HANOVER, GERMANY, November 4, 2011 - Baxter International Inc. (NYSE:BAX) announced today the European launch of NUMETA (emulsion for infusion). NUMETA was introduced at the 22nd Annual European Society of Pediatric and Neonatal Intensive Care (ESPNIC) Medical and Nursing Annual Congress in Hanover, Germany, as the first and only triple-chamber system with formulations specifically designed to meet the range of intravenous (IV) nutritional requirements of neonatal and pediatric patients (preterm newborns through age 18). This premix therapy addresses an important unmet medical need to support neonatal and pediatric patients' changing daily nutritional needs with ready-to-use IV nutrition.
Many preterm infants rely on IV nutrition, also known as parenteral nutrition (PN), at birth to meet all or part of their daily nutritional requirements. Unlike adults, children have a need for growth, which puts them at a particularly high risk of malnutrition because of higher nutritional demands.1 Acute malnutrition affects almost 25 percent of children admitted to local hospitals,2 with consequences that include impaired tissue function, suppressed immune systems, defective muscle function and reduced respiratory and cardiac reserve (or capacity).1
This ready-to-use nutrition system provides neonatal and pediatric patients with a balanced formulation of amino acids (protein), glucose (carbohydrates), lipids (fats) and electrolytes in a triple-chamber container. NUMETA is designed according to the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)-European Society for Clinical Nutrition and Metabolism (ESPEN) Guidelines for Pediatric Parenteral Nutrition1 to provide well-balanced nutrition that supports the growth of a majority of neonatal and pediatric patients. The ingredients are provided in separate compartments and can be mixed and administered at the point of care, reducing the possible risk of medication errors and contamination (associated with, for example, compounding), while simplifying the prescription and delivery of parenteral nutrition.3
"Parenteral nutrition provides important nutritional support for pediatric patients, allowing for survival and growth in various clinical situations, such as extremely low birth weight infants. There has been an unmet need for a triple-chamber system that offers stability and simplicity advantages over current alternatives of prescribing and preparing parenteral nutrition," said Jacques Rigo, M.D., Ph.D., head of the department of Pediatrics/Neonatal Unit at the University of Liège in Belgium. "As a well-balanced, ready-to-use formulation, this triple-chamber system may reduce incidences of nutrient deficiencies, excesses and omissions sometimes seen in the prescribing community."
"The availability of NUMETA builds on Baxter's history of innovative delivery technology designed to address patients' specific medical needs - in this case, the needs of some of the most medically vulnerable," said Scott Luce, Baxter's Global Franchise Head for Specialty Pharmaceuticals. "NUMETA is a particularly valuable addition to Baxter's nutrition portfolio as an effective, ready-to-use parenteral nutrition system focused on infants and children."
Treatment with the triple-chamber system in preterm infants was investigated in a Phase III clinical trial with results published online in the Journal of Pediatric Gastroenterology and Nutrition on August 23, 2011.4 This study, which was conducted in France and Belgium in five neonatal intensive care units (NICU), evaluated NUMETA in 97 preterm infants. Among results, the system provided well-balanced nutritional support in addressing the nutritional needs of preterm infants.
During the study period (of at least 5 days up to a maximum of 10 days), daily weight gain was evaluated based on postnatal age at study enrollment: newborns 1-3 days old (n=34), 4-7 days old (n=35) and more than 7 days old (n=28). Results showed that the system provided adequate nutrition to allow for appropriate weight gain ranging from 10 to 22 g/kg/day across the three age groups. Changes in body weight over the treatment period were within the ESPGHAN-ESPEN guidelines for parenteral nutrition. For the infants included after the first week of life, changes in body weight were also at the high end of the expected weight gain of 10-20 g/kg/day, as described in medical literature reports. In addition, a majority of daily prescriptions utilized the product "as is," with vitamins and trace elements added according to local NICU practice.
NUMETA is now licensed in 16 European countries, and Baxter expects to launch the product in several European countries in 2011-2012.
NUMETA is indicated for parenteral nutrition in the pediatric population when oral or enteral nutrition is impossible, insufficient or contraindicated.
NUMETA is offered in a range of three age-appropriate, adaptable formulations to support neonatal and pediatric patient growth at different ages: G13%E emulsion for infusion in 300 mL for preterm newborn infants (less than 37 weeks gestation age); G16%E emulsion for infusion in 500 mL for term infants and toddlers (term infants through two years of age); and G19%E emulsion for infusion in 1,000 mL for children and adolescents (2-18 years of age).
Important Risk Information
The general contraindications for administering NUMETA as an activated two-chamber container system (with the lipid chamber inactivated for intravenous infusion) are as follows: hypersensitivity to egg, soy or peanut proteins, or to any of the active substances, excipients or components of the container; congenital abnormality of the amino acid metabolism; pathogenically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorous; and severe hyperglycemia.
The addition of lipids (administering NUMETA as an activated three-chamber container system for intravenous emulsion) is contraindicated in the following additional clinical situations: severe hyperlipidemia, or severe disorders of lipid metabolism characterized by hypertriglyceridemia. Refer to the NUMETA product label for full prescribing information.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
1 Koletzko B, Goulet O, Hunt J, et al. ESPGHAN / ESPEN Guidelines on Paediatric Parenteral Nutrition. JPGN. 2005. Link: http://espghan.med.up.pt/joomla/position_papers/con_22.pdf
2 Pawellek I, Dokoupil K, and Koletzko B. Prevalence of Malnutrition in Paediatric Hospital Patients. Clinical Nutrition. 2008;27(1):72-76.
3 Riskin A, Shiff Y, Shamir R. Parenteral Nutrition in Neonatology - To Standardize or Individualize? IMAJ 2006;8:641-645
4 Rigo J et al. Practical Handling, Ease of Use, Safety, and Efficacy of a New Pediatric Triple- Chamber Bag for Parenteral Nutrition in Preterm Infants. JPGN 2011. Link: http://journals.lww.com/jpgn/Abstract/publishahead/Practical_Handling,_Ease_of_Use,_Safety,_and.99246.aspx