英文药名：Romiplate for s.c. injection（Romiplostim（Genetical Recombination））

中文药名：重组罗米司亭注射液

生产厂家：协和发酵麒麟
分类名称
血小板造血刺激因子制剂/血小板生成素受体激动剂
欧文商標名
Romiplate for s.c. injection
一般名
ロミプロスチム（遺伝子組換え）
Romiplostim（Genetical Recombination）
分子量
59,085
本質
Romiplostim（遗传重组）是一种重组FC-肽融合蛋白，Fc区的2至228人IgG1，也从229至269个由含有人血小板生成素受体结合序列的肽。 Romiplostim是两个亚基分子，它由269个氨基酸残基组成的蛋白质。
审批条件
由于临床试验的情况下在日本是非常有限的，上市后，直到一定数量案件的数据被集成，通过实施的所有情况下，使用效果的调查，该药物以及了解病人使用的背景资料，搜集有关这种药物的安全性和有效性的数据在年初，采取必要措施，正确使用此药。
药效药理
本剤直接作用于巨核细胞祖细胞，施加血小板造血
(1) 造血作用
本剤正常小鼠，大鼠，当在恒河猴和食蟹猴静脉内或皮下施用显示出血小板造血（增加血小板数），显示出类似的效果也可以在脾切除小鼠的皮下施用。还由自身抗体的产生对抗血小板，通过皮下给药至W/ BF1小鼠表现出血小板血小板破坏发生，并且显示了血小板数减少的改善效果。
(2) 作用机序
本剤结合血小板生成素受体，从巨核细胞祖细胞的集落形成分别升为人外周血和猕猴骨髓来源的造血祖细胞的浓度依赖性（体外）。
适应病症
慢性特发性血小板减少性紫癜
剂量和给药方法
成人，初始剂量1微克/公斤余皮下给药如Romiplostim（基因重组）。在给药开始后是血小板数量，以增加或减少根据状况的剂量，每周一次皮下施用适当。
此外，最高剂量I和每周为10μg/kg
包装规格
ロミプレート皮下注250μg調製用：1バイアル

生产厂商
协和发酵麒麟有限公司
原处方附件：http://www.info.pmda.go.jp/go/pack/3999430D1024_1_03/
Romiplate for s.c. injection（Romiplostim(Genetical Recombination)）
Romiplate for s.c. injection 250 mcg（ロミプレート皮下注250μg調製用） 
Brand name : Romiplate for s.c. injection 250 mcg
　Active ingredient: Romiplostim(Genetical Recombination)
　Dosage form: Injection
　Print on wrapping: 
Effects of this medicine
This medicine acts on cells that produce platelets and increases or maintains the number of platelets.
It is usually used to treat chronic idiopathic thrombocytopenic purpura.
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 a history of brain infarction, myocardial infarction and lung infarction.
If you have renal or hepatic disease.
•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, inject this medicine subcutaneously, once a week.
•This medicine may be used for a long period of time depending on your response to treatment.
•Before and during use of this medicine, blood tests will be performed regularly to investigate the number and shape of various types of blood cells.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include headache, malaise, back pain, joint pain, vertigo, nausea, fatigue, musculoskeletal stiffness, pain of the limbs, injection site reaction. 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.
•breathing difficulty/chest pain, edema/pain of lower limbs, feeling of suddenly compressed chest [thrombosis/thromboembolism]
•bone marrow fibrosis, hematopoietic disorder when bone marrow fibrosis becomes severe (general malaise caused by anemia, bleeding tendency)/splenomegaly(fullness, left upper quadrant pain) [increase in bone marrow reticulin]
•bleeding after withdrawal of this medicine [bleeding]
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.
Storage conditions and other information
•Stopping the use of this medicine may result in higher risks of worsening of thrombocytopenia or bleeding compared to those before the use of this medicine. The patient's status will be carefully observed, and attention will be paid to platelet count for at least 4 weeks after discontinuation. Blood tests will thus be performed frequently.
Kyowa Hakko Kirin Co.,LtdInjection
Revised: 3/2013
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.