Insulin glargine

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. BASAGLAR ® is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Limitations of Use: Not recommended for treating diabetic ketoacidosis. Limitations of Use BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.

The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analog lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

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.

BASAGLAR is contraindicated: During episodes of hypoglycemia. In patients with hypersensitivity to insulin glargine or any of the excipients in BASAGLAR. During episodes of hypoglycemia. Hypersensitivity to BASAGLAR or any of its excipients.

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.

The following adverse reactions are discussed elsewhere: Hypoglycemia. Hypoglycemia Due to Medication Errors. Hypersensitivity Reactions. Hypokalemia. Adverse reactions commonly (≥5%) associated with insulin glargine products are: Hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain.

Table 6 includes clinically significant drug interactions with BASAGLAR Table 6: Clinically Significant Drug Interactions with BASAGLAR Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose reductions and increased frequency of glucose monitoring may be required when BASAGLAR is co-administered with these drugs.

Storage conditions are summarized in the following table: Not In-Use (Unopened) Room Temperature (up to 86°F [30°C]) Not In-Use (Unopened) Refrigerated (36°F to 46°F [2°C to 8°C]) In-Use (Opened) Room Temperature, (up to 86°F [30°C]) 3 mL single-patient-use BASAGLAR KwikPen 28 days Until expiration date 28 days, Do not refrigerate. 3 mL single-patient-use BASAGAR Tempo Pen 28 days Until expiration date 28 days, Do not refrigerate.