度易达 (度拉糖肽注射液)说明书
度拉糖肽使用操作方法
度拉糖肽使用操作方法
度拉糖肽是一种口服的药物，用于治疗Ⅱ型糖尿病。
在使用过程中，需要根据医生给出的指示进行，以确保药物的使用效果和安全性。
首先，需要明确的是，如何选择剂量。
剂量一般依据病人的身体情况和血糖程度来决定。
在初始使用阶段，医生会根据病人的病情和反应来决定一个适合的初步剂量，通常建议病人从最低剂量开始使用，然后根据病情，逐步调整剂量。
不要自行更改剂量。
其次，关于服用方法。
度拉糖肽通常在饭前30分钟，随水服用。
要求每次口服前先用温水漱口，以保证口腔内没有残留物，避免对药物吸收产生影响。
在使用度拉糖肽的过程中，需要注意以下几点：
1.严格按照医生的指示来服用。
切勿自行更改剂量或服用时间。
2.度拉糖肽需要每天口服，一般建议在早餐前使用，在饭前30分钟服用。
3.口服前用温水漱口，并在服用药物过程中，保持口腔清洁，以确保药物的吸收。
4.对于漏服的药物，如未超过2个小时则可以追加，否则请在下一次剂量时补上。
5.每次口服后应该不要吃东西，可以稍微移动一下身体，以帮助身体吸收药物。
6.服用药物的同时，一定要注意饮食和生活习惯的调整，合理饮食和适度运动，可以加强药物治疗的效果。
7.如果使用过程中出现任何不良反应，请及时告诉医生。
总之，服用度拉糖肽需要遵循医生的指示，服用前需要注意漱口，服用后不要立即进食，把握好药物的剂量和时间，同时结合饮食和生活习惯的调整，可以有效地控制血糖，提高治疗效果。
度拉糖肽使用说明书2014年第一版
GLP-1受体激动剂Trulicity(dulaglutide度拉糖肽)使用说明书2014年第一版批准日期：2014年9月18日；公司：Eli Lilly和公司FDA药品评价和研究中心第II药物评价室副主任Mary Parks医学博士说：“2型糖尿病是一周严重慢性情况致血糖水平升高高于正常，”“Trulicity 是一种新治疗选择，在2型糖尿病的所有处理中可单独使用或添加至已存在治疗方案以控制血糖水平。
”/us/trulicity-uspi.pdf处方资料重点这些重点不包括安全和有效使用TRULICITY所需所有资料。
请参阅TRULICITY完整处方资料。
TRULICITY (dulaglutide)注射用，为皮下使用美国初次批准：2014适应证和用途TRULICITY™是一种胰高血糖素样肽(GLP-1)受体激动剂适用为辅助饮食和锻炼改善有2型糖尿病成年中血糖控制。
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(1，5.1).⑵未曾在有胰腺炎病史患者中研究。
考虑另外抗糖尿病治疗(1，5.2).⑶不是为1型糖尿病或糖尿病酮症酸中毒的治疗。
.⑷不是为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⑴在给药天任何时间给予每周1次。
(2.1).⑵在腹部，大腿，或上臂皮下注射(2.1).⑶开始时0.75 mg皮下每周1次。
为增加血糖控制剂量可被增加至1.5 mg每周1次(2.1)。
⑷如一剂被丢失在3天内给予丢失剂量(2.1).剂型和规格⑴注射用：在单-剂量笔中0.75 mg/0.5 mL溶液(3)⑵注射用：在单-剂量笔中1.5 mg/0.5 mL溶液(3)⑶注射用：在单-剂量预装注射器中0.75 mg/0.5 mL溶液(3)⑷注射用：在单-剂量预装注射器中1.5 mg/0.5 mL溶液(3)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(4.1，5.1，13.1)。
【PP-DG-CN-0719】解“易”答惑度易达临床实践中的10个疑问
【PP-DG-CN-0719】解“易”答惑度易达临床实践中的10个疑问答“易”解惑度易达临床实践中的10个疑问PP-DG-CN-0719度易达?2019年5月在中国上市，是中国首个人源性GLP-1RA周制剂适应症：适用于成人2型糖尿病患者的血糖控制单药治疗：仅靠饮食控制和运动血糖控制不佳的患者。
联合治疗：在饮食控制和运动基础上，接受二甲双胍、或磺脲类药物、或二甲双胍联合磺脲类药物治疗血糖仍控制不佳的成人2型糖尿病患者。
度易达?注射笔：每周一次自动注射上市之后，随着临床的广泛应用，很多医生对度易达?的使用非常感兴趣，也有一些常见的临床问题探讨…度拉糖肽注射液说明书使用度易达?临床常见问题探讨Part1：度易达?适用人群选择度易达?时，是否需要考虑患者的体重？对疗效有什么影响？使用胰岛素的患者是否可以联合度易达?治疗？度易达?在特殊人群的使用需要注意什么？度易达?是如何实现一周一次给药的？作用时间有保证吗？度易达?注射装置有什么特点？度易达?使用需要提前检测C肽水平吗？Part2：使用度易达?前Part3：使用度易达?中度易达?控制血糖疗效如何？度易达?控制血糖疗效可以持续多长时间，建议使用多长时间？度易达?如何联用口服药，联用口服药的剂量如何调整？度易达?胃肠道不良反应情况如何？发生后如何处理？Part1：度易达?适用人群选择度易达?时，是否需要考虑患者的体重？对疗效有什么影响？使用胰岛素的患者是否可以联合度易达?治疗？度易达?在特殊人群的使用需要注意什么？适用人群Q1：选择度易达?时，是否需要考虑患者的体重？对疗效有什么影响？度易达?可显著改善血糖和体重，且效果不会受到基线BMI的影响。
不同BMI基线的患者，治疗26周时HbA1c自基线的改变中国开展的AWARD-CHN2研究体现亚洲患者体重特征BMI≥25BMI<25基线HbA1c(%)8.4%N=878.4%N=1138.2%N=1108.5%N=85纳入研究的患者BMI在≥19.0和≤35.0kg/m2BMI均值为26.8kg/m2患者基线BMI<25kg/m2为42.8%研究结果：无论基线BMI高低，度易达?均能明显降低血糖。
度易达 (度拉糖肽注射液)说明书
度拉糖肽注射液药品名称：【通用名称】度拉糖肽注射液【商品名称】度易达 TRULICITY【英文名称】Dulaglutide Injection【汉语拼音】Du La Tang Tai Zhu She Ye警示语：请仔细阅读说明书并在医师指导下使用。
成份：度拉糖肽（通过DNA重组技术，利用CHO细胞生产）度拉糖肽结构式为:分子量： 59,671Da （非糖基化）62,561Da （糖基化主要形式）辅料：柠檬酸三钠二水合物，无水柠檬酸，甘露醇，聚山梨酯80,注射用水。
性状：本品为无色澄明溶液。
作用类别：长效GLP-1受体激动剂适应症：本品适用于成人2型糖尿病患者的血糖控制：单药治疗仅靠饮食控制和运动血糖控制不佳的患者。
联合治疗在饮食控制和运动基础上，接受二甲双胍、或磺脲类药物、或二甲双胍联合磺脲类药物治疗血糖仍控制不佳的成人2型糖尿病患者。
规格：0.75mg : 0.5ml （预填充注射笔）1.5mg :0.5ml （预填充注射笔）用法用量：用量本品的推荐起始剂量为0.75 mg每周一次。
为进一步改善血糖控制，剂量可增加至1.5mg 每周一次。
最大推荐剂量为1.5mg每周一次。
当在二甲双胍基础上加用度拉糖肽时，可继续二甲双胍的当前剂量。
当在磺脲类药物治疗的基础上加用度拉糖肽时，应当考虑减少磺脲类药物的剂量，以降低低血糖的风险（参见【不良反应】和【注意事项】）。
使用度拉糖肽时，不需要进行血糖自我监测。
可能需要进行血糖自我监测来调整磺脲类药物的剂量。
肾功能损害患者轻度、中度或重度肾功能损害患者无需进行剂量调整（eGFR在15〜90 mL/min/1.73m2之间）。
在终末期肾病患者（<15 ml/min/1.73m2）中的治疗经验非常有限，因此不推荐度拉糖肽用于此类人群（参见【临床试验】和【药代动力学】）。
肝功能损害患者肝功能损害患者无需进行剂量调整。
老年患者无需根据患者年龄进行剂量调整（参见【药代动力学】）。
度拉糖肽注射液治疗合并2型糖尿病的新型冠状病毒肺炎的临床效果
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杜拉鲁肽说明书
CENTER FOR DRUG EVALUATION ANDRESEARCHAPPLICATION NUMBER:125469Orig1s000LABELINGHIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.TRULICITY (dulaglutide) injection, for subcutaneous useInitial U.S. Approval: 2014WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • Dulaglutide causes thyroid C-cell tumors in rats. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as humanrelevance could not be determined from clinical or nonclinical studies (5.1, 13.1).• TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) (4.1).---------------------------- INDICATIONS AND USAGE --------------------------- TRULICITY™ is a glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Limitations of Use:• Not recommended as first-line therapy for patients inadequately controlled on diet and exercise (1, 5.1).• Has not been studied in patients with a history of pancreatitis.Consider another antidiabetic therapy (1, 5.2).• Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. • Not for patients with pre-existing severe gastrointestinal disease. • Has not been studied in combination with basal insulin.------------------------ D OSAGE AND ADMINISTRATION ----------------------- • Administer once weekly at any time of day (2.1).• Inject subcutaneously in the abdomen, thigh, or upper arm (2.1). • Initiate at 0.75 mg subcutaneously once weekly. Dose can be increased to 1.5 mg once weekly for additional glycemic control(2.1).• If a dose is missed administer within 3 days of missed dose (2.1).----------------------DOSAGE FORMS AND STRENGTHS --------------------- • Injection: 0.75 mg/0.5 mL solution in a single-dose pen (3)• Injection: 1.5 mg/0.5 mL solution in a single-dose pen (3)• Injection: 0.75 mg/0.5 mL solution in a single-dose prefilled syringe(3)• Injection: 1.5 mg/0.5 mL solution in a single-dose prefilled syringe(3) ------------------------------- CONTRAINDICATIONS ------------------------------ • Do not use in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4.1, 5.1, 13.1).• Do not use if history of serious hypersensitivity to TRULICITY or any product components (4.2, 5.4).------------------------ WARNINGS AND PRECAUTIONS ----------------------- • Thyroid C-cell tumors in animals: Counsel patients regarding the risk of medullary thyroid carcinoma and the symptoms of thyroid tumors(5.1).• Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients withhistory of pancreatitis (5.2).• Hypoglycemia: When TRULICITY is used with an insulin secretagogue (e.g., a sulfonylurea) or insulin, consider lowering the dose of the sulfonylurea or insulin to reduce the risk ofhypoglycemia (5.3).• Hypersensitivity Reactions: Discontinue TRULICITY if suspected.Monitor and treat promptly per standard of care until signs andsymptoms resolve (5.4).• Renal Impairment: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions (5.5). • Macrovascular outcomes: There have been no studies establishing conclusive evidence of macrovascular risk reduction withTRULICITY or any other antidiabetic drug (5.7).------------------------------- ADVERSE REACTIONS ------------------------------ The most common adverse reactions, reported in ≥5% of patients treated with TRULICITY are: nausea, diarrhea, vomiting, abdominal pain, and decreased appetite (6.1).To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or /medwatch.------------------------------- DRUG INTERACTIONS ------------------------------ Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications (7.1, 12.3).-----------------------USE IN SPECIFIC POPULATIONS ---------------------- • Pregnancy: TRULICITY may cause fetal harm; only use if potential benefit justifies potential risk to fetus (8.1).• Nursing Mothers: Discontinue nursing or discontinue TRULICITY(8.3).• Renal Impairment: No dosage adjustment recommended. Monitor renal function in patients with renal impairment reporting severeadverse gastrointestinal reactions (5.5, 8.7).See 17 for PATIENT COUNSELING INFORMATION and FDA-approved Medication GuideRevised: 09/2014FULL PRESCRIBING INFORMATION: CONTENTS*WARNING: RISK OF THYROID C-CELL TUMORS1 INDICATIONS AND USAGE1.1 Limitations of Use2 DOSAGE AND ADMINISTRATION2.1 Dosage2.2 Concomitant Use with an Insulin Secretagogue (e.g.,Sulfonylurea) or with Insulin2.3 Dosage in Patients with Renal Impairment2.4 Important Administration Instructions3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Medullary Thyroid Carcinoma4.2 Hypersensitivity5 WARNINGS AND PRECAUTIONS5.1 Risk of Thyroid C-cell Tumors5.2 Pancreatitis5.3 Hypoglycemia with Concomitant Use of InsulinSecretagogues or Insulin5.4 Hypersensitivity Reactions5.5 Renal Impairment5.6 Severe Gastrointestinal Disease5.7 Macrovascular Outcomes6 ADVERSE REACTIONS6.1 Clinical Studies Experience7 DRUG INTERACTIONS7.1 Oral Medications8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment8.8 Gastroparesis10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 Monotherapy14.2 Combination Therapy16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage and Handling17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescr bing information are not listedFULL PRESCRIBING INFORMATIONWARNING: RISK OF THYROID C-CELL TUMORS• In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance could not be determined from clinical or nonclinical studies [see Warnings and Precautions (5.1), and Nonclinical Toxicology (13.1)].• TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with TRULICITY. Counsel regarding the risk factors and symptoms of thyroid tumors [see Contraindications (4.1), Warnings and Precautions (5.1), and Nonclinical Toxicology (13.1)].1 INDICATIONS AND USAGETRULICITY™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.1.1 Limitations of Use• TRULICITY is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise [see Warnings and Precautions (5.1)].• TRULICITY has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)].Consider other antidiabetic therapies in patients with a history of pancreatitis.• TRULICITY should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. TRULICITY is not a substitute for insulin.• TRULICITY has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis.The use of TRULICITY is not recommended in patients with pre-existing severe gastrointestinal disease [seeWarnings and Precautions (5.6)]• The concurrent use of TRULICITY and basal insulin has not been studied.2 DOSAGE AND ADMINISTRATION2.1 DosageThe recommended initiating dose of TRULICITY is 0.75 mg once weekly. The dose may be increased to 1.5 mg once weekly for additional glycemic control. The maximum recommended dose is 1.5 mg once weekly.Administer TRULICITY once weekly, any time of day, with or without food. TRULICITY should be injected subcutaneously in the abdomen, thigh, or upper arm.If a dose is missed, instruct patients to administer as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. If less than 3 days remain before the next scheduled dose, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.2.2 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with InsulinWhen initiating TRULICITY, consider reducing the dosage of concomitantly administered insulin secretagogues(e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions (5.3)].2.3 Dosage in Patients with Renal ImpairmentNo dose adjustment is recommended in patients with renal impairment including end-stage renal disease (ESRD). Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. [see Warning and Precautions (5.5), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].2.4 Important Administration InstructionsPrior to initiation of TRULICITY, patients should be trained by their healthcare professional on proper injection technique. Training reduces the risk of administration errors such as improper injection site, needle sticks, and incomplete dosing. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. The instructions can also be found at .When using TRULICITY with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject TRULICITY and insulin in the same body region but the injections should not be adjacent to each other.When injecting in the same body region, advise patients to use a different injection site each week. TRULICITY must not be administered intravenously or intramuscularly.TRULICITY solution should be visually inspected for particulate matter and discoloration prior to administration.3 DOSAGE FORMS AND STRENGTHS• Injection: 0.75 mg/0.5 mL or solution in a single-dose pen• Injection: 1.5 mg/0.5 mL solution in a single-dose pen• Injection: 0.75 mg/0.5 mL solution in a single-dose prefilled syringe• Injection: 1.5 mg/0.5 mL solution in a single-dose prefilled syringe4 CONTRAINDICATIONS4.1 Medullary Thyroid CarcinomaTRULICITY is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1)].4.2 HypersensitivityTRULICITY is contraindicated in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components [see Warnings and Precautions (5.4)].5 WARNINGS AND PRECAUTIONS5.1 Risk of Thyroid C-cell TumorsIn male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure [see Nonclinical Toxicology (13.1)]. Glucagon-like peptide (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether TRULICITY will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of this signal could not be determined from the clinical or nonclinical studies.One case of MTC was reported in a patient treated with TRULICITY. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN).TRULICITY is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the risk for MTC with the use of TRULICITY and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness).The role of serum calcitonin monitoring or thyroid ultrasound monitoring for the purpose of early detection of MTC in patients treated with TRULICITY is unknown. Such monitoring may increase the risk of unnecessary procedures, due to the low specificity of serum calcitonin as a screening test for MTC and a high background incidence of thyroid disease. Very elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Patients with thyroid nodules noted on physical examination or neck imaging should also be referred to an endocrinologist for further evaluation.5.2 PancreatitisIn Phase 2 and Phase 3 clinical studies, 12 (3.4 cases per 1000 patient years) pancreatitis related adverse reactions were reported in patients exposed to TRULICITY versus 3 in non-incretin comparators (2.7 cases per 1000 patient years). An analyses of adjudicated events revealed 5 cases of confirmed pancreatitis in patients exposed to TRULICITY (1.4 cases per 1000 patient years) versus 1 case in non-incretin comparators (0.88 cases per 1000 patient years).After initiation of TRULICITY, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain. If pancreatitis is suspected, promptly discontinue TRULICITY. If pancreatitis is confirmed, TRULICITY should not be restarted. TRULICITY has not been evaluated in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.5.3 Hypoglycemia with Concomitant Use of Insulin Secretagogues or InsulinThe risk of hypoglycemia is increased when TRULICITY is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting [see Adverse Reactions (6.1)].5.4 Hypersensitivity ReactionsSystemic hypersensitivity reactions were observed in patients receiving TRULICITY in clinical trials [see Adverse Reactions (6.1)]. If a hypersensitivity reaction occurs, the patient should discontinue TRULICITY and promptly seek medical advice.5.5 Renal ImpairmentIn patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal function, use caution when initiating or escalating doses of TRULICITY in patients with renal impairment. Monitor renal function in patients with renalimpairment reporting severe adverse gastrointestinal reactions[see Dosage and Administration (2.3), Use in Specific Populations (8.7)].5.6 Severe Gastrointestinal DiseaseUse of TRULICITY may be associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6.1)]. TRULICITY has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.5.7 Macrovascular OutcomesThere have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with TRULICITY or any other antidiabetic drug.6 ADVERSE REACTIONSThe following serious reactions are described below or elsewhere in the labeling:• Risk of Thyroid C-cell Tumors [see Warnings and Precautions (5.1)]• Pancreatitis [see Warnings and Precautions (5.2)]• Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions (5.3)] • Hypersensitivity reactions [see Warnings and Precautions (5.4)]• Renal impairment [see Warnings and Precautions (5.5)]6.1 Clinical Studies ExperienceBecause clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.Pool of Placebo-controlled TrialsThe data in Table 1 are derived from the placebo-controlled trials [see Clinical Studies (14)].These data reflect exposure of 1670 patients to TRULICITY and a mean duration of exposure to TRULICITY of 23.8 weeks. Across the treatment arms, the mean age of patients was 56 years, 1% were 75 years or older and 53% were male. The population in these studies was 69% White, 7% Black or African American, 13% Asian; 30% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.0 years and had a mean HbA1c of 8.0%. At baseline, 2.5% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60mL/min/1.73 m2) in 96.0% of the pooled study populations.Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the use of TRULICITY in the pool of placebo-controlled trials. These adverse reactions were not present at baseline, occurred more commonly on TRULICITY than on placebo, and occurred in at least 5% of patients treated with TRULICITY.Table 1: Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of TRULICITY-Treated PatientsAdverse Reaction Placebo(N=568)% Trulicity 0.75 mg(N=836)%Trulicity 1.5 mg(N=834)%Nausea 5.3 12.4 21.1Diarrhea a 6.7 8.9 12.6Vomiting b 2.3 6.0 12.7 Abdominal Pain c 4.9 6.5 9.4Decreased Appetite 1.6 4.9 8.6Dyspepsia 2.3 4.1 5.8Fatigue d 2.6 4.2 5.6a Includes diarrhea, fecal volume increased, frequent bowel movements.b Includes retching, vomiting, vomiting projectile.c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, gastrointestinal pain.d Includes fatigue, asthenia, malaise.Note: Percentages reflect the number of patients that reported at least 1 treatment- emergent occurrence of the adverse reaction.Gastrointestinal Adverse ReactionsIn the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving TRULICITY than placebo (placebo 21.3%, 0.75 mg 31.6%, 1.5 mg 41.0%). More patients receiving TRULICITY 0.75 mg (1.3%) and TRULICITY 1.5 mg (3.5%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.2%). Investigators graded the severity of gastrointestinal adverse reactions occurring on0.75 mg and 1.5 mg of TRULICITY as “mild” in 58% and 48% of cases, respectively, “moderate” in 35% and 43% of cases, respectively, or “severe” in 7% and 11% of cases, respectively.In addition to the reactions in Table 1, the following adverse reactions were reported more frequently in TRULICITY-treated patients than placebo (frequencies listed, respectively, as: placebo; 0.75 mg; 1.5 mg): constipation (0.7%, 3.9%, 3.7%), flatulence (1.4%, 1.4%, 3.4%), abdominal distension (0.7%, 2.9%, 2.3%), gastroesophageal reflux disease (0.5%, 1.7%, 2.0%), and eructation (0.2%, 0.6%, 1.6%).Pool of Placebo- and Active-Controlled TrialsThe occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 6 placebo- and active-controlled trials evaluating the use of TRULICITY as monotherapy and add-on therapy to oral medications or insulin.[see Clinical Studies (14)]. In this pool, a total of 3342 patients with type 2 diabetes were treated with TRULICITY for a mean duration of 52 weeks. The mean age of patients was 56 years, 2% were 75 years or older and 51% were male. The population in these studies was 71% White, 7% Black or African American, 11% Asian; 32% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.2 years and had a mean HbA1c of 7.6-8.5%. At baseline, 5.2% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 ml/min/1.73 m2) in 95.7% of the TRULICITY population.In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed in Table 1.Other Adverse ReactionsHypoglycemiaTable 2 summarizes the incidence and rate of documented symptomatic (≤70 mg/dL glucose threshold) and severe hypoglycemia in the placebo-controlled clinical studies.Table 2: Incidence (%) of Documented Symptomatic and Severe Hypoglycemia Adverse Reactions in Placebo-Controlled TrialsPlacebo TRULICITY 0.75 mg TRULICITY 1.5 mg Add-on to Metformin(26 weeks) N=177 N=302 N=304Documented symptomatic 1.1% 2.6% 5.6%Severe 0 0 0Add-on to Metformin + Pioglitazone(26 weeks) N=141 N=280 N=279Documented symptomatic 1.4% 4.6% 5.0%Severe 0 0 0Hypoglycemia was more frequent when TRULICITY was used in combination with a sulfonylurea or insulin [see Warnings and Precautions (5.3)]. Documented symptomatic hypoglycemia occurred in 39% and 40% of patients when TRULICITY 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Severe hypoglycemia occurred in 0% and 0.7% of patients when TRULICITY 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Documented symptomatic hypoglycemia occurred in 85% and 80% of patients when TRULICITY 0.75 mg and 1.5 mg, respectively, was co-administered with prandial insulin. Severe hypoglycemia occurred in 2.4% and 3.4% of patients when TRULICITY 0.75 mg and 1.5 mg, respectively, was co-administered with prandial insulin.Heart Rate Increase and Tachycardia Related Adverse Reactions.TRULICITY 0.75 mg and 1.5 mg resulted in a mean increase in heart rate (HR) of 2-4 beats per minute (bpm). The long-term clinical effects of the increase in HR have not been established [see Warnings and Precautions(5.7)].Adverse reactions of sinus tachycardia were reported more frequently in patients exposed to TRULICITY. Sinus tachycardia was reported in 3.0%, 2.8%, and 5.6% of patient treated with placebo, TRULICITY 0.75 mg and TRULICITY 1.5 mg, respectively. Persistence of sinus tachycardia (reported at more than 2 visits) was reported in 0.2%, 0.4% and1.6% of patients treated with placebo, TRULICITY 0.75 mg and TRULICITY 1.5 mg, respectively. Episodes of sinus tachycardia, associated with a concomitant increase from baseline in heart rate of ≥15 beats per minute, were reported in 0.7%, 1.3% and2.2% of patient treated with placebo, TRULICITY 0.75 mg and TRULICITY 1.5 mg, respectively. ImmunogenicityAcross four Phase 2 and five Phase 3 clinical studies, 64 (1.6%) TRULICITY treated patients developed anti-drug antibodies (ADAs) to the active ingredient in TRULICITY (i.e., dulaglutide).Of the 64 dulaglutide-treated patients that developed dulaglutide ADAs, 34 patients (0.9% of the overall population) had dulaglutide-neutralizing antibodies, and 36 patients (0.9% of the overall population) developed antibodies against native GLP-1.The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to dulaglutide cannot be directly compared with the incidence of antibodies of other products.HypersensitivitySystemic hypersensitivity adverse reactions sometimes severe (e.g., severe urticaria, systemic rash, facial edema, lip swelling) occurred in 0.5% of patients on TRULICITY in the four Phase 2 and Phase 3 studies.Injection-site ReactionsIn the placebo-controlled studies, injection-site reactions (e.g., injection-site rash, erythema) were reported in 0.5% of TRULICITY-treated patients and in 0.0% of placebo-treated patients.PR Interval Prolongation and Adverse Reactions of First Degree Atrioventricular (AV) BlockA mean increase from baseline in PR interval of 2-3 milliseconds was observed in TRULICITY-treated patients in contrast to a mean decrease of 0.9 millisecond in placebo-treated patients. The adverse reaction of first degree AV block occurred more frequently in patients treated with TRULICITY than placebo (0.9%, 1.7% and 2.3% for placebo, TRULICITY 0.75 mg and TRULICITY 1.5 mg, respectively). On electrocardiograms, a PR interval increase to at least 220 milliseconds was observed in 0.7%, 2.5% and 3.2% of patients treated with placebo, TRULICITY 0.75 mg and TRULICITY 1.5 mg, respectively.Amylase and Lipase IncreasePatients exposed to TRULICITY had mean increases from baseline in lipase and/or pancreatic amylase of 14% to 20%, while placebo-treated patients had mean increases of up to 3%.7 DRUG INTERACTIONS7.1 Oral MedicationsTRULICITY slows gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with TRULICITY. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with TRULICITY. In clinical pharmacology studies, TRULICITY did not affect the absorption of the tested, orally administered medications to a clinically relevant degree [see Clinical Pharmacology (12.3)].8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category CThere are no adequate and well-controlled studies of TRULICITY in pregnant women. The risk of birth defects, loss, or other adverse outcomes is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes to maintain good metabolic control before conception and throughout pregnancy.TRULICITY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In rats and rabbits, dulaglutide administered during the major period of organogenesis produced fetal growth reductionsand/or skeletal anomalies and ossification deficits in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide.In pregnant rats given subcutaneous doses of 0.49, 1.63, or 4.89 mg/kg dulaglutide on Gestation Days 6, 9, 12, and 15 (organogenesis), reduced fetal weights associated with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide were observed at ≥1.63 mg/kg, a systemic exposure ≥14-fold the MRHD based on AUC. Irregular skeletal ossifications and increases in post implantation loss also were observed at 4.89 mg/kg, a systemic exposure 44-fold the MRHD based on AUC. No developmental adverse effects were observed at 4-fold the MRHD based on AUC.In pregnant rabbits given subcutaneous doses of 0.04, 0.12, or 0.41 mg/kg dulaglutide on Gestation Days 7, 10, 13, 16, and 19 (organogenesis), fetal skeletal malformations of the vertebrae and/or ribs were observed in conjunction with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide at 0.41 mg/kg, a systemic exposure 13-fold the MRHD based on AUC. No developmental adverse effects were observed at 4-fold the MRHD based on AUC.In a prenatal-postnatal study in F0 maternal rats given subcutaneous doses of 0.2, 0.49, or 1.63 mg/kg every third day from implantation through lactation, F1 pups from F0 maternal rats given 1.63 mg/kg dulaglutide had statistically significantly lower mean body weight from birth through post-natal day 63 for males and post-natal day 84 for females. F1 offspring from F0 maternal rats receiving 1.63 mg/kg dulaglutide had decreased forelimb and hindlimb grip strength and males had delayed balano-preputial separation. Females had decreased startle response. These physical findings may relate to the decreased size of the offspring relative to controls as they appeared at early postnatal assessments but were not observed at a later assessment. F1 female offspring of the F0 maternal rats given 1.63 mg/kg of dulaglutide had a。
度拉糖肽 质量标准
度拉糖肽质量标准1.外观度拉糖肽应呈白色至灰白色的冻干粉末，或无色澄清的液体。
不应有异物、杂质、沉淀或悬浮物。
2.化学组成度拉糖肽应由DNA重组技术生产的人胰高血糖素类多肽（GLP-1）衍生物组成，其氨基酸序列和碳水化合物部分应与天然人GLP-1比较，应有90%的相似性。
3.分子量通过N-乙酰葡萄糖胺（NAG）和甘露醇（MAN）残基的O-糖苷键，度拉糖肽与两个O-岩藻糖残基发生连接。
其分子量应为11789.28Da（单体），在N-末端甘氨酸的α-氨基上含有二硫键。
4.溶液稳定性在25℃、相对湿度60%的环境下，度拉糖肽的溶液应在28天内保持稳定。
在5℃、相对湿度60%的环境下，度拉糖肽的溶液应在6个月内保持稳定。
5.纯度通过高效液相色谱法（HPLC）测定，度拉糖肽的纯度应不小于98.5%。
在190nm处的吸光度应小于0.1。
6.细菌内毒素通过鲎试验法测定，度拉糖肽中的细菌内毒素应小于0.5EU/mg。
7.宿主细胞DNA残留通过特定的引物和探针，利用荧光PCR法进行检测，度拉糖肽中的宿主细胞DNA残留量应小于10ng/mg。
8.蛋白残留通过特定的抗体进行检测，度拉糖肽中的蛋白残留量应小于1%。
9.抗体产生在临床试验中，受试者给予度拉糖肽后，应通过免疫学方法检测其体内是否产生抗体。
如果受试者产生抗体，应对其进行滴度测定并记录。
对于抗体阳性的受试者，应考虑进行抗体的中和试验以确定抗体是否具有中和度拉糖肽的作用。
10.生物活性度拉糖肽的生物活性应通过其在体内对血糖浓度的影响以及对胰岛素分泌的刺激作用等实验进行测定。
此外，还应通过动物模型等实验验证其药效学作用。
度拉糖肽的功效与作用
度拉糖肽的功效与作用
度拉糖肽（dulaglutide）是一种新型的胰岛素增敏剂，具有降
血糖作用。
它被用于治疗2型糖尿病患者，可以有效地控制血糖水平，改善胰岛素的分泌和作用。
1. 降低血糖：度拉糖肽能够刺激胰岛素的分泌，特别是在血糖升高时。
它通过激活肠道GLP-1受体，增加GLP-1的稳定性，抑制胰岛素分解酶的活性，从而提高胰岛素的有效性。
这能够帮助控制血糖水平，减少糖尿病患者需要胰岛素的剂量。
2. 降低食欲：度拉糖肽能够延长胃肠道的排空时间，使饭后血糖上升速度减缓，同时减少胆固醇和甘油三酯的合成，从而产生饱腹感，降低食欲。
这对于减轻体重和控制糖尿病患者的饮食是非常有益的。
3. 保护胰岛细胞：度拉糖肽不仅可以增加胰岛素的分泌，还能够通过减少细胞凋亡、抑制炎症反应等机制，保护胰岛细胞的功能和数量。
这有助于延缓糖尿病的进展，并减少并发症的风险。
4. 控制血压：研究发现，度拉糖肽可以降低高血压患者的血压水平。
它能够通过改善胰岛素的分泌和作用，调节内皮功能，减少血管收缩素的合成，从而降低血压。
5. 具有很好的耐受性：相比其他同类药物，度拉糖肽的副作用相对较少，并且很少出现低血糖的情况。
患者一般能够很好地耐受度拉糖肽的治疗。
总的来说，度拉糖肽是一种安全、有效的治疗2型糖尿病的药物。
它通过增加胰岛素分泌、降低血糖、控制食欲、保护胰岛细胞等多种途径发挥作用，能够改善患者的病情和生活质量。
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度拉糖肽注射液药品名称：【通用名称】度拉糖肽注射液【商品名称】度易达 TRULICITY【英文名称】Dulaglutide Injection【汉语拼音】Du La Tang Tai Zhu She Ye警示语：请仔细阅读说明书并在医师指导下使用。
成份：度拉糖肽（通过DNA重组技术，利用CHO细胞生产）度拉糖肽结构式为:分子量： 59,671Da （非糖基化）62,561Da （糖基化主要形式）辅料：柠檬酸三钠二水合物，无水柠檬酸，甘露醇，聚山梨酯80,注射用水。
性状：本品为无色澄明溶液。
作用类别：长效GLP-1受体激动剂适应症：本品适用于成人2型糖尿病患者的血糖控制：单药治疗仅靠饮食控制和运动血糖控制不佳的患者。
联合治疗在饮食控制和运动基础上，接受二甲双胍、或磺脲类药物、或二甲双胍联合磺脲类药物治疗血糖仍控制不佳的成人2型糖尿病患者。
规格：0.75mg : 0.5ml （预填充注射笔）1.5mg :0.5ml （预填充注射笔）用法用量：用量本品的推荐起始剂量为0.75 mg每周一次。
为进一步改善血糖控制，剂量可增加至1.5mg 每周一次。
最大推荐剂量为1.5mg每周一次。
当在二甲双胍基础上加用度拉糖肽时，可继续二甲双胍的当前剂量。
当在磺脲类药物治疗的基础上加用度拉糖肽时，应当考虑减少磺脲类药物的剂量，以降低低血糖的风险（参见【不良反应】和【注意事项】）。
使用度拉糖肽时，不需要进行血糖自我监测。
可能需要进行血糖自我监测来调整磺脲类药物的剂量。
肾功能损害患者轻度、中度或重度肾功能损害患者无需进行剂量调整（eGFR在15〜90 mL/min/1.73m2之间）。
在终末期肾病患者（<15 ml/min/1.73m2）中的治疗经验非常有限，因此不推荐度拉糖肽用于此类人群（参见【临床试验】和【药代动力学】）。
肝功能损害患者肝功能损害患者无需进行剂量调整。
老年患者无需根据患者年龄进行剂量调整（参见【药代动力学】）。
然而，在年龄≥75岁患者中的治疗经验非常有限。
儿科人群目前尚无度拉糖肽在18岁以下儿童中的安全性和有效性数据。
给药方法度拉糖肽经皮下注射给药，部位可选择腹部、大腿或上臂。
不能静脉或肌肉注射。
可在一天中任意时间注射，和进餐与否无关。
若遗漏给药，如果距下一次预定给药至少为3天（72小时），应尽快给药。
如果距下一次预定给药少于3天（72小时），应放弃这次给药，且定期进行下一次计划给药。
在每一种情况中，患者均可再恢复其常规每周一次的给药方案。
若需要，只要距上一次给药超过3天（72小时），可改变每周给药的日期。
不良反应：安全性概要在己完成和进行中的II期，III/IIIb期和IV期临床研究中，共有12654名患者暴露于度拉糖肽。
临床试验中最常见的不良反应为胃肠道不良反应，包括恶心、呕吐和腹泻。
这些不良反应通常为轻度或中度，呈一过性。
不良反应列表根据对II期和III期临床研究以及上市后报告的评估确认以下不良反应，并列于表1，显示为按MedDRA系统器官分类/首选术语且按发生率降序排列（十分常见：≥1/10；常见：≥1/100, <1/10；偶见: ≥1/1000, <1/100；罕见：≥1/10000, <1/1000；十分罕见：<1/10000和未知：无法从现有数据中估算）。
在每个发生率组中，不良反应按发生率降序排列。
选定不良反应的描述低血糖当度拉糖肽0.75mg和1.5mg单药治疗或与二甲双胍或与二甲双胍和吡格列酮联用时，有记录的症状低血糖发生率为5.9%至10.9%,比率为0.14至0.62事件/患者/年，未报告重度低血糖事件。
当度拉糖肽0.75mg和1.5mg分别与磺脲类和二甲双胍联用时，有记录的症状性低血糖发生率分别为39.0%和40.3%,比率为1.67和1.67事件/患者/年。
重度低血糖事件的发生率分别为0%和0.7%,比率为0.00和0.01事件/患者/年。
当度拉糖肽1.5mg与磺脲类药物联用时，有记录的症状性低血糖发生率为 11.3%,比率为0.90事件/患者/年，无重度低血糖发作。
当度拉糖肽1.5mg与甘精胰岛素联用时，有记录的症状性低血糖发生率为 35.3%,比率为3.38事件/患者/年。
重度低血糖事件发生率为0.7%，比率为 0.01事件/患者/年。
当度拉糖肽0.75mg和1.5mg分别与餐时胰岛素联用时，有记录的症状性低血糖发生率分别为85.3%和80.0%,比率为35.66和31.06事件/患者/年。
重度低血糖事件的发生率为2.4%和3.4%,比率为0.05和0.06事件/患者/年。
胃肠道不良反应分别使用度拉糖肽0.75mg和1.5mg时，累积报告的104周的胃肠道不良事件发生率，包括恶心（12.9%和21.2%）、腹泻（10.7%和13.7%）和呕吐（6.9%和11.5%）。
这些事件一般为轻度或中度，且发生率在治疗的前2周达到峰值，在接下来的4周内迅速下降，之后维持相对稳定。
在2型糖尿病患者中进行的长达6周的临床药理学研究中，多数胃肠道不良事件报告于首次给药后的第2-3天，且在随后的给药中下降。
急性胰腺炎在II期和III期临床研究中，度拉糖肽组、安慰剂组和对照药物组急性胰腺炎发生率分别为0.07%, 0.14%和0.19% （无论伴或不伴其他降糖治疗）。
胰酶度拉糖肽治疗与胰酶（脂肪酶和/或胰淀粉酶）均值较基线增加有关，增加范围为11%-21%。
（参见【注意事项】）。
若不存在急性胰腺炎的其他体征和症状，仅胰酶水平升高不能提示急性胰腺炎。
心率增加使用度拉糖肽0.75mg和1.5mg时，心率平均小幅增加2至4次每分钟（bpm）,窦性心动过速且伴随相对基线增加≥15bpm的发生率分别为1.3%和1.4% 。
一度房室传导阻滞IPR间期延长使用度拉糖肽0.75mg和1.5mg时，据观察PR间期相对基线平均小幅增加 2至3毫秒（msec）, —度房室传导阻滞发生率分别为1.5%和2.4%。
免疫原性在临床研究中，度拉糖肽治疗期间抗度拉糖肽抗体的发生率为1.6%，表明度拉糖肽分子中GLP-1的结构修饰和IgG4部分的修饰以及与天然GLP-1和 IgG4的高同源性使度拉糖肽免疫反应的风险降至最低。
出现抗度拉糖肽抗体的患者人数较少，抗体滴度低，对III期研究数据的评估显示抗度拉糖肽抗体对糖化血红蛋白变化无显著影响。
发生全身性过敏反应的患者中均未出现抗度拉糖肽抗体。
过敏反应在II期和III期临床研究中，接受度拉糖肽治疗的患者中，0.5%的患者报告了全身性过敏反应事件（如荨麻疹、水肿）。
罕见报告使用上市后度拉糖肽出现速发过敏反应的病例。
注射部位反应在接受度拉糖肽治疗的患者中，1.9%的患者报告了注射部位不良事件。
0.7% 的患者报告了潜在的免疫介导的注射部位不良事件（如皮疹、红斑），且一般为轻度。
不良事件所致的停药在26周的研究期间，由于不良事件所致停药的发生率，度拉糖肽组为2.6% （0.75mg）和6.1% （1.5mg），安慰剂组为3.7%。
在整个研究期间（至104周），度拉糖肽组不良事件所致停药的发生率为5.1% （0.75mg）和8.4% （1.5mg）。
对于度拉糖肽0.75mg和1.5mg,最常见的导致停药的不良反应分别为恶心（1.0%、1.9%）、腹泻（0.5%、0.6%）、呕吐（0.4%、0.6%）,且一般报告于最初的4-6周。
禁忌：对本品活性成份或任何辅料过敏的患者。
本品禁用于有甲状腺髓样癌（MTC）个人既往病史或家族病史的患者或者2型多发性内分泌腺瘤综合征（MEN2）的患者（参见【注意事项】）。
注意事项：度拉糖肽不得用于1型糖尿病患者或糖尿病酮症酸中毒的治疗。
严重胃肠道疾病GLP-1受体激动剂的使用可能与胃肠道不良反应相关。
治疗肾功能损害患者时应予以考虑，因为恶心、呕吐和/或腹泻等不良反应可能会引起脱水，而导致肾功能的恶化。
尚未在重度胃肠道疾病患者中研究度拉糖肽，包括重度胃轻瘫，因此不推荐度拉糖肽用于此类人群。
甲状腺C细胞肿瘤的风险胰高血糖素样肽（GLP-1）受体激动剂类药物曾在临床相关暴露量下引起小鼠和大鼠的甲状腺C细胞腺瘤和腺癌。
雄性和雌性大鼠终身暴露后，度拉糖肽导致甲状腺C细胞肿瘤（腺瘤和腺癌）的发生率呈剂量相关和治疗持续时间依赖性增加（参见【药理毒理】。
度拉糖肽与人类甲状腺C细胞肿瘤的相关性尚未确定。
目前尚不清楚本品是否会导致人类甲状腺C细胞肿瘤，包括甲状腺髓样癌（MTC）。
接受度拉糖肽治疗的一名患者报告了 1例MTC。
该患者的治疗前降钙素水平约为正常上限（ULN）的8倍。
上市后报告显示，接受利拉鲁肽（另一种 GLP-1受体激动剂）治疗的患者中发生MTC病例。
这些报告中的数据不足以建立或排除人类MTC和GLP-1受体激动剂使用之间的因果关系。
本品禁用于有MTC个人既往病史或家族病史的患者或者患有MEN 2的患者。
告知患者关于使用本品可能引起MTC的潜在风险以及甲状腺肿瘤的症状（如颈部肿块、吞咽困难、呼吸困难、持续性声音嘶哑）。
对于使用本品治疗的患者，为早期发现MTC而常规进行血清降钙素监测或甲状腺超声监测的价值尚不明确。
此类监测可能增加不必要的程序风险，因为血清降钙素的检测特异性低，并且甲状腺疾病的背景发病率高。
血清降钙素值显著提高可能提示MTC，MTC患者的降钙素值通常＞50ng/L。
如果测定血清降钙素，发现升高，患者应进行进一步的评价。
体格检查或颈部影像学检查时发现甲状腺结节的患者也应进行进一步的评价。
急性胰腺炎GLP-1受体激动剂的使用与发生急性胰腺炎的风险相关。
在临床试验中，曾报告急性胰腺炎与度拉糖肽相关（参见【不良反应】）。
应告知并观察患者急性胰腺炎的特征性症状包括持续性剧烈腹痛。
若怀疑发生了胰腺炎，应停用度拉糖肽。
若确诊胰腺炎，不应再次使用度拉糖肽。
若不存在急性胰腺炎的其他体征和症状，仅胰酶升高不能提示急性胰腺炎（参见【不良反应】）。
低血糖度拉糖肽与磺脲类药物联用可能增加低血糖的风险。
可通过减少磺脲类药物的剂量以降低低血糖的风险（参见【用法用量】和【不良反应】）。
过敏反应己有接受度拉糖肽治疗的患者发生严重过敏反应（包括速发过敏反应和血管性水肿）的上市后报告（参见【不良反应】）。
如果发生过敏反应，停用度拉糖肽治疗；立即给予标准治疗，并进行监测，直至体征和症状消退。
既往曾对度拉糖肽发生过敏反应的患者不应使用本品（参见【禁忌】）。
其他GLP-1受体激动剂有引起速发过敏反应和血管性水肿的报告。
既往曾对另一种GLP-1受体激动剂有血管性水肿或速发过敏反应史的患者应慎用本品，因为尚不明确此类患者接受度拉糖肽治疗后是否更容易发生速发过敏反应。
急性肾损伤接受GLP-1受体激动剂包括度拉糖肽在内治疗的患者中，已有急性肾损伤和慢性肾病加重的上市后报告，有时可能需要透析。