Omegaven Drug Information

    Generic name: FISH OIL

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    Uses of Omegaven

    • 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). ( 1 ) 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. ( 1 )
    • 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. ( 1 )

    Dosage & Administration of Omegaven

    Nutritional RequirementsDirect Infusion Rate
    Recommended Initial Dosage and Maximum DosageInitial
    1 g/kg/day; this is also the maximum daily dose0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes

    Side Effects of Omegaven

    • 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 infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety database for Omegaven reflects exposure in 189 pediatric patients (19 days to 15 years of age) treated for a median of 14 weeks (3 days to 8 years) in two clinical trials. Omegaven was administered at a maximum dose of 1 g/kg/day as the lipid component of a PN regimen which also included dextrose, amino acids, vitamins, and trace elements; 158 (84%) of these patients received concurrent lipids from enteral nutrition [see Clinical Studies ( 14 )] . Adverse reactions that occurred in more than 5% of patients who received Omegaven and with a higher incidence than the comparator group are shown in Table 2 . Patients had a complicated medical and surgical history prior to receiving Omegaven treatment and the mortality was 13%. Underlying clinical conditions prior to the initiation of Omegaven therapy included prematurity, low birth weight, necrotizing enterocolitis, short bowel syndrome, ventilator dependence, coagulopathy, intraventricular hemorrhage, and sepsis. Table 2: Adverse Reactions in Greater Than 5% of Omegaven-Treated Pediatric Patients with PNAC Adverse Reaction Omegaven (N=189) n (%) Vomiting 87 (46) Agitation 67 (35) Bradycardia 66 (35) Apnea 38 (20) Viral Infection 30 (16) Erythema 23 (12) Rash 15 (8) Abscess 14 (7) Neutropenia 13 (7) Hypertonia 11 (6) Incision site erythema 11 (6) Twelve (6%) Omegaven-treated patients were listed for liver transplantation (1 patient was listed 18 days before treatment, and 11 patients after a median of 42 days [range: 2 days to 8 months] of treatment); 9 (5%) received a transplant after a median of 121 days (range: 25 days to 6 months) of treatment, and 3 (2%) were taken off the waiting list because cholestasis resolved. One hundred thirteen (60%) Omegaven-treated patients reached DBil levels less than 2 mg/dL and AST or ALT levels less than 3 times the upper limit of normal, with median AST and ALT levels for Omegaven-treated patients at 89 and 65 U/L, respectively, by the end of the study. Median hemoglobin levels and platelet counts for Omegaven-treated patients at baseline were 10.2 g/dL and 173 × 10 9 /L, and by the end of the study these levels were 10.5 g/dL and 217 × 10 9 /L, respectively. Adverse reactions associated with bleeding were experienced by 74 (39%) of Omegaven-treated patients. Median glucose levels at baseline and the end of the study were 86 and 87 mg/dL for Omegaven-treated patients, respectively. Hyperglycemia was experienced by 13 (7%) Omegaven-treated patients. Median triglyceride levels at baseline and the end of the study were 121 mg/dL and 72 mg/dL for Omegaven-treated patients respectively. Hypertriglyceridemia was experienced by 5 (3%) Omegaven-treated patients. The triene:tetraene (Mead acid:arachidonic acid) ratio was used to monitor essential fatty acid status in Omegaven-treated patients only in Study 1 (n = 123) [see Warnings and Precautions ( 5.8 )] . The median triene:tetraene ratio was 0.02 (interquartile range: 0.01 to 0.03) at both baseline and the end of the study. Blood samples for analysis may have been drawn while the lipid emulsion was being infused and patients received enteral or oral nutrition. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Omegaven. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hematologic system disorders: hemorrhage Immune system disorders: hypersensitivity reactions, including anaphylaxis [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]

    Warnings & Cautions for Omegaven

    • 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. ( 5.7 )
    • Monitoring and Laboratory Tests : Routine laboratory monitoring is recommended, including monitoring for essential fatty acid deficiency. ( 5.8 ) 5.1 Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants In the postmarket setting, serious adverse reactions including acute respiratory distress, metabolic acidosis, and death have been reported in neonates and infants after rapid infusion of intravenous lipid emulsions. Hypertriglyceridemia was commonly reported. Strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 1.5 mL/kg/hour [see Dosage and Administration ( 2.3 )]. Preterm and small for gestational age infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. Carefully monitor the infant's ability to eliminate the infused lipids from the circulation (e.g., measure serum triglycerides and/or plasma free fatty acid levels). If signs of poor clearance of lipids from the circulation occur, stop the infusion and initiate a medical evaluation [see Warnings and Precautions ( 5.4 , 5.6 ) and Overdosage ( 10 )]. 5.2 Hypersensitivity Reactions Omegaven contains fish oil and egg phospholipids, which may cause hypersensitivity reactions. In postmarketing experience, anaphylaxis has been reported following Omegaven administration [see Adverse Reactions ( 6.2 )] . Omegaven is contraindicated in patients with known hypersensitivity to fish or egg protein or to any of the active or inactive ingredients in Omegaven [see Contraindications ( 4 )] . If a hypersensitivity reaction occurs, stop infusion of Omegaven immediately and initiate appropriate treatment and supportive measures. 5.3 Infections Lipid emulsions, such as Omegaven, can support microbial growth and are an independent risk factor for the development of bloodstream infections. The risk of infection is increased in patients with malnutrition-associated immunosuppression, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other conditions or concomitant drugs. To decrease the risk of infectious complications, ensure aseptic technique in catheter placement and maintenance, as well as in the preparation and administration of Omegaven. Monitor for signs and symptoms of early infections including fever and chills, laboratory test results that might indicate infection (including leukocytosis and hyperglycemia), and frequently inspect the intravenous catheter insertion site for edema, redness, and discharge. 5.4 Fat Overload Syndrome Fat overload syndrome is a rare condition that has been reported with intravenous lipid emulsions. A 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 (e.g., coma). The cause of fat overload syndrome is unclear. Although it has been most frequently observed when the recommended lipid dose was exceeded, cases have also been described where the formulation was administered according to instructions. The syndrome is usually reversible when the infusion of the lipid emulsion is stopped. 5.5 Refeeding Syndrome 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. To prevent these complications, closely monitor severely malnourished patients and slowly increase their nutrient intake. 5.6 Hypertriglyceridemia Impaired lipid metabolism with hypertriglyceridemia may occur in conditions such as inherited lipid disorders, obesity, diabetes mellitus, and metabolic syndrome. Serum triglyceride levels greater than 1,000 mg/dL have been associated with an increased risk of pancreatitis [see Contraindications ( 4 )] . To evaluate the patient's capacity to metabolize and eliminate the infused lipid emulsion, measure serum triglycerides before the start of infusion (baseline value), and regularly throughout treatment. If hypertriglyceridemia (triglycerides greater than 250 mg/dL in neonates and infants or greater than 400 mg/dL in older children) develops, consider stopping the administration of Omegaven for 4 hours and obtain a repeat serum triglyceride level. Resume Omegaven based on new result as indicated [see Dosage and Administration ( 2.3 )] . 5.7 Aluminum Toxicity Omegaven contains no more than 25 mcg/L of aluminum. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Preterm infants are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Patients with impaired kidney function, including preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. 5.8 Monitoring/Laboratory Tests Routine Monitoring Monitor fluid status closely in patients with pulmonary edema or heart failure. Throughout treatment, monitor serum triglycerides [see Warnings and Precautions ( 5.7 )] , fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count (including platelets), and coagulation parameters. The lipids contained in Omegaven may interfere with the results of some laboratory tests (e.g., hemoglobin, lactate dehydrogenase, bilirubin, oxygen saturation) if the blood is sampled before the lipids have cleared from the bloodstream. Conduct these tests at least 6 hours after stopping the infusion. Omegaven contains Vitamin K that may counteract anticoagulant activity [see Drug Interactions ( 7 )]. Essential Fatty Acids Monitoring patients for signs and symptoms of essential fatty acid deficiency (EFAD) is recommended. Laboratory tests are available to determine serum fatty acids levels. Reference values should be consulted to help determine adequacy of essential fatty acid status. Increasing essential fatty acid intake (enterally or parenterally) is effective in treating and preventing EFAD.

    Drug Interactions with Omegaven

    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. Nonetheless, it is recommended to periodically monitor bleeding time in patients receiving Omegaven and concomitant antiplatelet agents or anticoagulants.

    Pregnancy Safety for Omegaven

    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.

    All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

    Pediatric Use of Omegaven

    Pediatric Use 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. 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.

    In the postmarketing setting, clinical decompensation with rapid infusion of intravenous lipid emulsion in neonates and infants, sometimes fatal has been reported. Preterm neonates and infants who receive treatment with Omegaven may be at risk of aluminum toxicity and other metabolic abnormalities .

    Contraindications for Omegaven

    • 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 )].
    • Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients. ( 4 )
    • Severe hemorrhagic disorders. ( 4 )
    • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (with serum triglycerides greater than 1,000 mg/dL). ( 4 , 5.6 )

    Overdosage Information for Omegaven

    In the event of an overdose, serious adverse reactions may occur . 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.

    Clinical Studies of Omegaven

    The efficacy of Omegaven was evaluated in two open-label single-center clinical trials (Study 1, NCT00910104, and Study 2, NCT00738101) in pediatric patients with PNAC (defined as direct or conjugated bilirubin equal to or greater than 2 mg/dL) who required PN for at least 14 days. Although Study 1 and Study 2 were not adequately designed to demonstrate noninferiority or superiority of Omegaven to the soybean oil-based lipid emulsion comparator, the data from these studies support Omegaven as a source of calories in pediatric patients with PNAC. Nutritional efficacy was assessed by biomarkers of lipid metabolism, growth indices (body weight, length/height and head circumference), and/or mean changes in fatty acid parameters. Both trials prospectively enrolled Omegaven-treated patients (maximum dose of 1 g/kg/day) and used historical control patients who received a soybean oil-based lipid emulsion (maximum dose of 3 g/kg/day) as a comparator.

    Patients were expected to require PN, which also included dextrose, amino acids, vitamins and trace elements, for at least 30 days (Study 1) or 14 days (Study 2), had PNAC, and had received standard therapies to prevent progression of liver disease. Study 1 enrolled patients less than 2 years of age and Study 2 enrolled patients less than 5 years of age. Patients with another cause of chronic liver disease (in the absence of intestinal failure) were excluded.

    Patients with an international normalized ratio (INR) greater than 2 and patients with portal vein thrombosis or reversal of portal flow by abdominal ultrasound were also excluded. For the efficacy analyses of Studies 1 and 2, Omegaven-treated patients were pair-matched in a 2:1 manner to historical control patients primarily based on DBil levels and postmenstrual age at baseline. There were 123 patients (82 Omegaven; 41 historical control) in this population, 78 (52; 26) were from Study 1, and 45 (30; 15) were from Study 2. A summary of concurrent enteral/oral nutrition intake for each study is provided in Table 3. Table 3: Summary of Median Enteral or Oral Intakes in Pediatric Patients with PNAC in Study 1 and Study 2 a.

    Two Omegaven-treated patients in Study 1 did not have data regarding enteral or oral intakes. Parameter Study 1 Study 2 Omegaven (n=50) a Historical Control (n=26) Omegaven (n=30) Historical Control (n=15) Number of patients who received concurrent enteral or oral nutrition 44 (88%) 26 (100%) 24 (80%) 14 (93%) Percentage of total calories provided enterally or orally, median (Min - Max) 24% (1% – 53%) 25% (0.4% – 68%) 21% (1% – 75%) 12% (3% – 40%) In the combined efficacy analysis population from Study 1 and Study 2, median chronological age was 9 weeks (range: 3 to 42 weeks) in the Omegaven group and 7 weeks (range: 0 to 41 weeks) in the historical control group. The majority of these patients were preterm infants at birth (90% Omegaven; 83% historical control), with gestational age categories as follows: extremely preterm (31%; 20%); very preterm (20%; 24%); moderate or late preterm (40%; 39%). A majority of patients were also considered to have low, very-low, or extremely-low birth weights (76%; 82%), with birth weight categories as follows: extremely-low birth weight (34%; 24%); very-low birth weight (17%; 21%); low birth weight (25%; 37%). The efficacy analysis population had more males (51%; 59%) than females, and the majority of patients were White (60%; 66%). At baseline, the median age-adjusted body weight (Z-score) was -1.3 for the Omegaven group and -1.1 for the historical control group; 27% and 28% were low-for-age in body weight, 43% and 40% were low-for-age in body height/length, and 25% and 15% were low-for-age in head circumference for the Omegaven and historical control groups, respectively (low-for-age corresponded to Z-scores less than or equal to -1.9 for each growth parameter). In the efficacy analysis population, baseline median DBil, AST, and ALT levels were 3.8 mg/dL, 101 U/L, and 67 U/L, respectively, for the Omegaven group; and 3.8 mg/dL, 115 U/L, and 52 U/L, respectively, for the historical control group.

    The median (range) of the duration of treatment was 2.7 months (5 days to 8 years) for the Omegaven group and 3.6 months (16 days to 2 years) for the historical control group. The changes in median age-adjusted body weight (Z-scores) over time for Omegaven- treated patients ( Figure 2 ) appeared similar to those for historical control patients. In both the Omegaven and historical control groups, there was an initial decline in all growth parameters (weight, height/length, head circumference) over the initial weeks of treatment, followed by catch-up growth and more age-appropriate values through the remainder of the study.

    By comparing the Omegaven study data to age-standardized Fenton and World Health Organization (WHO) growth charts to assess age appropriate growth in patients with PNAC, patients treated with Omegaven as their exclusive lipid source also achieved age- appropriate growth. Figure 2: Median Age-Adjusted Body Weight (Z-scores) Over Time in Omegaven- Treated Pediatric Patients with PNAC in Study 1 and Study 2* BL = baseline Error bars represent interquartile ranges. *Data from pair-matched Omegaven patients were truncated at week 132. Median values are only shown for visits with data from at least 2 patients at a particular visit. In the combined analysis from Study 1 and Study 2, the number of Omegaven and historical control patients who achieved full enteral feeding by the end of the study was 52 (63%) patients and 24 (59%) patients, respectively.

    The median time to full enteral feeding was approximately 15 weeks for both groups. At the end of the studies, the median DBil level for Omegaven-treated patients was 0.60 mg/dL (interquartile range: 0.1 to 2.8 mg/dL). The Kaplan-Meier estimate of the median time for DBil values to return to less than 2.0 mg/dL was approximately 5.7 weeks . Figure 2

    Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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