OLICLINOMEL

What it is

OLICLINOMEL is a lipid emulsion, amino acid solution and glucose solution presented in the form of a 3-compartment bag. There are eight different formulations of OLICLINOMEL, four with electrolytes and four without electrolytes. The lipid emulsion contains refined olive oil (80%) and soya oils (20%). The amino acid solution contains 15 L-series amino acids and electrolytes if present. OLICLINOMEL is a hypertonic emulsion. After the contents of the three compartments have been mixed, the 3-in-1 admixture is a milk-like homogeneous liquid.

Approved indications

— Parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Dosing overview

The dosage will depend on metabolic requirements, energy expenditure and the patient's clinical condition. For adults, average nitrogen requirements are 0.16 to 0.35 g/kg/day and energy requirements on average are 25 to 40 kcal/kg/day. For children above two years of age, average nitrogen requirements are 0.35 to 0.45 g/kg/day and energy requirements on average range between 60 and 110 kcal/kg/day. The recommended duration of the parenteral nutrition infusion is between 12 and 24 hours. OLICLINOMEL must be administered by intravenous administration through a central vein and should not be administered through a peripheral vein.

Key safety warnings

Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition, and in some cases fatal outcomes have occurred. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. If signs of pulmonary distress occur, the infusion should be stopped and medical evaluation initiated. Infection and sepsis may occur as a result of the use of intravenous catheters to administer parenteral nutrition, poor maintenance of catheters or contaminated solutions, and patients who require parenteral nutrition are often predisposed to vascular access sepsis and infectious complications due to hyperglycaemia, malnutrition and their underlying disease state. The occurrence of septic complications can be decreased with heightened emphasis on aseptic technique in catheter placement and maintenance as well as aseptic technique in nutritional formula preparation. Reduced or limited ability to remove the lipids contained in OLICLINOMEL, accompanied by prolonged plasma clearance, may result in a "fat overload syndrome" which may be caused by overdose or by regular doses, but may also occur at the start of an infusion when the product is administered according to instructions. The syndrome is characterised by hyperlipidaemia, fever, fatty liver infiltration, hepatomegaly, deteriorating liver function, anaemia, leukopaenia, thrombocytopaenia, coagulation disorders and central nervous system manifestations such as coma, and all of these symptoms are usually reversible when the lipid emulsion infusion is stopped. Refeeding severely undernourished patients may result in the refeeding syndrome characterised by the shift of potassium, phosphorus and magnesium intracellularly as the patient becomes anabolic, thiamine deficiency and fluid retention may also develop, and careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications.

Contraindications

OLICLINOMEL is contraindicated in premature neonates, infants and children less than 2 years old, as the calorie-nitrogen ratio and energy supply are inappropriate. OLICLINOMEL is contraindicated in patients with known hypersensitivity to any ingredient, egg, soya proteins or products, amino acids, olive products, components of the container or to any of the active substances or excipients. OLICLINOMEL is contraindicated in unstable conditions such as following severe post-traumatic conditions, uncompensated diabetes mellitus, acute phase of circulatory shock, acute myocardial infarction, severe metabolic acidosis, severe sepsis and hyperosmolar coma. OLICLINOMEL is contraindicated in severe renal insufficiency without the possibility of haemofiltration or dialysis, and in severe hepatic insufficiency. OLICLINOMEL is contraindicated in congenital abnormalities of amino acid metabolism that involve any of the constituent amino acids, severe blood coagulation disorders, severe hyperlipidaemia or severe disorders of lipid metabolism characterised by hypertriglyceridemia, and severe hyperglycaemia which requires more than 6 units insulin per hour. OLICLINOMEL is contraindicated in acute pulmonary oedema, hyperhydration, uncompensated cardiac insufficiency, hypotonic dehydration, and high and pathological plasma concentration of one of the electrolytes included in OLICLINOMEL.

Regulatory history

OLICLINOMEL was first included in the ARTG on 16 August 2002. Multiple ARTG registrations for various formulations and pack sizes of OLICLINOMEL were first listed on 4 September 2007.