白血病用药——博舒替尼简要说明书

印度代购提示您：博舒替尼(BOSUTINIB)说明书

通用名：博舒替尼

商品名称：BOSULIF

全部名称：伯舒替尼，博舒替尼，BOSUTINIB，BOSULIF

印度代购提示您：适应症和用法：

BOSULIF是一种激酶抑制剂，适用于治疗成人患者新诊断的慢性期Ph+慢性粒细胞白血病(CML)。该指示基于分子和细胞遗传学应答率在加速批准下获得批准。持续批准该适应症可能取决于正在进行的长期随访试验中的临床获益的验证和确认。慢性，加速或急变期Ph+CML，对先前治疗具有耐药性或不耐受性。

BOSULIF is a kinase inhibitor indicated for the treatment of newly diagnosed chronic Ph+ chronic myelogenous leukemia (CML) in adults. The directive was approved under accelerated approval based on molecular and cytogenetic response rates. Continued approval of this indication may depend on validation and confirmation of clinical benefit in ongoing long-term follow-up trials. Chronic, accelerated or acute Ph+CML, resistant or intolerant to prior treatment.

印度代购提示您：剂量和给药：

新诊断的慢性期Ph+CML：每日口服400毫克，食物一次。慢性，加速或爆炸期Ph+CML对先前治疗具有耐药性或不耐受性：每日一次口服500毫克食物。对于未达到完全血液学，细胞遗传学或分子反应并且没有3级或更高级不良反应的患者，考虑每日一次增加100mg剂量至每日最多600mg的剂量增加。调整剂量以防止毒性和器官损害剂量形式和强度片剂：100mg，400mg和500mg。

Newly diagnosed chronic Ph+CML: oral 400 mg daily, food once. Chronic, accelerated or explosive Ph+CML resistant or intolerant to previous treatment: oral 500 mg food once daily. For patients who have not achieved a complete hematologic, cytogenetic, or molecular response and who do not have grade 3 or higher adverse events, consider a dose increase of 100mg once daily up to a maximum of 600mg daily. Adjust dose to prevent toxicity and organ damage Dose form and strength tablets: 100mg, 400mg and 500mg.