Omegaven (Emulsion) Instructions for Use

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi Austria, GmbH (Austria)

ATC Code

B05BA02 (Fat emulsions)

Dosage Form

Omegaven

Infusion emulsion: fl. 50 mL or 100 mL 10 pcs with holders or without them.

Dosage Form, Packaging, and Composition

Infusion emulsion white or white with a creamy tint, homogeneous.

Excipients: egg yolk phospholipids, glycerol, sodium oleate, sodium hydroxide, water for injections.

50 ml – colorless glass bottles (10) – cardboard boxes.
50 ml – colorless glass bottles with plastic holders (10) – cardboard boxes.
100 ml – colorless glass bottles (10) – cardboard boxes.
100 ml – colorless glass bottles with plastic holders (10) – cardboard boxes.

Clinical-Pharmacological Group

Agent for parenteral nutrition – fat emulsion

Pharmacotherapeutic Group

Blood substitutes and perfusion solutions; solutions for intravenous administration; solutions for parenteral nutrition

Pharmacological Action

Parenteral nutrition agent.

Soybean oil is a source of energy and polyunsaturated essential omega-6 (linoleic) and omega-3 (linolenic) fatty acids, contains a high dose of choline.

Fish oil is a source of eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids. DHA is an important structural component of cell membranes, and EPA is a precursor of eicosanoids, such as prostaglandins, thromboxanes, and leukotrienes.

Medium-chain triglycerides provide the body with rapidly available energy due to their ability to be rapidly hydrolyzed.

Olive oil provides energy in the form of monounsaturated fatty acids, which are much less susceptible to hydrolysis compared to the corresponding amount of polyunsaturated fatty acids.

Tocopherol (vitamin E) has an antioxidant effect.

Does not affect kidney function, is isotonic to blood plasma, has high caloric content.

Indications

Conducting parenteral nutrition and providing the body with the necessary amount of energy and essential fatty acids when oral or enteral nutrition is impossible, insufficient, or contraindicated: digestive disorders in the pre- and postoperative period; surgical interventions on the gastrointestinal tract; gastrointestinal diseases; burns; chronic renal failure; cachexia.

ICD codes

Dosage Regimen

Intravenous, for infusion into a central or peripheral vein.

The dose depends on the drug used, the patient’s age, and the clinical situation.

When determining the dose and infusion rate, the individual characteristics of the patient’s body to eliminate intravenously administered lipids should be taken into account.

The duration of the treatment course depends on the clinical condition and individual characteristics of the patient.

Adverse Reactions

Immune system disorders rarely – hypersensitivity reactions (e.g., anaphylactic and anaphylactoid reactions).

Nervous system disorders rarely – headache.

Cardiovascular system disorders rarely – increase or decrease in blood pressure, hyperemia.

Metabolism and nutrition disorders rarely – hyperlipidemia, hyperglycemia, metabolic acidosis, fat overload syndrome.

Respiratory system disorders rarely – dyspnea, cyanosis.

Skin and subcutaneous tissue disorders rarely – skin rash, urticaria.

Gastrointestinal system disorders rarely – lack of appetite, nausea, vomiting.

Reproductive system disorders very rarely – priapism.

Musculoskeletal and connective tissue disorders rarely – pain in the neck, back, bones, chest, and lumbar region.

General disorders and administration site conditions frequently – slight increase in body temperature; infrequently – chills; rarely – feeling of heat, pallor.

Contraindications

Acute phase of shock; severe disorders of fat metabolism (pathological hyperlipidemia); metabolic disorders in severe post-traumatic conditions; sepsis; unstable hemodynamics with impairment of vital functions (collapse, acute stage of shock); suspicion of pulmonary hypertension; acute phase of myocardial infarction or stroke; decompensated chronic heart failure; acute thromboembolism; fat embolism; pulmonary edema; decompensated diabetes mellitus; acidosis; acute pancreatitis; pancreatic necrosis; hepatic failure; intrahepatic cholestasis; renal failure (if hemofiltration or dialysis is not possible); hypothyroidism (if hypertriglyceridemia is noted); severe coagulation disorders; hyperhydration; hypotonic dehydration; hypokalemia; history of allergic reactions (only after performing allergy tests); hypersensitivity to chicken protein, fish, soy, peanuts.

With caution

Disorders of fat metabolism, including in renal failure, diabetes mellitus, pancreatitis, liver dysfunction, hypothyroidism, sepsis; newborns with hyperbilirubinemia or pulmonary hypertension.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is acceptable in cases where the expected benefit of therapy for the mother outweighs the possible risk to the fetus or infant.

Use in Hepatic Impairment

Contraindicated in hepatic failure, intrahepatic cholestasis.

Use in Renal Impairment

Contraindicated in renal failure (if hemofiltration or dialysis is not possible).

Pediatric Use

Can be used in children according to indications in recommended doses in appropriate dosage forms.

Use with caution in newborns with hyperbilirubinemia or pulmonary hypertension.

Special Precautions

The ability to eliminate lipids is individual and depends on the patient’s metabolic state, so the patient’s lipid metabolism parameters should be constantly monitored. Monitoring usually involves daily determination of triglyceride concentration.

Special attention should be paid to patients at risk of developing hyperlipidemia (e.g., patients receiving high-dose lipid therapy, patients with severe sepsis, and newborn infants with extremely low birth weight). The plasma triglyceride concentration during the administration of the fat emulsion should usually not exceed 3 mmol/L. If the serum or plasma triglyceride concentration during or after the infusion exceeds 3 mmol/L, the possibility of reducing the dose or discontinuing the fat emulsion administration should be considered. Overdose may lead to the development of fat overload syndrome.

Cross-allergic reaction to soy and peanuts may develop. If any signs of an anaphylactic reaction (such as fever, chills, rash, or shortness of breath) occur, the infusion of the drug should be stopped immediately.

The use of medium-chain fatty acids as the sole source of energy may provoke the development of metabolic acidosis. The risk of developing metabolic acidosis is significantly reduced with the simultaneous administration of long-chain fatty acids. The simultaneous administration of carbohydrates with the fat emulsion further reduces the risk of developing metabolic acidosis. Thus, it is recommended to simultaneously infuse the fat emulsion with a carbohydrate solution or an amino acid solution containing carbohydrates.

To monitor the condition of patients receiving parenteral nutrition, regular monitoring of laboratory parameters is necessary, including determination of blood glucose concentration, liver function tests, acid-base status, water-electrolyte balance, complete blood count, and electrolyte concentrations.

If it is necessary to use in patients with impaired lipid metabolism, including in renal failure, diabetes mellitus, pancreatitis, liver dysfunction, hypothyroidism, and sepsis, constant monitoring of plasma triglyceride levels is required.

High concentrations of lipids in plasma may affect the results of some laboratory parameters, for example, hemoglobin content.

Use in pediatrics

In newborns, especially premature infants, who are on parenteral nutrition for a long time, it is necessary to constantly monitor plasma triglyceride and bilirubin concentrations, as well as platelet count and liver function indicators.

Exposure of parenteral nutrition solutions to light, especially with the addition of trace elements and (or) vitamins, causes the formation of potentially dangerous peroxides and other degradation products, which may lead to the development of adverse clinical reactions in newborns.

Drug Interactions

The use of heparin in clinical doses causes a transient increase in the secretion of lipoprotein lipase in the plasma. Initially, this may lead to increased lipolysis in the plasma, and then to a temporary decrease in triglyceride clearance.

Soybean oil is a source of natural vitamin K₁. This should be taken into account when using this agent in patients treated with indirect anticoagulants – coumarin derivatives.

Adding other drugs or medicinal products to fat emulsions for parenteral nutrition is generally not recommended, except in cases where their compatibility has been proven.

Mixing with other infusion solutions, with preparations of fat-soluble and water-soluble vitamins, with electrolyte concentrates can only be carried out if the compatibility is beyond doubt.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.