INTRALIPID

What it is

Intralipid is a sterile fat emulsion for intravenous infusion containing soya oil, available in three strengths: 10%, 20% and 30%. It is presented as an intravenous infusion for injection in the form of a milky white liquid. The 10%, 20% and 30% formulations contain 100 g, 200 g and 300 g of soya oil per 1000 mL respectively.

Approved indications

Intralipid is indicated as part of the intravenous diet in parenteral nutrition for the following conditions: — Preoperative and postoperative nutritional disturbances where an improved nitrogen balance is required — Nutritional disorders or disturbances of nitrogen balance due to inadequate or failing intestinal absorption caused by tumours in the gastrointestinal tract, acute or chronic intestinal diseases (peritonitis, ulcerative colitis, terminal ileitis) — Burns, to reduce the frequently excessive nitrogen losses — Prolonged unconsciousness, for example following cranial trauma or poisoning in cases where enteral feeding is inappropriate or impossible — Impaired renal function where a concentrated source of energy may be indicated to reduce protein breakdown — Cachexia — Essential Fatty Acid Deficiency in patients who cannot maintain or restore a normal essential fatty acid pattern by oral intake

Dosing overview

For adults receiving Intralipid 10% and 20%, the quantity given intravenously should normally not exceed 2 g triglycerides per kilogram bodyweight per day, with no more than 1 g triglycerides per kilogram bodyweight on the first day and a doubled dose on the second day provided the patient's ability to eliminate administered fat has been established. In patients with raised caloric requirements, the supply of Intralipid can be further increased but should not, without special precautions, exceed 3 g triglycerides per kilogram bodyweight per day. When starting, the rate of infusion should be about 1 mL per minute during the first 10 minutes, then gradually increased so that after 30 minutes it stabilises at the desired rate of 2 to 3 mL per minute for Intralipid 10% and 1 to 1.5 mL per minute for Intralipid 20%. For Intralipid 30%, the daily supplementation of 330 mL (100 g fat) is regarded as sufficient for a patient weighing 70 kg with basal energy requirement and on total parenteral nutrition, with a recommended maximum dosage of 3 g triglycerides per kilogram bodyweight per day. The infusion rate for Intralipid 30% is approximately 1 mL per minute and should not exceed 330 mL in 5 hours. For neonates and infants receiving Intralipid 10% and 20%, the recommended dosage range is 0.5 to 4 g triglycerides per kilogram per day, with the rate of infusion not exceeding 0.17 g triglycerides per kilogram per hour. Intralipid 30% is not recommended in infants and children because of lack of experience.

Key safety warnings

Intralipid is contraindicated in patients with an impaired ability to metabolise fat, such as in severe liver damage and acute shock, and in patients with hypersensitivity to egg, soya or peanut protein or to any of the active substances or excipients. Fat metabolism may be disturbed in conditions such as renal insufficiency, uncompensated diabetes, pancreatitis, certain forms of liver insufficiency, metabolic disorders and sepsis, and if intravenous fat is considered to be indicated in patients with these disorders, the elimination of fat should be checked daily. Intralipid contains soya oil and egg lecithin which may rarely cause allergic reactions, and cross allergic reaction has been observed between soya bean and peanut. An impaired capacity to eliminate Intralipid may lead to fat overload syndrome as a result of overdosage or at recommended rates of infusion in association with a sudden change in clinical condition such as renal function impairment or infection, characterised by bone marrow depression, anaemia, thrombocytopenia, hepatosplenomegaly, splenomegaly, hyperlipaemia, fever, fat infiltration, focal seizures and shock. All symptoms are usually reversible if the infusion of Intralipid is discontinued.

Contraindications

Intralipid is contraindicated in patients with an impaired ability to metabolise fat, such as in severe liver damage and acute shock, and in patients with hypersensitivity to egg, soya or peanut protein or to any of the active substances or excipients.

Regulatory history

Intralipid was first approved on 8 March 1994 for glass bottles and on 11 December 2001 for Biofine bags.