobinostatHepatic impairmentMild: Reduce panobinostat starting dose to 15 mgModerate: Reduce panobinostat starting dose to 10 mgSevere: Avoid useRenal impairmentMild-to-severe: Does not impact plasma exposure of panobinostatEnd-stage renal disease or patients on dialysis: Not studiedDialyzability: UnknownDosage ConsiderationsMultiple myeloma indication is approved under accelerated approval based on progression- continued approval may be contingent upon verification and description of clinical benefit in confirmatory trialsSafety and efficacy not establishedIn clinical trials, 42% of patients were ≥65 yrPatients older than 65 yr had a higher frequency of selected adverse events and of discontinuation of treatment because of adverse eventsThe incidence of deaths not related to disease progression was 9% in patients ≥65 yr compared with 5 % in patients &65 yr
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北京多发性骨髓瘤病友
北京多发性骨髓瘤病友?
　　骨髓瘤是恶性肿瘤之一，近年来它的发病率逐渐增高，给我们的生活带来严重的影响，也危害患者的身体健康。
北京多发性骨髓瘤病友?专家分析：
　　生物免疫疗法技术有效治疗骨髓瘤
　　生物免疫疗法是一种新兴的、具有显着疗效的骨髓瘤治疗模式，是一种自身免疫抗癌的新型治疗方法。它是运用生物技术和生物制剂对从病人体内 采集的免疫细胞进行体外培养和扩增后回输到骨髓瘤病人体内的方法，来激发，增强机体自身免疫功能，从而达到治疗骨髓瘤的目的。
　　生物免疫疗法的优势是最大限度的调动人体的免疫功能，同时生物治疗产生的大量特异而有效的免疫效应细胞可以对人体内残存骨髓瘤细胞具有更直接更有效的杀灭作用，从而可以达到消灭细胞、阻止骨髓瘤的转移和复发的作用，从源头上预防和转移，最大程度的提高患者的生命质量。
以上就是关于“北京多发性骨髓瘤病友?”的介绍
　　温馨提醒：我院骨髓瘤科以一流的管理、一流的技术、一流的服务在全市范围内享有很高声誉。生物免疫疗法以其安全、高效、无毒副作用等优点，已成为骨髓瘤患者的首选。希望每一位骨髓瘤患者都能早日康复!
推荐阅读：推荐阅读：　　以上是本站为您介绍北京多发性骨髓瘤病友，希望能对您有所帮助！如果发现不适症状，建议及时到医院做检查，一方面不会加速病情滋长，另一方面，早发现早治疗，节约费用。您的健康，是我们共同的期待！相关文章：/bst/mysh/38917.html/bst/mrzx/63904/index.html
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