LANTUS
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LANTUS (LANTUS).
Long-acting recombinant human insulin analog that binds to insulin receptors, activating downstream signaling pathways to facilitate glucose uptake, inhibit gluconeogenesis, and regulate lipid and protein metabolism.
| Metabolism | Primarily degraded by insulin-degrading enzyme (IDE). Minimal hepatic metabolism. |
| Excretion | Renal: minimal (degraded by insulin-degrading enzyme), biliary: negligible, fecal: negligible |
| Half-life | Terminal half-life: 24 hours (provides basal insulin coverage for 24 hours) |
| Protein binding | ~0% (insulin glargine does not bind to serum proteins); binding to insulin receptors is the primary interaction |
| Volume of Distribution | 0.4 L/kg (indicates distribution primarily into extracellular fluid; limited intracellular penetration) |
| Bioavailability | Subcutaneous: ~80% (absolute bioavailability compared to intravenous administration) |
| Onset of Action | Subcutaneous: 1-2 hours |
| Duration of Action | 24 hours (once-daily dosing for basal insulin coverage; consistent glucose-lowering over 24 hours) |
Subcutaneous injection once daily at the same time each day. Initial dose: 0.2-0.4 units/kg/day. Titrate based on blood glucose monitoring.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment for renal impairment. Monitor blood glucose closely; increased risk of hypoglycemia in severe renal impairment (eGFR <30 mL/min/1.73 m²). |
| Liver impairment | No specific dose adjustment for hepatic impairment. Impaired hepatic function may reduce glucose production, increasing hypoglycemia risk; monitor blood glucose closely. |
| Pediatric use | Children ≥6 years: Subcutaneous once daily. Initial dose: 0.2-0.5 units/kg/day. Titrate based on glucose monitoring. Not recommended for children <6 years. |
| Geriatric use | Start with lower doses (e.g., 0.2 units/kg/day) due to increased risk of hypoglycemia. Titrate cautiously with close monitoring. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for LANTUS (LANTUS).
| Breastfeeding | Insulin glargine is a large protein molecule that is unlikely to transfer into breast milk in clinically significant amounts. M/P ratio not available. It is considered compatible with breastfeeding, but maternal glycemic control should be monitored as insulin requirements may decrease postpartum. |
| Teratogenic Risk | Insulin glargine does not cross the placenta in significant amounts. No increased risk of major malformations has been observed with insulin use during pregnancy. However, poorly controlled diabetes increases the risk of fetal anomalies, macrosomia, and neonatal hypoglycemia. Close glycemic control is essential. |
■ FDA Black Box Warning
NOT FOR INTRAVENOUS USE. Concentration and brand of insulin should not be changed without careful medical supervision.
| 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 excipients","During episodes of hypoglycemia"]
| Precautions | ["Hypoglycemia (most common adverse effect)","Monitor glycemic control; dosage adjustment may be needed with changes in renal or hepatic function","May cause hypokalemia; monitor potassium levels","Caution with concurrent medications that affect glucose metabolism","Do not mix with other insulins or diluents","Rare allergic reactions; discontinue if anaphylaxis occurs"] |
| Food/Dietary |
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| Fetal Monitoring | Monitor maternal blood glucose levels frequently (multiple times daily). Assess hemoglobin A1c every 1-2 months. Fetal surveillance includes ultrasound for growth and anatomy, and non-stress tests or biophysical profiles as clinically indicated. Monitor for maternal hypoglycemia and diabetic ketoacidosis. |
| Fertility Effects | No direct effects on fertility. Poorly controlled diabetes may impair fertility due to hormonal imbalances and ovulatory dysfunction. Achieving good glycemic control prior to conception is recommended. |
| No specific food restrictions, but consistent carbohydrate intake is recommended to maintain glycemic control. Alcohol can cause unpredictable hypoglycemia. Grapefruit and other CYP3A4 inhibitors/inducers have minimal interaction; however, monitor glucose when changing diet. |
| Clinical Pearls | Do not mix Lantus with other insulins. It must be administered subcutaneously once daily at the same time each day. Use a clear, colorless solution; discard if cloudy or contains particles. Onset is 1-2 hours, peak is minimal (flat profile), duration up to 24 hours. Titrate dose based on fasting glucose. Monitor for hypoglycemia, especially nocturnal. Avoid injecting into lipodystrophied areas. Rotate injection sites to prevent lipohypertrophy. |
| Patient Advice | Inject Lantus at the same time each day, typically once daily. · Do not mix Lantus with any other insulin or dilute it. · Store unopened vials in the refrigerator; do not freeze. Once opened, keep at room temperature for up to 28 days. · Rotate injection sites (abdomen, thigh, upper arm) to avoid lumps or skin thickening. · Check blood glucose regularly as directed by your healthcare provider. · Be aware of symptoms of hypoglycemia (shaking, sweating, confusion) and have fast-acting sugar available. · Do not change insulin type or dose without consulting your doctor. · Do not use if the solution is cloudy or contains particles. · Avoid alcohol consumption, as it may increase risk of hypoglycemia. |