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. Limitations of Use: CLINOLIPID is not indicated for use in pediatric patients because there is insufficient data to demonstrate that CLINOLIPID provides sufficient amounts of essential fatty acids in this population. The omega-3: omega-6 fatty acid ratio in CLINOLIPID has not been shown to improve clinical outcomes compared to other intravenous lipid 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.
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^
*Please refer to the formulation parameters outlined in the Clinolipid Admixture Stability aid.
^Produced outside the U.S. and administered as Clinoleic, or as the lipid component in Olimel and Oliclinomel
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 may have immune neutral effects.7
- 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 may have immune neutral effects.7
- Clinolipid is 64% oleic acid by composition and contains the most MUFA of any Intravenious Lipid 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
Clinolipid Admixture Stability Aid
3 in 1 Admixtures with Clinolipid are stable for 9 days† when refrigerated at 2-8oC plus an 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.
†Only the physical compatibility of the 3-in-1 Clinolipid admixtures was evaluated, the chemical stability or bioavailability of each ingredient was not tested.
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Important Risk Information for Clinolipid
CLINOLIPID 20% (Lipid Injectable Emulsion) for intravenous use 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 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.
The use of CLINOLIPID injection is contraindicated in patients with the following:
• Known hypersensitivity to egg and 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 to avoid clinical consequences associated with hypertriglyceridemia.
• 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.
- When admixing CLINOLIPID, protect the admixed parenteral nutrition solution from light. Use only a 1.2 micron filter to administer CLINOLIPID and admixtures containing CLINOLIPID.
Click here for full Prescribing Information.