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 详细处方信息以本药内容附件PDF文件（201232720051326.pdf）的“原文Priscribing Information”为准
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部分中文瘤肯处方资料（仅供参考）

瘤肯(沙格司亭)LEUKINE(SARGRAMOSTIM)
英文药名: Leukine (Sargramostim Injection Vials)

中文药名: 莫拉司亭注射剂,沙格司亭

药品简介
药物名称: 莫拉司亭, 沙格司亭
别　名: 粒细胞-单核巨噬细胞集落刺激因子，生白能，先特能，沙格莫丁，生百能，重组人粒细胞巨噬细胞集落刺激因子、特尔立
英 文 名: Molgramostim, Sargramostim

药品说明:
贮于2-8℃，避光，可稳定保存36个月。用无菌溶媒溶解后，2-8℃，可保存1周。静注稀释液，2-8℃可保存24hr。必要时，本药用溶媒溶解后冻存28天。可以冻融2次。

适应症:
骨髓抑制疗法所引起的白细胞减少症、骨髓衰竭病人的白细胞低下，也用于预防白细胞减少时可能潜在的感染并发症。

用法用量:
皮下注射或静脉滴注，剂量视病情而定，使白细胞计数维持在期望的水平(通常<10×109/L)。
推荐剂量如下: 癌症化疗，5μg ～10μg/kg，皮下注射，1次/日，于化疗停药1日后开始使用，持续使用7～10日。停药后至少间隔48h后方进行下一疗程的抗癌化疗。
骨髓增生异常综合征(MDS)、再生障碍性贫血，3μg/kg，皮下注射1次/日，3～4日显效后调节剂量，使白细胞维持在<10×109/L。
骨髓移植，5μg ～10μg/kg，静滴4～6h，1次/日，持续用药至中性粒细胞绝对计数≥10×109/L达3日之久。
艾滋病(AIDS),1μg/kg，皮下注射，1次/日，如与叠氮胸苷（AZT）或AZT、(-干扰素合用，本品用量为每日1μg ～3μg/kg；如与更昔洛韦合用，每日3μg ～5μg/kg，皮下注射，1次/日。2～4日见效后，每隔3～5日调整1次剂量。
癌症化疗: 5-10 μg/kg体重，1次/日皮下注射。在化疗停止1日后使用，持续7-10天。
骨髓移殖: 5 μg/kg体重/日，静脉点滴4-6 hr，自骨髓移植后次日开始，持续使用不超过30天，或至连续3天中性粒细胞绝对值超过1 x 109/L。
骨髓异常增生综合征/再生障碍性贫血: 3 μg/kg体重，1次/日，一般需2-4日才能观察到白细胞增高的最初效应。以后应根据白细胞计数情况调节剂量。
艾滋病: 单独使用1 μg/kg体重，1次/日，皮下注射。与AZT或AZT/α干扰素合用，1-3 μg/kg体重，与甘昔洛韦合用3-5 μg/kg体重，1次/日，皮下注射。一般需2～4天才能观察到白细胞计数上升的最初效应。

注意事项:
妊娠C类。禁用于对本品或内在其他成分有过敏史的病人以及自身免疫性血小板减少性紫瘢的病人。
首次使用本药应在医疗监护下进行。用药期间应注意监测血象。
对妊娠和哺乳的影响: 孕期使用本药的安全性尚未建立。动物试验研究表明本药有生殖毒性。在灵长类动物模型中发现，剂量6-10μg/kg/日，可发生自发性流产。本药是否经乳汁分泌，尚不清楚。但由于对婴儿可能有不良作用，哺乳妇女在开始使用本药前应停止哺乳。
对儿童的影响: 本药对18岁以下病人的有效性和安全性尚未建立。

Indication
Leukine® is indicated for the following uses: (i) following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery; (ii) for mobilization and following transplantation of autologous peripheral blood progenitor cells; (iii) for myeloid reconstitution after autologous or allogeneic bone marrow transplantation (BMT); (iv) for use in bone marrow transplantation failure or engraftment delay.

Important Safety Considerations
Leukine is contraindicated in patients with excessive leukemic myeloid blasts in bone marrow or peripheral blood (≥10%); in patients with known hypersensitivity to GM-CSF, yeast-derived products, or any component of Leukine; and for concomitant use with chemotherapy and radiotherapy.
Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious allergic or anaphylactic reactions occur, Leukine therapy should be immediately discontinued and appropriate therapy initiated.
Liquid solutions containing benzyl alcohol (including liquid Leukine) or lyophilized Leukine reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates.
Leukine should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure, respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction.
Edema, capillary leak syndrome, pleural and/or pericardial effusion, sequestration of granulocytes in the pulmonary circulation, and dyspnea have been reported in patients after Leukine administration. Occasional transient supraventricular arrhythmia has been reported during Leukine administration. Leukine has induced the elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or hepatic dysfunction is recommended at least every other week during Leukine administration.
Adverse events occurring in >10% of patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were: in AML patients – (fever, skin reactions, metabolic disturbances, nausea, vomiting, weight-loss, edema, anorexia); in Autologous BMT patients – (asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder); and in Allogeneic BMT patients – (abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high BUN, and high cholesterol).
If ANC > 20,000 cells/mm3 or if platelet counts > 500,000/mm3, LEUKINE administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
Leukine therapy should be discontinued if disease progression is detected during treatment.

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 详细处方信息以本药内容附件PDF文件（201232720051326.pdf）的“原文Priscribing Information”为准
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