Baxter Gains FDA Nod for Clinolipid Use in Neonates and Pediatrics

Baxter International, Inc., a leading global entity in nutrition therapy, has announced that the U.S. FDA has approved an expanded use of Clinolipid (Lipid Injectable Emulsion) for pediatric patients, including both preterm and term neonates. Clinolipid, a proprietary mixed oil emulsion by Baxter, provides essential fatty acids and calories through parenteral (intravenous) nutrition when oral or enteral feeding is inadequate, impossible, or contraindicated. Having been available for adult patients in the U.S. since 2019, Clinolipid can now be administered to patients of all ages.

Cecilia Soriano, president of Baxter’s global Infusion Therapies and Technologies division, emphasized the company's dedication to improving patient outcomes. She highlighted that the expanded use of Clinolipid for neonatal and pediatric patients would offer healthcare providers more flexibility in selecting the most appropriate nutritional therapy for their patients.

Parenteral nutrition is crucial for preventing and treating malnutrition. In the U.S., approximately 40% of patients requiring intravenous nourishment are under 18 years old. Intravenous lipid emulsions (ILEs) provide these patients with the necessary calories and essential fatty acids when they cannot consume enough nutrients by mouth or through other feeding methods. Historically, 100% soybean oil-based emulsions were standard, but recent practices have shifted towards mixed lipid emulsions.

Clinolipid stands out in this category, being composed of 20% soybean oil and 80% olive oil, the lowest and highest respective concentrations among mixed ILEs in the U.S. market. With over 150 million doses administered globally, Clinolipid has proven to be a reliable source of energy and essential fatty acids essential for growth and development in neonatal and pediatric patients.

Clinolipid has several notable characteristics:
- It is rich in omega-9 oleic acid, a fatty acid prevalent in human breast milk.
- It helps minimize the decline in post-natal arachidonic acid levels.
- It is supported by extensive parenteral nutrition admixture stability.

Clinolipid’s availability in the U.S. begins today, offering a significant addition to Baxter’s clinical nutrition portfolio. Baxter’s comprehensive range of clinical nutrition products includes metabolic monitors, automated nutrition compounders, and various parenteral nutrition solutions. These tools help clinicians provide precise, controlled, and effective nutrition in a broad spectrum of healthcare settings.

Baxter has a rich history of innovation spanning over 90 years, with a diverse portfolio that addresses various medical needs, including diagnostics, critical care, kidney care, and nutrition. The company’s products and services are utilized in more than 100 countries, driving forward the next generation of healthcare innovations.

Clinolipid injection is indicated for adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition when other methods of feeding are inadequate or unsuitable.

However, there are certain risks associated with Clinolipid use. It is contraindicated in patients with known allergies to egg, soybean, peanut, or any other active or inactive ingredients, and those with severe lipid metabolism disorders characterized by hypertriglyceridemia. Rapid infusion in neonates and infants must be carefully monitored to avoid complications such as acute respiratory distress and metabolic acidosis. Long-term use can increase the risk of parenteral nutrition-associated liver disease, particularly in preterm neonates, and requires regular liver function monitoring. Hypersensitivity reactions, risk of infections, fat overload syndrome, refeeding syndrome, hypertriglyceridemia, and essential fatty acid deficiency are potential risks requiring close observation and management. Moreover, patients with renal impairment may face an increased risk of aluminum toxicity.

In clinical trials, the most common adverse reactions in adults included nausea, vomiting, hyperlipidemia, hyperglycemia, and abnormal liver function tests. In pediatric patients, common adverse reactions included hyperbilirubinemia, anemia, and sepsis among others.

Clinolipid can interact with certain anticoagulants like warfarin, potentially counteracting their effects. Comprehensive prescribing information is available for healthcare providers to ensure safe and effective use of Clinolipid.