英文药名：SAXENDA(liraglutide [rDNA origin] injection)

中文药名：利拉鲁肽注射剂

生产厂家：诺和诺德公司
药品介绍
SAXENDA(利拉鲁肽[rDNA origin] injection)，溶液FDA近来批准为治疗慢性肥胖的药物
FDA药品评价和研究中心代谢和内分泌部代理副主任说：“肥胖 是一个公共卫生关注问题和威胁患者的总体生活幸福，”“ Saxenda负责任地与健康生活方式包括减少热量饮食和体育锻炼联用，为肥胖或过重和有至少一种体重-相关相伴情况人们慢性体重处理提供一种而外的治疗选择。”
美国初次批准：2014
适应证和用途
Saxenda是一个胰高血糖素-样肽-1(GLP-1)受体激动剂适用作为一个辅助减低-热量饮食和增加体力活动为慢性体重处理在成年患者中有一个初始体重指数(BMI)
⑴ 30 kg/m2或更大(肥胖)(1)或
⑵ 27 kg/m2或更大(超重)存在至少一种体重相关的合并情况(如高血压，2型糖尿病，或血脂异常)。
使用限制：
Saxenda是不适用为2型糖尿病的治疗。
尚未确定Saxenda对心血管发病率和死亡率的影响。
尚未确定与其他产品共同给药对体重减轻的安全和疗效。
尚未在有胰腺炎病史患者中研究Saxenda。
剂量和给药方法
⑴ Saxenda的推荐剂量是3mg每天。在一天任何时间给予，不管进餐时间。
⑵ 开始在每天0.6mg共一周。在每周间隔，增加剂量直至达到剂量3mg。
⑶ 在腹部，大腿或上臂皮下注射。 
⑷ 注射部位和时间可比啊哈无剂量调整。
剂型和规格
为皮下注射溶液，预装，多剂量笔输送剂量0.6mg，1.2mg，1.8mg，2.4mg或3mg(6mg/mL，3mL)
禁忌证
髓性甲状腺癌或多发性内分泌肿瘤综合征型2的个人或家族史。
对利拉鲁肽或产品任何组分超敏性。
警告和注意事项
⑴ 甲状腺C细胞肿瘤：与患者商讨关于髓性甲状腺癌风险和甲状腺肿瘤症状。
⑵ 急性胰腺炎：如被怀疑胰腺炎及时终止。如确证胰腺炎不要重新开始.
⑶ 急性胆囊疾病：如怀疑胆石症或胆囊炎，适用胆囊研究。
⑷严重低血糖：当Saxenda与一种胰岛素分泌促进剂(如一种磺脲类[sulfonylurea])使用可能发生。考虑降低抗糖尿病药物剂量以减低低血糖风险.
⑸ 心率增加：在规则间隔监视心率。
⑹肾受损：上市后曾报道，通常伴随恶心，呕吐，腹泻，或脱水有时需要血液透析。在有肾受损患者中当开始或递增Saxenda剂量谨慎使用。
⑺超敏性反应：严重超敏性反应的上市后报告(如，过敏反应和血管水肿)。终止Saxenda和其他怀疑药物和技术寻求医疗咨询。
⑻自身行为和观念：监视抑郁或自杀念头。如症状发生终止Saxenda。
不良反应
最常见不良反应，报道大于或等于5%是：恶心，低血糖，腹泻，便秘，呕吐，头痛，食欲减低，消化不良，疲乏，眩晕，腹痛，和脂肪酶增加。
报告怀疑不良反应，联系诺和诺德公司电话1-877-484-2869或FDA电话 1-800-FDA-1088或www.fda.gov/medwatch.
药物相互作用
Saxenda延迟胃排空。可能影响同时给予口服药物的吸收。谨慎使用.
特殊人群中使用
哺乳母亲：终止药物或哺乳。
儿童使用：未确定安全性和有效性和建议不适用。

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产地国家: 美国
原产地英文商品名:
SAXENDA 18MG/3ML PF INJ 5
原产地英文药品名:
LIRAGLUTIDE
中文参考商品译名:
SAXENDA预装笔 18毫克/3毫升  5支/盒
中文参考药品译名:
利拉鲁肽
生产厂家英文名:
NOVO NORDISK PHARM
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产地国家: 德国
原产地英文商品名:
Saxenda 6mg/ml Injektionslösung in einem Fertigpen, 5X3ML
原产地英文药品名:
LIRAGLUTIDE
中文参考商品译名:
Saxenda预装笔 6毫克/毫升 5支X3毫升
中文参考药品译名:
利拉鲁肽
生产厂家英文名:
Novo Nordisk Pharma GmbH

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Saxenda Approval History
•FDA approved: Yes (First approved December 23rd, 2014)
•Brand name: Saxenda
•Generic name: liraglutide
•Company: Novo Nordisk Inc.
•Treatment for: Obesity
Saxenda (liraglutide) is a once-daily glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity.
Indications and Usage
Show Less•Saxenda® (liraglutide [rDNA origin] injection) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
Limitations of Use
•Saxenda® is not indicated for the treatment of type 2 diabetes.
•Saxenda® should not be used in combination with any other GLP-1 receptor agonist.
•Saxenda® should not be used with insulin.
•The effects of Saxenda® on cardiovascular morbidity and mortality have not been established.
•The safety and efficacy of coadministration with other products for weight loss have not been established.
•Saxenda® has not been studied in patients with a history of pancreatitis.
Important Safety Information
WARNING: RISK OF THYROID C-CELL TUMORS
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice.  It is unknown whether Saxenda® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.   Saxenda® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).  Counsel patients regarding the risk of MTC with use of Saxenda® and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).  Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Saxenda®.
Contraindications
Saxenda® is contraindicated in the following conditions:
•Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
•Patients with a prior serious hypersensitivity reaction to liraglutide or to any of the product components
•Pregnancy
Warnings and Precautions
•Acute Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide. After initiation of Saxenda® observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Saxenda® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Saxenda® should not be restarted.
•Acute Gallbladder Disease: Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in Saxenda®-treated patients than in placebo-treated patients even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
•Serious Hypoglycemia: When Saxenda® is used with an insulin secretagogue (e.g., a sulfonylurea) serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia. 
•Heart Rate Increase:  For patients who experience a sustained increase in resting heart rate while taking Saxenda®, Saxenda® should be discontinued.
•Renal Impairment: Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration, which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Saxenda® in patients with renal impairment.
•Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported during postmarketing use of liraglutide. If symptoms of hypersensitivity reactions occur, patients must stop taking Saxenda® and promptly seek medical advice.
•Suicidal Behavior and Ideation: Patients treated with Saxenda® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Saxenda® in patients who experience suicidal thoughts or behaviors. Avoid Saxenda® in patients with a history of suicidal attempts or active suicidal ideation.
Adverse Events
•The most common adverse reactions, reporting in ≥5% are:  nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase.
Use in Specific Populations
•Nursing mothers should either discontinue Saxenda® or discontinue nursing.
•Safety and effectiveness of Saxenda® have not been established in pediatric patients and is not recommended for use in pediatric patients.