FIASP FLEXTOUCH
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FIASP FLEXTOUCH (FIASP FLEXTOUCH).
Insulin analog that binds to insulin receptors, lowering blood glucose by facilitating cellular uptake of glucose and inhibiting hepatic glucose production.
| Metabolism | Degraded by insulin protease or insulin-degrading enzymes; metabolism primarily in liver and kidneys. |
| Excretion | Renal: approximately 60% of administered insulin is excreted via the kidneys, with the remainder undergoing hepatic metabolism and biliary excretion. |
| Half-life | Terminal elimination half-life is approximately 1.3 hours (range 1-1.5 hours) in healthy subjects, corresponding to the rapid clearance of monomeric insulin aspart. This short half-life supports prandial dosing to cover meal-related glucose excursions. |
| Protein binding | Approximately 50-60% bound to plasma proteins, primarily albumin and alpha-globulins. |
| Volume of Distribution | Volume of distribution (Vd) is approximately 0.3-0.4 L/kg, reflecting distribution primarily into extracellular fluid and tissues. |
| Bioavailability | Subcutaneous injection: absolute bioavailability is approximately 85-90% (based on euglycemic clamp studies), due to complete absorption from the injection site facilitated by the formulation enhancers. |
| Onset of Action | Subcutaneous administration: onset of action occurs within 2.5 minutes (range 1-5 minutes), due to the formulation containing niacinamide and L-arginine to accelerate absorption. |
| Duration of Action | Subcutaneous administration: duration of action is 3-5 hours (mean approximately 4 hours). The shorter duration compared to regular human insulin reduces risk of late postprandial hypoglycemia. |
| Action Class | Insulin analogues- rapid acting |
| Brand Substitutes | Fiasp 100IU/ml Penfill, Fiasp 100IU/ml Solution for Injection |
Subcutaneous injection at mealtime, 0.2-0.4 units/kg per dose, with total daily dose individualized; typically 50-70% of total daily insulin as bolus, remainder as basal.
| Dosage form | SOLUTION |
| Renal impairment | No specific dose adjustment; monitor glucose closely due to reduced insulin clearance in severe renal impairment (eGFR <30 mL/min/1.73m²); may require lower doses. |
| Liver impairment | No specific dose adjustment; caution in severe hepatic impairment (Child-Pugh class C) due to risk of hypoglycemia; may require dose reduction. |
| Pediatric use | Children ≥1 year: 0.2-0.5 units/kg per dose administered subcutaneously at mealtime; total daily dose individualized based on glucose monitoring. |
| Geriatric use | Initiate at lower doses (e.g., 0.1-0.2 units/kg per meal) due to increased risk of hypoglycemia; titrate slowly based on glucose response. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FIASP FLEXTOUCH (FIASP FLEXTOUCH).
| Breastfeeding | Insulin aspart is excreted in breast milk in negligible amounts; M/P ratio not available. Considered compatible with breastfeeding; monitor infant for hypoglycemia if high maternal doses. |
| Teratogenic Risk | Insulin aspart (FIASP) does not cross the placenta in significant amounts; no known teratogenic risk. Poor glycemic control increases congenital malformation risk in first trimester and macrosomia, neonatal hypoglycemia in second/third trimester. |
| Fetal Monitoring |
■ FDA Black Box Warning
Never share disposable prefilled pen between patients, even if needle changed, due to risk of transmission of blood-borne pathogens.
| Serious Effects |
["Hypersensitivity to insulin aspart or any excipients","During episodes of hypoglycemia"]
| Precautions | ["Hypoglycemia","Hypokalemia","Fluid retention and heart failure with concomitant thiazolidinediones","Hypersensitivity reactions","Needle sharing risk","Accidental mix-ups between insulin products"] |
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| Monitor maternal blood glucose frequently; HbA1c every 1-2 months. Fetal surveillance: ultrasound for growth anomalies, biophysical profile, nonstress test in third trimester; monitor for neonatal hypoglycemia post-delivery. |
| Fertility Effects | No direct adverse effects on fertility. Poor glycemic control can impair fertility due to menstrual irregularities and anovulation. |