度拉糖肽重组Trulicity 0.75mg剂量(每周注射一次)推荐用作单药疗法,同时可用作某些脆弱群体(包括75岁及以上群体)的起始治疗剂量。
药品名:TRULICITY (Dulaglutide)
初次批准:2014
批准日期:2014年9月18日(美国);2014年11月26日(欧盟)2015年9月(日本)公司:Eli Lilly and Company
适应证和用途 :
TRULICITY (Dulaglutide)是一种胰高血糖素样肽(GLP-1)受体激动剂,适用于在饮食和体育锻炼基础上改善成人2型糖尿病患者的血糖控制水平。
使用限制:
⑴ 不建议作为对饮食和锻炼控制欠佳患者一线治疗
⑵ 未曾在有胰腺炎病史患者中研究。有胰腺炎史患者考虑其他抗糖尿病治疗。
⑶ 不适于1型糖尿病或糖尿病酮症酸中毒的治疗。
⑷ 不适于有预先存在严重胃肠道疾病患者。
⑸ 未曾研究与基础胰岛素联用。
剂量和给药方法:
成人,TRULICITY(基因重组),每周一次注射给药0.75mg皮下注射。
禁忌证:
⑴ 在有髓性甲状腺癌个人或家族病史患者或有多发性内分泌腺瘤综合征2型患者中不要使用。
⑵ 如对TRULICITY或产品任何组分严重超敏性史不要使用。
警告和注意事项:
⑴ 甲状腺C-细胞肿瘤在动物中:与患者讨论关于髓性甲状腺癌的风险和甲状腺肿瘤的症状。
⑵ 胰腺炎:在临床试验中曾报道。如怀疑胰腺炎及时终止。如胰腺炎被确证不要再开始。有胰腺炎病史患者中考虑其他抗糖尿病治疗。
⑶ 高血糖:当TRULICITY与一种胰岛素分泌刺激剂使用(如,一种磺酰脲类)或胰岛素,考虑降低磺酰脲类或胰岛素的剂量以减低高血糖的风险。
⑷ 超敏性反应:如怀疑终止TRULICITY。监视和及时标准医护直至体征和症状解决。
⑸ 肾受损:在有肾受损报告严重不良胃肠道反应患者中监视肾功能。
⑹ 大血管病变的结果:没有研究确定用TRULICITY或任何其他抗糖尿病药物减低大血管风险的结论性证据。
不良反应:
最常见不良反应,用TRULICITY治疗患者报告≥5%是:恶心,腹泻,呕吐,腹痛,和食欲减退。
TRULICITY ATEOS(トルリシティ皮下注0.75mgアテオス Eli Lilly)
Brand name : TRULICITY ATEOS
Active ingredient: Dulaglutide(genetical recombination)
Dosage form: clear and colorless injectable preparation
Print on wrapping:
TRULICITY ATEOS(トルリシティ皮下注0.75mgアテオス Dainippon Sumitomo)
Brand name : TRULICITY ATEOS
Active ingredient: Dulaglutide(genetical recombination)
Dosage form: clear and colorless injectable preparation
Print on wrapping:
Effects of this medicine
This medicine is a glucagon-like peptide-1 (GLP-1) receptor agonist, designed so that extended efficacy can be obtained by once weekly injection. This medicine improves blood sugar (glucose) by enhancing glucose-dependent insulin secretion via direct action on GLP-1 receptor in the pancreas.
This medicine is commonly used for the treatment of type 2 diabetes mellitus.
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 diabetic ketoacidosis, diabetic coma, precoma, type 1 diabetes. In case of any emergent situation such as severe infections or surgery.
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, for adults, inject 0.75 mg subcutaneously once a week. Strictly follow the instructions.
Inject TRULICITY on the same day each week.
TRULICITY is injected into skin (subcutaneous injection) of your stomach area (abdomen), upper leg (thigh), or upper arm. Be sure to choose a different injection site each time if you use the same area of your body.
Read the attached instructions for use carefully before use.
If you miss a dose and there are at least 3 days (72 hours) until the next scheduled dose, inject the missed dose as soon as possible. You can then resume your regular once weekly dosing schedule. If there are less than 3 days (72 hours) remaining, skip the missed dose and then resume your regular once weekly dosing schedule. You should never inject two doses at one time.
If you accidentally injected more than your prescribed dose, consult with your doctor or pharmacist.
Do not stop using this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
Follow your instructed diet and exercise programs.
The medicine may cause hypoglycemia (low blood sugar). Take extreme care when you perform any operations with potential risk such as working at heights or driving a motor vehicle. You should inform your family and persons around you about the risk of hypoglycemia. If any symptoms of hypoglycemia occur, consume sugar or sugar-rich foods immediately.
Acute pancreatitis may occur. If persistent severe abdominal pain with vomiting occurs, please discontinue TRULICITY and contact your doctor immediately.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include constipation, nausea and diarrhea. 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.
great hunger, cold sweat, tremor of limbs [hypoglycemia]
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
Keep TRULICITY out of the reach of children. TRULICITY must be protected from light. Store TRULICITY at 2 to 8 degrees C (in a refrigerator, etc) but do not freeze. If stored at room temperature, TRULICITY should be protected from light and used within 14 days. TRULICITY should not be stored at over 30 degrees C.
Discard the used or remaining medicine as instructed by your doctor without keeping them.
Eli Lilly Japan K.K Self-injection
Published: 9/2015
Sumitomo Dainippon Pharma Co.,Ltd. Self-injection
Published: 9/2015
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.
http://www.info.pmda.go.jp/go/pack/2499416G1029_1_03/
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产地国家:日本
原产地英文商品名:
TRULICITY ATEOS(トルリシティ皮下注:アテオス)0.75mg/0.5ml/pen 2pen/box
原产地英文药品名:
Dulaglutide(Genetical Recombination)
中文参考商品译名:
Trulicity(トルリシティ皮下注:アテオス)0.75毫克/0.5毫升/注射笔 2注射笔/盒
中文参考药品译名:
度拉糖肽重组
生产厂家中文参考译名:
礼来日本有限公司
生产厂家英文名:
Eli Lilly Japan K.K
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产地国家:日本
原产地英文商品名:
TRULICITY ATEOS(トルリシティ皮下注:アテオス)0.75mg/0.5ml/pen 2pen/box
原产地英文药品名:
Dulaglutide(Genetical Recombination)
中文参考商品译名:
Trulicity(トルリシティ皮下注:アテオス)0.75毫克/0.5毫升/注射笔 2注射笔/盒
中文参考药品译名:
度拉糖肽重组
生产厂家中文参考译名:
大日本住友制药
生产厂家英文名:
Dainippon Sumitomo Pharma