SMOFlipid

What it is

SMOFlipid is an emulsion for intravenous infusion containing soya oil 60 g, medium chain triglycerides 60 g, olive oil 50 g and fish oil rich in omega-3 acids 30 g per 1000 mL. Each litre provides total energy of 8400 kJ (2000 kcal).

Approved indications

— Supply of energy and essential fatty acids to patients as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contraindicated.

Dosing overview

For adults, the standard dose is 1.0–2.0 g fat per kilogram body weight per day, with a recommended infusion rate of 0.125 g fat per kilogram body weight per hour, not exceeding 0.15 g fat per kilogram body weight per hour. For neonates and infants, the initial dose should be 0.5–1.0 g fat per kilogram body weight per day, increased successively by 0.5–1.0 g fat per kilogram body weight per day up to a maximum daily dose of 3 g fat per kilogram body weight per day, with infusion rates not exceeding 0.125 g fat per kilogram body weight per hour. In premature and low birth weight neonates, SMOFlipid should be infused continuously over approximately 24 hours. For children, the recommended maximum daily dose is 2 g fat per kilogram body weight per day, though up to 3 g fat per kilogram body weight per day can be considered for those with increased requirements. The daily dose should be increased gradually during the first week of administration, with infusion rates not exceeding 0.15 g fat per kilogram body weight per hour.

Key safety warnings

The capacity to eliminate fat is individual and should be monitored routinely by the clinician, generally by checking triglyceride levels. The concentration of triglycerides in serum should not exceed 3 mmol/L during infusion. Reduction of dosage or cessation of the lipid emulsion should be considered if serum or plasma triglyceride concentrations exceed 3 mmol/L. SMOFlipid contains soya oil, fish oil and egg lecithin, which may rarely cause allergic reactions. Cross-allergic reaction has been observed between soya bean and peanut. Any signs or symptoms of anaphylactic reaction, such as fever, shivering, rash or dyspnoea, should lead to immediate interruption of the infusion. Impaired capacity to eliminate triglycerides can lead to Fat Overload Syndrome, characterised by hyperlipaemia, fever, fat infiltration, hepatomegaly with or without icterus, splenomegaly, anaemia, leukopaenia, thrombocytopenia, coagulation disorder, haemolysis and reticulocytosis, abnormal liver function tests and coma. These symptoms are usually reversible if the infusion of the fat emulsion is discontinued, and the infusion of SMOFlipid should be stopped if signs of this syndrome occur. SMOFlipid should be given with caution in conditions of impaired lipid metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism and sepsis. SMOFlipid should be given with caution to neonates and premature infants with hyperbilirubinaemia and cases with pulmonary hypertension. When used in neonates and children below 2 years, SMOFlipid should be protected from ambient light until administration is completed.

Contraindications

SMOFlipid is contraindicated in hypersensitivity to fish, egg, soya or peanut protein or to any of the active ingredients or excipients; severe hyperlipidaemia; severe liver insufficiency; severe blood coagulation disorders; severe renal insufficiency without access to haemofiltration or dialysis; acute shock; acute pulmonary oedema; hyperhydration; decompensated cardiac insufficiency; and unstable conditions including severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration.

Regulatory history

SMOFlipid 500 mL bags (ARTG 158359) were first listed on 24 March 2010. SMOFlipid 250 mL and 100 mL bags (ARTG 262964 and 262963) were subsequently listed on 14 December 2015.