HUMALOG TEMPO PEN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HUMALOG TEMPO PEN (HUMALOG TEMPO PEN).
Insulin lispro is a rapid-acting insulin analog that lowers blood glucose by stimulating peripheral glucose uptake, especially in skeletal muscle and fat, and by inhibiting hepatic glucose production. It binds to the insulin receptor, activating tyrosine kinase and downstream signaling pathways.
| Metabolism | Insulin lispro is metabolized primarily by insulin-degrading enzyme (IDE) and possibly other proteases. It is degraded into inactive metabolites. |
| Excretion | Renal: 100% of absorbed dose is eliminated via degradation, primarily in the liver and kidneys; no significant biliary/fecal excretion. |
| Half-life | 1.0 hour (terminal elimination half-life); reflects rapid clearance of insulin lispro from circulation. |
| Protein binding | 0% (bound to plasma proteins, mainly albumin, but binding is negligible for insulin lispro; <10% bound). |
| Volume of Distribution | 0.3 L/kg (approximate; reflects distribution into extracellular fluid). |
| Bioavailability | Subcutaneous: 100% (completely absorbed; absolute bioavailability not determined but considered complete). |
| Onset of Action | Subcutaneous: 15 minutes (clinical effect: reduction in blood glucose). |
| Duration of Action | Subcutaneous: 2-5 hours (dose-dependent; shorter than regular human insulin, with peak effect at 1-2 hours). |
Subcutaneously, 0.2-0.5 units/kg within 15 minutes before or after a meal. Total daily dose is 0.5-1.0 units/kg.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment; monitor glucose and titrate carefully in renal impairment. |
| Liver impairment | No specific adjustment for Child-Pugh; use caution and monitor glucose. |
| Pediatric use | Subcutaneously, 0.25-0.5 units/kg within 15 minutes before or after meals, with total daily dose 0.5-1.0 units/kg. Individualize. |
| Geriatric use | Start with lower doses (e.g., 0.2 units/kg total daily) and titrate slowly to avoid hypoglycemia; monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HUMALOG TEMPO PEN (HUMALOG TEMPO PEN).
| Breastfeeding | Insulin lispro is excreted into breast milk in trace amounts, presenting minimal risk to the nursing infant. M/P ratio not established; endogenous insulin in milk is normal. Use compatible with breastfeeding. |
| Teratogenic Risk | Insulin lispro does not cross the placenta in significant amounts. No teratogenic effects have been reported; however, poorly controlled maternal diabetes is associated with increased fetal risks including congenital anomalies (first trimester), macrosomia, stillbirth, and neonatal hypoglycemia (second and third trimesters). |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to insulin lispro or any excipients","During episodes of hypoglycemia"]
| Precautions | ["Hypoglycemia is the most common adverse effect; may be life-threatening.","Changes in insulin strength, manufacturer, type, or method of administration may require dose adjustment.","Monitor glucose closely in patients with renal or hepatic impairment.","Do not mix with other insulins in the same syringe unless directed.","Hypersensitivity reactions may occur."] |
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| Fetal Monitoring |
| Monitor maternal blood glucose levels frequently; HbA1c every 1-2 months; fetal growth by ultrasound; assess for macrosomia and polyhydramnios. Monitor neonatal blood glucose after delivery. |
| Fertility Effects | Insulin lispro has no direct effect on fertility. Poor glycemic control may impair fertility; optimizing control may improve reproductive outcomes. |