LAKE ZURICH, Ill., January 29, 2020 – The Centers for Medicare and Medicaid Services (CMS) has assigned an HCPCS Level II code to Omegaven®, the newest parenteral nutrition product introduced in the United States by Fresenius Kabi. Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
The new HCPCS Level II code – B4187, Omegaven, 10 grams lipids – became effective January 1, 2020. CMS assigned the code in response to Fresenius Kabi’s appeal to change its preliminary coding recommendations, which had not included assignment of a HCPCS Level II code.
Omegaven is the first U.S.-approved lipid emulsion made entirely from fish oil. It is available as a 5 g/50 mL and 10 g/100 mL (0.1 g/mL) injectable emulsion in a single-dose bottle. It became commercially available in the U.S. in November 2018 as a source of calories and fatty acids in pediatric patients with PNAC. It has been available in the U.S. since 2007 for pediatric patients under the FDA’s expanded (compassionate) use program and has been clinically proven to help attain age-appropriate growth,1,2 lower direct or conjugated bilirubin levels,1,2 and improve liver function parameters2 in two prospective, open-label, single center trials.
Learn more about Omegaven at omegavenusa.com
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.
It has not been demonstrated that the clinical outcomes observed in pediatric patients treated with Omegaven are a result of the omega-6: omega-3 fatty acid ratio of the product.
IMPORTANT SAFETY INFORMATION
Prior to administration, correct severe fluid and electrolyte disorders and measure serum triglycerides to establish a baseline level. Initiate dosing in PN-dependent pediatric patients as soon as direct or conjugated bilirubin levels are 2 mg/dL or greater. The recommended daily dose (and the maximum dose) in pediatric patients is 1 g/kg/day. Administer Omegaven until direct or conjugated bilirubin levels are less than 2 mg/dL or until the patient no longer requires PN.
Omegaven is contraindicated in patients with a 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 greater than 1,000 mg/dL).
Risk of Death in Preterm Infants due to Pulmonary Lipid Accumulation: Deaths in preterm infants after infusion of soybean oil-based intravenous lipid emulsions have been reported in medical literature. Autopsy findings in these preterm infants included intravascular lipid accumulation in the lungs. The risk of pulmonary lipid accumulation with Omegaven is unknown. 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. This risk due to poor lipid clearance should be considered when administering intravenous lipid emulsions. Monitor patients receiving Omegaven for signs and symptoms of pleural or pericardial effusion.
Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reaction occurs.
Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, and Hypertriglyceridemia: Monitor for signs and symptoms; monitor laboratory parameters.
Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants.
Monitoring and Laboratory Tests: Routine laboratory monitoring is recommended, including serum triglyceride concentrations and laboratory evidence of essential fatty acid deficiency.
The most common adverse drug reactions (>15%) are: vomiting, agitation, bradycardia, apnea and viral infection.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This Important Safety Information does not include all the information needed to use Omegaven safely and effectively. Please click on the following link (https://tinyurl.com/y88rsmp5) to see the full prescribing information for Omegaven (fish oil triglycerides) injectable emulsion for intravenous use. Full prescribing information is also available at fresenius-kabi.com/us.
About Fresenius Kabi
Fresenius Kabi (fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters are in Lake Zurich, Illinois. The company’s global headquarters are in Bad Homburg, Germany.
1. Omegaven Prescribing Information. Fresenius Kabi USA, LLC. 2018.
2. Data on file.