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  药店国别: 香港药房
产地国家: 美国
所属类别: 抗癌药物->化疗药物
处方药:处方药
包装规格: 0.6mL/Vial, 1 vial/Box
计价单位:
  点击放大  
生产厂家英文名:
AMGEN ASIA HOLDING LIMITED/Amgen Inc.
该药品相关信息网址1:
https://reference.medscape.com/drug/neulasta-fulphila-pegfilgrastim-342167
该药品相关信息网址2:
https://www.drugs.com/international/neulastim.html
该药品相关信息网址3:
https://en.wikipedia.org/wiki/Pegfilgrastim
原产地英文商品名:
Neulastim® 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection
原产地英文药品名:
pegfilgrastim
中文参考商品译名:
Neulastim 0.6毫升(10毫克/毫升)注射用溶液
中文参考药品译名:
培非格司亭
原产地国家批准上市年份:
2002/00/00
英文适应病症1:
It is used to treat neutropenia caused by various causes (such as neutropenia caused by malignant tumor radiotherapy and chemotherapy), promote the recovery of myeloid hematopoietic function after hematopoietic stem cell transplantation, and stem cells be
英文适应病症2:
Its larger dose can also be used for myelodysplastic syndrome (MDS) and aplastic anemia associated with neutropenia, as well as congenital, periodic neutropenia, but long-term efficacy is not sure.
英文适应病症3:
Neutrophil reduction caused by acquired immunodeficiency syndrome (AIDS) itself and its infection or antiretroviral preparation.
英文适应病症4:
Prophylactic use: for patients with high-dose chemotherapy, previous history of severe myelosuppression after chemotherapy, and re-chemotherapy after extensive radiation therapy.
英文适应病症5:
For bone marrow transplantation: mainly used for mobilization of hematopoietic stem cells and reconstruction of bone marrow hematopoietic function after transplantation.
临床试验期:
完成
中文适应病症参考翻译1:
用于治疗各种原因引起的中性粒细胞减少症(如恶性肿瘤放疗与化疗引起的粒细胞减少),造血干细胞移植后促进髓系造血功能的恢复,周围血造血干细胞移植前的干细胞动员等。
中文适应病症参考翻译2:
其较大剂量亦可用于骨髓增生异常综合征(MDS)与再生障碍性贫血伴发的中性粒细胞减少症,以及先天性、周期性中性粒细胞减少症,但远期疗效不肯定。
中文适应病症参考翻译3:
用于获得性免疫缺陷综合征(艾滋病)本身及其感染或抗逆转录病毒制剂所引起的中性粒细胞减少。
中文适应病症参考翻译4:
预防用药:用于大剂量化疗后、既往有化疗后严重骨髓抑制史以及大范围放射治疗后再化疗的患者。
中文适应病症参考翻译5:
用于骨髓移植:主要用于造血干细胞的动员及移植后骨髓造血功能的重建。
药品信息:

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 详细处方信息以本药内容附件PDF文件(20189219194523.pdf)的“原文Priscribing Information”为准
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部分Neupogen处方资料(仅供参考)

Neupogen是一种蛋白质,它通过与造血细胞表面的受体结合,刺激造血细胞增生分化为中性粒细胞,并使细胞功能活化。

Neulasta是免疫刺激Neupogen(filgrastim,非格司亭)的长效制剂。 Neulasta是非格司亭的第二代聚乙二醇化制剂,在每个化疗同期以固定剂量用药一次(6mg),以降低用骨髓抑制性抗癌药治疗的非髓性恶性肿瘤患者感染的出现,感染是发热中性白细胞减少的症状。

Amgen新制剂的出现使从对中性白细胞减少症的治疗转为对其预防性治疗。目前,不到10%的化疗病人接受Neupogen来预防中性粒细胞减少症的发生,中性粒细胞数严重降低是癌症治疗的常见并发征。使用Neupogen主要的不便之处是必须每天注射,连续2周(或到白细胞计数恢复到正常水平)。Neulasta每一疗程注射一次,使用方便。公司认为其方便的用药方法更适宜于老年患者和免疫妥协患者。

药品名称 非格司亭

英文药名 Filgrastim

药品别名

优保津、非格司亭、重组人体白细胞生成素、非雷司替、惠尔血、特尔津、瑞白、格拉诺赛特、吉粒芬、吉赛欣、津恤力、粒细胞集落刺激因子、rhG-CSF Neupogen

药理作用

本药是由175个氨基酸组成的蛋白质通过重组DNA技术制成,与天然G-CSF的氨基酸序列和糖链完全相同,不同的是rhG-CSF链的N端含有蛋氨酸。分子量为1.8×104~2.4×104,编码基因位于17号染色体长臂的q21~q22之间。本药通过与粒系祖细胞及成熟中性粒细胞表面的特异性受体结合,促进前者的增殖分化并增强后者的功能(包括趋化性、吞噬和杀伤功能等)。本药还可促进髓系造血祖细胞的增殖、分化和成熟,调节中性粒细胞系的增殖与分化成熟;也可驱使中性粒细胞释放至血流,使外周中性粒细胞数量增多。

药动学

药代动力学研究发现,非格司亭的半衰期(t1/2)与用药剂量有关。对健康男子进行的静脉点滴和皮下注射给药的研究表明,用量为1μg/kg时,t1/2为1.4h;用量小于1.5μg/kg时,t1/2为1.4±0.3h,并有随剂量的增加而延长的现象,AUC为每小时21.6ng/ml;皮下注射,血药峰浓度(Cmax)出现在给药后3.5~4.5h,t1/2为2.15h,AUC为每小时21.6ng/ml,生物利用率为0.54。

用量在5μg/kg或以上时,机体清除力达到饱和,t1/2稳定在3.7±0.3h。相同剂量皮下注射给药4h后血药浓度比静脉点滴同一时间的为高。连续给药6天以上血药浓度与单次给药时无明显差异。本药皮下注射吸收良好,在血清中5min内即可测得。达峰时间为2~8h;静脉滴注后30min达血药峰浓度。半衰期约1~5h,静脉与皮下注射的消除半衰期相似,均约3~5h。本药起效迅速,静脉注射后5min先出现周围血中性粒细胞减少,4h后开始上升并逐渐超过原有水平,24h内达高峰。

连续静脉或皮下给药其血药浓度变化与单次给药相似,表明本药无蓄积作用。

适应证

1.用于治疗各种原因引起的中性粒细胞减少症(如恶性肿瘤放疗与化疗引起的粒细胞减少),造血干细胞移植后促进髓系造血功能的恢复,周围血造血干细胞移植前的干细胞动员等。

2.其较大剂量亦可用于骨髓增生异常综合征(MDS)与再生障碍性贫血伴发的中性粒细胞减少症,以及先天性、周期性中性粒细胞减少症,但远期疗效不肯定。

3.用于获得性免疫缺陷综合征(艾滋病)本身及其感染或抗逆转录病毒制剂所引起的中性粒细胞减少。

4.预防用药:用于大剂量化疗后、既往有化疗后严重骨髓抑制史以及大范围放射治疗后再化疗的患者。

5.用于骨髓移植:主要用于造血干细胞的动员及移植后骨髓造血功能的重建。

禁忌证

对本品或其他粒细胞刺激因子制剂过敏者禁用。自身免疫性血小板紫癜者禁用。在化疗前或癌症化疗同时禁用本品。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症者禁用。

注意事项

1.慎用:

(1)有药物过敏史者

(2)过敏体质者。

(3)肝、肾、心、肺功能重度障碍者。

(4)急、慢性髓性白血病化疗后的患者(本药对髓性白血病细胞有刺激增殖作用)。

(5)MDS难治性贫血伴原始细胞增多型患者(本药对某些肿瘤细胞有刺激增殖作用)。

2.交叉过敏:对大肠杆菌蛋白过敏者,使用大肠杆菌重组的rhG-CSF后可能出现交叉过敏反应。

3.药物对儿童的影响:本药对早产儿、婴儿的安全性尚未确认。

4.药物对妊娠的影响:本药在人类孕期的安全性尚不清楚,故孕妇不宜使用。

5.药物对哺乳的影响:本药是否由乳汁分泌尚不清楚,故哺乳期妇女不宜使用。

6.用药中应定期监测血象,以避免造成中性粒细胞过多。

7.本药的使用对象仅限于中性粒细胞减少的患者。

8.用药过程中若出现过敏反应,应立即停药并给予适当处理。

9.由于迅速增殖分化的造血祖细胞对放(化)疗敏感,本药不应和放(化)疗同时使用。

10.周围血白细胞升至(2~5)×109/L时可停药;若其大于10×109/L或周围血液出现幼稚细胞时,应立即停药。

11.本药使用前应避免振荡,因振荡后起泡可减少实际吸入注射器的剂量。若发现溶液已起泡,可静置数min后再抽取。本药供静脉注射须用5%葡萄糖注射剂稀释,浓度不低于15μg/ml,若rhG-CSF的终浓度在2~15μg/ml之间,须在加本药之前于5%葡萄糖注射剂中先加入终浓度为0.2%的人血白蛋白,以避免输液系统对本药的吸附。 本药滴注速度不宜过快(快速静脉用药可使其作用减低),每次至少持续1h以上,其稀释后应在6h内输完。

12.本药不能与其他注射剂混合使用。

13.皮下注射的血药浓度维持时间较长且用药更方便。

14.用药时间太短基本无效。非格司亭至少用5~7天,才能发挥刺激骨髓造血的作用,太短仅能刺激骨髓中的成熟粒细胞的释放,停药后则又降至低点。这种用法貌似经济,实则为浪费。

15.一般情况下化疗前或化疗中不要使用。因为此时应用非格司亭,促进骨髓中的造血细胞加速增殖,这些细胞对细胞毒化疗药物更为敏感。虽外周血白细胞数可达化疗所需指标,但是一旦很快给予化疗则发生严重骨髓抑制且不易恢复。

16.预防用药首次应在末次化疗给药后24~72h。根据所用化疗药物的代谢

情况而定,尽量减少细胞毒化疗药物对骨髓造血细胞的毒害。

17.化疗引起的骨髓抑制有时单用集落刺激因子效果不显,往往见于化疗反应重,致患者营养状况差。此时不要过于依赖集落刺激因子,如同时加强营养支持治疗可能更为有效。

18.有研究表明,相同剂量分一天两次用药比一次给药效果好。

19.尽可能不静脉用药。原因之一是集落刺激因子的作用与血中峰浓度无关,而与达到有效血浓度的持续时间有关。皮下注射或肌内注射药物代谢缓慢,有利于其发挥作用。另外,集落刺激因子静脉用药可能引起严重的变态反应。

20.在保证有效的前提下尽量用小剂量。因为用量加大不良反应的概率及程度也会加大。

21.考虑集落刺激因子在临床有滥用的情况,预防用药的指征应严格掌握。

22.如果除提高粒细胞外同时又需提高免疫功能,则选择GM-CSF为好。23.长期应用集落刺激因子可导致骨髓增生不良和肝肾功能受损。

24.对预防性用药,用药早疗效好。有研究比较化疗后不同时间开始预防性用药的效果,发现化疗结束后24~48h用药者,中性粒细胞减少的天数最短。化疗后72h之内用药者,中性粒细胞减少的天数最少。

25.放化疗同步应用时使用非格司亭或GM-CSF可导致严重的血小板减少,应予注意。

不良反应

1.较常见的不良反应为骨痛及关节肌肉酸痛,多出现于大剂量静脉用药或用药后白细胞升至接近正常水平的患者,其程度为轻至中度,无需临床处理。

2.有时会有消化道反应(食欲缺乏、恶心、呕吐等)、肝功能损害(轻度可逆性ALT、AST、碱性磷酸酶升高)、一过性低血压及室上性心动过速等,还可引起发热、头痛、倦怠、心悸、尿酸和肌酐升高等。

3.偶有皮肤发红、皮疹、急性发热白细胞增多性皮肤病(表现为发热伴皮损与疼痛)。

4.长期用药者有时可见脾大,但多为亚临床型。

5.较严重的不良反应如水钠潴留、血栓形成、低血压或过敏性休克等罕见。

用法用量

1.成人:

(1)静脉注射:

①造血干细胞移植:在移植后的次日或第5天起,每天1次,给药5μg/kg。

②肿瘤化疗引起的中性粒细胞减少症(白细胞数减至2.0×109/L以下时):每天5μg/kg。 (2)皮下注射:

①白血病及造血干细胞移植:每天2.5~5μg/kg,待白细胞升至大于2×109/L即停药。

②实体瘤日剂量可适当减少,一般为2~3μg/kg,每天1次。

③再生障碍性贫血、MDS或其他骨髓衰竭性疾病:每天剂量一般应超过肿瘤性疾病,且疗程宜长。

④用于外周血造血干细胞移植前的干细胞动员:于化疗后白细胞降至最低点(一般为停化疗后约2周)时开始用药,剂量为每天5~10μg/kg,至白细胞升至大于等于5.0×109/L时开始采集周围血干细胞,采集期间继续用药。

⑤肿瘤化疗引起的中性粒细胞减少症:每次2μg/kg,每天1次。

2.儿童:

(1)静脉注射:

①造血干细胞移植:用法用量同成人。

②肿瘤化疗引起的中性粒细胞减少症(白细胞数减至1.0×109/L以下时):每天2μg/kg。

(2)皮下注射:用法用量同成人。

3.非格司亭的治疗用药:在发生粒细胞减少症时非格司亭的最小有效剂量尚未准确地确定。对化疗所致的粒细胞减少症,临床通常的用法是根据粒细胞减少的程度给予相适应的剂量。

(1)白细胞总数在2.0×109/L以下或中性粒细胞在1.0×109/L以下时,非格司亭的用量为每天2.0~5.0μg/kg,皮下注射,持续10~14天。用药过程中需监测外周血白细胞的变化,如连测两天白细胞总数≥10×109/L或中性粒细胞≥6.0×109/L时停用。如果已连续使用14天无明显效果,再用也无益。

(2)白细胞总数在2.0×109~3.0×109/L时,非格司亭的用量为每天1.0~2.0μg/kg,皮下注射,持续7~10天。用药过程中需监测外周血白细胞的变化,白细胞总数≥8.0×109/L减至同一用量隔日1次。如连测两天白细胞总数≥5.0×10^9/L时停用。如果已连续使用14天无明显效果,再用也无益。4.非格司亭的预防用药:用药的剂量根据化疗所致的骨髓抑制的程度确定。用药一般采用低剂量即可,非格司亭的用量为每天1.0~2.0μg/kg,皮下注射,持续5~7天。白细胞总数≥10×109/L时停药。如果白细胞总数未达此指标,则可用7~10天或再用数日,达到上述指标再停药。

5.骨髓或外周血干细胞移植时造血干细胞的动员:单用时每天5~16μg/kg,皮下注射,每天分2次用,持续5~6天;与化疗联合动员时每天5~10μg/kg。常用量每天300μg。与GM-CSF联合应用于造血干细胞动员,可使CD+34细胞及原始的CD+34细胞增多。超过每天16μg/kg不良反应增加。 药物相应作用 本药与化疗药同时应用,会因迅速分化的定向造血干细胞对化疗药敏感而影响非格司亭的效果。对乙酰氨基酚或非甾体抗炎药治疗本品所致的胃痛是有效的,用解热镇痛的药治疗引起的发热、头痛

专家点评

本品是应用基因重组工程技术制成的一种蛋白质。作用机制为粒系祖细胞及成熟中性粒细胞表面的特异性受体结合,促进前者的增殖分化并增强后者的功能。本品为Ⅱ类造血刺激因子,有细胞系特异性,仅作用于中性粒细胞及其祖细胞。适用于治疗各种原因引起的中性粒细胞减少症,较大剂量也可用于骨髓增生异常综合征,与再生障碍性贫血伴发的中性粒细胞减少症。骨髓抑制是大多数化疗药物的剂量限制毒性。对治疗策略中需要化疗的大多数恶性肿瘤来说,用足剂量以及按化疗周期安排按时开始下一周期化疗对保证应有的疗效都至关重要。另有一些恶性肿瘤的化疗疗效更与化疗药物的剂量强度(DoseIntensity,DI)有关,如恶性淋巴瘤、小细胞肺癌、生殖细胞肿瘤等对化疗敏感并可获根治的恶性肿瘤。集落刺激因子的临床应用,使得上述要求变得可能。非格司亭预防用药可加大主要为骨髓限制毒性的化疗药物类的用量,提高化疗疗效。另外,非格司亭的预防用药可促进化疗后骨髓造血功能的恢复,缩短中性粒细胞在正常值以下持续的时间,使化疗可按计划进行。 目前由于考虑价效比,主要用于化疗敏感且可获根治的恶性肿瘤。在下述情况下预防性作用:

1.第一周期化疗,常规不需要,仅在发生发热性中性粒细胞减少症的可能性大时(大于40%)使用。如果患者有发生化疗导致的感染性并发症的危险因素,如已存在中性粒细胞减少症或合并感染,或已接受盆腔野或包含大量骨髓组织的放射治疗,可考虑使用。

2.第一周期之后的化疗:如果所用化疗在前一周期化疗后发生发热性中性粒细胞减少症(如果前一周期的中性粒细胞减少症时间很短且无发热则不必使用);但在下述情况下发生感染相关并发症的可能性加大,应预防用药:粒细胞减少症(中性粒细胞<0.5×109/L)、原发疾病未控制、合并肺炎、高血压、败血症、深部真菌感染以及老年患者。

3.如果中性粒细胞减少症持续时间长延误化疗,且所治疗的恶性肿瘤为化疗敏感且可获根治的恶性肿瘤则予以使用。

4.同步放化疗或放射治疗引起的粒细胞减少,尤其在放射野包括纵隔时。

5.在化疗间歇期如果放疗包括大的射野,中性粒细胞减少可能会导致治疗耽搁,即考虑使用。对于化疗引起的严重的中性粒细胞减少,常可发生感染、发热。 大量临床研究表明,应用非格司亭或GM-CSF可缩短中性粒细胞恢复期,使发热的危险性减少约34%。

Neupogen is a protein that stimulates the differentiation of hematopoietic cells into neutrophils and activates cellular functions by binding to receptors on the surface of hematopoietic cells.

Neulasta is a long-acting preparation for immunostimulating Neupogen (filgrastim, filgrastim). Neulasta is a second-generation PEGylated formulation of filgrastim, which is administered once daily (6 mg) at the same time for each chemotherapy to reduce the incidence of infection in patients with non-myeloid malignancies treated with myelosuppressive anticancer drugs. The infection is a symptom of feverish neutropenia.

The emergence of new Amgen formulations has shifted from treatment of neutropenia to prophylactic treatment. Currently, less than 10% of chemotherapy patients receive Neupogen to prevent neutropenia, and a severe reduction in neutrophil count is a common sign of cancer treatment. The main inconvenience of using Neupogen is that it must be injected daily for 2 weeks (or until the white blood cell count returns to normal). Neulasta is given once every course of treatment and is easy to use. The company believes that its convenient method of administration is more suitable for elderly patients and immunocompromised patients.

Drug name 格格斯特亭

English drug name Filgrastim

Drug alias

Youbaojin, filgrastim, recombinant human leukocyte-derived hormone, non-Riesti, Whirlpool blood, Terzin, Ruibai, Granosit, Ji gran, Gysaixin, refractory, granulocyte colony Stimulating factor, rhG-CSF Neupogen

Pharmacological action

This drug is made up of 175 amino acids by recombinant DNA technology, which is identical to the amino acid sequence and sugar chain of native G-CSF, except that the N-terminus of the rhG-CSF chain contains methionine. The molecular weight is 1.8×104 to 2.4×104, and the coding gene is located between q21 and q22 of the long arm of chromosome 17. The drug binds to specific receptors on the surface of granulocyte progenitor cells and mature neutrophils, promotes proliferation and differentiation of the former and enhances the functions of the latter (including chemotaxis, phagocytosis and killing function). The drug can also promote the proliferation, differentiation and maturation of myeloid hematopoietic progenitor cells, regulate the proliferation and differentiation of neutrophil cell lines; it can also drive the release of neutrophils to the bloodstream and increase the number of peripheral neutrophils.

Pharmacokinetics

Pharmacokinetic studies have found that the half-life (t1/2) of filgrastim is related to the dose. Studies on intravenous and subcutaneous injections of healthy men showed that t1/2 was 1.4h when the dosage was 1μg/kg, and 1.4±0.3h when the dosage was less than 1.5μg/kg. The increase in dose was prolonged, the AUC was 21.6 ng/ml per hour; the subcutaneous injection, peak plasma concentration (Cmax) appeared 3.5 to 4.5 h after administration, t1/2 was 2.15 h, and AUC was 21.6 ng per hour. /ml, bioavailability is 0.54.

When the dosage is 5μg/kg or more, the body's scavenging power is saturated, and t1/2 is stable at 3.7±0.3h. After 4 hours of subcutaneous injection of the same dose, the plasma concentration was higher than that of the intravenous drip. There was no significant difference in blood concentration between continuous administration for more than 6 days and single administration. The drug is well absorbed by subcutaneous injection and can be measured within 5 minutes in serum. The peak time was 2-8 hours; the peak concentration of blood was reached 30 minutes after intravenous drip. The half-life is about 1 to 5 hours, and the elimination half-life of intravenous and subcutaneous injection is similar, both about 3 to 5 hours. The drug was effective, and the peripheral blood neutrophils decreased at 5 minutes after intravenous injection. After 4 hours, it began to rise and gradually exceeded the original level, reaching a peak within 24 hours.

The change in blood concentration of continuous intravenous or subcutaneous administration is similar to that of single administration, indicating that the drug has no accumulation effect.

Indications

1. Used to treat neutropenia caused by various causes (such as neutropenia caused by malignant tumor radiotherapy and chemotherapy), promote the recovery of myeloid hematopoietic function after hematopoietic stem cell transplantation, peripheral blood stem cell transplantation The former stem cell mobilization and so on.

2. Its larger dose can also be used for myelodysplastic syndrome (MDS) and aplastic anemia associated with neutropenia, as well as congenital, periodic neutropenia, but far The efficacy is not certain.

3. Neutrophil reduction caused by acquired immunodeficiency syndrome (AIDS) itself and its infection or antiretroviral preparation.

4. Prophylactic use: for patients with high-dose chemotherapy, previous history of severe myelosuppression after chemotherapy, and re-chemotherapy after extensive radiation therapy.

5. For bone marrow transplantation: mainly used for mobilization of hematopoietic stem cells and reconstruction of bone marrow hematopoietic function after transplantation.

Contraindications

It is forbidden to be allergic to this product or other granulocyte stimulating factor preparations. Autoimmune platelet purpura is contraindicated. This product is banned before chemotherapy or at the same time as cancer chemotherapy. Myeloid leukemia in which bone marrow immature cells are not sufficiently reduced or in the presence of immature cells in peripheral blood is contraindicated.

Notes

1. Use with caution:

(1) Those with a history of drug allergy

(2) Those who are allergic.

(3) People with severe liver, kidney, heart and lung function.

(4) Patients with acute and chronic myeloid leukemia after chemotherapy (the drug has a proliferative effect on myeloid leukemia cells).

(5) MDS refractory anemia with blast-producing patients (this drug has a proliferative effect on certain tumor cells).

2. Cross-allergy: For those who are allergic to E. coli protein, cross-allergic reactions may occur after using recombinant rhG-CSF from E. coli.

3. Effects of drugs on children: The safety of this drug for premature infants and infants has not been confirmed.

4. The effect of drugs on pregnancy: The safety of this drug in human pregnancy is still unclear, so pregnant women should not use it.

5. The effect of drugs on breastfeeding: Whether the drug is secreted by milk is not clear, so lactating women should not use it.

6. Blood should be monitored regularly to avoid causing excessive neutrophils.

7. The drug is intended for use in patients with neutropenia.

8. If an allergic reaction occurs during the course of medication, the drug should be discontinued immediately and given appropriate treatment.

9. Because the rapidly proliferating and differentiated hematopoietic progenitor cells are sensitive to radiotherapy, this drug should not be used concurrently with the drug.

10. The peripheral white blood cells can be stopped when they rise to (2~5)×109/L; if they are larger than 10×109/L or the surrounding blood appears naive cells, they should be stopped immediately.

11. Avoid oscillating before using this medicine. Foaming after shaking can reduce the dose of the actual inhaled syringe. If the solution is found to be foaming, it can be allowed to stand for a few minutes before extraction. The drug should be diluted with 5% glucose injection for intravenous injection, the concentration is not less than 15μg/ml. If the final concentration of rhG-CSF is between 2 and 15μg/ml, it must be first in 5% glucose injection before adding this drug. Human albumin at a final concentration of 0.2% was added to avoid adsorption of the drug by the infusion system. The infusion rate of this drug should not be too fast (rapid intravenous drug can reduce its effect), at least for more than 1h each time, and it should be finished within 6h after dilution.

12. This medicine cannot be mixed with other injections.

13. The blood concentration of the subcutaneous injection is maintained for a long time and the administration is more convenient.

14. The medication time is too short and basically invalid. It takes at least 5-7 days for filgrastim to exert the effect of stimulating bone marrow hematopoiesis. Too short can only stimulate the release of mature granulocytes in the bone marrow, and then drop to a low point after stopping the drug. This usage seems to be economical, but it is waste.

15. Under normal circumstances, do not use before chemotherapy or chemotherapy. Because the use of filgrastim at this time promotes the accelerated proliferation of hematopoietic cells in the bone marrow, these cells are more sensitive to cytotoxic chemotherapy drugs. Although the number of peripheral white blood cells can reach the required index of chemotherapy, once the chemotherapy is given quickly, severe bone marrow suppression occurs and it is difficult to recover.

16. The first time the preventive drug should be administered 24 to 72 hours after the last chemotherapy. Depending on the metabolic

of the chemotherapeutic agent used, the toxicity of cytotoxic chemotherapy drugs to bone marrow hematopoietic cells should be minimized.

17. Myelosuppression caused by chemotherapy sometimes has no effect on colony-stimulating factor alone, and is often seen in heavy chemotherapy response, resulting in poor nutritional status of patients. Do not rely too much on colony stimuli at this time, such as strengthening nutritional support treatment at the same time may be more effective.

18. Studies have shown that the same dose is administered twice a day than once.

19. Try not to take intravenous medicine as much as possible. One of the reasons is that the effect of the colony stimulating factor is independent of the peak concentration in the blood and is related to the duration of reaching the effective blood concentration. Subcutaneous injection or intramuscular injection of drugs is slow to metabolize, which is beneficial to its function. In addition, intravenous administration of colony stimulating factors may cause severe allergic reactions.

20. Use small doses as much as possible while ensuring effectiveness. Because the dose increases the probability and extent of adverse reactions will also increase.

21. Consider the fact that colony stimulating factors are abused in the clinic, and the indications for preventive medication should be strictly controlled.

22. If it is necessary to improve immune function in addition to increasing granulocytes, then GM-CSF is preferred. 23. Long-term application of colony stimulating factors can lead to poor myeloproliferative and impaired liver and kidney function.

24. For preventive medication, early treatment with good effect. Some studies have compared the effects of prophylactic use at different times after chemotherapy. It was found that the number of days of neutropenia was the shortest when the drug was administered 24 to 48 hours after the end of chemotherapy. Those who took the drug within 72 hours after chemotherapy had the fewest days of neutropenia.

25. The use of filgrastim or GM-CSF in the simultaneous application of chemoradiotherapy can cause severe thrombocytopenia and should be noted.

Adverse reactions

1. The more common adverse reactions are bone pain and joint muscle soreness, which occur in patients with large doses of intravenous medication or leukocytes rising to near normal levels, with a mild to moderate degree and no clinical treatment.

2. Sometimes there are digestive tract reactions (appetite deficiency, nausea, vomiting, etc.), liver damage (light reversible ALT, AST, elevated alkaline phosphatase), transient hypotension and supraventricular Heart tachycardia, etc., can also cause fever, headache, burnout, palpitations, uric acid and elevated creatinine.

3. Occasional skin redness, rash, acute fever, leukocytosis skin disease (expressed as fever with skin lesions and pain).

4. Long-term medications sometimes show splenomegaly, but mostly subclinical.

5. More serious adverse reactions such as water and sodium retention, thrombosis, hypotension or anaphylactic shock are rare.

Usage and Usage

1. Adult:

(1) Intravenous:

1 Hematopoietic stem cell transplantation: 5 μg/kg was administered once a day from the next day or the fifth day after transplantation.

2 Tumor chemotherapy-induced neutropenia (when the number of white blood cells is reduced to 2.0 × 109 / L or less): 5 μg / kg per day. (2) Subcutaneous injection:

1 leukemia and hematopoietic stem cell transplantation: 2.5 to 5 μg/kg per day, and the white blood cells are raised to more than 2×109/L.

2 The daily dose of solid tumor can be appropriately reduced, generally 2 ~ 3μg / kg, once a day.

3 aplastic anemia, MDS or other bone marrow failure diseases: the daily dose should generally exceed the tumor disease, and the course of treatment should be long.

4 for stem cell mobilization before peripheral blood stem cell transplantation: starting from the lowest point of leukopenia after chemotherapy (usually about 2 weeks after stopping chemotherapy), the dose is 5 ~ 10μg / kg per day, until the white blood cells rise to greater than or equal At the time of 5.0×109/L, peripheral blood stem cells were collected, and the drug was continued during the collection.

5 Tumor chemotherapy-induced neutropenia: 2 μg/kg each time, once a day.

2. Children:

(1) Intravenous:

1 Hematopoietic stem cell transplantation: usage and dosage are the same as adults.

2 Neutrophilia caused by tumor chemotherapy (when the number of white blood cells is reduced to 1.0 × 109 / L or less): 2 μg / kg per day.

(2) Subcutaneous injection: the dosage is the same as that of adults.

3. Therapeutic use of filgrastimine: The minimum effective dose of filgrastim in the event of neutropenia has not been accurately determined. For chemotherapy-induced neutropenia, the usual clinical use is to give a compatible dose based on the degree of neutropenia.

(1) When the total number of white blood cells is below 2.0×109/L or the neutrophils are below 1.0×109/L, the amount of filgrastim is 2.0 to 5.0 μg/kg per day, and subcutaneous injection is continued for 10 to 14 days. The changes of peripheral blood leukocytes should be monitored during the course of medication, such as when the total number of white blood cells is ≥10×109/L or neutrophils≥6.0×109/L. If it has been used for 14 days without obvious effect, it is not helpful to use it again.

(2) When the total number of white blood cells is 2.0 × 109 ~ 3.0 × 109 / L, the amount of filgrastim is 1.0 ~ 2.0 μg / kg per day, subcutaneous injection, for 7 to 10 days. During the course of medication, the changes of peripheral blood leukocytes should be monitored. The total number of white blood cells is ≥8.0×109/L and reduced to the same amount once every other day. If the total number of white blood cells is ≥5.0×10^9/L for two days, it is stopped. If it has been used for 14 days without obvious effect, it is not helpful to use it again. 4. Prophylactic use of filgrastimine: The dose of the drug is determined according to the degree of myelosuppression caused by chemotherapy. The drug is generally administered at a low dose, and the amount of filgrastim is 1.0 to 2.0 μg/kg per day, subcutaneously, for 5 to 7 days. The drug was stopped when the total number of white blood cells was ≥10×109/L. If the total number of white blood cells does not reach this target, it can be used for 7 to 10 days or a few more days to achieve the above indicators and then discontinue the drug.

5. Mobilization of hematopoietic stem cells during bone marrow or peripheral blood stem cell transplantation: 5 to 16 μg/kg per day when administered alone, subcutaneous injection, 2 times a day for 5 to 6 days; 5 to 10 μg/kg per day when combined with chemotherapy. The usual amount is 300 μg per day. Combined with GM-CSF for hematopoietic stem cell mobilization, CD+34 cells and original CD+34 cells can be increased. An increase in adverse reactions of more than 16 μg/kg per day. Drug corresponding effect The simultaneous application of this drug and chemotherapeutic drugs may affect the effect of filgrastim on the differentiation of rapidly differentiated hematopoietic stem cells to chemotherapeutic drugs. Acetaminophen or non-steroidal anti-inflammatory drugs are effective in treating stomach pain caused by this product, and fever and headache caused by antipyretic and analgesic drugs.

Expert Review

This product is a protein made by genetic engineering technology. The mechanism of action is the specific receptor binding on the surface of granulocyte progenitor cells and mature neutrophils, promoting the proliferation and differentiation of the former and enhancing the function of the latter. This product is a type II hematopoietic stimulating factor with cell line specificity and only acts on neutrophils and their progenitor cells. It is suitable for the treatment of neutropenia caused by various causes. The larger dose can also be used for myelodysplastic syndrome and neutropenia associated with aplastic anemia. Myelosuppression is the dose limiting toxicity of most chemotherapeutic drugs. For most malignant tumors that require chemotherapy in a treatment strategy, it is important to use a full dose and a schedule of chemotherapy to start the next cycle of chemotherapy on time to ensure proper efficacy. Other chemotherapy effects of malignant tumors are more related to the dose intensity of chemotherapy drugs (Dose Intensity, DI), such as malignant lymphoma, small cell lung cancer, germ cell tumors and other malignant tumors that are sensitive to chemotherapy and can be cured. The clinical application of colony stimulating factors makes the above requirements possible. The use of filgrastimine prophylaxis can increase the amount of chemotherapeutic drugs that are mainly limited by bone marrow toxicity, and improve the efficacy of chemotherapy. In addition, the preventive use of filgrastim can promote the recovery of bone marrow hematopoietic function after chemotherapy, shorten the duration of neutrophils below normal, so that chemotherapy can be carried out as planned. Currently, due to the consideration of cost-effectiveness, it is mainly used for chemotherapy-sensitive and curable malignant tumors. Preventive effects in the following situations:

1. First-cycle chemotherapy, routinely not required, is only used when there is a high likelihood of febrile neutropenia (greater than 40%). If the patient has a risk factor for infectious complications due to chemotherapy, such as neutropenia or co-infection, or radiation therapy that has received pelvic fields or contains large amounts of bone marrow tissue, consider using it.

2. Chemotherapy after the first cycle: if the chemotherapy used in the previous cycle occurs after febrile neutropenia (if the neutropenia in the previous cycle is short and there is no fever, then it is not necessary Use); However, the possibility of infection-related complications increases under the following circumstances: Prophylaxis should be taken: neutropenia (neutrophils <0.5×109/L), uncontrolled primary disease, pneumonia, high Blood pressure, sepsis, deep fungal infections, and elderly patients.

3. If neutropenia lasts for a long time and chemotherapy is delayed, and the malignant tumor to be treated is a chemotherapy-sensitive and curable malignant tumor.

4. Granulocyte reduction caused by concurrent chemoradiotherapy or radiation therapy, especially in the radiation field including the mediastinum.

5. In the intermittent period of chemotherapy, if radiotherapy involves large fields, neutropenia may cause delays in treatment, ie consider use. For severe neutropenia caused by chemotherapy, infection and fever often occur. Numerous clinical studies have shown that the use of filgrastim or GM-CSF can shorten the recovery period of neutrophils and reduce the risk of fever by about 34%.

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更新日期: 2018-08-31
附件:
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20189219194523.pdf    

 
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