NOVOLOG
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NOVOLOG (NOVOLOG).
Insulin analog that lowers blood glucose by binding to insulin receptors, enhancing peripheral glucose uptake, and inhibiting hepatic glucose production.
| Metabolism | Metabolized by insulin-degrading enzyme (IDE) into inactive metabolites. |
| Excretion | Renal excretion accounts for approximately 60-80% of insulin aspart degradation products; unchanged drug is minimally excreted. Biliary/fecal excretion is negligible (<10%). |
| Half-life | Terminal elimination half-life is 1.2-1.5 hours in healthy individuals, reflecting rapid clearance. In renal impairment (e.g., eGFR <30 mL/min), half-life may be prolonged up to 2-3 hours due to reduced degradation. |
| Protein binding | Approximately 1-10% bound to plasma proteins (albumin and other proteins); binding is minimal and clinically insignificant. |
| Volume of Distribution | Approximately 0.5-0.7 L/kg. This Vd indicates distribution primarily into extracellular fluid; clinical meaning: rapid distribution to target tissues (muscle, fat, liver). |
| Bioavailability | Subcutaneous: 60-70% of the injected dose reaches systemic circulation due to local degradation at injection site. Intravenous: 100% bioavailability. |
| Onset of Action | Subcutaneous: 10-20 minutes (peak effect at 1-3 hours). Intravenous: immediate onset. Not intended for intramuscular use. |
| Duration of Action | Subcutaneous: 3-5 hours (dose-dependent; higher doses may extend duration up to 6 hours). Clinical note: Duration is shorter than regular human insulin; adjust subsequent doses to avoid stacking. |
Subcutaneous injection: 0.5-1 unit/kg/day divided into 3 or more doses given within 15 minutes before or after meals. Typical total daily dose range 0.5-1.5 units/kg.
| Dosage form | INJECTABLE |
| Renal impairment | No specific GFR-based dose reduction guidelines; monitor glucose closely and adjust dose based on clinical response. In severe renal impairment (eGFR <30 mL/min), reduce dose by 25-50% due to increased insulin sensitivity. |
| Liver impairment | No specific Child-Pugh-based guidelines; in hepatic impairment, consider reduced dose and close monitoring due to decreased gluconeogenesis and altered insulin metabolism. |
| Pediatric use | Subcutaneous injection: 0.5-1 unit/kg/day total, divided into 3 or more pre-meal doses. For children <2 years, no established dosing; use only under specialist supervision. For ages 2-18, typical starting dose 0.5-1 unit/kg/day. |
| Geriatric use | Elderly patients often have reduced renal function; initiate at lower doses (e.g., 0.5 unit/kg/day) with careful titration to avoid hypoglycemia. Monitor renal function and adjust dose accordingly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NOVOLOG (NOVOLOG).
| Breastfeeding | Insulin aspart is a large protein molecule that is not expected to pass into breast milk in significant amounts. It is compatible with breastfeeding. The M/P ratio is not applicable as insulin is an endogenous protein. Use during lactation does not pose a risk to the nursing infant, but maternal glucose control should be monitored. |
| Teratogenic Risk | Insulin aspart (NOVOLOG) does not cross the placenta appreciably. No increased risk of major congenital anomalies or fetal harm has been reported with insulin use during pregnancy. Tight glycemic control is essential to reduce risks of maternal and fetal complications. Insulin requirements may increase during the second and third trimesters due to insulin resistance. |
■ FDA Black Box Warning
Never share a NovoLog FlexPen, FlexTouch, or PenFill cartridge between patients, even if the needle is changed, because it poses a risk for transmission of bloodborne pathogens.
| Serious Effects |
["Hypoglycemia episodes","Hypersensitivity to insulin aspart or any excipients"]
| Precautions | ["Hypoglycemia is the most common adverse effect. Dose adjustment required in renal or hepatic impairment. Risk of severe hypoglycemia in patients with impaired counterregulatory mechanisms. Monitoring of glucose, A1c, and renal function recommended. Not recommended for use in patients with diabetic ketoacidosis (use rapid-acting insulin)."] |
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| Fetal Monitoring | Monitor maternal blood glucose levels frequently during pregnancy to achieve glycemic targets. Assess HbA1c every trimester. Monitor fetal growth and well-being via ultrasound and fetal monitoring as clinically indicated. Adjust insulin doses based on glucose patterns. Watch for maternal hypoglycemia, especially in the first trimester. |
| Fertility Effects | Poor glycemic control in diabetes can impair fertility. Insulin aspart does not adversely affect fertility when used to achieve euglycemia. Maintaining good glucose control may improve fertility outcomes in diabetic women. |