Bosulif (BOSUTINIB)

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BOSULIF（bosutinib 一水合物）片剂，薄膜包衣

美国首次批准：2012  公司：美国辉瑞制药（Pfizer Laboratories Div Pfizer Inc]

适应症及用法
BOSULIF是一种激酶抑制剂，用于治疗成人慢性，加速或急变期的Ph +之前的治疗耐药或不能耐受的慢性粒细胞性白血病（CML）患者表示。
 
【用法用量】
推荐剂量：口服500毫克，每日一次食品。
考虑剂量增加至600毫克，每天谁不达到完全血液学反应，8周或12周时完全细胞遗传学缓解，并且没有3级或更大的不良反应的患者中。
血液学和非血液学毒性调整剂量。
肝功能不全（基线）：减少BOSULIF剂量到每天200毫克。
 
剂型和优势
片剂：100毫克和500毫克。
 
禁忌
过敏BOSULIF。
 
警告和注意事项
胃肠道毒性：必要的监控和管理。截留，剂量减少，，或停止BOSULIF。
骨髓抑制：监测血细胞计数和必要的管理。
肝毒性：至少每月监测肝酶的前三个月，并根据需要。截留，剂量减少，，或停止BOSULIF。
体液潴留：监控病人及管理使用标准的护理治疗。截留，剂量减少，，或停止BOSULIF。
胚胎 - 胎仔毒性：可能引起胎儿危害。女性的生殖潜力，应避免怀孕，而正在接受治疗的BOSULIF。
 
不良反应
最常见的不良反应（发生率大于20％）是腹泻，恶心，血小板减少，呕吐，腹痛，皮疹，贫血，发热，和疲劳。

药物相互作用
CYP3A抑制剂和诱导剂：避免同时使用BOSULIF与强或中度的的CYP3A抑制剂和诱导。
质子泵抑制剂血药浓度可能会降低的bosutinib。考虑短效制酸剂，质子泵抑制剂的地方。

请参阅第17患者咨询信息和FDA批准的患者标签

日期：09/2012

美国FDA批准了辉瑞公司的博舒替尼（Bosutinib，商品名Bosulif）用于治疗慢性期、加速期、或急变期的Ph染色体阳性的曾接受过伊马替尼（Imatinib）治疗，但是对伊马替尼耐药或者不能耐受的慢性粒细胞白血病患者。
FDA has approved Bosulif (bosutinib) for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy.
The registrational trial (Study 200) was a global, single-arm, open-label, multi-cohort, Phase 1/2 study of >500 patients with imatinib (Gleevec; Novartis)-resistant or –intolerant Ph+ CML with separate cohorts for chronic, accelerated and blast phase disease previously treated with one prior TKI (imatinib) or more than one TKI (imatinib followed by dasatinib [Sprycel; Bristol-Myers Squibb] and/or nilotinib [Tasigna; Novartis]).
The major cytogenetic response (MCyR) at 24 weeks for patients with chronic phase CML who had been previously treated with imatinib only (n=266) was 33.8% (95% CI: 28.2, 39.9). With a minimum follow-up of 23 months, 53.4% of patients achieved a MCyR. Of patients who achieved MCyR, 52.8% had a MCyR lasting at least 18 months. The median duration of MCyR was not reached for these patients.
The MCyR by 24 weeks for patients with chronic phase CML who had been treated with imatinib and at least one other TKI (n=108) was 26.9% (95% CI: 18.8, 36.2). With a minimum follow-up of 13 months, 32.4% of patients achieved a MCyR. Of patients who achieved MCyR, 51.4% had a MCyR lasting at least nine months. The median duration of MCyR was not reached for these patients.
A low rate of transformation (4%, n=16) from the chronic phase to the advanced or blast phase was also observed in patients treated with Bosulif.
Bosulif is a kinase inhibitor that limits cancer cell growth by inhibiting the Abl and Src signaling pathways. Bosulif is expected to be available mid-September. It will be available as 100mg and 500mg tablets.
FDA has approved Bosulif (bosutinib) for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy.
The registrational trial (Study 200) was a global, single-arm, open-label, multi-cohort, Phase 1/2 study of >500 patients with imatinib (Gleevec; Novartis)-resistant or –intolerant Ph+ CML with separate cohorts for chronic, accelerated and blast phase disease previously treated with one prior TKI (imatinib) or more than one TKI (imatinib followed by dasatinib [Sprycel; Bristol-Myers Squibb] and/or nilotinib [Tasigna; Novartis]).
The major cytogenetic response (MCyR) at 24 weeks for patients with chronic phase CML who had been previously treated with imatinib only (n=266) was 33.8% (95% CI: 28.2, 39.9). With a minimum follow-up of 23 months, 53.4% of patients achieved a MCyR. Of patients who achieved MCyR, 52.8% had a MCyR lasting at least 18 months. The median duration of MCyR was not reached for these patients.
The MCyR by 24 weeks for patients with chronic phase CML who had been treated with imatinib and at least one other TKI (n=108) was 26.9% (95% CI: 18.8, 36.2). With a minimum follow-up of 13 months, 32.4% of patients achieved a MCyR. Of patients who achieved MCyR, 51.4% had a MCyR lasting at least nine months. The median duration of MCyR was not reached for these patients.
A low rate of transformation (4%, n=16) from the chronic phase to the advanced or blast phase was also observed in patients treated with Bosulif.
Bosulif is a kinase inhibitor that limits cancer cell growth by inhibiting the Abl and Src signaling pathways. Bosulif is expected to be available mid-September. It will be available as 100mg and 500mg tablets.