FIASP
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FIASP (FIASP).
FIASP is an insulin aspart formulation with faster absorption due to added L-arginine and niacinamide. It activates insulin receptor tyrosine kinase, promoting glucose uptake via GLUT4 translocation.
| Metabolism | Insulin aspart is metabolized by proteolytic degradation; no specific CYP450 involvement. |
| Excretion | Renal: Approximately 60-80% of insulin aspart is excreted via the kidneys following degradation. Fecal/biliary excretion accounts for <10%. |
| Half-life | 0.7-1.0 hours (ultra-rapid acting insulin; terminal half-life from subcutaneous absorption, not intravenous elimination). |
| Protein binding | <5% (minimal reversible binding to plasma proteins, primarily albumin; not clinically significant). |
| Volume of Distribution | 0.2-0.4 L/kg (approximately 15-30 L for a 70 kg individual, reflecting distribution into extracellular fluid). |
| Bioavailability | Subcutaneous: 50-70% (incomplete due to local degradation; exact value varies with injection site and technique). |
| Onset of Action | Subcutaneous: 2.5-5 minutes (time to initial glucose-lowering effect, faster than regular insulin). |
| Duration of Action | 3-5 hours (subcutaneous injection; dose-dependent, shorter duration than regular insulin, suitable for mealtime coverage). |
Subcutaneous injection at mealtimes, dose individualized. Typical starting total daily dose 0.5-1 unit/kg/day, given as 50% bolus and 50% basal. Bolus dose: 1-2 units or 0.1-0.2 units/kg per meal.
| Dosage form | SOLUTION |
| Renal impairment | No specific GFR-based dose adjustment required. For severe renal impairment (eGFR <30 mL/min), monitor glucose closely and reduce dose due to decreased insulin clearance. |
| Liver impairment | No specific Child-Pugh based dose adjustment. In severe hepatic impairment (Child-Pugh class C), dose reduction may be needed due to impaired gluconeogenesis; start with lower doses and titrate. |
| Pediatric use | Children ≥1 year: subcutaneous injection, dose individualized. Usual total daily dose 0.5-1 unit/kg/day, given as basal-bolus. Bolus dose: 0.1-0.2 units/kg per meal. Children <1 year: limited data; use with caution. |
| Geriatric use | Start with lower doses (e.g., 0.5 units/kg/day total) due to increased risk of hypoglycemia. Titrate slowly based on glucose monitoring. Monitor renal function as clearance may decrease. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FIASP (FIASP).
| Breastfeeding | Endogenous insulin and insulin aspart are excreted in breast milk in negligible amounts. No adverse effects on nursing infant expected. M/P ratio not established; considered compatible with breastfeeding. |
| Teratogenic Risk | Insulin aspart (FIASP) does not cross the placenta in significant amounts. Animal studies have not shown teratogenicity. Poorly controlled diabetes during pregnancy increases risk of fetal anomalies, macrosomia, and neonatal hypoglycemia. Use in all trimesters is considered safe when indicated. |
■ FDA Black Box Warning
Never share a FIASP FlexTouch pen or syringe between patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.
| Common Effects | Hypoglycemia low blood glucose level Headache Nasopharyngitis inflammation of the throat and nasal passages Upper respiratory tract infection |
| Serious Effects |
["Hypersensitivity to insulin aspart or any excipients","During episodes of hypoglycemia"]
| Precautions | ["Hypoglycemia is the most common adverse reaction","Changes in insulin regimen may cause hyperglycemia or hypoglycemia","Accidental mix-ups between insulin products can occur","Hypokalemia may occur","Fluid retention and heart failure with concomitant thiazolidinediones","Risk of hypoglycemia due to medication errors"] |
Loading safety data…
| Fetal Monitoring |
| Monitor maternal blood glucose, HbA1c, and ketones. Fetal monitoring includes ultrasound for growth and amniotic fluid volume, and fetal heart rate monitoring. Assess for neonatal hypoglycemia after delivery. |
| Fertility Effects | No known direct effects on fertility. Poor glycemic control can impair fertility; improved control may restore fertility. Animal studies show no impairment of fertility. |