Omegaven

Last updated on RxList: 5/27/2020
Omegaven Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Omegaven?

Omegaven (fish oil triglycerides) is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).

What Are Side Effects of Omegaven?

Common side effects of Omegaven include:

Dosage for Omegaven

The recommended daily dose of Omegaven (and the maximum dose) in pediatric patients is 1g/kg/day.

What Drugs, Substances, or Supplements Interact with Omegaven?

Omegaven may interact with antiplatelet agents or anticoagulants. Tell your doctor all medications and supplements you use.

Omegaven During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Omegaven; it is unknown how it would affect a fetus. It is unknown if Omegaven passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Omegaven (fish oil triglycerides) Injectable Emulsion, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Omegaven Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Risk of death in preterm infants due to pulmonary lipid accumulation [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Risk of infections [see WARNINGS AND PRECAUTIONS]
  • Fat overload syndrome [see WARNINGS AND PRECAUTIONS]
  • Refeeding syndrome [see WARNINGS AND PRECAUTIONS]
  • Hypertriglyceridemia [see WARNINGS AND PRECAUTIONS]
  • Aluminum toxicity [see WARNINGS AND PRECAUTIONS]

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].

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 1. 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 1 Adverse Reactions in Greater Than 5% of Omegaven-Treated Pediatric Patients with PNAC

Adverse ReactionOmegaven
(N=189)
n (%)
Vomiting87 (46)
Agitation67 (35)
Bradycardia66 (35)
Apnea38 (20)
Viral Infection30 (16)
Erythema23 (12)
Rash15 (8)
Abscess14 (7)
Neutropenia13 (7)
Hypertonia11 (6)
Incision site erythema11 (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 × 109/L, and by the end of the study these levels were 10.5 g/dL and 217 × 109/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]. 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.

Postmarketing Experience

The following adverse reaction has been identified with use of Omegaven in another country. Because this reaction was reported voluntarily from a population of uncertain size, it is not possible to reliably estimate its frequency or establish a causal relationship to drug exposure.

Life-threatening hemorrhage following a central venous catheter change was reported in a 9-month-old infant with intestinal failure who received PN with Omegaven as the sole lipid source; he had no prior history of bleeding, coagulopathy, or portal hypertension.

Read the entire FDA prescribing information for Omegaven (Fish Oil Triglycerides Injectable Emulsion)

QUESTION

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© Omegaven Patient Information is supplied by Cerner Multum, Inc. and Omegaven Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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