FDA Approves Baxter’s Phoxillum Renal Replacement Solutions

Deerfield, Ill.-based Baxter International Inc. has earned premarket approval from the U.S. Food and Drug Administration (FDA) for its Phoxillum renal replacement solutions 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. Phoxillum is the only FDA-approved pre-mixed solution containing phosphate in a 5-liter 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 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.