英文药名: Neupogen(Filgrastim Injections) 中文药名: 非格司亭注射剂 生产厂家: 美国安进制药 药品说明 通用名称：非格司亭注射液 英文名称：Filgrastim,Nemposen,rhG-CSF,GRAN 成分：非格司亭 药物毒理 本品是由DNA重组技术产生的人粒细胞集落刺激因子(G-CSF)，与天然的G-CSF的氨基酸序列和糖链完全相同，不同的是重组人G-CSF链的N端含有蛋氨酸。本品可与靶细胞膜受体结合而起作用。主要刺激粒细胞系造血，也可使多能造血干细胞进入细胞周期；促进髓系造血祖细胞的增殖、分化和成熟，调节中性粒细胞系细胞的增殖与分化成熟；并驱使中性粒细胞释至血流，使外周中性粒细胞数量增多，并提高其功能，吞噬活性，针对肿瘤细胞的抗体依赖细胞细胞毒(ADCC)活性等。 适应症 本品对慢性粒细胞缺乏症病人如骨髓异常增生综合征、周期性中性粒细胞缺乏症和再生障碍性贫血等疗效非常明显。因化疗致白细胞数减少者，用本品可提升白细胞数。 用法用量 1.在骨髓移植时促进中性粒细胞数的增加。通常，在骨髓移植后的次日或第五日起，以5μg/kg(或300μg/m2)的剂量每日1次静脉点滴。 2.对肿瘤化疗引起的中性粒细胞减少症。通常，对因抗癌化疗引起的中性粒细胞减至1×109/L(白细胞数2×109/L)以下的成人患者或0.5×109/L(白细胞数 1×109/L)的儿童患者，在使用化疗药物后，皮下注射本品2μg/kg(或50μg/m2)，每日1次。如皮下注射有困难，可改为静滴，成人5μg/kg(或100μg/m2)，儿童2μg/kg(或100μg/m2)。 不良反应 偶有皮肤发红、皮疹，有时会有食欲不振、恶心、呕吐等消化道反应及肝功能损害；还可引起骨痛、腰痛、胸痛等； 还可能引起ALP，LDH升高及发热、头痛、倦怠、心悸、尿酸和肌酐升高等。 禁忌 1．对本品或其它G-CSF制剂过敏者。 2．骨髓幼稚细胞未充分降低或外周血存在未成熟细胞的骨髓性白血病患者 注意事项 1.本品的使用对象仅限于中性粒细胞减少的患者。使用本品期间，要定期检查血象，当中性粒细胞增至必要值以上时，需减少剂量或停止用药。 2.应用时应注意过敏反应发生。 3.由于本品有刺激粒细胞增生的作用，对急性髓细胞白血病未缓解病人以及骨髓增生异常综合征伴原始细胞增多的患者，本品有无促进白血病进展作用，应用后利弊如何，尚无确定答案。暂应慎用，但也不排除在中性粒细胞严重缺乏而又面临感染时短期应急之用。 4.本品装于单点易折安瓿中，使用前先用酒精擦拭开口处，再行折开。 5.静滴使用时，应于5%葡萄糖注射液或生理盐水混合使用。 贮藏 应贮存于2～8℃，不可冷冻，忌摇动。 完整说明书附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97cc73cc-b5b7-458a-a933-77b00523e193 包装规格[注：以下药品目录是美国上市包装，不同规格和不同价格，采购者以咨询为准] NEUPOGEN 300MCG/0.5ML SYR 1/EA  FILGRASTIM  "AMGEN USA, INC."  55513-0924-91 NEUPOGEN 300MCG/0.5ML SYR 10/PAC FILGRASTIM  "AMGEN USA, INC."  55513-0924-10 NEUPOGEN 300MCG/ML 1ML SDV 10/PAC FILGRASTIM  "AMGEN USA, INC."  55513-0530-10 NEUPOGEN 480MCG/0.8ML SYR 1/EA  FILGRASTIM  "AMGEN USA, INC."  55513-0209-91 NEUPOGEN 480MCG/0.8ML SYR 10/PAC  FILGRASTIM  "AMGEN USA, INC."  55513-0209-10 NEUPOGEN 480MCG/1.6ML SDV 10/PAC  FILGRASTIM  "AMGEN USA, INC."  55513-0546-10 NEUPOGEN PFS 300MCG 0.5ML 10  FILGRASTIM  AMGEN USA INC  55513-0924-10             NEUPOGEN PFS 480MCG 0.8ML 10  FILGRASTIM  AMGEN USA INC  55513-0209-10             NEUPOGEN SDV 300MCG/ML 1ML 10  FILGRASTIM  AMGEN USA INC  55513-0530-10             NEUPOGEN SDV 480MCG 1.6ML 10  FILGRASTIM  AMGEN USA INC  55513-0546-10             NEUPOGEN PFS 300MCG 0.5ML 1  FILGRASTIM  AMGEN USA INC  55513-0924-91             NEUPOGEN PFS 480MCG 0.8ML 1  FILGRASTIM  AMGEN USA INC  55513-0209-91 ----------------------------------------------- Facts About Neupogen® When a person has received a very high dose of radiation, destruction of the bone marrow, potentially resulting in uncontrolled bleeding and infection, is a major concern. To help the recovery of the bone marrow, growth factors that stimulate the blood cells to multiply can be used. Filgrastim (trade name Neupogen®), is a drug that was approved for use by the FDA in 1991 for cancer patients with bone marrow damage due to chemotherapy or radiotherapy. Treated patients have had fewer infections, less need for intravenous antibiotics, and shortened hospital stays than those who did not receive the drug. Neupogen may also be useful for patients who have bone marrow damage from accidental exposures to high doses of radiation and it is expected to provide similar benefits. What Neupogen Is Filgrastim (trade name Neupogen®) is a human granulocyte colony stimulating factor (G-CSF) produced by recombinant DNA technology. It is a specific type of cytokine that stimulates the growth of white blood cells. What Cytokines Are Cytokines are hormone-like proteins that act as communicators between cells. They can relay messages between cells, telling them to grow, stop growing, move to a trouble spot, or otherwise change the cell's function. Neupogen® is a specific type of cytokine that stimulates the growth of white blood cells. Use of Neupogen® to Treat Persons Accidentally Exposed to High Doses of Radiation Just like a cancer patient who has received chemotherapy or radiation therapy, a person who has received a high dose of radiation may experience bone marrow destruction, possibly resulting in uncontrolled bleeding and infection. Since Neupogen® has been used successfully for cancer patients to stimulate the growth of the white blood cells, making them less vulnerable to infections, it is expected to help patients who have bone marrow damage from very high doses of radiation in much the same way. How Neupogen® Works Patients who receive very high doses of radiation often are left with very few white blood cells. The patients' own bone marrow will eventually create new blood cells, but this is a slow process. And until the white blood cell counts rise sufficiently, the patients are at a high risk of death from infection. Neupogen® can speed up the process of white blood cell creation, reducing the time that the patient is vulnerable to infection. Who Can Take Neupogen People may be prescribed Neupogen® following chemotherapy or radiation therapy to assist in their recovery. Also, people may be prescribed Neupogen® following a high dose of radiation from a radiation emergency. Neupogen® is safe for most adults, but should not be taken by people who have known hypersensitivity to E. coli-derived proteins, filgrastim, or any component of filgrastim. Children and pregnant women should take Neupogen® with caution. It is not known if Neupogen® is excreted in human milk, so breastfeeding women should take Neupogen with caution as well. Side Effects of Neupogen® The possible side effects of Neupogen® include fever, diarrhea, skin rash and weakness. The most common side effect is mild to moderate bone pain. How Neupogen® Is Given Neupogen® is given by injection under the skin or through intravenous infusion. What the Treatment Plan Is The treatment plan is to give 5 micrograms per kilogram of patient weight (mcg/kg) of G-CSF filgrastim (Neupogen®) daily for up to 2 weeks, either by injection or intravenous infusion