These highlights do not include all the information needed to use BASAGLAR safely and effectively. See full prescribing information for BASAGLAR
BASAGLAR (insulin glargine injection), for subcutaneous use
Initial U.S. Approval: 2000
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 06/2016
INDICATIONS AND USAGE
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. (1)
Limitations of Use:
Not recommended for treating diabetic ketoacidosis. (1)
DOSAGE AND ADMINISTRATION
-
Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, prior insulin use. (2.2, 2.3, 2.4)
-
Administer subcutaneously once daily at any time of day, but at the same time every day. (2.2)
-
Rotate injection sites to reduce the risk of lipodystrophy. (2.1)
-
Closely monitor glucose when converting to BASAGLAR and during initial weeks thereafter. (2.2)
-
Do not dilute or mix with any other insulin or solution. (2.1)
DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL (U-100) in 3 mL prefilled BASAGLAR® KwikPen® delivery device. (3)
CONTRAINDICATIONS
-
During episodes of hypoglycemia. (4)
-
Hypersensitivity to BASAGLAR or one of its excipients. (4)
WARNINGS AND PRECAUTIONS
-
Never share a BASAGLAR KwikPen between patients, even if the needle is changed. (5.1)
-
Hyper- or hypoglycemia with changes in insulin regimen: Carry out under close medical supervision. (5.2)
-
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. (5.3, 6.1)
-
Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. (5.4)
-
Hypersensitivity reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue BASAGLAR, monitor and treat if indicated. (5.5, 6.1)
-
Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. (5.6)
-
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. (5.7)
ADVERSE REACTIONS
Adverse reactions commonly associated with insulin glargine products (5% or greater incidence) are:
-
Hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
-
Drugs that affect glucose metabolism: Adjustment of insulin dosage may be needed; closely monitor blood glucose. (7)
-
Anti-Adrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Signs and symptoms of hypoglycemia may be reduced or absent. (7)
USE IN SPECIFIC POPULATIONS
-
Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2016
