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。

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】）。

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（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。

度拉糖肽注射操作方法v
度拉糖肽（Degarelix）是一种长效的激素治疗药物，用于治疗前列腺癌。

它需要通过注射给药途径进行使用。

以下是度拉糖肽注射的操作方法：
1. 准备工作：
a. 清洁工作台并准备所需的工具，包括一次性注射器、消毒酒精和棉球。

b. 从冰箱中取出储存度拉糖肽的药物，并将其静置一段时间，使其达到室温。

2. 使用消毒酒精和棉球彻底清洁注射部位，通常是腹部、大腿或上臂。

3. 打开一次性注射器的包装，并将其连接到度拉糖肽的药瓶上。

确保注射器连接牢固。

4. 把注射器慢慢地扭转瓶盖，将药物吸入注射器中。

注意不要碰触注射器或瓶口。

5. 检查一次性注射器上的药液是否有任何颜色、悬浮物或沉淀。

如果有异常，请不要使用。

6. 将注射器垂直握住，用手指轻轻敲击注射器的侧面，使药液上升到注射器的顶端，并尽量挤出气泡。

7. 找到注射部位的合适位置，用左手捏起一块皮肤。

8. 使用右手拇指和食指，将注射器以45度角插入皮肤。

注意不要刺穿太深。

9. 缓慢地推动注射器柱塞，将药物注射到皮下组织中。

10. 在完成注射后，用消毒酒精和棉球轻轻按压注射部位，以防止药物外溢。

11. 把使用过的注射器和其他废弃物放入专用的垃圾袋中，并正确处置。

以上是度拉糖肽注射的操作方法，但请注意这仅供参考，请在使用之前务必咨询医生以获取详细的使用说明和个体化的建议。

德谷胰岛素利拉鲁肽注射液英文名称: Insulin Degludec and Liraglutide Injection汉语拼音: Degu Yidaosu Lilalutai Zhusheye【成份】活性成分:德谷胰岛素和利拉鲁肽(采用重组DNA技术，利用酿酒酵母制成)。

1ml溶液含有100单位德谷胰岛素和3.6mg利拉鲁肽。

每支预填充注射笔装有3ml溶液，含有300单位德谷胰岛素和10.8mg利拉鲁肽。

1剂量单位含1单位德谷胰岛素和0.036mg利拉鲁肽。

德谷胰岛素化学名称:赖氨酸B29 (N ε -_羧基十五烷酰~γ -谷氨酰)去(B30)人胰岛素【性状】本品为无色或几乎无色的澄明液体。

【适应症】本品适用于血糖控制不佳的成人2型糖尿病患者，在饮食和运动基础上联合其他口服降糖药物，改善血糖控制。

【规格】每支3ml，含300单位德谷胰岛素和10.8mg利拉鲁肽。

【用法用量】用量：本品每日一次皮下注射给药。

可在一天中的任何时间进行给药，最好在每天相同时间给药。

本品的剂量应视患者个体需求而定。

建议根据空腹血糖进行剂量调整来优化血糖控制。

如果患者体力活动增加、日常饮食改变或发生伴随疾病，可能需要调整剂量。

遗漏用药的患者，建议他们一经发现，立即补药，并恢复常规的每日一次给药方案。

两次注射之间应至少保证间隔8小时。

这也适用于无法在每天的同一时间点给药的患者。

本品按剂量单位进行给药。

每剂量单位含1单位德谷胰岛素和0.036mg利拉鲁肽。

预填充注射笔可以1剂量单位为增量，一次注射1至50剂量单位。

本品的最大日剂量为50剂量单位(50单位德谷胰岛素和1.8mg利拉鲁肽)。

注射笔剂量计数器显示剂量单位的数量。

联合口服降糖药：本品推荐起始剂量为10剂量单位(10单位德谷胰岛素和0.36mg利拉鲁肽)。

本品可以联合现有口服降糖药物。

当本品联合磺脲类药物时，应考虑减少磺脲类药物的剂量(见[注意事项] )。

丛胰高糖素样肽-1 (GLP-1)受体激动剂转换【禁忌】对任一种或两种活性成分或者本品中任何一种辅料过敏者。