Basaglar

BASAGLAR^® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

• Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, prior insulin use.
• Administer subcutaneously once daily at any time of day, but at the same time every day.
• Rotate injection sites into the abdominal area, thigh, or deltoid to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
• Closely monitor glucose when converting to BASAGLAR and during initial weeks thereafter.
• Do not dilute or mix with any other insulin or solution.

Injection: 100 units/mL (U-100) clear and colorless solution available as:

• 3 mL single-patient-use BASAGLAR KwikPen
• 3 mL single-patient-use BASAGLAR Tempo Pen

Published studies with use of insulin glargine products during pregnancy have not reported a clear

association with insulin glargine products and adverse developmental outcomes

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

• Never share
  a BASAGLAR 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, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and 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 BASAGLAR, 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.