2012年4月17日，第一三共宣布,抗癌药RANMARK®（Denosumab(Genetic recombination)）皮下注射120mg在日本获批上市，在日本作为治疗多发性骨髓瘤和实体瘤骨转移引起的骨并发症的药物。
RANMARK®是世界上第一种靶向RANK配体的人类单克隆抗体。研究表明，RANMARK®可抑制多发性骨髓瘤骨并发症和实体瘤骨转移患者SRE（骨骼相关事件）的发生。
通过denosumab，Daiichi Sankyo旨在通过一种新的有效治疗方案，增加治疗多发性骨髓瘤和实体瘤骨转移引起的骨疾病的少数可用治疗方案，使患者受益。
在2013年6月，第一三共推出PRALIA皮下注射60mg注射器（PRALIA，subcutaneous injection 60mg syringe）。
目前，denosumab处于全球性III期临床开发，用于乳腺癌术后辅助治疗。在日本国内，denosumab处于II期临床开发，用于类风湿性关节炎的治疗
RANMARK®概述
商品名：RANMARK®Subcutaneous Injection 120 mg
英谅名：Denosumab(Genetic recombination)
中文名：地诺单抗重组注射剂
适应症：多发性骨髓瘤骨并发症和实体瘤骨转移的治疗
用法与用量
通常，成人每四周皮下注射一次120mg的剂量。
批准日期：2012年1月18日
包装
1.7mL 1瓶
保存方法
避免冷冻并储存在2-8°C
有效期
36个月
制造商和分销商
第一三共株式会社
提携
AMGEN®
注：以上中文资料不够完整，使用者以原处方资料为准。
完整说明资料附件：
https://www.info.pmda.go.jp/go/pack/3999435A1020_1_15/
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RANMARK Subcutaneous Injection（Denosumab (Genetical Recombination) ）
RANMARK Subcutaneous Injection 120mg [Giant Cell Tumor of Bone]（ランマーク皮下注120mg［骨巨細胞腫］）
Brand name : RANMARK Subcutaneous Injection 120mg [Giant Cell Tumor of Bone]
Active ingredient: Denosumab(Genetical Recombination)
Dosage form: injection
Print on wrapping:
RANMARK Subcutaneous Injection 120mg [bone lesion associated with multiple myeloma or bone metastases from solid tumors]（ランマーク皮下注120mg［多発性骨髄腫による骨病変および固形癌骨転移による骨病変］）
Brand name : RANMARK Subcutaneous Injection 120mg [bone lesion associated with multiple myeloma or bone metastases from solid tumors]
Active ingredient: Denosumab (Genetical Recombination)
Dosage form: injection
Print on wrapping:
Effects of this medicine
This medicine is anti-RANKL antibody which inhibits bone resorption and suppresses progression of bone lesion from tumors.
It is usually used to treat bone lesion associated with multiple myeloma or bone metastases from solid tumors.
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 hypocalcemia, renal disorder or a potential to develop hypocalcemia.
If you are using "PRALIA Subcutaneous Injection 60mg Syringe."
•If you are pregnant, possibly 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, administer by subcutaneous injection once every 4 weeks. It may be administered over a long period according to your response to the treatment.
Precautions while taking this medicine
•In order to prevent hypocalcemia, ingest calcium and vitamin D under the instruction of your doctor. If you have difficulty in taking them orally, consult with your doctor.
•Since hypocalcemia may occur without any symptoms, frequent blood test is needed. Keep blood test schedul |
