FREAMINE HBC 6.9%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FREAMINE HBC 6.9% (FREAMINE HBC 6.9%).
FREAMINE HBC 6.9% is a branched-chain amino acid (BCAA) solution that provides essential and non-essential amino acids. It promotes protein synthesis and serves as a substrate for gluconeogenesis. BCAAs may compete with tryptophan and aromatic amino acids for entry into the brain, potentially reducing hepatic encephalopathy.
| Metabolism | Primarily metabolized in the liver via transamination and oxidation of branched-chain amino acids. Branched-chain amino acids are also metabolized in muscle tissue. |
| Excretion | Amino acids are primarily eliminated via metabolism; <2% excreted unchanged in urine. Excess nitrogen is converted to urea and excreted renally as urea. Biliary/fecal elimination is negligible. |
| Half-life | Not applicable as a mixture; individual amino acids have half-lives ranging from minutes to hours. For clinical purposes, infusion rate and metabolic clearance are monitored rather than half-life. |
| Protein binding | Variable, generally low (<20%) for most amino acids; albumin and globulins bind some branched-chain amino acids (e.g., leucine, isoleucine, valine). |
| Volume of Distribution | Approximately 0.15–0.25 L/kg, reflecting distribution primarily in extracellular fluid and lean tissue. |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: Immediate upon infusion; plasma amino acid levels rise within minutes. |
| Duration of Action | Duration of effect is continuous during infusion; after cessation, plasma levels decline rapidly over 1–2 hours due to metabolism and redistribution. |
Intravenous infusion, 1.0 to 2.0 g amino acids/kg/day (14.5 to 29.0 mL/kg/day of FREAMINE HBC 6.9%). Typically 0.5-1.0 L per day in adults, titrated to metabolic needs.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in severe renal impairment (GFR < 25 mL/min) unless dialysis is used. In moderate impairment (GFR 25-50 mL/min), reduce dose by 50% and monitor BUN, creatinine, electrolytes. |
| Liver impairment | Contraindicated in Child-Pugh class C. In Child-Pugh class A or B, use with caution; reduce dose by 50% and monitor ammonia levels frequently. |
| Pediatric use | Neonates and infants: 2.0-3.0 g/kg/day (29-43.5 mL/kg/day). Older children: 1.5-2.5 g/kg/day (21.7-36.2 mL/kg/day). Administer as continuous intravenous infusion with appropriate electrolytes and energy sources. |
| Geriatric use | Start at low end of adult dosing (1.0 g/kg/day). Monitor renal function and fluid balance closely due to decreased renal reserve and higher risk of fluid overload. Adjust dose based on creatinine clearance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FREAMINE HBC 6.9% (FREAMINE HBC 6.9%).
| Breastfeeding | It is not known whether amino acids administered intravenously are excreted in human milk. Many drugs are excreted, so caution is advised. M/P ratio is unknown. |
| Teratogenic Risk | FREAMINE HBC 6.9% is an amino acid injection used in parenteral nutrition. No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Therefore, potential fetal risk cannot be ruled out, especially in first trimester. Use only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to any component of the formulation","Inborn errors of amino acid metabolism (e.g., maple syrup urine disease)","Severe hyponatremia or hypervolemia"]
| Precautions | ["Monitor serum electrolytes, fluid status, and liver function tests regularly.","Use with caution in patients with severe renal impairment or hyperammonemia.","May cause metabolic acidosis or hyperglycemia."] |
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| Monitor maternal electrolytes, blood glucose, acid-base balance, fluid status, liver and renal function. Fetal monitoring per standard obstetric care. Watch for signs of fluid overload or metabolic complications. |
| Fertility Effects | No data on effects of FREAMINE HBC 6.9% on fertility. Parental nutrition may correct nutritional deficiencies that could improve fertility; however, no direct evidence. |