TOUJEO Max

TOUJEO MAX- insulin glargine injection, solution
A-S Medication Solutions

1 INDICATIONS AND USAGE

TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.

Limitations of Use:

TOUJEO is not recommended for the treatment of diabetic ketoacidosis.

2 DOSAGE AND ADMINISTRATION

2.1 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)].

2.2 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.
  • 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 individual’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)].

2.3 Starting Dose in Insulin-Naive Pediatric and Adult 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)]. When initiating TOUJEO, monitor glucose daily.

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.

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

  • 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 changing patients to TOUJEO, monitor glucose frequently in the first weeks of therapy [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)].

3 DOSAGE FORMS AND STRENGTHS

Injection: 300 units per mL of insulin glargine available as a clear, colorless, solution in:

  • 1.5 mL TOUJEO SoloStar single-patient-use prefilled pen (450 units/1.5 mL).
  • 3 mL TOUJEO Max SoloStar single-patient-use prefilled pen (900 units/3 mL).

4 CONTRAINDICATIONS

TOUJEO is contraindicated:

5 WARNINGS AND PRECAUTIONS

5.1 Never Share a TOUJEO SoloStar or TOUJEO Max SoloStar Pen Between Patients

TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pens must never be shared between patients, even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens.

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

Changes in Insulin Regimen Including Changes to Administration Site

Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site, or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.3)] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia, and a sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6)].

Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant oral antidiabetic products may be needed.

Changing to TOUJEO from other Insulins

On a unit-to-unit basis, TOUJEO has a lower glucose lowering effect than LANTUS [see Clinical Pharmacology (12.2)]. In clinical trials, patients who changed to TOUJEO from other basal insulins experienced higher average fasting plasma glucose levels in the first weeks of therapy compared to patients who were changed to LANTUS. Higher doses of TOUJEO were required to achieve similar levels of glucose control compared to LANTUS in clinical trials [see Clinical Studies (14.1)].

The onset of action of TOUJEO develops over 6 hours following an injection. In type 1 diabetes patients treated with IV insulin, consider the longer onset of action of TOUJEO before stopping IV insulin. The full glucose lowering effect may not be apparent for at least 5 days [see Dosage and Administration (2.2) and Clinical Pharmacology (12.2)].

To minimize the risk of hyperglycemia when initiating TOUJEO monitor glucose daily, titrate TOUJEO as described in this prescribing information, and adjust coadministered glucose-lowering therapies per standard of care [see Dosage and Administration (2.2, 2.3)].

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