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Toujeo® (insulin glargine injection) 300 Units/mL is an insulin of today

Toujeo® is a Once-daily Long-acting Basal Insulin for Adults With Diabetes Mellitus

  • Contains 300 units/mL of insulin glargine

Toujeo®: A stable activity profile to last beyond 24 hours1-3

  • Once-daily Toujeo® should be injected at the same time each day1
  • Toujeo® at steady state had a different activity profile than an equivalent dose of Lantus®1
  • In patients with T1DM, steady-state insulin levels are reached by at least 5 days of once-daily injections1

Toujeo® (insulin glargine injection) 300 Units/mL: Significant A1C reductions in patients with T2DM previously not at goal1

  • In all the EDITION studies, Toujeo® met the primary endpoint [prespecified noninferiority margin of 0.4% and the 95% CI]4-7
  • After changing to Toujeo®, patients may experience a temporary rise in FPG in the first weeks of therapy1
  • In EDITION 2 and EDITION 3, patients on Toujeo® were titrated to a higher average dose (12% and 15% more, respectively) than those on Lantus®1

Demonstrated safety
≤1% of subjects with T2DM experienced severe hypoglycemia with Toujeo®

  • Most common adverse events with Toujeo® in patients with T2DM were nasopharyngitis: 7.1%; upper respiratory tract infection: 5.7%1
  • There were no clinically important differences in body weight between treatment groups1

References: 1. Toujeo Prescribing Information. September 2015. 2. Becker RHA, Dahmen R, Bergmann K, Lehmann A, Jax T, Heise T. Diabetes Care. 2015;38(4):637-643. 3. Becker RHA, Nowotny I, Teichert L, Bergmann K, Kapitza C. Diabetes Obes Metab. 2015;17(3):261-267. 4. Data on file, Sanofi US. 5. Data on file, Sanofi US. 6. Data on file, Sanofi US. 7. Data on file, Sanofi US.

Clinical trials

Toujeo® was studied in 4 pivotal clinical trials with Lantus®.

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Toujeo® is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.

Important Limitations of Use: Toujeo® is not recommended for treating diabetic ketoacidosis.
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 (eg, 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.

Toujeo® SoloStar® is a disposable prefilled insulin pen. 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.

Do not withdraw Toujeo® from the SoloStar® disposable prefilled pen with a syringe.