Toujeo

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

• Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal.
• Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time during the day, at the same time every day.
• Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
• Do not dilute or mix with any other insulin or solution.
• See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes and how to switch to TOUJEO from other insulins
• Closely monitor glucose when switching to TOUJEO and during initial weeks thereafter.

Injection: 300 units/mL (U-300) of insulin glargine in a clear, colorless, solution available as:

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

Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes

Rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dose of 0.2 unit/kg/day. Overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated background risk of major birth defects is 6% to 10% in women with pregestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20% to 25% in women with a peri-conceptional HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown.

• Never share
  a TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen between patients, even if the needle is changed.
• Hyperglycemia or hypoglycemia with changes in insulin regimen:
  Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site, or method of administration) under close medical supervision with increased frequency of blood glucose monitoring.
• Hypoglycemia:
  May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitant drugs, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.
• Hypoglycemia Due to Medication errors:
  Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection.
• Hypersensitivity reactions:
  Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue TOUJEO, monitor and treat if indicated.
• Hypokalemia:
  May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
• Fluid retention and heart failure with concomitant use of Thiazolidinediones (TZDs):
  Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs.