Clinolipid 20% Lipid Injectable Emulsion, USP
Clinolipid 20% Lipid Injectable Emulsion, USP for intravenous use is a proprietary 80% olive oil, 20% soybean oil emulsion that offers healthcare professionals a prescribing alternative to meet the diverse needs of adult patients requiring Parenteral Nutrition (PN).
Indication
Clinolipid Injection is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Please read the accompanying full Indication(s) and Important Risk Information, including the Boxed Warning for Death in Preterm Infants, and the Package Insert for full Prescribing Information.
20+
Clinolipid utilizes Baxter’s proprietary lipid blend, which has been used for more than 20 years outside the U.S.
Stability
PN admixtures physically stable up to 9 days in refrigerated storage, followed by 48 hours at room temperature.1*
100M+
Clinolipid utilizes Baxter’s proprietary lipid blend, which has more than 100M+ doses administered globally.2*
Clinolipid IV Fat Emulsion
- Is a dense source of energy
- Low in Omega-6. Contains Soybean Oil to provide essential fatty acids3
- Rich in Omega-9 fatty acids.3 Omega-9 MUFAs is immune neutral7
- Stable and well tolerated. PN admixtures are physically stable up to 9 days in refrigerated storage, followed by 48 hours at room temperature1*
Clinolipid Composition
- Clinolipid’s largest component is olive oil, which is rich in Omega-9 oleic acid.3 Oleic acid is a Monounsaturated Fatty Acid (MUFA) that is considered to be immune neutral.7
- Clinolipid is 64% oleic acid by composition and contains the most MUFA of any Lipid Injectable Emulsions (ILE) available in the United States.3,4,5,6,9
The omega-3 and Omega-6 fatty acid ratio in Clinolipid has not been shown to improve clinical outcomes compared to other intravenous emulsions. Please read the accompanying full Indication(s) and Important Risk Information, including the Boxed Warning for Death in Preterm Infants, and the Package Insert for full Prescribing Information.
Selected Important Risk Information
Limitations of Use
● Clinolipid Injection is not indicated for use in pediatric patients because there is insufficient data to demonstrate that Clinolipid Injection provides sufficient amounts of essential fatty acids in this population.
● The omega-3: omega-6 fatty acid ratio in Clinolipid Injection has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.
See full prescribing information for complete boxed warning.
● Deaths in preterm infants have been reported in literature.
● Autopsy findings included intravascular fat accumulation in the lungs.
● Preterm and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.
Re-thinking Lipids
ASPEN/SCCM guidelines suggest withholding or limiting soy oil-based ILE during the first week following initiation of PN in the critically-ill patient to a maximum of 100g/week (often divided into 2 doses per week) if there is concern for essential fatty acid deficiency.8
ASPEN/SCCM guidelines suggest that alternative ILEs should be considered for critically ill patients who are appropriate candidates for PN.8
Clinolipid is formulated with a low concentration of soybean oil but provides enough to prevent essential fatty acid deficiency.3,4,5,6
Clinolipid Admixture Stability Aid
3 in 1 Admixtures with Clinolipid are stable for 9 days when refrigerated at 2-8oC plus additional 48 hours at room temperature of 25oC (+/-2oC).1 Use this aid to support introducing Clinolipid (Lipid Injectable Emulsion, USP), 20% for intravenous use into your PN program.
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Important Risk Information for Clinolipid
Clinolipid (Lipid Injectable Emulsion) for Intravenous Use 20% Indication
Clinolipid injection is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Limitations of Use
Clinolipid injection is not indicated for use in pediatric patients because there is insufficient data to demonstrate that Clinolipid injection provides sufficient amounts of essential fatty acids in this population.
The omega-3: omega-6 fatty acid ratio in Clinolipid injection has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.
Important Risk Information
● Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature.
● Autopsy findings included intravascular fat accumulation in the lungs.
● Preterm infants and low birth weight infants have poor clearance of intravenous lipid emulsion and increase free fatty acid plasma levels following lipid emulsion infusion.
The use of Clinolipid injection is contraindicated in patients with the following:
- Known hypersensitivity to egg or soybean proteins, the lipid emulsion and/or excipients.
- Severe hyperlipidemia or severe disorders of lipid metabolism
Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity or allergic reaction develop.
Monitor for signs and symptoms of fat overload, essential fatty acid deficiency (EFAD) and infections including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device.
Carefully monitor severely undernourished patients and slowly increase their nutrient intakes, while avoiding overfeeding, to prevent refeeding complications.
Frequent clinical and laboratory determinations are necessary throughout treatment. Monitor fluid status closely in patients with pulmonary edema or heart failure.
Content of vitamin K may counteract anticoagulant activity.
Clinolipid injection contains no more than 25 mcg/L of aluminum. There is an increased aluminum toxicity risk in patients with impaired kidney function, including preterm infants.
Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. Monitor liver function tests. If patients develop liver test abnormalities consider discontinuation or dose reduction.
Reduce dose of Clinolipid injection and monitor serum triglyceride levels in patients with serum triglyceride concentrations above 400 mg/dL.
The most common (5%) adverse drug reactions reported during Clinolipid injection clinical trials were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests.
Click here for full Prescribing Information.