NOVOLOG FLEXTOUCH
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NOVOLOG FLEXTOUCH (NOVOLOG FLEXTOUCH).
Insulin analog with rapid onset and short duration of action; binds to insulin receptors, promoting cellular glucose uptake and inhibiting hepatic glucose production.
| Metabolism | Primarily metabolized by insulin-degrading enzyme (IDE); hepatic and renal clearance. |
| Excretion | Renal: ~60% as unchanged drug and metabolites; biliary/fecal: ~40% |
| Half-life | 1.5-2 hours (subcutaneous); terminal elimination half-life: 1.8 hours |
| Protein binding | ~90% bound to albumin and other plasma proteins |
| Volume of Distribution | 0.37-0.55 L/kg (approximately 26-39 L in 70 kg adult); reflects distribution into extracellular fluid |
| Bioavailability | Subcutaneous: ~55-60%; intravenous: 100% |
| Onset of Action | Subcutaneous: 10-20 minutes; intravenous: immediate |
| Duration of Action | Subcutaneous: 3-5 hours; dose-dependent, with higher doses extending duration up to 6 hours |
Subcutaneous injection; typical adult dose is 0.5-1 unit/kg/day divided into multiple doses; for type 1 diabetes, administered 5-10 minutes before meals with a basal insulin; for type 2 diabetes, initial dose 4 units or 0.1-0.2 units/kg with meals.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment guidelines; monitor glucose closely; dose may need reduction due to decreased insulin clearance in severe renal impairment. |
| Liver impairment | No specific Child-Pugh based guidelines; dose may need adjustment due to impaired gluconeogenesis and altered insulin clearance. |
| Pediatric use | Type 1 diabetes: 0.5-1 unit/kg/day in divided doses with meals; type 2 diabetes: 0.2-0.5 units/kg/day divided; adjust based on blood glucose monitoring. |
| Geriatric use | Use with caution; start with lower doses due to increased risk of hypoglycemia; monitor renal function and adjust accordingly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NOVOLOG FLEXTOUCH (NOVOLOG FLEXTOUCH).
| Breastfeeding | Insulin aspart is excreted in human milk in negligible amounts and is not orally bioavailable to the infant. M/P ratio not established. Considered compatible with breastfeeding. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies. Insulin aspart does not cross the placenta in significant amounts. Poor glycemic control increases risk of fetal malformations, macrosomia, and neonatal hypoglycemia. Use during pregnancy is preferred over oral hypoglycemics. |
| Fetal Monitoring |
■ FDA Black Box Warning
Never share a NovoLog FlexTouch pen between patients, even if the needle is changed; sharing poses a risk for transmission of blood-borne pathogens.
| Serious Effects |
["Hypersensitivity to insulin aspart or any excipients","During episodes of hypoglycemia"]
| Precautions | ["Hypoglycemia is the most common adverse effect","Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control","May cause hypokalemia","Not recommended for treatment of diabetic ketoacidosis (use intravenous short-acting insulin instead)"] |
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| Monitor maternal blood glucose levels frequently. Fetal monitoring for growth and well-being via ultrasound and non-stress tests as per standard diabetes in pregnancy protocols. Assess for maternal hypoglycemia. |
| Fertility Effects | No direct effects on fertility. Poor glycemic control may impair fertility due to menstrual irregularities and anovulation. Optimal glycemic control improves fertility outcomes. |