TRAVAMULSION 10%

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TRAVAMULSION 10% (TRAVAMULSION 10%).

How it works

Travamulsion 10% is a lipid emulsion providing essential fatty acids (linoleic acid, alpha-linolenic acid) and calories for parenteral nutrition. It serves as a source of calories and essential fatty acids, preventing or treating essential fatty acid deficiency. The mechanism is nutritional, not pharmacological.

What the body does with it

Metabolism	Metabolized by lipoprotein lipase and hepatic lipase; cleared from plasma via hydrolysis and tissue uptake.
Excretion	Travamulsion 10% is a lipid emulsion primarily used for parenteral nutrition. The triglycerides are hydrolyzed by lipoprotein lipase, and the resulting free fatty acids are metabolized or incorporated into tissues. Elimination is not via renal or biliary excretion in a drug-like manner; instead, the components are utilized in metabolic pathways. Less than 5% of the infused lipid is excreted unchanged in urine or feces.
Half-life	The terminal elimination half-life of the triglyceride component is approximately 30-60 minutes, reflecting rapid clearance from the bloodstream by lipoprotein lipase. Clinically, this supports continuous infusion for maintenance of lipid levels.
Protein binding	The lipid emulsion components are not protein-bound in a pharmacokinetic sense; they are incorporated into chylomicrons and very-low-density lipoproteins. Albumin binding of free fatty acids occurs after lipolysis, but overall protein binding is less than 10% for the intact emulsion.
Volume of Distribution	The volume of distribution for the lipid emulsion is approximately 0.1-0.3 L/kg, reflecting plasma and interstitial space, as the large particle size restricts extravascular distribution. This is clinically relevant as it indicates minimal tissue uptake of intact emulsion.
Bioavailability	Intravenous: 100%.
Onset of Action	Intravenous: Caloric and essential fatty acid provision begins immediately upon infusion. Clinical effects on energy balance and fatty acid deficiency prevention are apparent within hours to days of continuous administration.
Duration of Action	The duration of action for caloric support is limited to the infusion period; once stopped, lipid clearance occurs within hours. For correction of essential fatty acid deficiency, continuous infusion over several days to weeks is required.

Classification & Brands

Dosing & administration

Intravenous infusion: 1-2 g/kg/day of amino acids (10% solution provides 10 g amino acids per 100 mL). Typical adult dose: 500 mL to 1000 mL per day, infused at a rate not exceeding 0.1 g/kg/hour. Adjust based on nitrogen balance and clinical response.

Dosage form	INJECTABLE
Renal impairment	For GFR 30-60 mL/min: reduce dose by 50%. For GFR <30 mL/min: avoid use unless on renal replacement therapy; if used, reduce to 0.5-1 g/kg/day and monitor serum amino acid levels. No specific adjustment for GFR >60 mL/min.
Liver impairment	Child-Pugh Class A: no adjustment. Class B: reduce dose by 50% and monitor ammonia. Class C: contraindicated due to risk of hepatic encephalopathy (use branched-chain amino acid solutions instead).
Pediatric use	Infants and children: 0.5-3 g/kg/day of amino acids, administered as a 10% solution. Start at lower end and titrate based on metabolic tolerance. Max infusion rate: 0.1 g/kg/hour. For neonates, consider 1-2 g/kg/day initially, increasing gradually.
Geriatric use	Initiate at lower end of adult dose (e.g., 0.5-1 g/kg/day). Monitor renal function and fluid status closely due to increased risk of fluid overload and electrolyte imbalances. Adjust dose based on estimated GFR and clinical response.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TRAVAMULSION 10% (TRAVAMULSION 10%).

Breastfeeding	Lipid emulsions are normal components of breast milk. Travamulsion 10% is considered compatible with breastfeeding. No M/P ratio available; physiological lipids are secreted in milk. No adverse effects on nursing infant expected.
Teratogenic Risk	Travamulsion 10% (lipid emulsion) does not cross the placenta in significant amounts. No teratogenic effects reported in animal studies. First trimester: no increased risk of malformations. Second and third trimesters: safe for maternal nutrition when indicated. Use only if clearly needed.

Warnings & precautions

■ FDA Black Box Warning

WARNING: Death in preterm infants has been reported in association with intravenous lipid emulsion products. Autopsy findings included intravascular fat accumulation in the lungs. Preterm and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels, which may be associated with pulmonary complications.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to eggs, soybean, or peanut protein","Severe hyperlipidemia or severe disorders of lipid metabolism","Unstable conditions such as acute myocardial infarction, stroke, or shock","Pancreatitis associated with hypertriglyceridemia"]

Clinical Precautions

Precautions

["Risk of death in preterm infants due to intravascular fat accumulation","Monitor for signs of fat overload syndrome (hepatomegaly, splenomegaly, thrombocytopenia, coagulopathy, hypertriglyceridemia)","Use caution in patients with impaired lipid metabolism (e.g., renal failure, pancreatitis, hypertriglyceridemia)","Potential for allergic reactions (egg, soybean, or peanut protein allergy)","Monitor serum triglycerides; discontinue if persistently elevated","Risk of infection due to catheter-related bloodstream infections"]

Clinical Tips & Counseling

Drug interactions

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TRAVAMULSION 10%

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TRAVAMULSION 10% (TRAVAMULSION 10%).

How it works

What the body does with it

Metabolism	Metabolized by lipoprotein lipase and hepatic lipase; cleared from plasma via hydrolysis and tissue uptake.
Excretion	Travamulsion 10% is a lipid emulsion primarily used for parenteral nutrition. The triglycerides are hydrolyzed by lipoprotein lipase, and the resulting free fatty acids are metabolized or incorporated into tissues. Elimination is not via renal or biliary excretion in a drug-like manner; instead, the components are utilized in metabolic pathways. Less than 5% of the infused lipid is excreted unchanged in urine or feces.
Half-life	The terminal elimination half-life of the triglyceride component is approximately 30-60 minutes, reflecting rapid clearance from the bloodstream by lipoprotein lipase. Clinically, this supports continuous infusion for maintenance of lipid levels.
Protein binding	The lipid emulsion components are not protein-bound in a pharmacokinetic sense; they are incorporated into chylomicrons and very-low-density lipoproteins. Albumin binding of free fatty acids occurs after lipolysis, but overall protein binding is less than 10% for the intact emulsion.
Volume of Distribution	The volume of distribution for the lipid emulsion is approximately 0.1-0.3 L/kg, reflecting plasma and interstitial space, as the large particle size restricts extravascular distribution. This is clinically relevant as it indicates minimal tissue uptake of intact emulsion.
Bioavailability	Intravenous: 100%.
Onset of Action	Intravenous: Caloric and essential fatty acid provision begins immediately upon infusion. Clinical effects on energy balance and fatty acid deficiency prevention are apparent within hours to days of continuous administration.
Duration of Action	The duration of action for caloric support is limited to the infusion period; once stopped, lipid clearance occurs within hours. For correction of essential fatty acid deficiency, continuous infusion over several days to weeks is required.

Classification & Brands

Dosing & administration

Dosage form	INJECTABLE
Renal impairment	For GFR 30-60 mL/min: reduce dose by 50%. For GFR <30 mL/min: avoid use unless on renal replacement therapy; if used, reduce to 0.5-1 g/kg/day and monitor serum amino acid levels. No specific adjustment for GFR >60 mL/min.
Liver impairment	Child-Pugh Class A: no adjustment. Class B: reduce dose by 50% and monitor ammonia. Class C: contraindicated due to risk of hepatic encephalopathy (use branched-chain amino acid solutions instead).
Pediatric use	Infants and children: 0.5-3 g/kg/day of amino acids, administered as a 10% solution. Start at lower end and titrate based on metabolic tolerance. Max infusion rate: 0.1 g/kg/hour. For neonates, consider 1-2 g/kg/day initially, increasing gradually.
Geriatric use	Initiate at lower end of adult dose (e.g., 0.5-1 g/kg/day). Monitor renal function and fluid status closely due to increased risk of fluid overload and electrolyte imbalances. Adjust dose based on estimated GFR and clinical response.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TRAVAMULSION 10% (TRAVAMULSION 10%).

Breastfeeding	Lipid emulsions are normal components of breast milk. Travamulsion 10% is considered compatible with breastfeeding. No M/P ratio available; physiological lipids are secreted in milk. No adverse effects on nursing infant expected.
Teratogenic Risk	Travamulsion 10% (lipid emulsion) does not cross the placenta in significant amounts. No teratogenic effects reported in animal studies. First trimester: no increased risk of malformations. Second and third trimesters: safe for maternal nutrition when indicated. Use only if clearly needed.