Contraindications

Toujeo is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or any of the excipients in Toujeo.

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 (U-300).

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 only under medical supervision. Changes in insulin regimen, strength, manufacturer, type, injection site 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. Dosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to Toujeo from another insulin therapy.

Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis may result in hyperglycemia; sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate injection site to unaffected areas and closely monitor for hypoglycemia.

Unit for unit, patients started on, or switched to, Toujeo required a higher dose than patients controlled with Lantus. When switching 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 in patients treated with Toujeo and may be life-threatening. The long-acting effect of Toujeo may delay recovery from hypoglycemia compared to shorter-acting insulins.

Medication errors that may lead to hypoglycemia, such as accidental mix-ups between insulin products, 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.

All insulins, including Toujeo, 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 dosage 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, hypersensitivity reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.

Important Safety Information for Toujeo U-300 (insulin glargine) injection SoloStar and Toujeo Max SoloStar

Toujeo SoloStar and Toujeo Max SoloStar are single-patient-use prefilled insulin pens. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying their 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 single-patient-use prefilled pens with a syringe.