简介：

英文药名：JAKAVI Tablets（RUXOLITINIB PHOSPHATE）

中文药名：磷酸鲁索替尼片

生产厂家：瑞士诺华日本公司
给药说明
适应证和用途
Jakafi是一种激酶抑制剂适用于治疗中间或高危骨髓纤维化, 包括原发性骨髓纤维化，真性红细胞增多症后骨髓纤维化和原发性血小板增多症后骨髓纤维化患者。
剂量和给药方法
（1）对血小板计数大于200/μL患者，Jakafi的开始剂量是20mg口服每天2次给药，而对血小板计数100/μL和200/μL间患者15 mg每天2次。
（2）起始用Jakafi治疗前进行完全血细胞计数。监视完全血细胞计数s 每2至4周直至剂量稳定化，,和然后当临床指示。对血小板计数减低调整剂量。
（3）根据反应增加剂量和因推荐至最大每天2次25mg。如脾脏无减小或症状无改善6个月后终止。
剂型和规格
片：5mg，10mg，15mg，20mg和25mg。
禁忌证
无。
警告和注意事项
（1）可能发生血小板计数减低，贫血和中性粒细胞减少。用减低剂量,或中断或输血处理。
（2）评估患者感染的体征和症状和及时开始适当治疗。开始用Jakafi治疗前严重感染应已解决。
不良反应
最常见血液学不良反应(发生率 > 20%)是血小板计数减低和贫血。最常见非血液学不良反应(发生率 >10%) 是瘀斑, 眩晕和头痛。
药物相互作用
（1）强CYP3A4抑制剂：对血小板计数大于或等于100/μL患者减低Jakafi开始剂量至10mg每天2次和同时强CYP3A4抑制剂。血小板计数小于100/μL患者中避免使用。
特殊人群中使用
（1）肾受损：对中度(CrCl 30-59mL/min)或严重肾受损(CrCl 15-29mL/min)和血小板计数间100/μL和150X109/L患者Jakafi开始剂量减低至10mg每天2次。终末肾病(CrCl 小于15mL/min)不需要透析患者中和有中度或严重肾受损和血小板计数小于100/μL患者避免使用。
（2）肝受损：对任何程度肝受损和血小板计数100/μL和150/μL间患者Jakafi开始剂量减低至10mg每天2次。肝受损与血小板计数小于100/μL患者避免使用。
（3）哺乳母亲: 终止哺乳或终止药物考虑药物对母亲的重要性。
原处方资料附件：http://www.info.pmda.go.jp/go/pack/4291034F1029_1_06/
Myelofibrosis and polycythemia hyperaemia "Jacabi tablets" Applying for approval for addition of dosage form - Novartis
Aim for improvement of medication adherence
Novartis Pharma Co., Ltd. announced on March 25 that it filed an application for approval for addition of a dosage form for "Jacabi (R) tablet 10 mg" (generic name: luxosolinib phosphate). At present, 5 mg of the same drug is approved with myelofibrosis and polycythemia vera as an indication or an effect, but by decreasing the number of tablets taken by a patient at a time, improvement of convenience and improvement of medication adherence It is said that we have done this development aiming at.
Jacobi was first approved in the United States for the first time in the United States as an indication for myelofibrosis as an indication in November 2011. As of December 2015, Jakabi is used as a remedy for myelofibrosis in 96 countries or regions, in 51 countries or regions It is approved as a treatment for polycythemia. In Japan, it is approved as a therapeutic agent for myelofibrosis in July 2014, polycythemia multiforme (only when the existing treatment is ineffective or inappropriate) in September 2015.
10 mg formulation has already been approved in 39 countries or regions
Bone marrow fibrosis and polycythemia vera are all types of myeloproliferative tumors, and it is predicted that due to their disease characteristics, the medication period due to drug treatment will be long-term. Long-term medications may lead to a reduction in adherence, so it is considered desirable to prescribe fewer burdens on patients, such as fewer dosing times and tablet counts.
10 mg of the same drug applied this time is a preparation that already has been marketed and has a content of 5 mg of the same drug. Overseas, as of December 2015, it is approved in 39 countries or regions.