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博舒替尼薄膜片BOSULIF filmcoated Tablets 500mg(Bosutinib)

药店国别:

产地国家:英国

处方药:

所属类别: 500毫克/片 28片/盒

包装规格: 500毫克/片 28片/盒

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Pfizer

原产地英文商品名:BOSULIF filmcoated tablets 500MG/Tablets 28Tablets/box

原产地英文药品名:BOSUTINIB

中文参考商品译名:BOSULIF薄膜片 500毫克/片 28片/盒

中文参考药品译名:博舒替尼

曾用名:伯舒替尼

简介

部份中文博舒替尼处方资料(仅供参考)商品名称:Bosulif通用名称:博舒替尼英文名称:Bosutinib汉语拼音:Boshutini

适应症

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。考虑剂量增加至600毫克,每天谁不达到完全血液学反应,伯舒替尼多少钱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-性调整剂量。肝功能不全(基线):减少BOSULIF剂量到每天200毫克。

不良反应

在接受Bosulif治疗的患者中观察到的最常见的不良反应为:腹泻、恶心、血小板低、呕吐、腹痛、皮疹、红细胞计数低(贫血)、发热和疲劳。

禁忌

对博舒替尼过敏者禁用。

注意事项

胃肠道-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-性:至少每月监测肝酶的前三个月,伯舒替尼哪里卖并根据需要。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-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。贮藏贮存在25℃以下,密封保存。生产企业辉瑞制药有限公司Bosulif(Bosutinib,博舒替尼水合物)为白血病治疗增加新选择,用于治疗慢性髓性白血病(CML)。该病是常见于老年人的血液和骨髓疾病。

博舒替尼薄膜片英文版说明书

Bosulif IndicationBOSULIF safety informationIMPORTANT SAFETY INFORMATIONContraindication: History of hypersensitivity to BOSULIF. Reactions have included anaphylaxis. Anaphylactic shock occurred in less than 0.2% of treated patients in clinical trials.Gastrointestinal Toxicity: Diarrhea, nausea, vomiting, and abdominal pain can occur. In the clinical trial, median time to onset for diarrhea was 2 days, median duration was 1 day, and median number of episodes per patient was 3 (range 1-221). Monitor and manage patients using standards of care, including antidiarrheals, antiemetics, and/or fluid replacement. Withhold, dose reduce, or discontinue BOSULIF as necessary.Myelosuppression: Thrombocytopenia, anemia, and neutropenia can occur. Perform complete blood counts weekly for the first month and then monthly or as clinically indicated. Withhold, dose reduce, or discontinue BOSULIF as necessary.Hepatic Toxicity: Twenty percent of patients experienced an increase in either ALT or AST. Liver enzyme elevation usually occurs early in treatment. Perform hepatic enzyme tests monthly for the first 3 months and as clinically indicated. In patients with transaminase elevations, monitor liver enzymes more frequently. Drug-induced liver injury has occurred. Withhold, dose reduce, or discontinue BOSULIF as necessary. In patients with mild, moderate, or severe hepatic impairment, the recommended starting dose is 200 mg daily.Renal Toxicity: An on-treatment decline in estimated glomerular filtration rate has occurred in patients treated with BOSULIF. Monitor renal function at baseline and during therapy, with particular attention to patients with preexisting renal impairment or risk factors. Consider dose adjustment in patients with baseline and treatment emergent renal impairment. The recommended starting doses for patients with severe renal impairment (CrCL <30 mL/min) or moderate renal impairment (CrCL 30-50 mL/min) are 300 mg and 400 mg daily, respectively.Fluid Retention: Fluid retention can occur and may cause pericardial effusion, pleural effusion, pulmonary edema, and/or peripheral edema. Monitor and manage patients using standards of care. Interrupt, dose reduce, or discontinue BOSULIF as necessary.Embryofetal Toxicity: BOSULIF may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised of potential hazard to the fetus and to avoid becoming pregnant while receiving BOSULIF.Adverse Reactions: The most common adverse reactions observed in greater than 20% of patients in the Phase 1/2 safety population (N=546) were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue. The most common Grade 3/4 adverse reactions and laboratory abnormalities observed in greater than 10% of patients were thrombocytopenia, anemia, and neutropenia.CYP3A Inhibitors and Inducers: Avoid concurrent use with strong or moderate CYP3A inhibitors or inducers.Proton Pump Inhibitors: Consider using short-acting antacids or H2 blockers instead of PPIs to avoid a reduction in BOSULIF exposure. Separate antacid or H2 blocker dosing and BOSULIF dosing by more than 2 hours.Nursing Mothers: Given the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or BOSULIF, taking into account the importance of the drug to the mother.INDICATIONBOSULIF® (bosutinib) is indicated 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.

用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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