TOUJEO ® SOLOSTAR U-300 ( INSULIN GLARGINE 300 UNITS/ ML ) SOLUTION FOR SUBCUTANEOUS INJECTION — 3 PREFILLED PENS X 1.5 ML

Toujeo® U-300 (Insulin Glargine) Injection 300 Units/mL

Description

Toujeo® (insulin glargine) U-300 is a prescription, long-acting basal insulin indicated to improve glycemic control in adults and children aged 6 years and older with diabetes mellitus. It provides a steady release of insulin over an extended period, helping maintain stable blood glucose levels throughout the day and night.

Toujeo® is not indicated for the treatment of diabetic ketoacidosis (DKA). The safety and efficacy of Toujeo® have not been established in children younger than 6 years of age.

Important Safety Information

Contraindications

Do not use Toujeo® if:

• You are experiencing an episode of hypoglycemia (low blood sugar).
• You have a known hypersensitivity to insulin glargine or any of the product’s components.

Warnings and Precautions

Sharing of Injection Pens

Toujeo® SoloStar® and Toujeo® Max SoloStar® pens are intended for single-patient use only. Never share your insulin pen with another person, even if the needle has been changed, as this may result in the transmission of serious infections.

Medical Conditions

Before initiating treatment, inform your healthcare provider if you:

• Have liver or kidney impairment.
• Are pregnant, planning to become pregnant, or breastfeeding.
• Have a history of heart failure or other cardiovascular conditions.
• Take any prescription medications, over-the-counter products, vitamins, herbal supplements, or dietary supplements.

Injection Site Rotation

To reduce the risk of lipodystrophy (changes in fat tissue) and localized cutaneous amyloidosis, rotate injection sites within the chosen injection area with each dose. Avoid injecting into skin that is:

• Thickened or hardened
• Lumpy or pitted
• Tender, bruised, or scarred
• Red, swollen, or otherwise damaged

Risk of Heart Failure

The concurrent use of insulin and thiazolidinediones (TZDs) may increase the risk of heart failure or worsen existing heart failure. Contact your healthcare provider immediately if you experience:

• Shortness of breath
• Rapid or unexplained weight gain
• Swelling of the feet, ankles, or legs

Your healthcare provider may adjust or discontinue therapy if symptoms develop or worsen.

Administration Guidelines

• Administer Toujeo® once daily at the same time each day.
• Monitor blood glucose regularly as directed by your healthcare provider.
• Do not change your insulin dose or insulin type without medical supervision.
• Always verify the insulin label before administration to avoid medication errors.
• Never withdraw insulin from the pen using a syringe.
• Do not dilute or mix Toujeo® with any other insulin or injectable solution.
• Use only if the solution is clear, colorless, and free of visible particles.

Activities and Alcohol Use

Until you know how Toujeo® affects you:

• Avoid driving or operating heavy machinery if your blood glucose is not well controlled.

• Avoid alcohol consumption and medications containing alcohol, as they may affect blood glucose levels.

Possible Side Effects

Hypoglycemia (Low Blood Sugar)

Hypoglycemia is the most common adverse effect associated with Toujeo® and may be severe or life-threatening. Symptoms may include:

• Shaking or trembling
• Sweating
• Rapid heartbeat
• Blurred vision
• Dizziness
• Confusion

Because Toujeo® is a long-acting insulin, recovery from hypoglycemia may take longer compared with shorter-acting insulin products.

Serious Allergic Reactions

Seek immediate medical attention if you develop signs of a severe allergic reaction, including:

• Generalized skin rash
• Difficulty breathing
• Swelling of the face, tongue, or throat
• Severe dizziness or drowsiness
• Rapid heartbeat
• Excessive sweating

Additional Adverse Effects

Other reported side effects may include:

• Injection-site reactions (redness, swelling, itching)
• Changes in subcutaneous fat tissue
• Peripheral edema (fluid retention)
• Weight gain
• Hypokalemia (low potassium levels)

Patient Counseling Information

Toujeo® SoloStar® and Toujeo® Max SoloStar® are prefilled insulin pens designed for single-patient use. Patients should perform a safety test before first use of a new pen and follow the instructions provided in the accompanying Patient Information Leaflet and Instructions for Use.

Proper injection technique and regular blood glucose monitoring are essential for achieving optimal treatment outcomes and minimizing the risk of complications.

Patient Disclaimer

This information is intended for educational purposes only and does not replace professional medical advice. Patients should consult their physician, diabetes educator, or healthcare provider for individualized treatment recommendations, dosing instructions, and management of potential side effects. Always use Toujeo® exactly as prescribed.

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