Fish oil

Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). Limitations of Use: • Omegaven is not indicated for the prevention of PNAC. It has not been demonstrated that Omegaven prevents PNAC in parenteral nutrition (PN)-dependent patients [see Clinical Studies ( 14 )]. • It has not been demonstrated that the clinical outcomes observed in patients treated with Omegaven are a result of the omega-6: omega-3 fatty acid ratio of the product [see Clinical Studies ( 14 )]. Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). …

• For infusion into a central or peripheral vein. • See full prescribing information for administration and admixing instructions. • Protect the admixed PN solution from light. • Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize, and consideration of additional energy sources given to the patient
• The recommended daily dose (and the maximum dose)
• In pediatric patients is 1 g/kg/day. • For information on infusion rate when initiating dosing and in patients with elevated triglyceride levels, see the full prescribing information. • The recommended duration for infusion is between 8 and 24 hours, depending on the clinical situation
• Administration Instructions • Omegaven can be administered alone or as part of a PN admixture. • Omegaven is for central or peripheral intravenous infusion
• When administered with dextrose and amino acids, the choice of a central or peripheral venous route should depend on the osmolarity of the final infusate
• Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central vein. • Do not exceed the recommended maximum infusion rate in Table 1 [see Dosage and Administration and Warnings and Precautions ] . • Use a 1.2 micron in-line filter during administration. • Use a dedicated line for PN. …

Injectable Emulsion: 5 g/50 mL and 10 g/100 mL (0.1 g/mL) sterile, white, homogenous emulsion in a 50-mL and 100-mL single-dose bottle. Injectable Emulsion: 5 g/50 mL and 10 g/100 mL (0.1 g/mL) in a single-dose bottle ( 3 )

• The effectiveness of Omegaven was established in two open-label clinical trials of 82
• Pediatric patients, 3 to 42 weeks of age, including preterm
• Neonates with estimated gestational age of greater than 24 weeks at birth
• Patients administered Omegaven attained and maintained growth through at least 108 weeks of treatment [see Clinical Studies ]
• The safety of Omegaven was established in 189
• Pediatric patients (19 days to 15 years of age)
• The most common adverse reactions in Omegaven-treated patients were vomiting, agitation, and bradycardia [see Adverse Reactions ]. …

Clinical trials of Omegaven did not include patients 65 years of age and older.

• When initiating Omegaven administration, discuss the following information: Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants Inform caregivers that acute respiratory distress and death may occur in neonates and infants after rapid infusion of intravenous lipid emulsions
• If Omegaven is infused at home, instruct caregivers not to exceed the maximum infusion rate [see Warnings and Precautions ]
• Hypersensitivity reactions Inform caregivers that Omegaven may cause hypersensitivity reactions, including anaphylaxis. …

Use of Omegaven is contraindicated in patients with: • Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients [see Warnings and Precautions ( 5.2 )]. • Severe hemorrhagic disorders due to a potential effect on platelet aggregation. • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentrations greater than 1,000 mg/dL) [see Warnings and Precautions ( 5.6 )]. …

Antiplatelet Agents and Anticoagulants : Prolonged bleeding time has been reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving Omegaven and concomitant antiplatelet agents or anticoagulants. ( 7.1 ) 7.1 Antiplatelet Agents and Anticoagulants Some published studies have demonstrated prolongation of bleeding time in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. The prolongation of bleeding times reported in those studies did not exceed normal limits and there were no clinically significant bleeding episodes. …

• Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported. ( 5.1 ) • Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reaction occurs. ( 5.2 ) • Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, and Hypertriglyceridemia : Monitor for signs and symptoms; monitor laboratory parameters. ( 5.3 , 5.4 , 5.5 , 5.6 ) • Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm infants. …

The following clinically significant adverse reactions are described elsewhere in the labeling: • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions ( 5.1 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] • Infections [see Warnings and Precautions ( 5.3 )] • Fat overload syndrome [see Warnings and Precautions ( 5.4 )] • Refeeding syndrome [see Warnings and Precautions ( 5.5 )] • Hypertriglyceridemia [see Warnings and Precautions ( 5.6 )] • Aluminum toxicity [see Warnings and Precautions ( 5.7 )] Most common adverse drug reactions (>15%) are: vomiting, agitation, bradycardia, apnea and viral infe …

8.1 Pregnancy Risk Summary There are no available data on Omegaven use in pregnant women to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with fish oil triglycerides. The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. …

In the event of an overdose, serious adverse reactions may occur [see Warnings and Precautions ( 5.1 , 5.4 )] . Stop the infusion of Omegaven until triglyceride levels have normalized and any symptoms have abated. The effects are usually reversible by stopping the lipid infusion. If medically appropriate, further intervention may be indicated. Lipids are not dialyzable from serum.

Store below 25°C (77°F). Avoid excessive heat. Do not freeze. If accidentally frozen, discard product. Once the bottle is connected to the infusion set, use Omegaven immediately. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.