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Health System Management • December 2016

BASAGLAR (insulin glargine injection) Brief Summary: Consult the package insert for complete prescribing information. INDICATIONS AND USAGE 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. Limitations of Use: BASAGLAR is not recommended for the treatment of diabetic ketoacidosis. DOSAGE AND ADMINISTRATION • In patients with Type 1 diabetes, BASAGLAR must be used concomitantly with short-acting insulin. • In patients with Type 2 diabetes, one may need to adjust the amount and timing of short or rapid acting insulins and dosages of any antidiabetic drugs. • Inject BASAGLAR subcutaneously once daily any time of day, but at the same time every day. DOSE ADJUSTMENT AND MONITORING Glucose monitoring is essential for patients receiving insulin therapy. Changes to an insulin regimen should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose. Concomitant oral antidiabetic treatment may need to be adjusted. As with all insulin preparations, the time course of action for BASAGLAR may vary in different individuals or at different times in the same individual and is dependent on many conditions, including the site of injection, local blood supply, or local temperature. Patients who change their level of physical activity or meal plan may require adjustment of insulin dosages. IMPORTANT DOSING INFORMATION • Always check insulin labels before administration. Administer BASAGLAR subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy see Adverse Reactions. • Do not dilute or mix BASAGLAR with any other insulin or solution as the onset of action or time peak effect of BASAGLAR and the mixed insulin may be altered in an unpredictable manner. • Do NOT administer intravenously or via an insulin pump because this could result in severe hypoglycemia. • Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), during acute illness, or changes in renal or hepatic function and should be made under medical supervision with appropriate glucose monitoring see Warnings and Precautions. • If changing patients from another insulin glargine product, 100 units/mL, to BASAGLAR, the dose of BASAGLAR should be the same as the other insulin glargine product, 100 units/mL, and the time of day for administration should be determined by the physician. • If changing patients from a once-daily insulin glargine product 300 units/mL, to once-daily BASAGLAR, the recommended initial BASAGLAR dosage is 80% of the insulin glargine product, 300 units/mL, dose that is being discontinued in order to lower the likelihood of hypoglycemia see Warnings and Precautions. • If changing patients from twice-daily NPH insulin to once-daily BASAGLAR, the recommended initial BASAGLAR dosage is 80% of the total NPH dosage that is being discontinued in order to lower the likelihood of hypoglycemia see Warnings and Precautions. CONTRAINDICATIONS BASAGLAR is contraindicated: • During episodes of hypoglycemia. • In patients who are hypersensitive to insulin glargine or to any of its excipients. WARNINGS AND PRECAUTIONS • Never Share a BASAGLAR KwikPen Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens. • Changes in Insulin Regimen: Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously under close medical supervision and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed. • Hypoglycemia: Hypoglycemia is the most common adverse reaction of BASAGLAR. Severe hypoglycemia may be life threatening and can cause seizures or death. The patient’s ability to concentrate and react may be impaired as a result of hypoglycemia. Hypoglycemia can happen suddenly and symptoms may vary for each person and may change over time. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system, or in patients who experience recurrent hypoglycemia. The risk of hypoglycemia after an injection is related to the duration of action of the insulin which may vary in different individuals or at different times in the same individual. Other factors such as changes in food intake, injection site, exercise, and concomitant medications may increase the risk of hypoglycemia. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia Educate patients and caregivers to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. The long-acting effect of BASAGLAR may delay recovery from hypoglycemia • Medication Errors: Accidental mix-ups between insulin glargine product, 100 units/mL, and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between BASAGLAR and other insulins, instruct patients to always check the insulin label before each injection. • Hypersensitivity and Allergic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products including BASAGLAR. If hypersensitivity reactions occur, discontinue BASAGLAR and treat per standard of care and monitor until symptoms and signs resolve. • Hypokalemia: All insulin products, including BASAGLAR, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations). • Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are PPAR-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin, including BASAGLAR. This may lead to or exacerbate heart failure. Observe patients for signs and symptoms of heart failure and consider discontinuation or dose reduction of the PPAR-gamma agonist. DRUG INTERACTIONS Some medications may alter glucose metabolism, insulin requirements, and the risk for hypoglycemia or hyperglycemia. Signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs. Particularly close monitoring may be required. 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. BASAGLAR (insulin glargine injection) BV HCP BS 12SEP2016 BASAGLAR (insulin glargine injection) BV HCP BS 12SEP2016 BASAGLAR, BV HCP BS 12SEP2016 Brief Summary 7.125 x 9.75 PRINTER VERSION 1 OF 2


Health System Management • December 2016
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