Generic name: insulin glargine 300U in 1mL
Dosage form: injection, solution
Medically reviewed on March 22, 2018.
General Dosing Instructions
- TOUJEO is available in 2 disposable 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.
- Inject TOUJEO subcutaneously once a day into the abdominal area, thigh, or deltoid at the same time each day.
- Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy [see Adverse Reactions (6.1)].
- Individualize and titrate the dosage of TOUJEO based on the individual's metabolic needs, blood glucose monitoring results, and glycemic control goal.
- To minimize the risk of hypoglycemia, 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)].
- Use TOUJEO with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
Starting Dose in Insulin-Naive Patients
Type 1 Diabetes
- The recommended starting dose of TOUJEO in insulin-naive patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be given as a short-acting insulin and divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin-naive patients with type 1 diabetes.
- The maximum glucose lowering effect of a dose of TOUJEO may take five days to fully manifest and the first TOUJEO dose may be insufficient to cover metabolic needs in the first 24 hours of use [see Clinical Pharmacology (12.2)]. To minimize risks associated with insufficient insulinization when initiating TOUJEO, monitor glucose daily, titrate TOUJEO per instructions, and adjust coadministered glucose-lowering therapies per standard of care.
Type 2 Diabetes
- The recommended starting dose of TOUJEO in insulin-naive patients with type 2 diabetes is 0.2 units per kilogram of body weight once daily. The dosage of other antidiabetic drugs may need to be adjusted when starting TOUJEO to minimize the risk of hypoglycemia [see Warnings and Precautions (5.3)].
Starting Dose in Patients with Either Type 1 or Type 2 Diabetes Already on Insulin Therapy
- To minimize the risk of hypoglycemia when changing patients from a once-daily long-acting or intermediate-acting insulin product to TOUJEO, the starting dose of TOUJEO can be the same as the once-daily long-acting 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)].
- To minimize the risk of hypoglycemia when changing patients from twice-daily NPH insulin to once-daily TOUJEO, the recommended starting TOUJEO dose is 80% of the total daily NPH dosage.
- To minimize the risk of hyperglycemia when changing patients to TOUJEO, monitor glucose frequently in the first weeks of therapy titrate the dose of TOUJEO per instructions and the dose of other glucose-lowering therapies per standard of care [see Warning and Precautions (5.2) and Clinical Pharmacology (12.2)].
Important Administration Instructions
- Always check insulin labels before administration [see Warnings and Precautions (5.4)].
- 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.
- The dose counter of the TOUJEO SoloStar or TOUJEO Max SoloStar disposable prefilled pen shows the number of units of TOUJEO to be injected and no conversion is required.
- Instruct patients to 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.
- Do not administer TOUJEO intravenously, intramuscularly, 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)].
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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