Fish Oil Triglycerides

Fish Oil Triglycerides is a lipid supplement used as a source of calories and fatty acids for pediatric patients with parenteral nutrition-associated cholestasis.

• Fish Oil Triglycerides are available under the following different brand names: Omegaven

Common side effects of Fish Oil Triglycerides include:

• vomiting
• agitation
• slow heart rate
• breathing interruption (apnea)
• viral infection
• redness
• rash
• abscess
• low white blood cell count (neutropenia)
• muscle stiffness
• incision site redness

Serious side effects of Fish Oil Triglycerides include:

• blurred vision
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• nausea

Rare side effects of Fish Oil Triglycerides include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

• Injectable emulsion, single-dose emulsion
• 5 g/50 mL
• 10 g/100 mL

Nutrition-associated cholestasis

Pediatric dosage

• Recommended dose: 1 g/kg/day IV (maximum daily dose)
• Initial rate of IV infusion should not exceed 0.05 mL/min for the first 15-30 min of infusion
• If tolerated, gradually increase until reaching the required rate after 30 min; the maximum infusion rate should not exceed 1.5 mL/kg/h, corresponding to 0.15 g/kg/h.
• Clinical trial efficacy and safety
• Effectiveness was established in 2 open-label clinical trials of 82 pediatric patients (aged 3 to 42 wk), including preterm neonates with an estimated gestational age of more than 24 wk at birth
• Safety was established in 189 pediatric patients (aged 19 d to 15 y); the most common adverse reactions were vomiting, agitation, and bradycardia

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Fish Oil Triglycerides have severe interactions with no other drugs.
• Fish Oil Triglycerides have serious interactions with no other drugs.
• Fish Oil Triglycerides have moderate interactions with at least 73 other drugs.
• Fish Oil Triglycerides have minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients
• Severe hemorrhagic disorders due to a potential effect on platelet aggregation
• Severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentrations more than 1000 mg/dL)

Effects of drug abuse

• None

Short-Term Effects

• See "“What Are Side Effects Associated with Using Fish Oil Triglycerides?"”

Long-Term Effects

• See "What Are Side Effects Associated with Using Fish Oil Triglycerides?"

Cautions

• Preterm neonates and infants who receive treatment with this product may be at risk for aluminum toxicity and other metabolic abnormalities
• Fat overload syndrome reported with IV lipid emulsions; reduced or limited ability to metabolize lipids accompanied by prolonged plasma clearance may result in this syndrome, which is characterized by a sudden deterioration in the patient's condition including fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, hepatomegaly, deteriorating liver function, and central nervous system manifestations (eg, coma); the syndrome is usually reversible when the lipid infusion is discontinued
• Administering PN to severely malnourished patients may result in refeeding syndrome, which is characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic; thiamine deficiency and fluid retention may also develop; closely monitor severely malnourished patients and slowly increase their nutrient intake; impaired lipid metabolism with hypertriglyceridemia may occur in conditions such as inherited lipid disorders, obesity, diabetes mellitus, and metabolic syndrome; serum triglyceride levels more than 1000 mg/dL have been associated with an increased risk for pancreatitis; measure serum triglycerides before the start of infusion (baseline value) and regularly throughout treatment (see Dosage Modifications)
• Fish oil triglyceride contains no more than 25 mcg/L of aluminum; aluminum may reach toxic levels with prolonged IV administration if kidney function is impaired; patients with impaired kidney function, including preterm infants, who receive parenteral levels of aluminum at greater than 4-5 mcg/kg/day accumulate aluminum at levels associated with the central nervous system and bone toxicity
• Monitor serum triglycerides, fluid and electrolyte status, blood glucose, liver and kidney function, coagulation parameters, and complete blood count throughout treatment
• Monitor patients for laboratory evidence of essential fatty acid deficiency (EFAD) is recommended; consider laboratory tests determining serum fatty acid level values to help determine the adequacy of essential fatty acid status; increasing essential fatty acid intake (enterally or parenterally) is effective in treating and preventing EFAD
• Lipids contained in fish oil triglyceride may interfere with some laboratory blood tests (eg, hemoglobin, lactate dehydrogenase, bilirubin, and oxygen saturation) if blood is sampled before lipids have cleared from the bloodstream; lipids are normally cleared after a period of 5-6 h once the lipid infusion is stopped
• Clinical decompensation with rapid infusion
  • In a postmarket setting, serious adverse reactions including acute respiratory distress, metabolic acidosis, and death reported in neonates and infants after rapid infusion of intravenous lipid emulsions; hypertriglyceridemia was commonly reported
  • Strictly adhere to recommended total daily dosage; the hourly infusion rate should not exceed 1.5 mL/kg/h.
• Infections
  • Lipid emulsions, such as fish oil triglyceride, can support microbial growth and are an independent risk factor for the development of bloodstream infections; the risk for infection is increased in patients with malnutrition-associated immunosuppression, long-term use and poor maintenance of IV catheters, or immunosuppressive effects of other conditions or concomitant drugs; monitor for signs and symptoms of early infections including fever and chills, laboratory tests results indicating possible infection (including leukocytosis and hyperglycemia), and frequently inspect IV catheter site for edema, redness, and discharge
  • Ensure aseptic technique in catheter placement and maintenance, as well as in the preparation and administration of the drug to decrease the risk for infection
• Hypersensitivity reactions
  • Drug contains fish oil and egg phospholipids, which may cause hypersensitivity reactions
  • Signs or symptoms of a hypersensitivity reaction include tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, fever, or chills
  • If a hypersensitivity reaction occurs, stop infusion immediately and initiate appropriate treatment and supportive measures
• Pulmonary lipid accumulation
  • Deaths in preterm infants after infusion of soybean oil–based IV lipid emulsions have been reported in the medical literature; the risk for pulmonary lipid accumulation with Fish Oil Triglycerides is unknown
  • Preterm and small-for-gestational-age infants have poor clearance of IV lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion; consider this risk due to poor lipid clearance when administering IV lipid emulsions
  • Monitor the infant’s ability to eliminate infused lipids from the circulation (eg, measure serum triglycerides and/or plasma-free fatty acid levels); if signs of poor clearance of lipids from circulation occur, stop an infusion and initiate medical evaluation
• Drug interaction overview
  • Prolonged bleeding time in patients reported with oral omega-3 fatty acids taking antiplatelet agents or anticoagulants
  • Clinical trials of IV Fish Oil Triglycerides did not observe bleeding times that exceeded normal limits or clinically significant bleeding episodes; however, the prescribing information recommends periodic monitoring of bleeding time in patients receiving Fish Oil Triglycerides receiving concomitant antiplatelet agents or anticoagulants

Pregnancy and Lactation

• There are no available data on use in pregnant women to establish a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Animal reproduction studies have not been conducted with Fish Oil Triglycerides
• Lactation
  • No data are available regarding the presence of Fish Oil Triglycerides from Fish Oil Triglycerides in human milk, the effects on the breastfed infant, or the effects on milk production
  • Lactating women receiving oral omega-3 fatty acids have been shown to have higher levels of fatty acids in their milk