——新类别治疗糖尿病的药物的第一个
批准日期：2013年3月29日；公司：Janssen Research & Development，LLC
FDA 药物评价和研究中心代谢和内分泌产品部主任Mary Parks，M.D.说：“Invokana是在一种新类型药物已知为钠-葡萄糖共-转运蛋白2(SGLT2)抑制剂糖尿病治疗中被批准的第一个，”“我们继续以提供另外的治疗选泽影响公众健康的慢性疾病新类药物的批准推动创新。”
INVOKANA(canagliflozin)片，为口服使用
美国初始批准：2013
适应证和用途
INVOKANA是一种钠-葡萄糖共-转运蛋白2(SGLT2)抑制剂适用作为对食物和运动的一种辅助在有2型糖尿病成年中改善血糖控制。
使用的限制：
● 不为1型糖尿病或糖尿病酮症酸中毒的治疗。
剂型和给药方法
（1）推荐开始剂量是100 mg每天1次服药天第一餐前服用。
（2）在耐受INVOKANA 100 mg每天1次患者有eGFR为60 mL/min/1.73m2或大于和需要额外的血糖控制剂量可以增加至300 mg每天1次。
（3）在有eGFR为45至小于60 mL/min/1.73 m2患者INVOKANA被限制至100 mg每天1次。
（4）开始INVOKANA前评估肾功能。如eGFR低于45 mL/min/1.73 m2不要开始INVOKANA。
（5）终止INVOKANA如eGFR下降低于45mL/min/1.73m2。
剂型和规格
片：100mg，300mg
INVOKANA Rx
Generic Name and Formulations:
Canagliflozin 100mg, 300mg; tablets.
Company:
Janssen Pharmaceuticals, Inc.
Indications for INVOKANA:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis.
Adult:
See full labeling. Take before first meal of the day. Initially 100mg once daily; if tolerated and with eGFR ≥60mL/min/1.73m2, and need additional glycemic control; may increase to 300mg once daily. Moderate renal impairment (eGFR 45–<60mL/min/1.73m2): 100mg once daily; if eGFR <45mL/min/1.73m2: do not initiate. Concomitant UGT inducers in patients with eGFR ≥60mL/min/1.73m2: consider increase to 300mg once daily; if eGFR 45–<60mL/min/1.73m2: consider other antihyperglycemics.
Children:
<18yrs: not established.
Pharmacological Class:
Sodium-glucose co-transporter 2 (SGLT2) inhibitor.
Contraindications:
Severe renal impairment (eGFR <30mL/min/1.73m2), ESRD, or patients on dialysis.
Warnings/Precautions:
Correct volume depletion before starting therapy. Monitor for symptomatic hypotension in patients with renal impairment (eGFR <30mL/min/1.73m2), elderly, low systolic BP, concomitant diuretics or drugs that interfere with the renin-angiotensin-aldosterone system (eg, ACEIs, ARBs). Monitor renal function before and during therapy; more frequently if eGFR <60mL/min/1.73m2. Monitor K+ levels in patients with renal impairment and predisposed to hyperkalemia. Risk of genital mycotic infections; monitor and treat. Monitor LDL levels and treat per standard of care. Severe hepatic impairment: not recommended. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions:
Antagonized by UGT inducers (eg, rifampin, phenytoin, phenobarbital, ritonavir): see Adults dose. Concomitant digoxin: monitor. Concomitant insulin or insulin secretagogue: consider a lower dose of insulin/insulin secretagogue to reduce risk of hypoglycemia. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.
Adverse Reactions:
Female genital mycotic infections, urinary tract infection, increased urination; hyperkalemia, hypoglycemia, increases in LDL-C, hypersensitivity reactions (discontinue if occurs).
How Supplied:
Tabs—30, 90, (10x10 blister cards), 500
