普乐沙福注射溶液Mozobil 24mg/ml 1.2ml sdv dpsh(Plerixafor)

药店国别:

产地国家:荷兰

处方药:

所属类别: 24毫克/毫升 1.2毫升/瓶

包装规格: 24毫克/毫升 1.2毫升/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:SANOFI-AVENTIS

原产地英文商品名:MOZOBIL 20MG/ML 1.2ML SDV DPSH 1/EA

原产地英文药品名:PLERIXAFOR

中文参考商品译名:MOZOBIL注射溶液 24毫克/毫升 1.2毫升/瓶

中文参考药品译名:普乐沙福

曾用名:

简介:近日,美国FDA批准MOZOBIL (plerixafor) 上市,与粒细胞集落刺激因子(G-CSF)联合用药促进红细胞生成素干细胞进入非霍奇金淋巴瘤(NHL)和多发性骨髓瘤(MM)患者血流以收集、随后自体移植。本品还被获准作为罕用药物。批准日期:2013月9月2日 公司:Genzyme CorporationMOZOBIL(普乐沙福[plerixafor])注射液,皮下使用的溶液美国最初批准:2008年

作用机制

Plerixafor是CXCR4趋化因子受体的抑制剂,并阻断其同源配体,基质细胞衍生因子-1α(SDF-1α)的结合。SDF-1α和CXCR4被认为在人造血干细胞(HSC)向骨髓室的运输和归巢中起作用。一旦进入骨髓,干细胞CXCR4可以通过SDF-1α或通过诱导其他粘附分子帮助将这些细胞锚定到骨髓基质中。用plerixafor治疗导致小鼠,狗和人的白细胞增多和循环造血祖细胞的升高。由plerixafor动员的CD34+细胞能够在犬移植模型中植入长达一年的再生能力。

适应症和用法

Mozobil是一种造血干细胞动员,与粒细胞集落刺激因子(G-CSF)联合应用,可以将造血干细胞(HSCs)动员到外周血中,用于非霍奇金淋巴瘤和多发性肝癌患者的采集和随后的自体移植骨髓瘤。剂量和给药在患者每天一次接受G-CSF 4天后开始Mozobil治疗。连续4天重复Mozobil剂量。剂量基于患者体重≤83kg:20mg剂量或基于0.24mg/kg实际体重的选择剂量。> 83 kg:根据0.24mg/kg实际体重选择剂量。在开始单采血液成分术前约11小时通过皮下注射给药。肾功能损害:如果肌酐清除率≤50mL/min,则剂量减少三分之一至0.16mg/kg。剂量形式和强度一次性小瓶,含有1.2mL的20mg/mL溶液。

禁忌症

对Mozobil过敏的历史。

警告和注意事项

发生了过敏性休克和严重超敏反应。在完成Mozobil给药期间和之后监测患者。白血病患者的肿瘤细胞动员:Mozobil可以动员白血病细胞,不应该用于白血病患者。血液学影响:观察到循环白细胞增加和血小板计数减少。在Mozobil使用期间监测血细胞计数和血小板计数。肿瘤细胞动员的可能性:在用Mozobil和G-CSF动员HSC期间,肿瘤细胞可能从骨髓中释放出来。肿瘤细胞再输注的效果尚不清楚。脾破裂:评估报告左上腹部和/或肩胛或肩部疼痛的患者。胚胎 – 胎儿毒性:可能导致胎儿伤害。建议女性服用Mozobil时不要怀孕。

不良反应

最常见的不良反应(≥10%):腹泻,恶心,疲劳,注射部位反应,头痛,关节痛,头晕和呕吐。

包装提供/存储和处理

每个一次性小瓶被填充以提供1.2mL的20mg / mL含有24mg plerixafor的溶液。

普乐沙福注射溶液英文版说明书

General InformationMozobil is a hematopoietic stem cell mobilizer and inhibitor of the CXCR4 chemokine receptor. CXXR4 is specific for stromal-derived-factor-1 (SDF-1), a molecule endowed with potent chemotactic activity for lymphocytes. Because the interaction between SDF-1 and CXCR4 plays an important role in holding hematopoietic stem cells in the bone marrow, drugs that block the CXCR4 receptor appear to be capable of “mobilizing” hematopoietic stem cells into the bloodstream.Mozobil, in combination with granulocyte-colony stimulating factor (G-CSF), is specifically indicated to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM).Mozobil is supplied as a solution designed for subcutaneous injection. Treatment with Mozobil should begin after the patient has received G-CSF once daily for four days. Mozobil should be administered approximately 11 hours prior to initiation of apheresis for up to 4 consecutive days. The recommended initial dose of the drug is 0.24 mg/kg body weight by subcutaneous (SC) injection. The dose should not exceed 40 mg/day. In patients with moderate and severe renal impairment (estimated creatinine clearance (CLCR) = 50 mL/min), the dose of Mozobil should be reduced by one-third, to 0.16 mg/kg.Clinical ResultsFDA ApprovalFDA approval of Mozobil was based on the results of two placebo-controlled clinical trials: Study 1 and Study 2. In both studies, the subjects were randomized to receive either Mozobil 0.24 mg/kg or placebo on each evening prior to apheresis. They received daily morning doses of G-CSF 10 micrograms/kg for 4 days prior to the first dose of Mozobil or placebo and on each morning prior to apheresis.Study 1This study enrolled 298 subjects with non-Hodgkin’s lymphoma. Data showed that 59% of the subjects with NHL who were mobilized with Mozobil and G-CSF collected ≥ 5 X 106 CD34+ cells/kg from the peripheral blood in four or fewer apheresis sessions, compared with 20% of patients who were mobilized with placebo and G-CSF (p < 0.001). The median number of days to reach ≥ 5 x 106 CD34+ cells/kg was 3 days for the Mozobil group and not eva luable for the placebo group.Study 2This trial enrolled 302 subjects with multiple myeloma. Data showed that 72% of MM patients who were mobilized with Mozobil and G-CSF collected ≥ 6 X 106 CD34+ cells/kg from the peripheral blood in two or fewer apheresis sessions, compared with 34% of patients who were mobilized with placebo and G-CSF (p < 0.001). The median number of days to reach ≥ 6 x 106 CD34+ cells/kg was 1 day for the Mozobil group and 4 days for the placebo group.Ongoing Study CommitmentsGenzyme has agreed to provide follow up safety and efficacy information for trial 3101-LTF for 5 years which will include death and disease status (relapse or disease-free). Updated status reports to be submitted annually.Protocol Submission Date: April 3, 2006Trial Start Date: December 15, 2006First Annual Report: February 2010Second Annual Report: February 2011Third Annual Report: February 2012Fourth Annual Report: February 2013Fifth Annual Report: February 2014Genzyme has agreed to provide follow up safety and efficacy information for trial 3102-LTF for 5 years which will include death and disease status (relapse or disease-free). Updated status reports to be submitted annually.Protocol Submission Date: April 20, 2006Trial Start Date: January 11, 2007First Annual Report: February 2010Second Annual Report: February 2011Third Annual Report: February 2012Fourth Annual Report: February 2013Fifth Annual Report: February 2014Genzyme has agreed to complete and submit the data and final report from the thorough QT/QTc trial.Protocol Submission: October 24, 2007Trial Start: March 31, 2008Final Report Submission: by January 31, 2009Side EffectsAdverse events associated with the use of Mozobil may include, but are not limited to, the following:DiarrheaNauseaFatigueInjection site reactionsHeadacheArthralgiaDizzinessVomitingMechanism of ActionMozobil is a hematopoietic stem cell mobilizer and inhibitor of the CXCR4 chemokine receptor. It blocks the binding of the CXCR4 cognate ligand, stromal cell-derived factor-1a (SDF-1a). SDF-1a and CXCR4 are recognized to play a role in the trafficking and homing of human hematopoietic stem cells to the marrow compartment. Once in the marrow, stem cell CXCR4 can act to help anchor these cells to the marrow matrix, either directly via SDF-1a or through the induction of other adhesion molecules.

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