DEERFIELD, Ill., (January 20, 2015) - Baxter International Inc. (NYSE:BAX) today announced the United States Food and Drug Administration (FDA) has approved PHOXILLUM Renal Replacement Solutions (BK4/2.5 and B22K4/0) as replacement solutions in continuous renal replacement therapy (CRRT) to correct electrolyte and acid-base imbalances, and in case of drug poisoning when CRRT is used to remove dialyzable substances. The FDA has granted PHOXILLUM orphan drug designation for use in CRRT.
"The approval of PHOXILLUM allows us to offer healthcare providers additional options in managing critically ill acute kidney injury patients treated with CRRT," said Bruce Culleton, M.D., vice president, renal therapeutic area lead, Baxter. "Introducing products like PHOXILLUM is part of Baxter's commitment to offering healthcare providers a range of therapy options for patients."
Hypophosphatemia (abnormally low concentration of phosphate in the blood) is a common electrolyte disturbance in patients treated with CRRT.1 PHOXILLUM is the only FDA approved pre-mixed solution containing phosphate in a 5L bag. It is designed to facilitate electrolyte management during CRRT by allowing use of a single type of solution across a wide clinical spectrum of acute kidney injury (AKI) patients.
Hemodynamic status and fluid, electrolyte and acid-base balance should be monitored. These abnormalities may be corrected by changing the formulations of replacement solution or by supplementation. The approval includes PHOXILLUM formulations containing different bicarbonate concentrations.
CRRT is a dialysis modality used to treat disorders that develop as a result of AKI, especially toxin accumulation, fluid overload, and both acid-base and electrolyte disturbances. Due to its continuous nature, CRRT slowly corrects these abnormalities over time, allowing for treatment to be provided for unstable patients in the intensive care unit. AKI often occurs in hospitalized patients treated in an intensive care environment, and it typically occurs over a few hours to a few days. Patients losing the ability to filter waste products and excess fluid adequately require renal replacement therapy in most cases.
Baxter anticipates PHOXILLUM phosphate-containing solutions will be available in the United States in the second quarter of 2015.
PHOXILLUM solution is indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. It may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.
Important Risk Information
Monitor hemodynamic status and fluid, electrolyte and acid-base balance throughout the procedure. During hemofiltration or hemodiafiltration using PHOXILLUM replacement solutions, abnormalities in the plasma concentration of potassium, calcium, magnesium, and phosphate may develop. These abnormalities may be corrected by changing the formulations of replacement solution or by supplementation.
PHOXILLUM is for Rx use only. Please see the full Prescribing Information.
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.
This release includes forward-looking statements concerning PHOXILLUM, including expectations with regard to its availability in the US. 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: 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 other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
1Bellomo, R, et al. The relationship between hypophosphatemia and outcomes during low-intensity and high-intensity continuous renal replacement therapy. Crit Care Resusc (2014, March), 16(1): 34-41.