SOYACAL 10%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SOYACAL 10% (SOYACAL 10%).
Soybean oil provides essential fatty acids (linoleic and linolenic acids) as a caloric source and prevents essential fatty acid deficiency; intravenous fat emulsions are metabolized to free fatty acids, which are oxidized for energy or stored as triglycerides.
| Metabolism | Intravenous fat emulsions are cleared from the bloodstream by lipoprotein lipase, which hydrolyzes triglycerides to free fatty acids and glycerol. The free fatty acids are then metabolized primarily via beta-oxidation in tissues. |
| Excretion | Soyacal 10% (soybean oil emulsion) is metabolized via β-oxidation and cleared from the bloodstream by lipoprotein lipase; <5% excreted renally, ~95% eliminated as CO2 via lungs, minimal fecal excretion. |
| Half-life | 3.5 hours (terminal elimination half-life in adults; may be prolonged in preterm infants or hepatic dysfunction). |
| Protein binding | >99% (bound to lipoproteins, primarily chylomicrons and VLDL). |
| Volume of Distribution | 3.5-5.0 L/kg (distributes to plasma and extravascular spaces, including adipose tissue; increased in sepsis or burns). |
| Bioavailability | 100% (intravenous administration only; not bioavailable orally). |
| Onset of Action | 10-20 minutes (intravenous infusion: onset of caloric effect and fatty acid provision). |
| Duration of Action | 4-6 hours (clinical effect persists as long as infusion continues; complete clearance from plasma within 12-24 hours after cessation). |
Intravenous infusion: 500 mL/day as part of parenteral nutrition, adjusted to meet individual caloric and protein needs. Typical rate: 0.5-1.5 mL/kg/h.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-60 mL/min: No adjustment required. GFR <30 mL/min: Caution due to risk of fluid overload and electrolyte imbalances; monitor serum potassium and phosphate. Hemodialysis: Use with caution, adjust volume to avoid fluid overload. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Reduce dose by 20-30% due to impaired amino acid metabolism. Child-Pugh C: Avoid use or use with extreme caution; monitor ammonia levels closely. |
| Pediatric use | Neonates and infants: Start at 0.5 g/kg/day of amino acids, increase by 0.5 g/kg/day to max 2.5 g/kg/day. Children: 1-2 g/kg/day, administered as continuous infusion. Adjust based on weight and metabolic needs. |
| Geriatric use | No specific adjustment from adult dose. Monitor renal function, fluid status, and electrolytes; reduce infusion rate to prevent fluid overload in patients with compromised cardiovascular function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SOYACAL 10% (SOYACAL 10%).
| Breastfeeding | Excreted in breast milk in negligible amounts; M/P ratio not established. Considered compatible with breastfeeding when clinically necessary. |
| Teratogenic Risk | No evidence of teratogenicity; SOYACAL 10% (soybean oil emulsion) is not associated with structural anomalies. Use in all trimesters considered safe when indicated for parenteral nutrition. |
| Fetal Monitoring |
■ FDA Black Box Warning
Deaths in preterm infants after infusion of intravenous fat emulsion have been reported in the literature. Autopsy findings included intravascular fat accumulation in the lungs. Treatment of preterm and low-birth-weight infants with intravenous fat emulsion must be based on the benefit-risk assessment. Strict adherence to the recommended total daily dosage is mandatory; hourly infusion rate should be as slow as possible in each case and should not exceed 1 g/kg in 4 hours.
| Serious Effects |
["Hypersensitivity to soybean oil, eggs, or any component of the formulation","Severe hyperlipidemia","Acute pancreatitis with hypertriglyceridemia","Lipoid nephrosis or pathologic hyperlipidemia"]
| Precautions | ["Risk of fat overload syndrome (hepatomegaly, splenomegaly, thrombocytopenia, coagulopathy, and hypertriglyceridemia) with rapid infusion or overdose","Monitor serum triglycerides regularly; reduce infusion rate if elevated","Use with caution in patients with hyperlipidemia, pancreatitis, hepatic or renal impairment","Risk of infection due to catheter-related sepsis","Contains aluminum which may accumulate and cause toxicity in patients with renal impairment"] |
Loading safety data…
| Monitor triglycerides, liver function tests, and clinical signs of fat overload syndrome. In pregnancy, assess fetal growth and amniotic fluid volume if prolonged use. |
| Fertility Effects | No known adverse effects on fertility; use in parenteral nutrition does not impair reproductive function. |