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。

包装规格：
·250mcg/ml  5 (支)Vials SDV  (注射干粉)
·500mcg/ml  5 Vials (支) (注射液)

Leukine®(sargramostim)

Indication:
Leukine is indicated for use following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death.

For additional indications please see full prescribing information.

Leukine is a recombinant human granulocyte macrophage colony stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system. GM-CSF is a hematopoietic growth factor which stimulates proliferation and differentiation of hematopoietic progenitor cells. Leukine is a glycoprotein of 127 amino acids characterized by three primary molecular species having molecular masses of 19,500, 16,800 and 15,500 daltons. The amino acid sequence of LEUKINE differs from the natural human GM-CSF by a substitution of leucine at position 23, and the carbohydrate moiety may be different from the native protein. Sargramostim has been selected as the proper name for yeast derived rhu GM-CSF.

WARNINGS:
Pediatric Use Benzyl alcohol is a constituent of liquid Leukine and Bacteriostatic Water for Injection diluent. Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants. Fluid Retention Edema, capillary leak syndrome, pleural and/or pericardial effusion have been reported in patients after Leukine administration. Sequestration of granulocytes in the pulmonary circulation has been documented following Leukine infusion and dyspnea has been reported occasionally in patients treated with Leukine. Occasional transient supraventricular arrhythmia has been reported in uncontrolled studies during Leukine administration, particularly in patients with a previous history of cardiac arrhythmia. In some patients with preexisting renal or hepatic dysfunction enrolled in uncontrolled clinical trials, administration of Leukine has induced elevation of serum creatinine or bilirubin and hepatic enzymes.

Important Safety Considerations:
Leukine is contraindicated in patients with excessive leukemic 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 or anaphylactic reactions occur, Leukine therapy should immediately be discontinued and appropriate therapy initiated.

Liquid solutions containing benzyl alcohol (including liquid LEUKINE) or lyophilized LEUKINE reconstituted with Bacteriostatic Water for Injection, USA (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 CHF; respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction.

Edema, capillary leak syndrome, pleural and or/pericardial effusion, supraventricular tachycardia, sequestration of granulocytes in the pulmonary circulation and dyspnea have been reported in patients after 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.

Nearly all patients reported leukopenia, thrombocytopenia, and anemia. Adverse events occurring in >10% of AML patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were: fever, skin reactions, metabolic disturbances, nausea, vomiting, weight-loss, edema, and anorexia.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.