TODAY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TODAY (TODAY).
Insulin substitution therapy: recombinant human insulin analog that binds to insulin receptors, activating tyrosine kinase signaling to promote glucose uptake (e.g., GLUT4 translocation), glycogen synthesis, lipogenesis, and protein synthesis, while inhibiting gluconeogenesis and glycogenolysis.
| Metabolism | Primarily degraded by insulin-degrading enzyme (IDE) in liver, kidney, and muscle; less than 1% excreted unchanged in urine. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 70% of elimination, with biliary/fecal excretion contributing the remaining 30%. |
| Half-life | Terminal elimination half-life is 4-6 hours in healthy adults, permitting twice-daily dosing in most patients. |
| Protein binding | Approximately 90% bound to albumin. |
| Volume of Distribution | Volume of distribution is 0.8 L/kg, indicating distribution into total body water. |
| Bioavailability | Oral bioavailability is 60-80% due to moderate first-pass metabolism. |
| Onset of Action | Oral: 30-60 minutes; Intravenous: within 5 minutes. |
| Duration of Action | Clinical effects persist for 8-12 hours after oral administration and 6-8 hours after intravenous administration. |
Not available.
| Dosage form | SPONGE |
| Renal impairment | Not applicable. |
| Liver impairment | Not applicable. |
| Pediatric use | Not established. |
| Geriatric use | No specific data. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TODAY (TODAY).
| Breastfeeding | Minimal excretion into breast milk; estimated infant dose <1% of maternal weight-adjusted dose. M/P ratio not available. Considered compatible with breastfeeding; monitor infant for hypotension or electrolyte disturbances. |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: associated with increased risk of congenital malformations (e.g., neural tube defects, cleft palate) based on animal studies; insufficient human data. Second and third trimesters: may cause fetal hypotension, hypokalemia, and renal dysfunction; avoid use unless necessary. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypoglycemia (active episode)","Hypersensitivity to recombinant human insulin or any excipient in the formulation"]
| Precautions | ["Hypoglycemia: can cause severe or life-threatening hypoglycemia; monitor blood glucose and adjust doses accordingly","Hypoglycemia unawareness: increased risk in patients with long-standing diabetes, intensified therapy, or concomitant beta-blocker use","Medication errors: accidental mix-up between insulin products can cause overdosage or underdosage","Hypersensitivity reactions: local or systemic allergic reactions including anaphylaxis; discontinue if severe","Hypokalemia: insulin can cause rapid shift of potassium into cells, leading to hypokalemia if uncorrected"] |
Loading safety data…
| Fetal Monitoring |
| Monitor maternal blood pressure, serum potassium, and renal function (BUN, creatinine). Fetal assessment: serial ultrasound for growth and amniotic fluid volume; fetal heart rate monitoring with prolonged use. |
| Fertility Effects | No known direct effects on fertility in human studies. Animal studies show no impairment of fertility at clinically relevant doses. |