NOVAMINE 11.4%

Clinical safety rating: caution

Comprehensive clinical and safety monograph for NOVAMINE 11.4% (NOVAMINE 11.4%).

How it works

Amino acid solution providing essential and non-essential amino acids for protein synthesis and nitrogen balance in parenteral nutrition.

What the body does with it

Metabolism	Amino acids are metabolized via transamination, deamination, and urea cycle pathways; primarily in the liver.
Excretion	Amino acids are metabolized via transamination and deamination; nitrogen is excreted renally as urea (75-90%), with minimal biliary/fecal elimination (<5%).
Half-life	Variable, dependent on amino acid profile; net protein synthesis occurs over 4-6 hours post-infusion; no classical terminal half-life; clinical steady state achieved within 24-48 hours of continuous infusion.
Protein binding	Amino acids are minimally protein-bound (<10%); primarily bound to albumin for transport, but binding is saturable and variable.
Volume of Distribution	Total body water distribution; approximately 0.2-0.4 L/kg for most amino acids, reflecting distribution into extracellular and intracellular compartments.
Bioavailability	100% intravenous; not absorbed orally due to dipeptide composition requiring enzymatic cleavage.
Onset of Action	Intravenous: nitrogen retention and protein synthesis begin within minutes to hours; maximal effect on nitrogen balance seen after 24-48 hours of continuous infusion.
Duration of Action	Cessation of infusion leads to decline in nitrogen retention over 24-48 hours; prolonged effect with continuous administration.

Classification & Brands

Dosing & administration

Intravenous infusion: initial dose 1.5 mL/kg/day (0.17 g amino acids/kg/day) increased by 0.5 mL/kg/day to 2.0-3.0 mL/kg/day (0.23-0.34 g amino acids/kg/day) maximum 3.5 mL/kg/day (0.4 g amino acids/kg/day). Infusion rate not to exceed 0.1 mL/kg/hour in neonates and 0.2 mL/kg/hour in older patients.

Dosage form	INJECTABLE
Renal impairment	Contraindicated in severe renal impairment (GFR < 25 mL/min) unless dialysis is performed. In moderate impairment (GFR 25-50 mL/min), reduce dose by 50% and monitor BUN and creatinine. No adjustment for mild impairment.
Liver impairment	Contraindicated in Child-Pugh class C cirrhosis. In Child-Pugh class B, reduce dose by 50% and monitor ammonia levels. No adjustment for Child-Pugh class A.
Pediatric use	Neonates and infants: initiate at 1.5 mL/kg/day (0.17 g amino acids/kg/day), increase by 0.5 mL/kg/day to target 2.0-3.0 mL/kg/day (0.23-0.34 g amino acids/kg/day). Maximum infusion rate 0.1 mL/kg/hour. Children: same dosing as adults but adjusted for weight, maximum 3.5 mL/kg/day.
Geriatric use	No specific dose adjustment recommended, but use with caution due to increased risk of fluid overload and electrolyte imbalances. Monitor renal function and adjust dose if renal impairment present.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for NOVAMINE 11.4% (NOVAMINE 11.4%).

Breastfeeding	No M/P ratio available. Breastfeeding generally considered safe when maternal nutrition is optimized; monitor infant for metabolic disturbances.
Teratogenic Risk	Amino acid solutions are essential for fetal growth; however, high osmolality or electrolyte imbalances may pose risks. No specific teratogenicity documented in first trimester; second/third trimester risk relates to maternal metabolic disturbances (e.g., acidosis, hyperammonemia).
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Not for intravenous injection directly; must be administered via central line or peripheral vein with appropriate dilution. Risk of metabolic acidosis, hyperammonemia, and electrolyte imbalances.

Side Effect Profile

Serious Effects

Absolute Contraindications

Severe hepatic failure, hyperammonemia, inborn errors of amino acid metabolism, severe renal impairment without dialysis, and hypersensitivity to any component.

Clinical Precautions

Precautions

Monitor serum electrolytes, blood urea nitrogen, ammonia, and glucose regularly. Use with caution in renal impairment, hepatic failure, and metabolic disorders. Risk of fluid overload and electrolyte disturbances.

Clinical Tips & Counseling

Drug interactions

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NOVAMINE 11.4%

Clinical safety rating: caution

Comprehensive clinical and safety monograph for NOVAMINE 11.4% (NOVAMINE 11.4%).

How it works

Amino acid solution providing essential and non-essential amino acids for protein synthesis and nitrogen balance in parenteral nutrition.

What the body does with it

Metabolism	Amino acids are metabolized via transamination, deamination, and urea cycle pathways; primarily in the liver.
Excretion	Amino acids are metabolized via transamination and deamination; nitrogen is excreted renally as urea (75-90%), with minimal biliary/fecal elimination (<5%).
Half-life	Variable, dependent on amino acid profile; net protein synthesis occurs over 4-6 hours post-infusion; no classical terminal half-life; clinical steady state achieved within 24-48 hours of continuous infusion.
Protein binding	Amino acids are minimally protein-bound (<10%); primarily bound to albumin for transport, but binding is saturable and variable.
Volume of Distribution	Total body water distribution; approximately 0.2-0.4 L/kg for most amino acids, reflecting distribution into extracellular and intracellular compartments.
Bioavailability	100% intravenous; not absorbed orally due to dipeptide composition requiring enzymatic cleavage.
Onset of Action	Intravenous: nitrogen retention and protein synthesis begin within minutes to hours; maximal effect on nitrogen balance seen after 24-48 hours of continuous infusion.
Duration of Action	Cessation of infusion leads to decline in nitrogen retention over 24-48 hours; prolonged effect with continuous administration.

Classification & Brands

Dosing & administration

Dosage form	INJECTABLE
Renal impairment	Contraindicated in severe renal impairment (GFR < 25 mL/min) unless dialysis is performed. In moderate impairment (GFR 25-50 mL/min), reduce dose by 50% and monitor BUN and creatinine. No adjustment for mild impairment.
Liver impairment	Contraindicated in Child-Pugh class C cirrhosis. In Child-Pugh class B, reduce dose by 50% and monitor ammonia levels. No adjustment for Child-Pugh class A.
Pediatric use	Neonates and infants: initiate at 1.5 mL/kg/day (0.17 g amino acids/kg/day), increase by 0.5 mL/kg/day to target 2.0-3.0 mL/kg/day (0.23-0.34 g amino acids/kg/day). Maximum infusion rate 0.1 mL/kg/hour. Children: same dosing as adults but adjusted for weight, maximum 3.5 mL/kg/day.
Geriatric use	No specific dose adjustment recommended, but use with caution due to increased risk of fluid overload and electrolyte imbalances. Monitor renal function and adjust dose if renal impairment present.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for NOVAMINE 11.4% (NOVAMINE 11.4%).

Breastfeeding	No M/P ratio available. Breastfeeding generally considered safe when maternal nutrition is optimized; monitor infant for metabolic disturbances.
Teratogenic Risk	Amino acid solutions are essential for fetal growth; however, high osmolality or electrolyte imbalances may pose risks. No specific teratogenicity documented in first trimester; second/third trimester risk relates to maternal metabolic disturbances (e.g., acidosis, hyperammonemia).
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Not for intravenous injection directly; must be administered via central line or peripheral vein with appropriate dilution. Risk of metabolic acidosis, hyperammonemia, and electrolyte imbalances.

Side Effect Profile

Serious Effects

Absolute Contraindications

Severe hepatic failure, hyperammonemia, inborn errors of amino acid metabolism, severe renal impairment without dialysis, and hypersensitivity to any component.