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ZOLINZA(vorinostat,伏立诺他胶囊)

2012-07-19 23:21:35  作者:新特药房  来源:中国新特药网天津分站  浏览次数:188  文字大小:【】【】【
简介: 治疗皮肤T淋巴细胞瘤的Zolinza胶囊,近日获得了美国食品与药品管理局(FDA)批准,推荐用于其他药物治疗疗效欠佳时使用。   Zolinza被批准用于治疗该病,并成为美国食品与药品管理局罕用药计划的一部 ...

治疗皮肤T淋巴细胞瘤的Zolinza胶囊,近日获得了美国食品与药品管理局(FDA)批准,推荐用于其他药物治疗疗效欠佳时使用。  

Zolinza被批准用于治疗该病,并成为美国食品与药品管理局罕用药计划的一部分。这个计划提供经济资助以鼓励制药公司开发新型药物来治疗每年美国患者少于200,000人的疾病。
 
恶性淋巴瘤(Malignant Lymphoma,ML)是指来源于淋巴细胞的恶性肿瘤每年每百万美国人中有有3人被诊断为皮肤T淋巴细胞瘤

ZOLINZA®(伏立诺他胶囊)处方信息

最初美国批准:2006年
 
适应症
ZOLINZA是一种组蛋白去乙酰化酶(HDAC)抑制剂表示为:

治疗皮肤T细胞淋巴瘤(CTCL)有进步,持续性或复发性疾病或两个全身治疗后患者的皮肤表现。
 
剂量和用法
食品每天一次口服400毫克。
如果病人不能耐受治疗,剂量可降低到300毫克,每天一次口服食物。如果有必要,可进一步减少剂量到300毫克,每日一次,连续5天,每星期与食物。
 
剂型和优势
胶囊:100毫克
 
禁忌
严重肝功能不全
 
注意事项:
肺栓塞和深静脉血栓形成的报道。监测有关的症状和体征的病人。
剂量相关的血小板减少和贫血的发生,并可能需要调整剂量或停药。
肠胃功能紊乱(如恶心,呕吐和腹泻)的报道。病人可能需要止吐,antidiarrheals和体液和电解质的更换(以防止脱水)。
轻度和中度肝功能不全的患者应谨慎对待。
高血糖已被观察到。调整饮食和/或增加血糖的治疗可能是必要的。
在基线和治疗期间定期监测电解质。
监测血细胞计数和化学测试,其中包括电解质,血糖和血清肌酐,每2周,在第2个月的治疗,此后每月。
严重的血小板减少症和消化道出血已报告的ZOLINZA和其他HDAC抑制剂(如丙戊酸)同时使用。监测血小板计数。
管理到孕妇时可能发生的胎儿造成伤害。妇女应告知对胎儿的潜在危害。
 
不良反应
最常见的不良反应(发生率≥20%),腹泻,疲劳,恶心,血小板减少,厌食和味觉障碍。
 
药物相互作用
香豆素衍生物抗凝血剂:延长凝血酶原时间和国际标准化比值已观察同时使用。认真监督。

日期:11/2011

 

Zolinza Combination Treatments Offer Benefit For Multiple Myeloma Patients
The 2009 American Society of Hematology (ASH) Meeting showcased several presentations on Zolinza (vorinostat), a histone deacetylase inhibitor developed by Merck Pharmaceuticals that is currently investigated for the treatment of multiple myeloma.

Zolinza alters the way a cancer cell’s DNA creates proteins, which is important in cancer treatment because such a drug can slow down cell proliferation, minimize mutations in DNA and control cell death.

Zolinza With Revlimid And Dexamethasone

Preliminary data from an ongoing Phase 1 study suggest that the combination treatment of Zolinza, Revlimid (lenalidomide) and dexamethasone (Decadron) is safe and active in relapsed and refractory multiple myeloma patients.

Researchers have enrolled 28 patients with relapsed or refactory myeloma to determine the maximum tolerated dose of the combination treatment. They are also studying the safety and efficacy of the combination treatment.

The participants have received five escalating dosages of Zolinza, Revlimid and dexamethasone for at least eight cycles of treatment.

Twenty five of the 28 enrolled patients have been evaluated with regard to the efficacy of the treatment. Of those 25 patients, 21 (84%) have seen an improvement in their disease. The overall response rate is 64 percent.

Twenty-four patients have experienced at least one side effect, with the most common being diarrhea, fatigue, neutropenia (low white blood cell count) and thrombocytopenia (low platelet count).

One dose-limiting toxicity has been observed at the highest dose level. Six additional patients were escalated to that dose level. No additional dose-limiting toxicities have been observed since then. The maximum tolerated dose has therefore not been reached yet.

Researchers continue to investigate the combination treatment to further evaluate the efficacy and safety of this treatment.

Zolinza With Doxil And Velcade

Results from another Phase 1 study that was presented at the ASH meeting show that Zolinza in combination with Doxil (pegylated liposomal doxorubicin) and Velcade (bortezomib) is safe and efficacious in patients with relapsed and refractory multiple myeloma.

Nine patients (median age of 56) with relapsed or refractory myeloma enrolled in this study, receiving 1.3mg/m² of Velcade on days 1, 4, 8, and 11, and 30mg/m² of Doxil on day 4 of treatment. In addition, they were given escalating doses of Zolinza once daily on days 4 through 11 of a 3-week cycle. Three patients received 200 mg of Zolinza, four received 300 mg and two were given 400 mg.

Six out of seven evaluable patients responded to the treatment. One patient experienced a complete response, one patient went into very good partial remission and the remaining four experienced partial remission.

Common side effects included fatigue, diarrhea, nausea, vomiting and peripheral neuropathy (nerve damage in the extremities that can cause pain and tingling sensations). Three patients required dose reductions due to the side effects.

Blood-related side effects included neutropenia (low white blood cell count), lymphopenia (low lymphocyte count), and thrombocytopenia (low platelet count).

Researchers point out that they will have to consider side effects when determining the optimal dose for the Phase 2 study.

Zolinza With Velcade

Preliminary results from an ongoing Phase 1 trial suggest that extended treatment of Velcade in combination with Zolinza shows long-term activity in patients with relapsed and refractory myeloma.

The study sequentially enrolled 34 patients with relapsed or refractory multiple myeloma. They received escalating doses of Zolinza (200 or 400 mg) for at least eight treatment cycles. Plus, they either were given 0.7 or 0.9 mg/m2 of Velade on days 4, 8, 11 and 15, or 0.9, 1.1 or 1.3 mg/m2 of Velcade on days 1, 4, 8 and 11. Patients received 20 mg of oral dexamethasone (Decadron) on days 1-4 and 9-12 of each cycle if their disease progressed.

Nine patients have completed the study through twelve or more treatment cycles so far. Of these nine patients, five patients have experienced a partial response, two have had a minimal response, and two have been given the diagnosis of a stable disease.

All of the nine patients experienced mild to moderate side effects, most commonly diarrhea, nausea and fatigue.

Seven out of the nine patients have discontinued the treatment because their disease has progressed. The median time to progression was 294 days.

Based on these preliminary results, the study authors feel that the Zolinza/Velcade combination treatment could provide long-term responses to relapsed/refractory myeloma patients.

责任编辑:admin


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