新药Steglatro(Ertugliflozin）获得FDA批准上市，用于治疗II型糖尿病。
近日，由默克公司(MRK.N)和辉瑞公司(PFE.N)共同开发的一种新药Steglatro(ertugliflozin)获得FDA的批准，将用于治疗II型糖尿病。
Steglatro属于一种SGLT2抑制剂，其通过使患者通过尿液排出过量葡萄糖而起作用，值得欣喜的是这一治疗不依赖胰岛素，为糖尿病的治疗提供了全新的思路。
默克和辉瑞在获得Steglatro作为单一疗法的批准之后，将与默克的糖尿病药物Januvia或二甲双胍(一种通常给予新诊断的患者的通用疗法)进行固定剂量组合。
批准日期：2017年12月20日
适应症
STEGLATRO™是一种辅助饮食和运动, 以改善血糖控制的成人2型糖尿病。
使用限制
•STEGLATRO 1型糖尿病患者或糖尿病酮症酸中毒的治疗不推荐使用。
剂量和管理
推荐用量
·推荐的 STEGLATRO 剂量为每天5毫克, 早上服用或无食物。在每天耐受STEGLATRO 5毫克的患者中, 如果需要额外的血糖控制, 剂量可以增加到建议剂量的15毫克。
•In 患者的体积耗尽, 纠正这一情况之前开始的 STEGLATRO[见警告和预防措施]。
肾功能损害患者
•Assess肾功能启动前STEGLATRO和定期[见警告和预防措施]。
•Use的STEGLATRO 是禁忌的患者与 eGFR 少于30毫升/分钟/1.73 m² [见禁忌症]。
在30毫升/分钟/1.73 m²的 eGFR 到少于60毫升/分钟/1.73 m²的患者中, 不推荐使用 STEGLATRO 的•Initiation [请参阅警告和预防措施, 并在特定人群中应用]。
当 eGFR 持续在30和少于60毫升/分钟/1.73 m²之间时, 建议不要使用STEGLATRO •Continued。轻度肾功能损害患者不需要剂量调节。
包装提供/贮存
剂型和强度
•Tablets: 5 毫克, 粉红色, 三角形形 debossed 与 "701" 一侧和平原上的另一侧。
•Tablets:15 毫克, 红色, 三角形形 debossed 与 "702" 在一侧和平原上的另一侧。
存储和处理
STEGLATRO (ertugliflozin) 片可在下面列出的优势:
5毫克片剂, 是粉红色, 三角形形, 凸透镜, 与 "701" debossed 在一边和平原上的另一边。它们提供如下:
NDC 0006-5363-03 单位使用瓶30
NDC 0006-5363-06 单位使用瓶90
NDC 0006-5363-07 散瓶500
15毫克片剂, 是红色, 三角形形, 凸透镜, 与 "702" debossed 在一边和平原在另一边。它们提供如下:
NDC 0006-5364-03 单位使用瓶30
NDC 0006-5364-06 单位使用瓶90
NDC 0006-5364-07 散瓶500
贮存瓶
贮存在 20°c-25°c (68°F-77°F), 允许在 59°F-30°c 之间的远足 [参见 USP 控制的室温]。防止湿气。存放在干燥的地方。
Steglatro(Ertugliflozin Tables for Oral Use)
STEGLATRO Rx
Generic Name and Formulations:
Ertugliflozin 5mg, 15mg; tabs.
Company:
Merck & Co., Inc.
Indications for STEGLATRO:
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 mellitus or diabetic ketoacidosis.
Adult:
Take in the AM. Initially 5mg once daily; if tolerated and need additional glycemic control; may increase to max 15mg once daily. Renal impairment: if eGFR 30–<60mL/min/1.73m2: do not initiate; if persistently between 30–<60mL/min/1.73m2: continued use is not recommended.
Children:
<18yrs: not established.
Contraindications:
Severe renal impairment (eGFR <30mL/min/1.73m2), ESRD, or on dialysis.
Warnings/Precautions:
Correct volume depletion before initiating. Monitor for signs/symptoms of hypotension (esp. elderly, patients with renal impairment, low systolic BP, or on diuretics). Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Evaluate renal function prior to starting and monitor periodically thereafter. Risk of acute kidney injury in hypovolemia, chronic renal insufficiency, CHF, and concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Increased risk of genital mycotic infections or UTIs; monitor and treat if occurs. History of prior amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers. Monitor for sign/symptoms of infection (including osteomyelitis), new pain/tenderness, sores or ulcers involving the lower limbs; discontinue if occur. Monitor for increases in LDL-C; treat if occur. Severe hepatic impairment: not recommended. Elderly. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.
Interactions:
Consider a lower dose of concomitant insulin/insulin secretagogue to reduce risk of hypoglycemia. Hypotension with concomitant diuretics. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.
Pharmacological Class:
Sodium-glucose co-transporter 2 (SGLT2) inhibitor.
Adverse Reactions:
Female genital mycotic infections, UTIs, headache, vaginal pruritus, increased urination, nasopharyngitis, back pain, weight decrease, thirst; volume depletion, renal impairment, ketoacidosis, amputation, hypoglycemia, urosepsis, pyelonephritis.
Generic Availability:
NO
How Supplied:
Tabs—30, 90, 500
https://www.rxlist.com/steglatro-drug.htm