PERIKABIVEN IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PERIKABIVEN IN PLASTIC CONTAINER (PERIKABIVEN IN PLASTIC CONTAINER).
Perikabiven provides a balanced mixture of amino acids, electrolytes, dextrose, and lipids for parenteral nutrition. Amino acids serve as building blocks for protein synthesis, dextrose provides glucose for energy, and lipids supply essential fatty acids and a concentrated energy source. Electrolytes maintain osmotic balance and support biochemical reactions.
| Metabolism | Metabolized via standard pathways: dextrose undergoes glycolysis and oxidative phosphorylation; amino acids are catabolized via deamination and urea cycle; lipids are hydrolyzed by lipoprotein lipase to fatty acids and oxidized or stored. |
| Excretion | Renal (primarily as ammonium and urea) and biliary (fecal loss of unabsorbed lipids). The amino acids, dextrose, and electrolytes are eliminated via renal excretion; lipids are metabolized and eliminated as CO2 and water. Approximately 20-30% of the lipid dose is excreted renally as metabolites, with <5% excreted unchanged. |
| Half-life | Amino acids: ~0.5-1 hour (rapid clearance due to metabolic incorporation and urinary elimination). Lipids: terminal elimination half-life of ~30 minutes to 1.5 hours for triglycerides, with longer half-life for essential fatty acids (days to weeks due to incorporation into cell membranes). Clinical context: rapid clearance from plasma with continuous infusion. |
| Protein binding | Lipids: >99% bound to lipoproteins (VLDL, chylomicrons). Amino acids: minimal protein binding (<10%). Dextrose: not bound. |
| Volume of Distribution | Amino acids: Vd ~0.15-0.25 L/kg (primarily extracellular fluid). Lipids: Vd ~0.05-0.1 L/kg (plasma volume). Dextrose: Vd ~0.2 L/kg. |
| Bioavailability | Intravenous: 100%. Not administered via other routes (oral bioavailability not applicable due to formulation for IV use only). |
| Onset of Action | Intravenous: immediate (within minutes) for metabolic effects; lipid clearance begins within 30 minutes. |
| Duration of Action | Intravenous: 6-24 hours for plasma amino acid and lipid levels to return to baseline after infusion stop; clinical effects on nitrogen balance and energy provision persist for 1-2 days post-infusion. |
Intravenous administration: usual adult dose is 1.5 to 2.0 g amino acids per kg per day, corresponding to 25-30 mL/kg/day of Perikabiven, with a maximum infusion rate of 2.5 mL/kg/hour.
| Dosage form | EMULSION |
| Renal impairment | For GFR 30-60 mL/min: consider reducing dose by 25-50% of standard; for GFR <30 mL/min: use only if benefit outweighs risk, reduce to 0.5-1.0 g amino acids/kg/day and monitor electrolytes and fluid balance closely. |
| Liver impairment | Child-Pugh Class A: no adjustment; Child-Pugh B: reduce to 0.8-1.2 g amino acids/kg/day; Child-Pugh C: contraindicated or use with extreme caution at reduced dose with close monitoring. |
| Pediatric use | Administer only under specialist guidance; typical dose: 0.2-2.5 g amino acids/kg/day via central line; adjust infusion rate to meet caloric and fluid needs; maximum infusion rate not established in children. |
| Geriatric use | No specific dose adjustment required, but consider reduced renal function; initiate at low end of dosing range and monitor fluid and electrolyte balance closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PERIKABIVEN IN PLASTIC CONTAINER (PERIKABIVEN IN PLASTIC CONTAINER).
| Breastfeeding | No specific data on excretion into breast milk. The components (amino acids, glucose, lipids, electrolytes) are normally present in breast milk in varying amounts. Use with caution in lactating women; consider the benefits of breastfeeding and the mother's need for parenteral nutrition. M/P ratio not available. |
| Teratogenic Risk | PERIKABIVEN IN PLASTIC CONTAINER is a parenteral nutrition formulation containing amino acids, dextrose, lipids, and electrolytes. There are no adequate and well-controlled studies in pregnant women. The components are endogenous substances or nutrients that are generally considered safe in pregnancy when used as indicated. However, the risk of fetal harm cannot be excluded due to potential maternal metabolic disturbances (e.g., hyperglycemia, electrolyte imbalances). In the first trimester, risks are theoretical; in second and third trimesters, maternal nutritional support may improve fetal outcomes. Overall, FDA Pregnancy Category C (based on individual components). |
■ FDA Black Box Warning
Not FDA-approved for pediatric use (<18 years) due to risk of aluminum toxicity, which can cause impaired neurological development, osteopenia, and encephalopathy.
| Serious Effects |
Absolute: Hypersensitivity to any component, inborn errors of amino acid metabolism, severe hyperglycemia, severe hyperlipidemia, unstable cardiovascular status, severe hepatic or renal impairment without appropriate monitoring.
| Precautions | Risk of infection from catheter-related sepsis, fluid overload, electrolyte imbalances, hyperglycemia, hypoglycemia upon abrupt cessation, aluminum toxicity, and pulmonary embolism if lipid infusion is too rapid. |
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| Fetal Monitoring | Monitor maternal serum glucose, electrolytes (sodium, potassium, calcium, magnesium, phosphate), acid-base status, liver function tests, triglycerides, and serum osmolality. Fetal monitoring includes ultrasound for growth and amniotic fluid volume, and nonstress test or biophysical profile as clinically indicated. Monitor for signs of fluid overload, infection, and metabolic complications. |
| Fertility Effects | No known adverse effects on fertility. The components are essential nutrients; adequate nutritional status supports normal reproductive function. No specific data on impairment of fertility. |