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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗癌药物->治疗白血病药物
处方药:处方药
包装规格: 100毫克 90片/盒
计价单位:
  点击放大  
生产厂家英文名:
Sun Pharmaceutical Industries, Inc.
该药品相关信息网址1:
https://www.rxlist.com/gleevec-drug.htm
原产地英文商品名:
IMATINIB MESYLATE 100mg 90tabs/box
原产地英文药品名:
imatinib mesylate
中文参考商品译名:
甲磺酸伊马替尼 100毫克 90片/盒
中文参考药品译名:
甲磺酸伊马替尼
原产地国家批准上市年份:
2016/02/01
英文适应病症1:
Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase
英文适应病症2:
Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy
临床试验期:
完成
中文适应病症参考翻译1:
成人和儿童患者的慢性期费城染色体阳性慢性粒细胞白血病
中文适应病症参考翻译2:
急性染色体阳性慢性粒细胞白血病
药品信息:

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详细处方信息以本药内容附件PDF文件(201941019433739.pdf)的“原文Priscribing Information”为准
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部分中文阿立哌唑处方资料(仅供参考)


【英文名称】
Abilify


【中文名称】
阿立哌唑

【适用证】

甲磺酸伊马替尼是一种激酶抑制剂,适用于治疗:

---新诊断成人和儿童患者的慢性期费城染色体阳性慢性粒细胞白血病(Ph + CML)(1.1)

---患有急性染色体阳性慢性粒细胞白血病(Ph + CML)的患者在急变期(BC),加速 阶段(AP),或干扰素-α治疗失败后的慢性期(CP)(1.2)

---成人复发或难治性费城染色体阳性急性淋巴细胞白血病(Ph + ALL)患者 (1.3)

---成人骨髓增生异常/骨髓增生性疾病(MDS / MPD)与PDGFR相关的患者(血小板衍生) 经FDA批准的测试确定的生长因子受体基因重排(1.5)

---具有侵袭性系统性肥大细胞增多症(ASM)但没有D816V c-Kit突变的成年患者 FDA批准的测试或c-Kit突变状态未知(1.6)

---患有嗜酸性粒细胞增多症(HES)和/或慢性嗜酸性粒细胞白血病(CEL)的成人患者 FIP1L1-PDGFRα融合激酶(CHIC2等位基因缺失的突变分析或FISH演示)和患者 与HES和/或CEL谁是FIP1L1-PDGFRα融合激酶阴性或未知(1.7)

---成人患者无法切除,复发和/或转移性皮肤纤维肉瘤(DFSP)(1.8)

【用法用量】

成人Ph + CMLCP(2.2):400毫克/天

患有Ph + CML AP或BC(2.2)的成人:600mg /天

儿科与Ph + CMLCP(2.3):340 mg / m /天

成人Ph + ALL(2.4):600毫克/天

患有MDS / MPD的成人(2.6):400mg /天

ASM成人(2.7):100毫克/天或400毫克/天

患有HES / CEL(2.8)的成人:100毫克/天或400毫克/天

成人DFSP(2.9):800毫克/天

轻度至中度肝功能损害患者(2.12):400 mg /天

严重肝功能不全患者(2.12):300毫克/天

所有剂量的甲磺酸伊马替尼片应与膳食和一大杯水一起服用。 每天应给予400mg或600mg的剂量,而每天两次给予400mg的剂量400mg。 对于吞咽困难的患者,甲磺酸伊马替尼片剂可溶于水或苹果汁中。 应使用400mg片剂完成800mg及以上的每日剂量以减少暴露于铁。

【不良反应】

最常报告的不良反应(大于或等于30%)是水肿,恶心,呕吐,肌肉痉挛,肌肉骨骼疼痛,腹泻,皮疹,疲劳和腹痛。(6.1)

【INDICATIONS AND USAGE】

Imatinib mesylate is a kinase inhibitor indicated for the treatment of:

---Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (1.1)

---Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy (1.2)

---Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)(1.3)

---Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test (1.5)

---Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation as determined with an FDA-approved test or with c-Kit mutationalstatus unknown (1.6)

---Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISHdemonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown (1.7)

---Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) (1.8)

【DOSAGE AND ADMINISTRATION】

Adults with Ph+ CMLCP (2.2): 400 mg/day

Adults with Ph+ CML AP or BC (2.2): 600 mg/day

Pediatrics with Ph+ CMLCP (2.3): 340 mg/m /day

Adults with Ph+ ALL (2.4): 600 mg/day

Adults with MDS/MPD (2.6): 400 mg/day

Adults with ASM (2.7): 100 mg/day or 400 mg/day

Adults with HES/CEL (2.8): 100 mg/day or 400 mg/day

Adults with DFSP (2.9): 800 mg/day

Patients with mild to moderate hepatic impairment (2.12): 400 mg/day

Patients with severe hepatic impairment (2.12): 300 mg/day

All doses of imatinib mesylate tablets should be taken with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day. Imatinib mesylate tablets can be dissolved in water or apple juice for patients having difficulty swallowing. Daily dosing of 800 mg and above should be accomplished using the 400 mg tablet to reduce exposure to iron.

【ADVERSE REACTIONS】

The most frequently reported adverse reactions (greater than or equal to 30%) were edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue and abdominal pain. (6.1)

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详细处方信息以本药内容附件PDF文件(201941019433739.pdf)的“原文Priscribing Information”为准
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更新日期:  2019-4-10
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