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Jakafi(Ruxolitinib)片

2012-07-09 15:42:00  作者:新特药房  来源:本站原创  浏览次数:460  文字大小:【】【】【
简介: JAKAFI(ruxolitinib)片口服给药 最初美国批准:2011Incyte的公司 适应症jakafi是一种激酶抑制剂,与中间或高风险的骨髓纤维化患者的治疗,包括原发性骨髓纤维化,后真性红细胞增多症骨髓纤维化及原 ...

 JAKAFI(ruxolitinib)片口服给药

最初美国批准:2011
Incyte的公司

适应症
jakafi是一种激酶抑制剂,与中间或高风险的骨髓纤维化患者的治疗,包括原发性骨髓纤维化,后真性红细胞增多症骨髓纤维化及原发性血小板后骨髓纤维化表示。


剂量和用法
患者血小板计数大于200×109 / L时,患者之间的100×109 / L和200×109 / L,血小板计数和15毫克,每日两次口服,每日两次的Jakafi起始剂量为20毫克
执行完整的血球计数前启动与Jakafi治疗的。监测全血球计数,每2至4周,直到剂量稳定,然后作为临床指征。修改为血小板减少剂量。
基于响应增加剂量和建议最多25毫克,每天两次。停止6个月后,如果没有脾脏减少或症状改善。


剂型和优势
片剂:15毫克,10毫克,5毫克,20毫克和25毫克。


禁忌
没有。


注意事项:
可发生血小板减少,贫血和中性粒细胞。剂量减少或中断或输血管理。
评估患者的感染症状和体征,并及时采取适当的治疗。应该解决的严重感染开始前与Jakafi治疗。


不良反应
最常见的血液系统不良反应(发生率> 20%),血小板减少和贫血。最常见的非血液学不良反应(发生率> 10%)是青紫,头晕,头痛。


药物相互作用
强CYP3A4抑制剂:减少Jakafi起始剂量为10毫克,每天两次为患者血小板计数大于或等于100×109 / L和强CYP3A4抑制剂同时使用。避免与患者的血小板计数小于100×109 / L


在特殊人群中使用
肾功能不全:Jakafi起始剂量10毫克,每天两次为患者减少中度(肌酐清除率30-59毫升/分钟)或严重肾功能不全(肌酐清除率15-29毫升/分钟)和血小板计数100×109 / L和150之间×109 / L。避免在不需要透析患者终末期肾病(肌酐清除率小于15毫升/分钟)和中度或重度肾功能损害和血小板计数的患者小于100×109 / L。
肝功能损害:减少Jakafi起始剂量10毫克,每天两次为任何肝功能损害的程度和血小板计数100×109 / L和150×109 / L之间的患者避免在肝功能不全患者血小板计数小于100×109 / L。
哺乳母亲:终止哺乳或终止药物,考虑到母亲的药物的重要性。

日期:11/2011

Jakafi® (ruxolitinib) Is FDA-Approved for Patients with Intermediate or High-Risk Myelofibrosis

FDA approved ruxolitinib (Jakafi) as the first drug to specifically treat patients with myelofibrosis, a bone marrow disease.

Ruxolitinib is an oral JAK1 and JAK2 inhibitor typically prescribed in 15 mg to 20 mg doses twice daily. Deregulation of these pathways is responsible for myelofibrosis, a condition in which scar tissue replaces healthy bone marrow. Because of the bone marrow’s inability to generate new blood cells, the liver and spleen become responsible for producing new blood cells. The spleen often becomes enlarged in these patients. Other health issues associated with myelofibrosis include anemia, night sweats, and muscle and bone pain.

The FDA approved the drug based on the results of 2 clinical trials that evaluated 528 patients. In both trials, the patients were resistant or refractory to existing myelofibrosis therapy or ineligible for bone marrow transplantation. All patients had enlarged spleens.

In the first study, the phase III Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment (COMFORT-I), patients were divided into a ruxolitinib arm and a placebo arm. The first study showed that 41.9% of patients receiving ruxolitinib had at least a 35% reduction in spleen size, compared to only 0.7% of patients receiving the placebo by week 24 of the study (P <.0001). In this study, 45.9% of patients receiving ruxolitinib reported a reduction in symptoms compared to 5.3% of patients in the placebo arm.

In the COMFORT-II study, 28.5% of patients in the ruxolitinib arm experienced a 35% or greater reduction in spleen size. No patients receiving best available therapy (ie, hydroxyurea, a chemotherapy agent, or glucocorticoids) experienced the same kind of reduction (P <.0001). The median response time was 12 weeks.

“Jakafi represents another example of an increasing trend in oncology where a detailed scientific understanding of the mechanisms of a disease allows a drug to be directed toward specific molecular pathways,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The clinical trials leading to this approval focused on problems that patients with myelofibrosis commonly encounter, including enlarged spleens and pain.”

Side effects associated with ruxolitinib included low blood platelet levels, anemia, fatigue, diarrhea, shortness of breath, headache, dizziness, and nausea. Recent studies have also suggested that serious adverse events may occur in patients who stop taking the drug. A long-term follow-up with patients was published in the New England Journal of Medicine in October. The study showed that 11% of patients who were taking ruxolitinib who stopped taking the drug required hospitalization related to drug cessation.


临床研究
COMFORT-1研究
在这项双盲试验中,研究人员将中危-2或高危骨髓纤维化患者随机分为两组,一组接受口服ruxolitinib治疗,每日2次(155例患者),另一组接受安慰剂,每日2次(154例患者)。主要终点是在第24周脾体积(通过磁共振成像的方法评估)减少≥35%的患者比例。次要终点包括(临床)反应的持久性、症状负荷的变化(通过总症状评分来评估)和总生存期。
COMFORT-2研究
研究将219例中危-2或高危原发性骨髓纤维化患者、真性红细胞增多症后骨髓纤维化患者或原发性血小板增多症后骨髓纤维化患者随机分为两组,一组接受口服ruxolitinib治疗,另一组接受最佳可用疗法。研究的主要终点和关键次要终点分别是在第48周和24周脾体积(用磁共振成像或计算机体层摄影检查评估)减少≥35%的患者百分率。

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