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news.The US Food and Drug Administration (FDA) has approved Baxter International's Phoxillum Renal Replacement Solutions (BK4/2.5 and B22K4/0) for use during continuous renal replacement therapy (CRRT).
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Phoxillum, a pre-mixed solution containing phosphate in a 5l bag, is designed to treat hypophosphatemia in patients receiving CRRT, such as in an intensive care environment for patients who develop acute kidney injury (AKI).
Phoxillum can replace plasma volume removed by ultrafiltration and correct electrolyte and acid-base imbalances, while it may also be used in cases of drug poisoning when CRRT is selected to remove dialyzable substances.
The FDA has also granted orphan drug designation for Phoxillum for use in CRRT.
The solution is approved for both pediatric and adult patients, and will be made available in the second quarter of 2015.
Baxter vice-president renal therapeutic area lead Bruce Culleton said: "The approval of Phoxillum allows us to offer healthcare providers additional options in managing critically ill acute kidney injury patients treated with CRRT.
"Introducing products like Phoxillum is part of Baxter’s commitment to offering healthcare providers a range of therapy options for patients."
According to the company, healthcare providers need to monitor hemodynamic status and fluid, electrolyte and acid-base balance throughout the CRRT procedure.
Image: Baxter Canada’s new headquarters building in Mississauga, Ontario. Photo: courtesy of Baxter.