PeriOLIMEL

What it is

PeriOLIMEL is a sterile non-pyrogenic combination of a 10% amino acid solution with electrolytes, a 20% lipid emulsion and 42% glucose solution . It is an emulsion for intravenous infusion . The formulation 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 . PeriOLIMEL 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 PeriOLIMEL, as well as additional energy or proteins given orally or enterally, and the bag size should be chosen accordingly . Average daily requirements for adults range from 0.6–0.9 g amino acids per kilogram body weight per day in patients with normal nutritional state or mild catabolic stress, to 0.9–1.6 g amino acids per kilogram body weight per day in patients with moderate to high metabolic stress with or without malnutrition . A 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 kcal per kilogram body weight per day of total energy . The recommended infusion period is 14–24 hours .

Key safety warnings

PeriOLIMEL must only be administered through a central vein and infusion must be stopped immediately if any signs or symptoms of an allergic reaction develop . PeriOLIMEL 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 fatal outcomes in some cases, and excessive addition of calcium and phosphate increases the risk of calcium phosphate precipitate formation . Fat overload syndrome has been reported with similar products and may be caused by inappropriate administration or when the product is administered according to instructions due to reduced ability to metabolise lipids, characterised by fever, anaemia, leucopoenia, thrombocytopenia, coagulation disorders, hyperlipidaemia, liver fatty infiltration, deteriorating liver function, and central nervous system manifestations . Refeeding severely undernourished patients may result in refeeding syndrome characterised by shift of potassium, phosphorus, and magnesium intracellularly, with thiamine deficiency and fluid retention also developing, which can be prevented by careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding . 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

PeriOLIMEL is contraindicated in patients with hypersensitivity or known allergy to corn or corn products, fish, egg, soya, or peanut proteins or to any of the 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 of the included electrolytes; and general contraindications to infusion therapy including acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency . Use is also contraindicated in 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 .

Regulatory history

PeriOLIMEL (ARTG 197419) was first listed on the ARTG on 9 August 2013 . The TGA approved registration on 23 July 2013 for parenteral nutrition in adults when oral or enteral nutrition is impossible, insufficient or contraindicated . Approval was granted after comprehensive evaluation of quality, nonclinical, and clinical data, with a recommendation for careful monitoring of patient electrolyte levels during treatment .