SMOFKABIVEN

What it is

SmofKabiven NTense is a three chamber bag system of amino acid solution with electrolytes, glucose solution and lipid emulsion for intravenous infusion. It contains amino acids 6.5%, electrolytes 0.7%, lipids 2.9% and glucose 8.5%. The lipid component includes soya oil, fish oil rich in Omega-3 acids, medium-chain triglycerides, and olive oil. It is administered as an intravenous infusion into a central vein.

Approved indications

— Parenteral nutrition for adult patients and paediatric patients aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.

Dosing overview

The patient's ability to eliminate lipids and metabolise nitrogen and glucose, and nutritional requirements should govern the dosage and infusion rate. The dose should be individualised to the patient's clinical condition, body weight, nutritional and energy requirements, adjusting dosage based upon additional oral or enteral intake. In the normal nutritional state or in conditions with mild catabolic stress, requirements are 0.10–0.15 g nitrogen per kg body weight per day. In patients with moderate to high metabolic stress with or without malnutrition, requirements are in the range of 0.15–0.25 g nitrogen per kg body weight per day. The dosage range of 13–31 mL SmofKabiven NTense per kg body weight per day corresponds to 0.14–0.32 g nitrogen per kg body weight per day and 12–28 kcal per kg body weight per day of total energy, covering the need of the majority of patients. The recommended maximum daily dose is 31 mL per kg body weight per day. The recommended infusion period is 14–24 hours. For children aged 2–11 years, the dose up to 31 mL per kg body weight per day should be regularly adjusted to the patient's requirements, with a recommended maximum infusion rate of 1.8 mL per kg body weight per hour and a recommended infusion period of 12–24 hours. In adolescents aged 12–17 years, SmofKabiven NTense can be used as in adults.

Key safety warnings

The capacity to eliminate lipids is individual and should be monitored by checking triglyceride levels. The concentration of triglycerides in serum should not exceed 3 mmol per litre during infusion. Impaired capacity to eliminate triglycerides can lead to fat overload syndrome, which may be caused by overdose and may appear during severe hypertriglyceridaemia or in association with sudden changes in clinical condition such as renal function impairment or infection. This syndrome is characterised by hyperlipemia, fever, lipid infiltration, hepatomegaly, splenomegaly, anaemia, leukopenia, thrombocytopenia, coagulation disorder, haemolysis and reticulocytosis, abnormal liver function tests and coma. Symptoms are usually reversible if the lipid emulsion infusion is discontinued. SmofKabiven NTense contains soya oil, fish oil and egg lecithin, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut. Any sign or symptom of anaphylactic reaction such as fever, shivering, rash or dyspnoea should lead to immediate interruption of the infusion. In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary oedema and congestive heart failure as well as a decrease in the serum concentration of potassium, phosphorus, magnesium and water-soluble vitamins within 24 to 48 hours. Careful and slow initiation of parenteral nutrition is recommended in this patient group, together with close monitoring and appropriate adjustments of fluid, electrolytes, minerals and vitamins.

Contraindications

SmofKabiven NTense is contraindicated in hypersensitivity to fish, egg, soya or peanut protein or to any of the active substances or excipients; severe hyperlipidaemia; severe liver insufficiency; severe blood coagulation disorders; congenital errors of amino acid metabolism; severe renal insufficiency without access to haemofiltration or dialysis; acute shock; uncontrolled hyperglycaemia; pathologically elevated serum levels of any of the included electrolytes; acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency; haemophagocytotic syndrome; 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; and in neonates and infants under 2 years of age.

Regulatory history

SmofKabiven was approved by the TGA on 2011-12-20 for parenteral nutrition in adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated. The original ARTG registrations (180547, 180549, 180550, 173890, 173891, 180548, 180543, 180546) for SmofKabiven formulations were first listed on 2012-01-09. SmofKabiven NTense variant registrations (313924, 314980, 314977, 314979, 314978) were first listed on 2020-01-22. SmofKabiven Low Osmo variant registrations (329432, 329617, 329618, 329619) were first listed on 2020-08-27.