Olimel

What it is

OLIMEL is an emulsion for intravenous infusion. It is presented in the form of a three-compartment bag, with individual compartments containing a glucose solution, a lipid emulsion and an amino acid solution. There are seven different formulations of OLIMEL (four with electrolytes and three without electrolytes) and one formulation of PeriOLIMEL. OLIMEL is a three-in-one admixture enabling the nitrogen and energy balance to be maintained from the nitrogen source (L-series amino acids) and energy in the form of glucose and essential fatty acids, which are required for normal functioning of all cells in the body, protein synthesis, growth, wound healing, immune function and muscle function.

Approved indications

— Parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.

Dosing overview

The dosage depends on the patient's energy expenditure, clinical status, body weight and ability to metabolise constituents of OLIMEL, as well as on additional energy or proteins given orally or enterally, with the bag size chosen with regard to the patient's body weight. Average daily requirements for adults are protein of 0.16 to 0.35 g nitrogen per kg body weight (1 to 2 g of amino acids per kg) depending on nutritional status and degree of catabolic stress, with special populations requiring up to 0.4 g nitrogen per kg body weight; energy of 20 to 40 kcal per kg; and fluid of 20 to 40 mL per kg or 1 to 1.5 mL per expended kcal. PeriOLIMEL N4-600E may be administered through a peripheral or central vein due to its low osmolarity of 760 mOsmol per litre. OLIMEL N5-860E, N7-960E, N7-960, N9-840E, N9-840, N12-640 and N12-640E must only be administered through a central vein due to their high osmolarity. The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours.

Key safety warnings

Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition, with fatal outcomes occurring in some cases, and excessive addition of calcium and phosphate increasing the risk of calcium phosphate precipitate formation. Fat overload syndrome has been reported with similar products, which may be caused by inappropriate administration such as overdose or infusion rates higher than recommended, and the reduced or limited ability to metabolise lipids contained in OLIMEL accompanied by prolonged plasma clearance may result in fat overload syndrome. Refeeding severely undernourished patients may result in refeeding syndrome characterised by the shift of potassium, phosphorus and magnesium intracellularly, with thiamine deficiency and fluid retention also potentially developing, though careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications. The infusion must be stopped immediately if any signs or symptoms of an allergic reaction such as fever, shivering, skin rashes or dyspnoea develop. Extravasation has been reported with administration of OLIMEL, and catheter site should be monitored regularly to identify signs of extravasation.

Contraindications

OLIMEL is contraindicated in premature neonates, infants and children less than two years old; in patients with known hypersensitivity to egg or soya proteins, peanut protein, corn or corn products, or components of the container; in patients with congenital abnormalities of amino acid metabolism; in patients with severe hyperlipidaemia or severe disorders of lipid metabolism characterised by hypertriglyceridaemia; in patients with severe hyperglycaemia; in unstable conditions such as following severe post-traumatic conditions, acute phase of circulatory shock, acute myocardial infarction, severe sepsis and hyperosmolar coma; and in formulations with electrolytes administered to patients with pathologically elevated plasma concentrations of sodium, potassium, magnesium, calcium or phosphorus.

PBS listing

No information regarding PBS listing is available in the source documents.

Regulatory history

OLIMEL N5-860E, N7-960, N7-960E, N9-840, N9-840E and the N12-640/N12-640E formulations were first listed on the Australian Register of Therapeutic Goods in August 2013, with N12-640 and N12-640E additionally listed in July 2019. An AusPAR (Australian Public Assessment Report) was approved on 23 July 2013, with the TGA approving registration of OLIMEL for parenteral nutrition in adults. The approval was granted after a comprehensive evaluation of quality, nonclinical and clinical data, with a recommendation for careful monitoring of patient electrolyte levels during treatment.