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BUSULFEX®

发布日期:2010-01-20 11:47:44  作者:  来源:互联网  浏览次数:0  文字大小:【】【】【
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【药品名称】 白消安注射液
【药品通用名】 白消安
【商品名】 白舒非
【英文名】 Busulfan Injection
【拼音名】 Baixiao'an zhusheye
【药品批准文号】 注册证号BH20040642
【生产企业】 Ben Venue Laboratories,Inc.
【药学一级分类】 抗肿瘤药物
【药学二级分类】 细胞毒药物
【药学三级分类】 作用于DNA化学结构的药物
【功能主治/适应症】 主要用于治疗慢性粒细胞白血病及真性红细胞增多症、骨髓纤维化等。
【用法用量】 口服:每日量成人2-8mg,儿童每千克体重0.05mg。直到白细胞下降到1万~2万后停药或改为维持量(0.5~ 2mg,每日1次或每周2次)。 用间歇大剂量治疗慢性粒细胞白血病,疗效与上法基本相同,但可缩短诱导缓解的时间,且可能减少招致再生障碍性贫血的机会。用法为:根据病人白细胞及血小板计数,分别选用1次给药80-100mg、50mg、20-30mg的三种不同剂量(若1次服100mg,一般分2次服用,在1~2日内服完)。2次服药的间歇时间为1~2周(根据血象而定),1次若服药80~100mg,需间隔2周以上。
【注意事项】
1.可致胎儿畸形,因而在妊娠前3个月禁用。
2.一般很少引起消化道反应。如用量过大或给药时间过长可引起严重骨髓再生障碍。有的病人有闭经、胎儿发育障碍、色素沉着、脱发、皮疹、男性乳腺发育、睾丸萎缩等。个别病人长期服用时可有肺纤维变及肾上腺皮质功能低下。
3.慢性粒细胞白血病有急性变时应停用。
4.急性白血病和再生障碍性贫血或其他出血性疾患病人忌用。 5.肾上腺皮质功能不全病人慎用。
【关联病症】 慢性粒细胞白血病  真性红细胞增多症  骨髓纤维

价格:1850元

OAPI IV BUSULFEX?/font> (busulfan)

?/span>

IV BUSULFEX1 is the only FDA approved agent for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic stem cell transplantation for chronic myelogenous leukemia (CML).

IV BUSULFEX is an intravenous form of oral busulfan, a chemotherapeutic agent commonly used as part of a conditioning regimen in the transplant setting.

IV BUSULFEX is 100% bioavailable, so the entire amount given is available in the systemic circulation immediately after infusion. Because it is administered intravenously, each dose of IV BUSULFEX can be precisely administered and controlled. With IV BUSULFEX, there is also no drug loss through emesis.

IMPORTANT SAFETY INFORMATION

WARNING: BUSULFEX?/sup> (busulfan) Injection is a potent cytotoxic drug that causes profound myelosuppression at the recommended dosage. It should be administered under the supervision of a qualified physician who is experienced in allogeneic hematopoietic stem cell transplantation, the use of cancer chemotherapeutic drugs, and the management of patients with severe pancytopenia. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available.  SEE "WARNINGS' SECTION FOR INFORMATION REGARDING BUSULFAN-INDUCED PANCYTOPENIA IN HUMANS.

At the recommended dosage, IV BUSULFEX?(busulfan) produced profound myelosuppression in all patients (i.e., severe granulocytopenia, thrombocytopenia, anemia, or a combination thereof). Frequent complete blood counts should be monitored during treatment and until recovery. Hepatic veno-occlusive disease was diagnosed in 5/61 patients and was fatal in 2/5 cases. Anticonvulsant prophylactic therapy should be administered prior to treatment. Caution should be exercised in patients with a history of seizure disorder or head trauma or who are receiving other potentially epileptogenic drugs. Bronchopulmonary dysplasia with pulmonary fibrosis is a rare but serious condition following chronic busulfan therapy. Women of childbearing potential should be advised to avoid becoming pregnant as busulfan may cause fetal harm.

The most common nonhematologic adverse events were nausea (92% mild or moderate, 7% severe), stomatitis (71% grade 1-2, 26% grade 3-4), and vomiting (95% mild or moderate), anorexia (64% mild or moderate, 21% severe), diarrhea (75% mild or moderate, 5% grade 3-4), insomnia (83% mild or moderate, 1% severe), and fever (78% mild or moderate, 3% life-threatening).

 

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