产地国家：美国

处方药：是

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：瓶

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

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：（1）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。（2）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。（3）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。（4）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。（5）脾破裂：评估报告左上腹部和/或肩胛或肩部疼痛的患者。（6）胚胎 – 胎儿毒性：可能导致胎儿伤害。（7）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。储存于25oC（77oF）; 偏移允许15o-30oC（59o-86oF）

英文版说明书：

Mozobil (Plerixafor Injection)Raise your expectations for apheresis success in non-Hodgkin’s lymphoma (NHL) and multiple myleoma (MM) patients with Mozobil+granulocyte-colony stimulating factor (G-CSF) compared to G-CSF alone.IndicationMozobil (plerixafor injection) is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM).Important Safety Information for Mozobil (plerixafor injection)•Severe， life-threatening allergic reactions (anaphylaxis) can happen in people who take Mozobil. Tell your doctor right away if you experience hives (itchy raised bumps)， eye swelling， or trouble breathing.•Mozobil is not intended for hematopoietic stem cell transplantation (HSCT) mobilization and collection in patients with leukemia.•Mozobil in combination with G-CSF increases circulating white blood cells (WBCs). Your WBC counts will be monitored.•Thrombocytopenia (a decrease in the number of platelets circulating in the blood) has been observed in patients receiving Mozobil. Your platelet counts will be monitored.•Cancer cells may be released from the bone marrow and subsequently collected along with your stem cells during apheresis. The potential effects of infusing cancer cells during your transplant have not been well-studied.•Your spleen may be examined if you experience pain in the left upper stomach area or left shoulder area as these may be signs of an enlarged or burst (ruptured) spleen.•Mozobil may harm the unborn child when administered to a pregnant woman. Scientific studies have shown that Mozobil causes harm to unborn animals. The safety of Mozobil in pregnant women has not been established in clinical trials.If you are of childbearing potential you should be advised to avoid becoming pregnant while receiving treatment with Mozobil. If this drug is used during pregnancy， or if you become pregnant while taking this drug， you should be apprised of the potential hazard to the unborn child.•The most common adverse reactions (occurring in greater than or equal to 10% of patients) during HSC mobilization and apheresis were: diarrhea (37%)， nausea (34%)， tiredness (fatigue) (27%)， injection site reactions (34%)， headache (22%)， pain in your joints (arthralgia) (13%)， dizziness (11%)， and vomiting (10%).