简介:
部份中文盐酸阿那莫林处方资料(仅供参考)
英文名:anamorelin Hydrochloride
商品名:Adlumiz Tablets
中文名:盐酸阿那莫林片
生产商:小野制药
药品简介
首个癌症恶病质新药Adlumiz(anamorelin)在日本推出:有效增加体重/肌肉质量/食欲!
2021年04月28日,抗癌新药Adlumiz(anamorelin)在日本推出,该药是一种胃饥饿素(ghrelin)受体激动剂,用于治疗非小细胞肺癌、胃癌、胰腺癌、结直肠癌等恶性肿瘤患者的癌症恶病质(cancer cachexia)。
Adlumiz(anamorelin)是首个治疗癌症恶病质的药物。临床数据显示,Adlumiz在癌症恶病质患者中具有增加体重、肌肉质量、食欲的作用。Adlumiz的上市,将为没有治疗方法的癌症恶病质患者提供一种新的治疗选择。
癌症恶病质是一种复杂的代谢紊乱综合征,其特征是体重下降(尤其是肌肉质量下降)和与癌症相关的厌食。癌症恶病质会对患者的生活质量和预后造成很大的不利影响。
エドルミズ錠50mg
药效分类名称
胃饥饿素样激动剂
批准日期:2021年4月
商標名
ADLUMIZ Tablets
一般名
アナモレリン塩酸塩(Anamorelin Hydrochloride)
化学名
(3R)-3-Benzyl-N,N’,N’-trimethyl-1-(2-methylalanyl-D-tryptophyl)piperidine-3-carbohydrazide monohydrochloride
分子式
C31H42N6O3・HCl
分子量
583.16
性状
本品为白色至灰白色固体,易溶于水、甲醇、乙醇或N-甲基吡咯烷酮。
構造式
批准条件
1.制定药品风险管理计划并妥善实施。
2. 生产和销售后,在积累一定数量的病例数据之前,将通过对所有病例进行用药结果调查,尽早收集该药物的安全性和有效性数据。正确使用该药物的措施。
药效药理
1. 作用机制
这种药物对生长激素释放肽受体GHS-R1a(生长激素释放促进因子受体1a型)有作用。这种药物通过激活GHS-R1a和增加食欲来促进生长激素(GH)的分泌,从而增加体重。
2.药理作用
(1) 该药物与重组人GHS-R1a结合,作用于大鼠垂体细胞,促进GH分泌(体外)。
(2) 大鼠单次口服本品可增加血浆GH浓度。
(3)本药反复给大鼠口服,增加摄食量和体重。
适应症
下列恶性肿瘤中的癌性恶病质
非小细胞肺癌、胃癌、胰腺癌、结肠癌
用法与用量
成人每天一次空腹口服100mg 阿拉莫林盐酸盐。
包装
片
50毫克:100片 (PTP)
制造和销售
小野制药株式会社
提携
HELSINN
注:以上中文处方资料不够完整,使用者以原处方资料为准!
完整处方资料附件:
https://www.info.pmda.go.jp/go/pack/3999054F1028_1_01/?
view=frame&style=SGML&lang=ja
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Launch of Adlumiz(anamorelin), a Ghrelin Receptor Agonist in Japan
Provides a New Treatment Option to Patients with Cancer Cachexia in Malignant Tumors。
Adlumiz(generic name: anamorelin hydrochloride)Tablet 50mg(“Adlumiz”), a ghrelin receptor agonist, for the treatment of cancer cachexia in malignant tumors of non-small cell lung cancer, gastric cancer, pancreatic cancer or colorectal cancer in Japan.
Cancer cachexia is a complex metabolic disorder syndrome, characterized by decreased body weight(especially decreased muscle mass)and anorexia associated with cancer. It has been well documented that cancer cachexia causes a significant impact on patients’ quality of life(QOL)and prognosis. However, no drug was approved in Japan for the treatment of cancer cachexia.
Adlumiz is a selective, novel, orally active ghrelin receptor agonist. Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite and metabolism. Adlumiz has shown effects in increasing body weight and muscle mass, as well as appetite in patients with cancer cachexia.
With the launch of Adlumiz this time, we believe that a new treatment option can be provided to patients with cancer cachexia who have no treatment method in Japan and contribute to improving the QOL in these patient populations.
Overview of Adlumiz® Tablet 50 mg
Product name |
Adlumiz® Tablet 50mg |
Generic name (JAN) |
anamorelin hydrochloride |
Indication |
Cancer cachexia in the following malignant tumors:
Non-small cell lung cancer, gastric cancer, pancreatic cancer and colorectal cancer |
Dosage and administration |
Usually, for adults, administer 100 mg of anamorelin hydrochloride at fasting state orally once a day. |
Approval date |
January 22, 2021 |
NHI price listing date |
April 21, 2021 |
Manufacturer/distributor:Ono Pharmaceutical Co., Ltd.
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