FINOMEL

What it is

FINOMEL is an emulsion for intravenous infusion presented in a three-compartment plastic bag containing a sterile, non-pyrogenic combination of a ten per cent amino acid solution with electrolytes, a twenty per cent lipid emulsion and forty-two per cent glucose solution. The product contains alanine, arginine, glycine, histidine, isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, sodium acetate trihydrate, potassium chloride, calcium chloride dihydrate, magnesium sulfate heptahydrate, sodium glycerophosphate hydrate, zinc sulfate heptahydrate, glucose monohydrate, soya oil, olive oil, medium chain triglycerides and fish oil-rich omega-3 acids. FINOMEL is a hypertonic emulsion.

Approved indications

— Parenteral nutrition in adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated.

Dosing overview

Dosage should be individualised depending on energy expenditure, the patient's clinical status, body weight, and ability to metabolise constituents of FINOMEL, as well as additional energy or proteins given orally or enterally, and the bag size should be chosen accordingly. In patients with normal nutritional state or mild catabolic stress, the average daily requirement is 0.6–0.9 g amino acids per kilogram body weight per day, and in patients with moderate to high metabolic stress with or without malnutrition, 0.9–1.6 g amino acids per kilogram body weight per day. The dosage range of 13–31 mL per kilogram body weight per day will provide 0.7–1.6 g amino acids per kilogram body weight per day and 14–33 kilocalories per kilogram body weight per day of total energy. The recommended infusion period is 14–24 hours.

Key safety warnings

FINOMEL must only be administered through a central vein, and the infusion must be stopped immediately if any signs or symptoms of an allergic reaction such as fever, shivering, rash or dyspnoea develop. FINOMEL contains soya oil, fish oil and egg phospholipids, which may rarely cause allergic reactions, and cross-allergic reaction has been observed between soybean and peanut. Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition, with some cases resulting in fatal outcomes, and excessive addition of calcium and phosphate increases the risk of formation of calcium phosphate precipitates. Fat overload syndrome has been reported with similar products and may be caused by inappropriate administration or overdose, and is characterised by findings such as fever, anaemia, leucopoenia, thrombocytopenia, coagulation disorders, hyperlipidaemia, liver fatty infiltration, deteriorating liver function, and central nervous system manifestations. The patient's capacity to eliminate lipids should be monitored by checking triglyceride levels, with serum triglyceride concentration not exceeding 4.6 millimoles per litre during infusion. 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 potentially developing, and careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications. Patients on parenteral nutrition may experience hepatic complications including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure, as well as cholecystitis and cholelithiasis, and should be monitored accordingly.

Contraindications

FINOMEL is contraindicated in hypersensitivity or known allergy to corn or corn products, fish, egg, soya or peanut proteins or any active substances or excipients, severe hyperlipidaemia, severe hepatic impairment, severe blood coagulation disorders, congenital abnormalities of amino acid metabolism, severe renal impairment without access to haemofiltration or dialysis, uncontrolled hyperglycaemia, pathologically elevated serum levels of any included electrolytes, general contraindications to infusion therapy including acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency, and unstable conditions such as severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma.

PBS listing

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

Regulatory history

FINOMEL was first listed on the Australian Register of Therapeutic Goods on 28 June 2019 in three presentations: the 1085 mL intravenous infusion bag (ARTG 297694), the 1435 mL intravenous infusion bag (ARTG 307361), and the 1820 mL intravenous infusion bag (ARTG 307363), all in licence category RE.