近日,美国FDA批准Toujeo（甘精胰岛素[重组DNA来源]insulin glargine）注射液作为一种每日一次的长效胰岛素，用于1型和2型糖尿病成人患者，以改善血糖控制。
Toujeo与来得时有相同的活性成分-甘精胰岛素，但浓度是来得时的三倍，并且更能逐步地释放胰岛素。这款药物提供了与来得时一样的血糖控制，但能明显降低低血糖发生率，低血糖是一种潜在危险的血糖下降。
批准日期：2015年3月2日  公司：赛诺菲公司
TOUJEO（甘精胰岛素[insulin glargine]）注射液U-300，用于皮下使用
美国最初批准：2015年
作用机制
胰岛素的主要活性，包括甘精胰岛素，是葡萄糖代谢的调节。 胰岛素及其类似物通过刺激外周葡萄糖摄取，特别是通过骨骼肌和脂肪，以及通过抑制肝葡萄糖产生来降低血糖。 胰岛素抑制脂肪分解和蛋白水解，并增强蛋白质合成。
适应症和用法
TOUJEO是一种长效人胰岛素类似物，用于改善糖尿病患者的血糖控制。
使用限制：
不建议用于治疗糖尿病酮症酸中毒。
剂量和给药
根据糖尿病类型，代谢需求，血糖监测结果和血糖控制目标个体化剂量。
每天在任何时间每天一次皮下注射，每天在同一时间。
旋转注射部位以降低脂肪代谢障碍的风险。
不要稀释或与任何其他胰岛素或溶液混合。
更换为TOUJEO时以及之后的最初几周内密切监测葡萄糖。
剂量形式和强度
注射：在1.5mLSoloStar®一次性预填充笔中使用300单位/mL甘精胰岛素。
禁忌症
在低血糖发作期间。
对TOUJEO或其中一种辅料过敏。
警告和注意事项
切勿在患者之间共用TOUJEOLoloStar®一次性预充笔，即使更换针头也是如此。
胰岛素治疗方案改变的高血糖或低血糖症：在密切的医疗监督下进行。
低血糖：可能危及生命。增加葡萄糖监测的频率，改变：胰岛素剂量，共同给予葡萄糖降低药物，膳食模式，身体活动;并且在肾功能不全或肝功能不全或低血糖的患者中无意识。
药物治疗错误：可能发生胰岛素产品之间的意外混淆。指导患者在注射前检查胰岛素标签。
过敏反应：可能发生严重的，危及生命的全身性过敏，包括过敏反应。停止使用TOUJEO，如果有指示，进行监测和治疗。
低钾血症：可能危及生命。监测有低钾血症风险的患者的钾水平，并进行治疗。
伴随使用噻唑烷二酮（TZDs）的液体潴留和心力衰竭：观察心力衰竭的体征和症状;如果发生心力衰竭，考虑减少剂量或停药。
不良反应
通常与TOUJEO（≥5％）相关的不良反应是：
低血糖，过敏反应，注射部位反应，脂肪营养不良，瘙痒，皮疹，水肿和体重增加。
要报告疑似不良反应，请致电1-800-633-1610联系赛诺菲尼克斯，或致电1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
药物相互作用
影响葡萄糖代谢的药物：可能需要调整胰岛素剂量;密切监测血糖。
抗肾上腺素药物（例如，β-受体阻滞剂，可乐定，胍乙啶和利血平）：低血糖的体征和症状可能减少或消失。
用于特定人群
怀孕：只有在潜在的益处证明对胎儿有潜在风险的情况下才能在怀孕期间使用。
包装提供/存储和处理
产品：50090-2193
NDC：50090-2193-0在SYRINGE中1.5mL
完整说明书附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=257ca17b-6ff7-4f2e-9037-4c185bac5768
Toujeo(insulin glargine injection) 300Units/mL
Toujeo® is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.
Limitations of Use: Toujeo® is not recommended for treating diabetic ketoacidosis.
Important Safety Information for Toujeo® (insulin glargine injection) 300 Units/mL
Contraindications
Toujeo® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or any of its excipients.
Warnings and Precautions
Toujeo® contains the same active ingredient, insulin glargine, as Lantus®. The concentration of insulin glargine in Toujeo® is 300 units per mL.
Insulin pens and needles must never be shared between patients. Do NOT reuse needles.
Monitor blood glucose in all patients treated with insulin. Modify insulin regimens cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Changes in insulin regimen may result in hyperglycemia or hypoglycemia.
Unit for unit, patients started on, or changed to, Toujeo® required a higher dose than patients controlled with Lantus®. When changing from another basal insulin to Toujeo®, patients experienced higher average fasting plasma glucose levels in the first few weeks of therapy until titrated to their individualized fasting plasma glucose targets. Higher doses were required in titrate-to-target studies to achieve glucose control similar to Lantus®.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Toujeo®, and may be life-threatening.
Medication errors, such as accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. Patients should be instructed to always verify the insulin label before each injection.
Do not dilute or mix Toujeo® with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Toujeo® via an insulin pump or intravenously because severe hypoglycemia can occur.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Toujeo®, monitor and treat if indicated.
A reduction in the Toujeo® dose may be required in patients with renal or hepatic impairment.
As with all insulins, Toujeo® use can lead to life-threatening hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.
Drug Interactions
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).
Adverse Reactions
Adverse reactions commonly associated with Toujeo® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.
Important Safety Information for Toujeo® (insulin glargine injection) 300 Units/mL SoloStar® and Toujeo® Max SoloStar®
Toujeo® SoloStar® and Toujeo® Max SoloStar® are disposable prefilled insulin pens. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose levels. It is especially important to perform a safety test when a patient is using a new pen for the first time.
Do not withdraw Toujeo® from the SoloStar® and Max SoloStar® disposable prefilled pens with a syringe.