部份中文培非司亭重组处方资料（仅供参考）
商标名：G-Lasta Subcutaneous Injection
英文名：Pegfilgrastim
中文名：培非司亭重组预充注射器
生产商：协和麒麟制药
药品简介
2022年8月1日,协和麒麟株式宣布,G-Lasta Subcutaneous Injection 3.6mg(pegfilgrastim（遗传重组）)被日本厚生劳动省批准，用于减少化疗患者的发热性中性粒细胞减少症的发生率。
Pegfilgrastim是一种人造蛋白质，刺激称为中性粒细胞的白细胞在身体里生长。白血细胞帮助人体抵抗感染的危害。用于治疗白细胞减少及某些接受癌症化疗引起的白血球缺乏。也用在除了骨髓癌的其他癌症。
ジーラスタ皮下注3.6mg
药物分类名称
连续G-CSF准备
批准日期：2014年11月
欧文商標名
G-LASTA Subcutaneous Injection
一般的名称
ペグフィルグラスチム（遺伝子組換え）
（Pegfilgrastim（Genetical Recombination））
分子量
約40,000
本質
甲氧基聚乙二醇（分子量：约20000）1分子是与Filgrastim（基因重组）的Met1的氨基结合的修饰蛋白质。
使用注意事项
尽量不要在使用前从枕形包装中取出注射器。外箱开封后应遮光保存。
注射器前端部的薄膜·芯片盖脱落或注射器破损等异常时，请勿使用。
批准条件
制定医药品风险管理计划并妥善实施。
〈同种外周血干细胞移植造血干细胞在外周血中的动员〉
由于国内临床试验中的被给药例极其有限，因此在制造销售后，在收集到一定数量的与被给药例有关的数据之前，通过以全部例为对象实施使用成绩调查，在掌握本剂被给药者的背景信息的同时，早期收集与本剂的安全性及有效性相关的数据应采取适当使用本品所需的措施。
药效药理
作用机制
据推测，本制剂与骨髓中嗜中性粒细胞前体中存在的颗粒球集落形成刺激因子受体结合，促使嗜中性粒细胞前体细胞向嗜中性粒细胞分化，增加外周血中嗜中性粒细胞数。
药理作用
嗜中性粒细胞前体的促分化作用
在in vitro菌落形成试验中，通过在本制剂存在下培养人源CD34阳性细胞和小鼠源骨髓细胞，促进了嗜中性粒细胞前体细胞的分化。
对中性粒细胞减少的作用
通过向通过投用环磷酰胺诱导外周血嗜中性粒细胞减少的小鼠投用本制剂，抑制了嗜中性粒细胞减少。
适应症
○癌症化疗抑制发热性嗜中性粒细胞减少症的发病
○同种外周血干细胞移植造血干细胞在外周血中的动员
用法与用量
〈通过癌症化疗抑制发热性嗜中性粒细胞减少症的发病〉
成人在癌症化疗剂给药结束后的第二天以后，作为培非司亭（基因重组），每1个化疗周期皮下给药3.6mg。
〈同种外周血干细胞移植造血干细胞在外周血中的动员〉
成人皮下给药7.2mg作为白蛋白（基因重组）。
包装
皮下注射3.6mg：1个注射器
制造供应商
协和发酵麒麟有限公司
Kyowa Hakko Kirin Co.Ltd。
注：以上中文资料不够完整，使用者以原处方资料为准。
完整资料附件：
https://www.info.pmda.go.jp/go/pack/3399410G1020_1_10/ 
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G-LASTA Subcutaneous Injection 3.6mg（Pegfilgrastim[Genetical recombination]）
Brand name :G-LASTA Subcutaneous Injection 3.6mg
　Active ingredient:Pegfilgrastim(Genetical recombination)
　Dosage form:
injection
　Print on wrapping:
Effects of this medicine
This medicine increases leukocytes (neutrophils) which play an important role for protection against infection.
It is usually used to treat leukopenia (neutropenia) attributed to anticancer agents.
Before using this medicine, be sure to tell your doctor and pharmacist
If you have previously experienced any allergic reactions(itch, rash, etc.)to any medicines.
If you have previously experienced rash or itch after administrating any other medicines which increases leukocytes (neutrophils).
If you have myeloid leukemia(including myelodysplastic syndrome)with insufficient decrease of leukemic cells in the bone marrow or presence of leukemic cells in the blood.
If you have been administered an anticancer agent within 24 hours.
If you are pregnant or breastfeeding.
If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
Your dosing schedule prescribed by your doctor is ((to be written by a healthcare professional))
In general, this medicine is administered subcutaneously once per chemotherapy course, on or after the next day of treatment completion with anticancer agent.
Duration of administration will be determined by monitoring the effects. Ask your doctor about the duration of administration.
Precautions while taking this medicine
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include back pain, fever, arthralgia, malaise, headache, muscle pain and rash. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
chilliness, palpitation, cold sweat, grow pale[shock, anaphylaxis]
fever, dry cough, difficult to breathe[interstitial lung disease]
hard to breathe, rapid breathing, lips turn blue, nails and toenails turn blue [acute respiratory distress syndrome]
shortness of breath, fever, general malaise, easy to bleed, dizziness[increase of blasts]
left upper quadrant pain, shoulder pain, abdominal bloating [splenomegaly, splenic rupture]
hypotension, edema, rapid weight increase[capillary leak syndrome]
fever, raised red rash with pain[Sweet's syndrome]
fever, bruise, blood blister[cutaneous vasculitis]
fever, general malaise, headache, dizziness[large vessel vasculitis(inflammation of aorta, common carotid artery, subclavian artery, etc)]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Injection
Revised: 6/2018
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.