药品信息:
英文药名：FARXIGA（dapagliflozin Tablets）
中文药名：达帕格列净膜包衣片剂
生产厂家：阿斯利康
药品介绍：
FDA药物评价和研究中心药物评价II室主任Curtis Rosebraugh，M.D.，M.P.H. 说：“在糖尿病总体治疗和护理中控制血糖水平很重要，而Farxiga为美国数以百万2型糖尿病患者提供一种另外选择。“
适应证和用途
FARXIGA是一种钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂适用在有2型糖尿病成人中作为辅助饮食和运动改善血糖控制。
使用限制：不为1型糖尿病或糖尿病酮症酸中毒治疗。
剂量和给药方法
（1）推荐起始剂量是5 mg每天1次，早晨服用，有或无食物。
（2）在耐受FARXIGA需要附加血糖控制患者中剂量可增加至10 mg每天1次。
（3）开始FARXIGA前评估肾功能。如eGFR低于60 mL/min/1.73 m2不要开始FARXIGA。
（4）终止FARXIGA如eGFR下降持续低于60 mL/min/1.73 m2。
剂型和规格
片：5mg和10mg。
禁忌证
（1）对FARXIGA严重超敏反应史。
（2）严重肾受损，肾病终末期，或透析。
警告和注意事项
（1）低血压：开始FARXIGA前，评估血容量状态和在老年人，在有肾受损或低收缩压患者，和用利尿药患者中纠正低血容量。治疗期间监视体征和症状。
（2）肾功能受损：治疗期间监视肾功能。
（3）低血糖：在用FARXIGA服用胰岛素或一种胰岛素促分泌素患者，考虑较低剂量胰岛素或胰岛素促分泌素以减低低血糖风险。
（4）生殖器真菌感染：如适用监视和治疗。
（5）LDL-C增高：每标准医护监视和治疗。
（6）膀胱癌：在临床试验中观察到膀胱癌不平衡。有活动性膀胱癌患者中不应使用FARXIGA和有膀胱癌既往史患者中应谨慎使用。
（7）大血管病变结局：没有临床研究确定用FARXIGA或任何其他抗糖尿病药物减低大血管风险结论性证据。
不良反应
伴随FARXIGA最常见不良反应(5%或更高发生率)是女性生殖器真菌感染，鼻咽炎，和泌尿道感染。
报告怀疑不良反应，联系Bristol-Myers Squibb电话1-800-721-5072或FDA电话1-800-FDA-1088或www.fda.gov/medwatch。
在特殊人群中使用
（1）妊娠：在妊娠妇女中没有适当和对照良好研究。妊娠期间只有潜在获益胜过对胎儿潜在风险才使用。
（2）哺乳母亲：终止FARXIGA或终止哺乳.
（3）老年人：与减低血管内容量相关不良反应发生率较高。
（4）肾受损：与减低血管内容量和肾功能相关不良反应发生率较高。
US FDA approves FARXIGA™ (dapagliflozin) tablets for the treatment of adult patients with type 2 diabetes
Monday, 13 January 2014
AstraZeneca and Bristol-Myers Squibb Company announced the US Food and Drug Administration (FDA) approved FARXIGA™ [far-SEE-ga] (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. FARXIGA should not be used for the treatment of patients with type 1 diabetes or diabetic ketoacidosis.
The recommended starting dose of FARXIGA is 5 mg once daily, taken in the morning, with or without food. In patients tolerating FARXIGA 5 mg once daily who require additional glycaemic control, the dose can be increased to 10 mg once daily. FARXIGA is part of a newer class of medicines called sodium-glucose cotransporter 2 (SGLT2) inhibitors, which remove glucose via the kidneys.
“With the diabetes epidemic escalating and many people with type 2 diabetes struggling to reach their blood sugar goals, FARXIGA offers an important new option for healthcare professionals and adult patients,” said Brian Daniels, Senior Vice President, Global Development and Medical Affairs, Bristol-Myers Squibb. “In clinical trials, FARXIGA helped improve glycaemic control, and offered additional benefits of weight and blood pressure reductions.”
FARXIGA is contraindicated in patients with a history of a serious hypersensitivity reaction to FARXIGA or with severe renal impairment, end stage renal disease, or patients on dialysis.
“The addition of FARXIGA to our US treatment portfolio is a step forward as we work to help reduce the burden of type 2 diabetes by offering a range of treatment options with different modes of action,” said Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca. “We aim to help adults with type 2 diabetes, and their doctors, create individualised treatment programmes that will help patients lower their glucose levels.”
Dapagliflozin (marketed outside of the United States as FORXIGA®) is approved for the treatment of adults with type 2 diabetes, along with diet and exercise, in 40 countries, including European Union countries and Australia.
NOTES TO EDITORS
FARXIGA Clinical Development Programme
The robust FARXIGA clinical development programme included 24 clinical studies eva luating safety and efficacy. The studies included more than 11,000 adults with type 2 diabetes, including more than 6,000 patients treated with FARXIGA.
FARXIGA causes intravascular volume contraction. Symptomatic hypotension can occur after initiating FARXIGA 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 these characteristics, volume status should be assessed and corrected. Monitor for signs and symptoms of hypotension after initiating therapy. FARXIGA increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Adverse reactions related to renal function can occur after initiating FARXIGA. Renal function should be eva luated prior to initiation of FARXIGA and monitored periodically thereafter.
In a 24-week, add-on to metformin clinical trial, adult patients with type 2 diabetes treated with FARXIGA 5 mg (n=137; baseline HbA1c 8.2%) or 10 mg (n=135; baseline HbA1c 7.9%) had significant reductions in HbA1c of -0.7% and -0.8%, respectively, compared with placebo plus metformin reductions of -0.3% (n=137; baseline HbA1c 8.1%). In the same study, the placebo-adjusted reduction in body weight was -2.2 kg with FARXIGA 5 mg (baseline 84.7 kg) and -2.0 kg with 10 mg (baseline 86.3 kg). Also, mean changes from baseline in systolic blood pressure relative to placebo plus metformin were -4.5 mmHg and -5.3 mmHg with FARXIGA 5 mg or 10 mg plus metformin, respectively. No major episodes of hypoglycaemia were seen in any of the treatment arms. Minor episodes of hypoglycaemia were reported in 1.5%, 0.7%, and 0% with FARXIGA 5 mg, 10 mg, and placebo plus metformin, respectively.
In addition to the clinical development programme, the AstraZeneca/Bristol-Myers Squibb Diabetes Alliance has initiated DECLARE, a large, randomised, placebo-controlled study of more than 17,000 adult patients with type 2 diabetes designed to determine the effect of FARXIGA, when added to the patients’ current anti-diabetes therapy, on the risk of CV events, such as CV death, myocardial infarction or ischaemic stroke, compared with placebo. The study, which will also provide additional data on the long-term safety profile, initiated enrolment in April 2013 and has an anticipated completion date of 2019. |
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