BASAGLAR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BASAGLAR (BASAGLAR).
Insulin glargine is a recombinant human insulin analog with a prolonged duration of action due to precipitation at the injection site, providing a constant basal insulin supply. It binds to the insulin receptor, activating downstream signaling pathways that promote glucose uptake, glycogen synthesis, and lipogenesis while inhibiting gluconeogenesis and glycogenolysis.
| Metabolism | Insulin glargine is metabolized by subcutaneous tissue proteases into two active metabolites, M1 and M2, which have similar activity to native insulin. |
| Excretion | Renal: minimal (<1% as unchanged drug); hepatic metabolism to inactive metabolites; fecal: not significant. |
| Half-life | 13.2 hours (range 10.0-20.6 hours) for insulin glargine; reflects extended duration after subcutaneous injection. |
| Protein binding | Primarily to albumin (binding affinity similar to endogenous insulin); ~30-40% bound. |
| Volume of Distribution | 0.31 L/kg (apparent); reflects distribution into extracellular fluid, limited by protein binding. |
| Bioavailability | Subcutaneous: Approximately 80-90% (relative to intravenous administration; prolonged absorption due to precipitation at injection site). |
| Onset of Action | Subcutaneous: Approximately 2-4 hours (slow, prolonged release from depot). |
| Duration of Action | Subcutaneous: Up to 24 hours (dose-dependent, providing basal insulin coverage with no pronounced peak). |
Subcutaneous injection, initial dose 0.2-0.4 units/kg/day, titrated to target glycemic control; typical maintenance 0.5-1.0 units/kg/day
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for renal impairment; monitor glucose more frequently due to increased hypoglycemia risk in advanced CKD |
| Liver impairment | No formal Child-Pugh based guidelines; use with caution and consider dose reduction in severe hepatic impairment due to reduced gluconeogenesis |
| Pediatric use | Age ≥6 years: initial dose 0.2-0.5 units/kg/day subcutaneously; titrate based on blood glucose; not established for age <6 |
| Geriatric use | Initiate at lower doses (e.g., 0.2 units/kg/day) with cautious titration; monitor for hypoglycemia due to reduced renal function and multiple comorbidities |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BASAGLAR (BASAGLAR).
| Breastfeeding | Insulin glargine is a large protein molecule that is not expected to appear in breast milk in significant amounts. No specific studies on the milk-to-plasma (M/P) ratio are available. Insulin glargine is considered compatible with breastfeeding as it is unlikely to be absorbed orally by the infant. Caution is advised due to lack of specific data. |
| Teratogenic Risk | Insulin glargine (Basaglar) does not cross the placenta in significant amounts. Available data from postmarketing studies and pregnancy registries do not indicate an increased risk of major birth defects or miscarriage with insulin glargine use during pregnancy. However, uncontrolled maternal diabetes increases the risk of fetal malformations (first trimester), macrosomia, neonatal hypoglycemia, and respiratory distress (second and third trimesters). |
■ FDA Black Box Warning
Not safe for use in the treatment of diabetic ketoacidosis. Insulin glargine is not recommended for the treatment of diabetic ketoacidosis; short-acting insulin is preferred.
| Common Effects | Hypoglycemia low blood glucose level Peripheral edema Lipodystrophy skin thickening or pits at the injection site Allergic reaction Injection site reactions pain swelling redness Itching Rash Weight gain |
| Serious Effects |
["Hypersensitivity to insulin glargine or any of its excipients","During episodes of hypoglycemia"]
| Precautions | ["Hypoglycemia: Potentially severe and life-threatening; dose adjustment, patient monitoring, and education are essential.","Changes in insulin regimen: Changes in strength, manufacturer, type, or method of administration may require dose adjustment.","Hypokalemia: May be caused by all insulins; monitor potassium levels if at risk.","Fluid retention and heart failure: Use of thiazolidinediones (TZDs) with insulin may increase risk; observe for signs of heart failure."] |
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| Fetal Monitoring | Monitor maternal blood glucose levels frequently, including fasting, preprandial, and postprandial. Assess hemoglobin A1c (HbA1c) every 1-2 months. Monitor fetal growth via ultrasound to detect macrosomia or growth restriction. Perform fetal nonstress tests or biophysical profiles in third trimester if indicated. Monitor for maternal hypoglycemia and diabetic complications. |
| Fertility Effects | No known adverse effects on fertility. Poorly controlled diabetes can impair fertility due to hormonal imbalances and ovulatory dysfunction. Insulin glargine improves glycemic control and may help restore normal menstrual cycles and fertility in diabetic women. |
| Food/Dietary | No specific food-drug interactions. However, alcohol consumption can increase the risk of hypoglycemia. Missed meals or changes in carbohydrate intake require dose adjustment. Consistent meal timing and carbohydrate intake are important to maintain glycemic control. |
| Clinical Pearls | Basaglar (insulin glargine) is a long-acting insulin analog with a duration of action up to 24 hours. It should be administered once daily at the same time each day. Do not mix with other insulins. The primary risk is hypoglycemia, especially if dose timing or meals are missed. Monitor blood glucose closely when initiating or adjusting therapy. Lantus and Basaglar are biosimilar; switching is safe but requires dose adjustment only if needed. Injection site rotation is critical to prevent lipodystrophy. Use in pediatric patients is approved for type 1 diabetes. |
| Patient Advice | Inject Basaglar subcutaneously once daily at the same time each day, preferably in the morning or evening as directed by your doctor. · Do not mix Basaglar with any other insulin in the same syringe or vial. · Always check your blood sugar levels before each injection and regularly throughout the day, especially after dose changes. · Common side effects include hypoglycemia (low blood sugar), injection site reactions, and weight gain. Recognize signs of hypoglycemia: shakiness, sweating, confusion, and treat with fast-acting sugar. · Store unopened vials and pens in the refrigerator. Once opened, you can store them at room temperature for up to 28 days. · Rotate injection sites (abdomen, thighs, upper arms) to avoid skin thickening or dimpling (lipodystrophy). · Do not skip meals or change your diet without consulting your healthcare provider, as this can affect your insulin needs. · Keep a record of your blood sugar readings and insulin doses to share with your doctor. |