Basaglar - Drug Monograph

Introduction

Basaglar (insulin glargine) is a long-acting basal insulin analog used to improve glycemic control in patients with diabetes mellitus. It is a biosimilar to Lantus (insulin glargine) and provides a consistent, peakless insulin delivery over approximately 24 hours. Basaglar is indicated for both type 1 and type 2 diabetes and is administered subcutaneously once daily.

Mechanism of Action

Basaglar works by binding to insulin receptors on target cells, primarily in muscle, fat, and liver tissues. This binding activates receptor tyrosine kinase, initiating intracellular signaling pathways that promote glucose uptake, glycogen synthesis, lipogenesis, and protein synthesis. As a long-acting insulin analog, insulin glargine is designed to form microprecipitates in the subcutaneous tissue, resulting in a slow, consistent release into circulation with no pronounced peak, mimicking basal insulin secretion.

Indications

• Treatment of type 1 diabetes mellitus in adults and pediatric patients
• Treatment of type 2 diabetes mellitus in adults
• May be used alone or in combination with other antihyperglycemic agents

Dosage and Administration

• Route: Subcutaneous injection only
• Standard dosing: Individualized based on patient needs; typically initiated at 0.2 units/kg or 10 units once daily
• Administration: Administer at the same time each day, preferably in the evening
• Special populations:

- Renal impairment: Requires careful titration and monitoring - Hepatic impairment: Increased risk of hypoglycemia; requires dose reduction and close monitoring - Pediatrics: Safety and effectiveness established in children ≥6 years with type 1 diabetes - Geriatrics: May require more conservative dosing due to increased hypoglycemia risk

Pharmacokinetics

• Absorption: Slow, consistent absorption from subcutaneous tissue with onset of action within 2-4 hours
• Distribution: Distributed throughout extracellular fluid; 100% bioavailable after subcutaneous administration
• Metabolism: Metabolized primarily in liver and kidney to active metabolites
• Elimination: Half-life approximately 12 hours; duration of action up to 24 hours
• Time to peak effect: No pronounced peak; steady action profile

Contraindications

• Hypersensitivity to insulin glargine or any component of the formulation
• During episodes of hypoglycemia
• Hypersensitivity reactions including anaphylaxis

Warnings and Precautions

• Hypoglycemia: Most common adverse effect; risk increased with renal/hepatic impairment, changes in meal patterns, exercise, and concomitant glucose-lowering medications
• Hypokalemia: Insulin therapy may cause potassium shifts into cells, potentially leading to hypokalemia
• Lipodystrophy: May occur at injection sites; rotate injection sites to minimize
• Weight gain: Can occur with insulin therapy
• Fluid retention: May cause peripheral edema, particularly when initiating therapy or rapidly improving glycemic control
• Allergic reactions: Both local and systemic reactions possible

Drug Interactions

• Other glucose-lowering agents: Increased hypoglycemia risk with sulfonylureas, meglitinides, GLP-1 receptor agonists, SGLT2 inhibitors, and other insulins
• Medications that increase hypoglycemia risk: Beta-blockers, ACE inhibitors, salicylates, fibrates, fluoxetine, pentamidine, sulfonamide antibiotics
• Medications that decrease hypoglycemia risk: Corticosteroids, thyroid hormones, sympathomimetics, phenytoin, niacin, diuretics, atypical antipsychotics
• Beta-blockers: May mask hypoglycemia symptoms
• Alcohol: Potentiates insulin's hypoglycemic effect

Adverse Effects

• Hypoglycemia
• Injection site reactions (redness, swelling, itching)
• Weight gain
• Peripheral edema

• Severe hypoglycemia
• Hypokalemia
• Anaphylaxis
• Lipodystrophy
• Severe hypersensitivity reactions

Monitoring Parameters

• Blood glucose levels (fasting and postprandial)
• HbA1c every 3 months until stable, then every 6 months
• Renal function (serum creatinine, eGFR)
• Hepatic function (ALT, AST)
• Serum potassium levels
• Signs and symptoms of hypoglycemia
• Injection sites for lipodystrophy or reactions
• Weight changes
• Hypersensitivity reactions

Patient Education

• Administration: Demonstrate proper injection technique and site rotation
• Timing: Administer at the same time each day
• Hypoglycemia: Recognize symptoms (sweating, tremor, palpitations, hunger) and treatment (15-20g fast-acting carbohydrate)
• Storage: Refrigerate unopened pens; opened pens may be stored at room temperature for 28 days
• Missed dose: Instructions for handling missed doses
• Travel: Plan for time zone changes and insulin storage during travel
• Sick days: Management during illness (continue insulin, monitor glucose more frequently)
• Device training: Proper use of KwikPen delivery system
• When to seek medical attention: Severe hypoglycemia, allergic reactions, persistent hyperglycemia

References

1. FDA Prescribing Information: Basaglar (insulin glargine) injection. 2022 2. American Diabetes Association. Standards of Medical Care in Diabetes - 2023. Diabetes Care. 2023;46(Suppl 1) 3. Home PD. The Evolution of Insulin Therapy. Diabetes Res Clin Pract. 2021;175:108816 4. Rosenstock J, et al. Advancing Therapy with Basal Insulin. Diabetes Technol Ther. 2022;24(S1):S-1-S-13 5. Blonde L, et al. Patient-Reported Outcomes with Basal Insulin. Diabetes Ther. 2021;12(5):1337-1349 6. Heinemann L, et al. Pharmacokinetic and Pharmacodynamic Properties of Insulin Glargine. Clin Pharmacokinet. 2022;61(3):347-362