2015年2月25日，美国FDA已批准其每日一次长效基础胰岛素Toujeo（insulin glargine [rDNAorigin] injection，甘精胰岛素[rDNA来源]注射剂，300单位/毫升）用于改善I型和II型糖尿病成人患者血糖控制。
Toujeo预计今年第二季度初将在美国上市。
“赛诺菲在糖尿病和胰岛素治疗领域有悠久历史，包括Lantus（Insulin Glargine jection
，甘精胰岛素注射液/来得时）支持患者糖尿病已逾十年。在Toujeo获准后，赛诺菲将继续巩固其传统并为患者带来了新的治疗选择。
FDA审查了该公司的EDITION临床试验方案，该方案由在3500多名广泛而多样的糖尿病成人患者（包括I型和II型）中评估Toujeo的疗效和安全性的一系列国际III期研究组成。在这些最终作为获准依据的临床试验计划中，每日一次Toujeo与每日一次Lantus（100单位/毫升）作开放标记、随机对照的平行研究，治疗时间长达26周，随后作6个月的安全性扩展研究。

Important Safety Information for Toujeo® (insulin glargine injection) 300 Units/mL
Do not take Toujeo® if you have low blood sugar or if you are allergic to insulin or any of the ingredients in Toujeo®.
TOUJEO Rx
Generic Name and Formulations:
Insulin glargine (recombinant) 300 Units/mL; soln for SC inj.

Company:
Sanofi Aventis
Indications for TOUJEO:
Diabetes.

Limitations Of use:
Not for treating ketoacidosis.

Adult:
Give by SC inj once daily at same time each day into abdominal area, thigh, or deltoid. Rotate inj sites. Onset 6hrs, duration 24hrs–5 days. Individualize; monitor and adjust as needed. Usual range: 1–80 Units per inj. Titrate every 3–4 days. Insulin-naïve with type 1 diabetes: Initially ⅓–½ of total daily insulin dose. Give remainder of the total dose as short-acting insulin divided between each daily meal. Insulin-naïve with type 2 diabetes: Initially 0.2 Units/kg once daily. May need to adjust dose of other co-administered antidiabetic drugs. Switching from once-daily long-acting or intermediate acting insulin: initial dose should be the same on a unit-for-unit basis. Switching from Lantus: higher daily dose will be needed. Switching from twice-daily NPH: reduce initial insulin glargine dose by 20% from previous total daily NPH dose.

Children:
Not established.

Contraindications:
During episodes of hypoglycemia.

Warnings/Precautions:
Increased risk of hypoglycemia if changes in physical activity, meal patterns, renal or hepatic function, insulin regimen and if acute illness occurs: monitor glucose more frequently and may need to adjust dose. Discontinue if hypersensitivity reactions occur. Elderly. Pregnancy. Nursing mothers.

Interactions:
Do not mix or dilute with other insulins or solutions. Caution with K+-depleting drugs or those sensitive to serum K+ concentrations; may cause hypokalemia. Concomitant thiazolidinediones (TZDs) may cause fluid retention and heart failure; consider dose reduction or discontinue TZDs. Increased risk of hypoglycemia with concomitant antidiabetics, ACEIs, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (eg, octreotide), sulfonamides; monitor more frequently and adjust dose as needed. Reduced efficacy with concomitant atypical antipsychotics (eg, olanzapine, clozapine), steroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, protease inhibitors, somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), thyroid hormones; monitor more frequently and adjust dose if needed. Variable effects with alcohol, β-blockers, clonidine, lithium salts, pentamidine; monitor more frequently and adjust dose if needed. Concomitant β-blockers, clonidine, guanethidine, or reserpine may reduce or mask signs/symptoms of hypoglycemia.

Adverse Reactions:
Hypoglycemia, allergic reactions, inj. site reactions, lipodystrophy, pruritus, rash, edema, weight gain; hypokalemia (monitor).

Generic Availability:
NO

How Supplied:
SoloStar pen (1.5mL)—3, 5 (prefilled, disposable inj device)