Important Administration Instructions

• Always check insulin labels before administration [see Warnings and Precautions (5.4)].
• Visually inspect the TOUJEO solution for particulate matter and discoloration prior to administration and only use if the solution is clear and colorless with no visible particles.
• Inject TOUJEO subcutaneously into the abdominal area, thigh, or deltoid.
• Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2), Adverse Reactions (6)].
• Use TOUJEO with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
• Do not administer TOUJEO intravenously or in an insulin pump.
• Do not dilute or mix TOUJEO with any other insulin products or solutions.
• Never transfer TOUJEO from the cartridges of the TOUJEO SoloStar or TOUJEO Max SoloStar prefilled pen into a syringe for administration [see Warnings and Precautions (5.4)].

General Dosing Instructions

• TOUJEO is available in 2 single-patient-use prefilled pens:
  • TOUJEO SoloStar contains 450 units of TOUJEO U-300. It delivers doses in 1-unit increments and can deliver up to 80 units in a single injection.
  • TOUJEO Max SoloStar contains 900 units of TOUJEO U-300. It delivers doses in 2-unit increments and can deliver up to 160 units in a single injection. It is recommended for patients requiring at least 20 units per day.
• When changing between TOUJEO SoloStar and TOUJEO Max SoloStar, if the patient's previous dose was an odd number, the dose should be increased or decreased by 1 unit to match the dose increments dialable on each prefilled pen.
• The dose counter of the TOUJEO SoloStar or TOUJEO Max SoloStar prefilled pen shows the number of units of TOUJEO to be injected and no conversion is required.
• Inject TOUJEO subcutaneously once a day at the same time of day.
• During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)].
• Individualize and titrate the dosage of TOUJEO based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal.
• Titrate the dose of TOUJEO no more frequently than every 3 to 4 days.
• Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6, 8.7)].

Starting Dose in Insulin-Naive Pediatric and Adult Patients

Starting Dose in Pediatric and Adult Patients with Either Type 1 or Type 2 Diabetes Already on Insulin Therapy

Dosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to TOUJEO from another insulin therapy [see Warnings and Precautions (5.3)].

• For patients currently on once-daily long or intermediate-acting insulin, start TOUJEO at the same unit dose as the once-daily long-acting insulin dose. For patients controlled on LANTUS (insulin glargine, 100 units/mL), expect that a higher daily dose of TOUJEO will be needed to maintain the same level of glycemic control [see Clinical Pharmacology (12.2) and Clinical Studies (14.1)].
• For patients currently on twice-daily long or intermediate-acting insulin, start TOUJEO at 80% of the total daily NPH or insulin detemir twice-daily dosage.
• When switching patients to TOUJEO, monitor glucose frequently in the first weeks of therapy [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)].