NOVOLOG PENFILL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NOVOLOG PENFILL (NOVOLOG PENFILL).
Insulin aspart is a rapid-acting recombinant human insulin analog. It lowers blood glucose by binding to insulin receptors on skeletal muscle and adipose tissue, promoting glucose uptake, and inhibiting hepatic glucose production via glycogenolysis and gluconeogenesis.
| Metabolism | Insulin aspart is metabolized primarily by insulin-degrading enzyme (IDE). It has a half-life of approximately 81 minutes following subcutaneous administration. |
| Excretion | Renal: 60-80% as metabolites; unchanged drug excreted minimally. Fecal: <10% |
| Half-life | ~5-7 minutes (free insulin aspart); clinical effect duration correlates with SC absorption half-life ~1-2 hours |
| Protein binding | ~5-10% bound to plasma proteins (no specific binding proteins mentioned; likely albumin) |
| Volume of Distribution | ~0.15-0.2 L/kg (confined primarily to extracellular fluid) |
| Bioavailability | Subcutaneous: 60-80% (compared to IV) |
| Onset of Action | Subcutaneous: 10-20 minutes; Intravenous: <5 minutes |
| Duration of Action | Subcutaneous: 3-5 hours; Intravenous: ~1 hour (discontinued infusion) |
Subcutaneous injection: 0.5-1 unit/kg/day divided into multiple doses (e.g., basal-bolus regimen). Individualized based on glucose monitoring.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <15 mL/min/1.73 m2: Consider dose reduction. No specific guidelines for mild-moderate impairment. |
| Liver impairment | Child-Pugh Class B or C: Monitor glucose closely; dose reduction may be necessary due to impaired gluconeogenesis. |
| Pediatric use | Children ≥2 years: 0.5-1 unit/kg/day divided into multiple doses. Titrate based on insulin requirements and glycemic control. |
| Geriatric use | Use lower initial doses (e.g., 0.2-0.4 units/kg/day) due to reduced renal function and risk of hypoglycemia. Titrate cautiously. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NOVOLOG PENFILL (NOVOLOG PENFILL).
| Breastfeeding | Insulin aspart is excreted into breast milk in negligible amounts (M/P ratio not established; endogenous insulin is present). No adverse effects on the nursing infant are expected. The drug is considered compatible with breastfeeding. Monitor infant for signs of hypoglycemia if high doses are used. |
| Teratogenic Risk | Insulin aspart (NovoLog) does not cross the placenta in significant amounts. No increased risk of major congenital anomalies or adverse fetal outcomes has been reported from maternal use. Poorly controlled diabetes carries risks for fetal malformations, macrosomia, and neonatal complications. Adequate glycemic control during pregnancy is essential. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to insulin aspart or any of its excipients","Hypoglycemia (episodes of low blood sugar)"]
| Precautions | ["Never share a Novolog Penfill cartridge between patients, even if the needle is changed, as it poses a risk for transmission of blood-borne pathogens","Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia","Hypoglycemia is the most common adverse reaction; it may be severe and life-threatening","Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration","Accumulation of insulin may occur if the patient does not rotate injection sites, leading to lipodystrophy"] |
Loading safety data…
| Fetal Monitoring | Monitor maternal blood glucose levels frequently. Assess HbA1c at least every trimester. Fetal surveillance includes ultrasound for growth and anatomy, nonstress tests, and biophysical profiles as clinically indicated. Monitor for maternal hypoglycemia and adjust doses accordingly. |
| Fertility Effects | No known adverse effects on fertility in males or females. Well-controlled diabetes is important for normal reproductive function. Insulin aspart does not impair fertility. |