FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE 适应症和用途
FARXIGA (dapagliflozin) is indicated as an adjunct to diet and exerci to improve glycemic control in adults with type 2 diabetes mellitus [e Clinical Studies (14)].
本药用于配合饮食控制和运动改善2型糖尿病患者的血糖控制。
1.1 Limitation of U 使用限制
你的歌词
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
本药不适用于1型糖尿病或糖尿病酮症酸中毒患者。
2 DOSAGE AND ADMINISTRATION 用法用量
爱国简笔画
2.1 Recommended Dosing 推荐剂量
The recommended starting do of FARXIGA is 5 mg once daily, taken in the morning, with or without f
ood. In patients tolerating FARXIGA 5 mg once daily who require additional glycemic control, the do can be incread to 10 mg once daily.
推荐起始剂量为一次5mg，一日1次，早晨服用，可与或不与食物同服。对本药一次5mg，一日1次剂量耐受且须更多血糖扩指着，可增至一次10mg，一日1次。
In patients with volume depletion, correcting this condition prior to initiation of FARXIGA is recommended [e Warnings and Precautions (5.1), U in Specific Populations (8.5, 8.6), and Patient Counling Information (17)].
血容量减少患者，推荐用药前应先纠正血容量减少。
2.2 Patients with Renal Impairment 肾功能不全时剂量
Asssment of renal function is recommended prior to initiation of FARXIGA therapy and periodically thereafter.
建议在开始使用本药前及使用期间定期评估肾功能。
FARXIGA should not be initiated in patients with an eGFR less than 60 mL/min/1.73 m2.
肾小球滤过率＜60ml/(min/1.73m2)患者不得开始用药。
No do adjustment is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m2 or greater).
轻度肾功能损害者[肾小球滤过率≥60ml/(min/1.73m2)]无需调整剂量。
FARXIGA should be discontinued when eGFR is persistently less than 60 mL/min/1.73 m2[e Warnings and Precautions (5.2) and U in Specific Populations (8.6)].
肾小球滤过率持续＜60ml/(min/1.73m2)时应停药。
3 DOSAGE FORMS AND STRENGTHS 剂型和规格
●FARXIGA 5 mg tablets are yellow, biconvex, round, film-coated tablets with “5” engraved on
one side and “1427” engraved on the other side.
●FARXIGA 10 mg tablets are yellow, biconvex, diamond-shaped, film-coated tablets with “10”
engraved on one side and “1428” engraved on the other side.
达格列净片 (1)5mg。(2)10mg。
4 CONTRAINDICATIONS 禁忌症
●History of a rious hypernsitivity reaction to FARXIGA [e Adver Reactions (6.1)].
●Severe renal impairment, end-stage renal dia (ESRD), or patients on dialysis [e U in
Specific Populations (8.6)].
1.对本药有严重过敏史者。
2.重度肾功能损害、晚期肾病患者。
3.透析患者。
5 WARNINGS AND PRECAUTIONS 警告和注意事项
5.1 Hypotension 低血压
FARXIGA caus intravascular volume contraction. Symptomatic hypotension can occur after initiati
ng FARXIGA [e Adver Reactions (6.1)] particularly in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics. Before initiating FARXIGA in patients with one or more of the characteristics, volume status should be assd and corrected. Monitor for signs and symptoms of hypotension after initiating therapy.
本药可引起血管收缩，开始用药后可出现症状性低血压。尤其肾功能损害者[(肾小球滤过率＜60ml/(min/1.73m2)]、老年患者、使用髓袢利尿药的患者。以上患者开始使用本药前应先评估并纠正血容量状况。用药后应监测低血压迹象和症状。
5.2 Impairment in Renal Function 肾功能损害
FARXIGA increas rum creatinine and decreas eGFR. Elderly patients and patients with impaired renal function may be more susceptible to the changes. Adver reactions related to renal function can occur after initiating FARXIGA [e Adver Reactions (6.1)]. Renal function should be evaluated prior to initiation of FARXIGA and monitored periodically thereafter
本药可增加血清肌酸酐并降低肾小球滤过率。老年患者和肾功能损害者对此类作用更为敏感。用药后可能出现与肾功能相关的不良反应，开始使用本药前及使用期间应定期评估肾功能。
5.3 Hypoglycemia with Concomitant U with Insulin and Insulin Secretagogues 低血糖(与
胰岛素和胰岛素促泌剂合用时)油辣椒怎么做才又香又辣又红
Insulin and insulin cretagogues are known to cau hypoglycemia. FARXIGA can increa the risk of hypoglycemia when combined with insulin or an insulin cretagogue [e Adver Reactions (6.1)]. Therefore, a lower do of insulin or insulin cretagogue may be required to minimize the risk of hypoglycemia when the agents are ud in combination with FARXIGA.
已知胰岛素和胰岛素促泌剂可引起低血糖。本药与以上两种药物合用时发生低血糖的风险增加。合用时可能需降低胰岛素或胰岛素促泌剂的剂量，以降低低血糖风险。
5.4 Genital Mycotic Infections 生殖器霉菌感染
FARXIGA increas the risk of genital mycotic infections. Patients with a history of genital mycotic infections were more likely to develop genital mycotic infections [e Adver Reactions (6.1)]. Monitor and treat appropriately.
本药增加发生生殖器霉菌感染的风险。有生殖器霉菌感染病史的患者更易出现。应进行适当的监测和治疗。
5.5 Increas in Low-Density Lipoprotein Cholesterol (LDL-C) 低密度脂蛋白(LDL-C)升高Increas in
LDL-C occur with FARXIGA [e Adver Reactions (
6.1)]. Monitor LDL-C and treat per standard of care after initiating FARXIGA.
本药可使LDL-C升高，开始用药后应监测LDL-C并进行标准治疗。
5.6 Bladder Cancer 膀胱癌
Across 22 clinical studies, newly diagnod cas of bladder cancer were reported in 10/6045
patients (0.17%) treated with FARXIGA and 1/3512 patient (0.03%) treated with placebo/comparator. After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 4 cas with FARXIGA and no cas with placebo/comparator. Bladder cancer risk factors and hematuria (a potential indicator of preexisting tumors) were balanced between treatment arms at baline. There were too few cas to determine whether the emergence of the events is related to FARXIGA.
22项临床试验中，有0.17%(10/6045)使用本药和0.03%(1/3512)使用安慰剂患者出现新近诊断的膀胱癌的报道。排除诊断为膀胱癌时用药不足一年的患者，有4例使用本药患者出现膀胱癌(使用安慰剂患者0例)。开始用药时在治疗组中评估膀胱癌风险因素和血尿(已存在肿瘤的潜在指标)，评估人数过少
无法确定膀胱癌是否与本药相关。
There are insufficient data to determine whether FARXIGA has an effect on pre-existing bladder tumors. Conquently, FARXIGA should not be ud in patients with active bladder cancer. In patients with prior history of bladder cancer, the benefits of glycemic control versus unknown risks for cancer recurrence with FARXIGA should be considered.
尚无充分的数据确定本药对已存在的膀胱癌是否有作用。故活动期膀胱癌患者不得用药。有膀胱癌病史者，用药时应权衡血糖控制与复发的未知风险。
5.7 Macrovascular Outcomes 大血管病变
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with FARXIGA or any other antidiabetic drug.
尚无本药或其他任一抗糖尿病药降低大血管病变风险的临床试验证据。
6 ADVERSE REACTIONS 不良反应
报纸杂志The following important adver reactions are described below and elwhere in the labeling:
下列重要不良反应已在说明书其他章节讨论：
●Hypotension [e Warnings and Precautions (5.1)]
●Impairment in Renal Function [e Warnings and Precautions (5.2)]
●Hypoglycemia with Concomitant U with Insulin and Insulin Secretagogues [e Warnings
and Precautions (5.3)]
●Genital Mycotic Infections [e Warnings and Precautions (5.4)]
棒棒糖的英文●Increas in Low-Density Lipoprotein Cholesterol (LDL-C) [e Warnings and Precautions
(5.5)]
●Bladder Cancer [e Warnings and Precautions (5.6)]
低血压、肾功能损害、低血糖(与胰岛素和胰岛素促泌剂合用时)、生殖器霉菌感染、LDL-C 升高、膀胱癌。
6.1 Clinical Trials Experience 临床试验经验
Becau clinical trials are conducted under widely varying conditions, adver reaction rates obrved in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates obrved in clinical practice.
由于临床试验是在各种不同条件下进行的，观察到的不良反应发生率不能直接与其他临床试验中的发生率相比较，可能也不能反应临床实践中观察到的发生率。
Pool of 12 Placebo-Controlled Studies for FARXIGA 5 and 10 mg
12项本药5mg、10mg安慰剂对照试验合并数据
The data in Table 1 is derived from 12 placebo-controlled studies ranging from 12 to 24 weeks. In 4 studies FARXIGA was ud as monotherapy, and in 8 studies FARXIGA was ud as add-on to
background antidiabetic therapy or as combination therapy with metformin [e Clinical Studies (14)].
表1中的数据来源于12项安慰剂对照试验，试验时长12-24周。其中4项为本药单药治疗，另外8项为本药加入标准糖尿病治疗方案或与二甲双胍合用。
The data reflect exposure of 2338 patients to FARXIGA with a mean exposure duration of 21 weeks. Patients received placebo (N=1393), FARXIGA 5 mg (N=1145), or FARXIGA 10 mg (N=1193) once daily. The mean age of the population was 55 years and 2% were older than 75 years of age. Fifty percent (50%) of the population were male; 81% were White, 14% were Asian, and 3% were Black or African American. At baline, the population had diabetes for an average of 6 years, had a mean hemoglobin A1c (HbA1c) of 8.3%, and 21% had established microvascular complications of diabetes. Baline renal function was normal or mildly impaired in 92% of patients and moderately impaired in 8% of patients (mean eGFR 86 mL/min/1.73 m2).
试验数据中，2338名患者接受本药治疗，平均暴露时间为21周。其中安慰剂组1393名患者、本药5mg组1145名患者、本药10mg组1193名患者，患者均接受一日1次用药。受试者平均年龄55岁，其中2%＞75岁。50%为男性，81%为白种人，14%为亚洲人，3%为黑人或非暨美国人。基线水平，受试者患病平均年数为6年，糖化血红蛋白(HbA1c)平均值为8.3%，其中21%受试者出现糖尿病微血管并发症。92%受试者肾功能正常或出现轻度肾功能损害，8%受试者出现中度肾功能损害，平均肾小球滤过率为86ml/(min/1.73m2)。
Table 1 shows common adver reactions associated with the u of FARXIGA. The adver reactions were not prent at baline, occurred more commonly on FARXIGA than on placebo, and
occurred in at least 2% of patients treated with either FARXIGA 5 mg or FARXIGA 10
mg.
本药的常见不良反应见表1。这些不良反应并不是在基线时出现，本药较安慰剂更为常
见发生程度，在本药5mg或10mg组中发生率≥2%。
三岁小孩学画画Table 1: Adver Reactions in Placebo-Controlled Studies Reported in ≥2% of Patients Treated with FARXIGA 表1 安慰剂对照试验中本药发生率≥2%的不良反应
reported for females: vulvovaginal mycotic infection, vaginal infection, vulvovaginal candidiasis, vulvovaginitis, genital infection, genital candidiasis, fungal genital infection, vulvitis, genitourinary tract infection, vulval abscess, and vaginitis bacterial. (N for females: Placebo=677, FARXIGA 5 mg=581, FARXIGA 10 mg=598).
* 女性生殖器霉菌感染包括以下不良反应(按发生率排序)：外阴阴道霉菌感染、阴道感染、外阴阴道念珠菌病、外阴阴道炎、生殖感染、生殖器念珠菌病、生殖器真菌感染、外阴炎、泌尿生殖道感染、外阴脓肿、细菌性阴道炎。
† Urinary tract infections include the following adver reactions, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection, and prostatitis.
产业分析
早恋的危害† 尿道感染包括以下不良反应(按发生率排序)：尿道感染、膀胱炎、大肠埃希菌型尿路感染、泌尿生殖道感染、肾盂肾炎、膀胱三角炎、尿道炎、肾脏感染、前列腺炎。
‡ Incread urination includes the following adver reactions, listed in order of frequency reported: pollakiuria, polyuria, and urine output incread.
‡ 排尿增加包括以下不良反应(按发生率排序)：尿频、多尿、尿量增加。
§ Genital mycotic infections include the following adver reactions, listed in order of frequency reported for males: balanitis, fungal genital infection, balanitis candida, genital candidiasis, genital infection male, penile infection, balanoposthitis, balanoposthitis infective, genital infection, posthitis. (N for males: Placebo=716, FARXIGA 5 mg=564, FARXIGA 10 mg=595). § 男性生殖器霉菌感染包括以下不良反应(按发生率排序)：龟头炎、生殖器真菌感染、龟头念珠菌病、生殖器念珠菌病、男性生殖器感染、阴茎感染、龟头包皮炎、感染性龟头包皮炎、生殖感染、包皮炎。
Pool of 13 Placebo-Controlled Studies for FARXIGA 10 mg
13项本药10mg安慰剂对照试验合并数据
The safety and tolerability of FARXIGA 10 mg was also evaluated in a larger placebo-controlled study pool. This pool combined 13 placebo-controlled studies, including 3 monotherapy studies, 9 add-on to background antidiabetic therapy studies, and an initial combination with metformin study. Across the 13 studies, 2360 patients were treated once daily with FARXIGA 10 mg for a mean duration of exposure of 22 weeks. The mean age of the population was 59 years and 4% were older than 75 years. Fifty-eight percent (58%) of the population were male; 84% were White, 9% were Asi
an, and 3% were Black or African American. At baline, the population had diabetes for an average of 9 years, had a mean HbA1c of 8.2%, and 30% had established microvascular dia. Baline renal function was normal or mildly impaired in 88% of patients and moderately impaired in 11% of patients (mean eGFR 82 mL/min/1.73 m2).
本药10mg的安全性和耐受性在一项大型安慰剂对照合并研究中进行评估。这项合并对照研究包括13项临床试验，其中3项为本药单药治疗，另外9项为本药加入标准糖尿病治疗方案或用药初期与二甲双胍合用。试验数据中，2360名患者接受本药10mg治疗，一日1次，患者平均暴露时间为22周。受试者平均年龄59岁，其中4%＞75岁。58%为男性，84%为白种人，9%为亚洲人，3%为黑人或非暨美国人。基线水平，受试者患病平均年数为9年，HbA1c平均值为8.2%，其中30%受试者出现糖尿病微血管并发症。88%受试者肾功能正常或出现轻度肾功能损害，11%受试者出现中度肾功能损害，平均肾小球滤过率为82ml/(min/1.73m2)。
Volume Depletion 血容量不足
FARXIGA caus an osmotic diuresis, which may lead to reductions in intravascular volume. Adver reactions related to volume depletion (including reports of dehydration, hypovolemia,
