- Clinolipid provides calories and essential fatty acids
for parenteral nutrition
- Expanded indication demonstrates Baxter’s continued commitment
to meeting the diverse nutritional needs of patients, from preterm
neonates to adults
Baxter International Inc. (NYSE:BAX), a global leader in
nutrition therapy, today announced U.S. FDA approval of an expanded
indication for Clinolipid (Lipid Injectable Emulsion) to be
used in pediatric patients, including preterm and term neonates.
Clinolipid is Baxter’s proprietary mixed oil lipid emulsion
that is used to provide calories and essential fatty acids in
parenteral (intravenous) nutrition (PN) when oral or enteral
nutrition is not possible, insufficient or contraindicated.
Clinolipid has been available in the U.S. for adults since
2019 and is now available for use in all ages.
“Improving patient outcomes inspires our work every day, and we
are proud to continue to address the unique nutritional needs of
neonatal and pediatric patients through innovative products and
therapies,” said Cecilia Soriano, president of Baxter’s global
Infusion Therapies and Technologies division. “Expanding access to
Clinolipid for this critical and vulnerable patient
population offers clinicians versatility in choosing the product
that best meets their patients’ needs when it matters most.”
A Mixed Lipid Emulsion with Unique Characteristics
Parenteral nutrition plays an important role in helping treat
and reduce the risk of malnutrition. In the U.S., it’s estimated
that about 40 percent of patients who receive PN as an intravenous
source of nourishment are under the age of 18.1,2 Intravenous lipid
emulsions (ILEs) are used to provide calories and essential fatty
acids for patients who cannot intake a sufficient source of
nutrition orally or enterally. Over the last several years,
clinical practice has shifted away from using 100 percent soybean
oil lipid emulsions – which was the standard of care for decades –
to mixed lipid emulsions. Baxter’s Clinolipid contains the
lowest amount of soybean oil (20 percent) and highest amount of
olive oil (80 percent) of any mixed ILE available in the U.S.
today.3,4 With more than 150 million doses worldwide,5
Clinolipid has been shown to be a safe and effective source
of energy and essential fatty acids needed for growth and
development in neonatal and pediatric patients.3 Specifically,
Clinolipid:
- Is rich in omega-9 oleic acid, the most prevalent fatty acid in
human breast milk;6
- Minimizes the decline in post-natal arachidonic acid
levels;7
- Is supported by extensive PN admixture stability.8,9
Clinolipid is available to order in the U.S. today. Click
here to learn more about Baxter’s clinical nutrition portfolio.
About Baxter’s Global Clinical Nutrition Business
Baxter’s broad portfolio of clinical nutrition products includes
metabolic monitors, automated nutrition compounders and parenteral
nutrition solutions. These tools and solutions help enable
clinicians to measure accurately, mix with control and nourish
effectively. Our innovative and accessible clinical nutrition
products and services are used extensively across a wide array of
acute and alternate care settings.
About Baxter
Every day, millions of patients, caregivers and healthcare
providers rely on Baxter’s leading portfolio of diagnostic,
critical care, kidney care, nutrition, hospital and surgical
products used across patient homes, hospitals, physician offices
and other sites of care. For more than 90 years, we’ve been
operating at the critical intersection where innovations that save
and sustain lives meet the healthcare providers who make it happen.
With products, digital health solutions and therapies available in
more than 100 countries, Baxter’s employees worldwide are now
building upon the company’s rich heritage of medical breakthroughs
to advance the next generation of transformative healthcare
innovations. To learn more, visit www.baxter.com and follow us on
X/Twitter, LinkedIn and Facebook.
Indication
CLINOLIPID injection is indicated in adults and pediatric
patients, including term and preterm neonates as a source of
calories and essential fatty acids for parenteral nutrition (PN)
when oral or enteral nutrition is not possible, insufficient, or
contraindicated.
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. Carefully monitor
the infant’s ability to eliminate the infused lipids from the
circulation (e.g., measure serum triglycerides and/or plasma free
fatty acid levels). If signs of poor clearance of lipids from the
circulation occur, stop the infusion and initiate a medical
evaluation.
- 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. − Laboratory testing using the triene to
tetraene ratio may not be adequate to diagnose EFAD, and assessment
of individual fatty acid levels may be needed.
- Aluminum Toxicity: Increased risk in patients with renal
impairment, including preterm neonates. CLINOLIPID injection
contains no more than 25 mcg/L of aluminum.
- Most common (≥5%) adverse drug reactions from clinical trials
in adults were nausea and vomiting, hyperlipidemia, hyperglycemia,
hypoproteinemia, and abnormal liver function tests.
- Most common (≥5%) adverse reactions from clinical trials in
pediatric patients were hyperbilirubinemia, patent ductus
arteriosus, anemia, gastroesophageal reflux disease, bradycardia,
feeding intolerance, neonatal intraventricular hemorrhage,
increased alkaline phosphatase, atrial septal defect, hyponatremia,
sepsis, and infantile apnea.
- The anticoagulant activity of coumarin derivatives, including
warfarin, may be counteracted.
Please see accompanying full Prescribing Information for
CLINOLIPID.
This release includes forward-looking statements concerning
potential benefits associated with Clinolipid. The
statements are based on assumptions about many important factors,
including the following, which could cause actual results to differ
materially from those in the forward-looking statements: demand for
and market acceptance for new and existing products; product
development risks; inability to create additional production
capacity in a timely manner or the occurrence of other
manufacturing or supply difficulties (including as a result of
natural disasters, public health crises and epidemics/pandemics,
regulatory actions or otherwise); satisfaction of regulatory and
other requirements; actions of regulatory bodies and other
governmental authorities; product quality, manufacturing or supply,
or patient safety issues; changes in law and regulations; and other
risks identified in Baxter's most recent filing on Form 10-K and
Form 10-Q and other SEC filings, all of which are available on
Baxter's website. Baxter does not undertake to update its
forward-looking statements.
Baxter and Clinolipid are registered trademarks of Baxter
International Inc.
1 Agency for Healthcare Quality and Research. HCUP NIS data on
parenteral nutrition use. 2016. https://hcupnet.ahrq.gov/#setup.
Accessed June 23, 2019.
2 Kraft M et al. Parenteral Nutrition Prescribing and Order
Review Safety Study: The Need for Pharmacist Intervention. Nutr
Clin Pract. 2021;36:480–488.
3 CLINOLIPID 20% (Lipid Injectable Emulsion) for intravenous use
PI, 4/2024.
4 SMOFLIPID® (lipid injectable emulsion), for intravenous use
PI, 6/2023.
5 Internal Baxter Data on File
6 Miliku K, Duan QL, Moraes TJ, et al. Human milk fatty acid
composition is associated with dietary, genetic, sociodemographic,
and environmental factors in the CHILD Cohort Study. Am J Clin
Nutr. 2019;110(6):1370-1383. doi:10.1093/ajcn/nqz229.
7 Baxter Internal Data on File
8 Baxter Internal Data on File
9 Baxter Internal Data on File
US-CN6-240011 v1.0 5/2024
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version on businesswire.com: https://www.businesswire.com/news/home/20240510213278/en/
Media Contact Bess Featherstone McGuire, (224) 948-5353
media@baxter.com
Investor Contact Clare Trachtman, (224) 948-3020
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