SEMGLEE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SEMGLEE (SEMGLEE).
Long-acting insulin analog that lowers blood glucose by stimulating peripheral glucose uptake (especially in skeletal muscle and fat) and inhibiting hepatic glucose production via binding to insulin receptors, activating the insulin receptor tyrosine kinase cascade.
| Metabolism | Insulin glargine is partially metabolized at the carboxyl terminus of the B-chain, forming two active metabolites M1 and M2. Metabolism is not CYP450-mediated. |
| Excretion | Renal (30-80% as intact insulin); fecal (negligible) |
| Half-life | 18.3 hours; reflects protracted absorption from subcutaneous depot, enabling once-daily dosing |
| Protein binding | Bound primarily to albumin (approximately 50-60%) |
| Volume of Distribution | 0.75 L/kg; reflects distribution into extracellular fluid and peripheral tissues |
| Bioavailability | Subcutaneous: 100% (compared to IV; complete absorption but slow release from injection site) |
| Onset of Action | Subcutaneous: 3-6 hours (gradual onset designed to provide basal insulin coverage) |
| Duration of Action | 24 hours (up to 36 hours at higher doses); provides consistent basal insulin levels over 24 hours with once-daily administration |
Subcutaneous injection, 0.2 units/kg/day initially, adjusted based on blood glucose levels. Typical maintenance dose: 0.5-1 unit/kg/day.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min, reduce dose by 25% and monitor glucose closely. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose by 50%. Child-Pugh Class C: contraindicated due to risk of hypoglycemia. |
| Pediatric use | Weight-based: 0.5 units/kg/day subcutaneously, titrated to glycemic goals. Maximum initial dose 10 units/day. |
| Geriatric use | Start with 0.1-0.2 units/kg/day; titrate slowly to avoid hypoglycemia. Monitor renal function. Reduce dose by 20% if eGFR <60 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SEMGLEE (SEMGLEE).
| Breastfeeding | Insulin glargine is a large protein molecule that is minimally excreted into breast milk. It is unlikely to be absorbed orally by the infant. M/P ratio not available. The drug is considered compatible with breastfeeding. |
| Teratogenic Risk | Insulin glargine (SEMGLEE) does not cross the placenta in significant amounts. No increased risk of major birth defects or spontaneous abortion has been associated with insulin use during pregnancy. Maternal hyperglycemia itself poses risks (e.g., congenital anomalies in first trimester, macrosomia in third trimester). |
■ FDA Black Box Warning
Accidental mix-ups between insulin products have resulted in serious adverse events, including death. To avoid medication errors, do not transfer insulin glargine from its pen or vial into a syringe. The dose window on the pen shows the exact dose; do not use a syringe to withdraw insulin glargine from the pen.
| Serious Effects |
["Hypersensitivity to insulin glargine or any excipients","During episodes of hypoglycemia"]
| Precautions | ["Never share an insulin pen or syringe between patients, even if the needle is changed; risk of blood-borne pathogen transmission.","Monitor glucose closely, especially during illness, stress, changes in diet, or changes in concomitant medications.","Hypoglycemia is the most common adverse reaction; severe hypoglycemia may be life-threatening.","May cause hypokalemia; monitor potassium levels in patients at risk.","Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs).","In patients with type 1 diabetes, do not use insulin glargine alone for treatment; must be combined with rapid-acting insulin."] |
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| Fetal Monitoring |
| Monitor blood glucose and HbA1c. Fetal monitoring: ultrasound for growth and amniotic fluid index, especially in third trimester. Assess for maternal hypoglycemia, especially if dose is adjusted. |
| Fertility Effects | Insulin glargine does not directly impair fertility. Poor glycemic control in women with diabetes may alter menstrual cycles and reduce fertility; optimizing glycemic control may improve fertility outcomes. |