Generic name: insulin glargine 300U in 1mL
Dosage form: injection, solution
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General Dosing Instructions
- 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. The dosage of TOUJEO ranges from 1 to 80 units per one injection.
- 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 (8.5, 8.6)].
- To minimize the risk of hypoglycemia, do not administer TOUJEO intravenously, intramuscularly or in an insulin pump.
- To minimize the risk of hypoglycemia, do not dilute or mix TOUJEO with any other insulin products or solutions.
Starting Dose in Insulin-Naïve Patients
Type 1 Diabetes:
- The recommended starting dose of TOUJEO in insulin naïve 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 naïve 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 co-administered glucose lowering therapies per standard of care.
Type 2 Diabetes:
- The recommended starting dose of TOUJEO in insulin naïve patients with type 2 diabetes is 0.2 units per kilogram of body weight once daily. The dosage of other anti-diabetic 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 Section (12.2)].
Important Administration Instructions
- Prior to initiation of TOUJEO, patients should be trained by their healthcare professional on proper use and injection technique. Training reduces the risk of administration errors such as needle sticks and incomplete dosing.
- Patient should follow the Instructions for Use to correctly use the pen device and administer TOUJEO.
- Patients should be informed that the dose counter of the TOUJEO SoloStar disposable prefilled pen shows the number of units of TOUJEO to be injected. The TOUJEO SoloStar prefilled pen has been specifically designed for TOUJEO, therefore no dose conversion is required [Patient counseling information (17)].
- Patients should be instructed 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.
- For single patient use only [see Warnings and Precautions (5.1)].
- Refrigerate unused (unopened) TOUJEO SoloStar prefilled pens.
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- Drug class: insulin