GLAMIN

What it is

GLAMIN is a sterile, non-pyrogenic emulsion for intravenous infusion containing 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. The product is presented in a three-chamber plastic bag containing a 10% amino acid solution with electrolytes, a 20% lipid emulsion and a 42% glucose solution.

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 GLAMIN, as well as additional energy or proteins given orally or enterally, with the bag size chosen accordingly. Average daily requirements for adults in normal nutritional state or with mild catabolic stress are 0.6–0.9 g amino acids per kg bodyweight per day, while patients with moderate to high metabolic stress with or without malnutrition require 0.9–1.6 g amino acids per kg bodyweight per day. A dosage range of 13–31 ml per kg bodyweight per day provides 0.7–1.6 g amino acids per kg bodyweight per day and 14–33 kcal per kg bodyweight per day of total energy. The recommended infusion period is 14–24 hours.

Key safety warnings

GLAMIN 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. GLAMIN 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 occurring in some cases, and excessive addition of calcium and phosphate increases the risk of calcium phosphate precipitate formation. The infusion set and catheter should periodically be checked for precipitates, and if signs of pulmonary distress occur, the infusion should be stopped and medical evaluation initiated. Fat overload syndrome has been reported with similar products and may be caused by inappropriate administration, though signs and symptoms may also occur when the product is administered according to instructions, and reduced or limited ability to metabolise the lipids contained in GLAMIN accompanied by prolonged plasma clearance may result in fat overload syndrome. This syndrome is associated with sudden deterioration in the patient's clinical condition and is characterised by fever, anaemia, leucopoenia, thrombocytopenia, coagulation disorders, hyperlipidaemia, liver fatty infiltration, deteriorating liver function, and central nervous system manifestations such as coma. Refeeding severely undernourished patients may result in refeeding syndrome characterised by 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. In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary oedema and congestive heart failure as well as decrease in serum concentration of potassium, phosphorus, magnesium and water-soluble vitamins, with these changes occurring within 24 to 48 hours, therefore careful and slow initiation of parenteral nutrition is recommended with close monitoring and appropriate adjustments.

Contraindications

GLAMIN is contraindicated in hypersensitivity or known allergy to corn or corn products, fish, egg, soya, or peanut proteins or to 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 of the included electrolytes, acute pulmonary oedema, hyperhydration, 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.

Regulatory history

GLAMIN was first registered on the ARTG on 29 May 2002 with two variants: GLAMIN amino acids/dipeptides 250 mL intravenous infusion injection bottle (ARTG 77749) and GLAMIN amino acids/dipeptides 500 mL intravenous infusion injection bottle (ARTG 77750).