Clinolipid 20% (Lipid Injectable Emulsion) for Intravenous Use

Important Risk Information for Clinolipid

CLINOLIPID 20% (Lipid Injectable Emulsion) for intravenous use Indications and Important Risk Information

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

• The use of CLINOLIPID injection is contraindicated in patients with the following:
  • Known hypersensitivity to egg, soybean, peanut or any of the active or inactive ingredients.
  • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).
• 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.
• Parenteral Nutrition-Associated Liver Disease (PNALD): Increased risk in patients who receive parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests; if abnormalities occur, consider discontinuation or dosage reduction.
• Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur.
• Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, Hypertriglyceridemia, and Essential Fatty Acid Deficiency (EFAD): Monitor for signs and symptoms; monitor laboratory parameters.
  • Ensure aseptic techniques are used for catheter placement, catheter maintenance, and preparation and administration of CLINOLIPID.
  • If signs or symptoms of fat overload syndrome occur, stop CLINOLIPID.
  • To prevent complications from Refeeding Syndrome, closely monitor severely malnourished patients and slowly increase their nutrient intake.
  • Measure serum triglycerides before the start of infusion and regularly throughout treatment. If triglyceride levels are above 400 mg/dL in adults, stop the CLINOLIPID infusion and monitor serum triglyceride levels to avoid clinical consequences of hypertriglyceridemia.
• Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm neonates. CLINOLIPID injection contains no more than 25 mcg/L of aluminum.
• 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 coumarin derivatives, including warfarin.
• The most common (5%) adverse drug reactions reported from clinical trials were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests.
• For infusion into a central or peripheral vein. When administered with dextrose and amino acids, choice of central or peripheral venous route is dependent on the osmolarity of the final infusate.
• When admixing CLINOLIPID, protect the admixed parenteral nutrition solution from light.
• Use only a 1.2 micron in-line filter during administration of CLINOLIPID alone and or as part of an admixture.
• CLINOLIPID 1,000mL Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures.

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