[BTK] Ibrutinib (Imbruvica，PCI-32765)

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药优 2020-04-05 16:07 16:07

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【中文通用名】

【中文商品名】
【研发代码】PCI-32765
【英文通用名】ibrutinib
【英文商品名】Imbruvica
【性状】
【药理毒理】
Ibrutinib (PCI-32765)是一种有效的，高选择性的Brutons tyrosine kinase (Btk)抑制剂。
对Bmx， CSK， FGR， BRK及HCK适度有效，对EGFR， Yes， ErbB2， JAK3等作用效果较弱。
1、药物动力学特性
2、药物代谢动力学特性
3、吸收
4、分布
5、代谢
6、清除
7、特殊人群：
8、与处方者有关的临床前安全资料
【适应症】
美国食品药品监督管理局（FDA）已授予Ibrutinib“突破性”地位用于治疗两种B细胞恶性肿瘤：复发或难治性套细胞淋巴瘤（MCL；既往经过治疗的患者）及Waldenstrom巨球蛋白血症(WM)。
Mantle Cell Lymphoma
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Waldenström’s Macroglobulinemia
Marginal Zone Lymphoma
Chronic Graft Versus Host Disease
【用法与用量】
Mantle Cell Lymphoma And Marginal Zone Lymphoma
IMBRUVICA for MCL and MZL is 560 mg (four 140 mg capsules) orally once daily until disease progression or unacceptable toxicity.
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma And Waldenström’s Macroglobulinemia
IMBRUVICA for CLL/SLL and WM is 420 mg (three 140 mg capsules) orally once daily until disease progression or unacceptable toxicity.
The recommended dose of IMBRUVICA for CLL/SLL when used in combination with bendamustine and rituximab (administered every 28 days for up to 6 cycles) is 420 mg (three 140 mg capsules) orally once daily until disease progression or unacceptable toxicity.
Chronic Graft Versus Host Disease
IMBRUVICA for cGVHD is 420 mg (three 140 mg capsules) orally once daily until cGVHD progression, recurrence of an underlying malignancy, or unacceptable toxicity. When a patient no longer requires therapy for the treatment of cGVHD, IMBRUVICA should be discontinued considering the medical assessment of the individual patient.
【不良反应】