FDA approves renal therapy solution

January 22, 2015

FDA approved Phoxillum Renal Replacement Solutions.

Earlier this week, FDA approved Baxter International’s Phoxillum Renal Replacement Solutions (BK4/2.5 and B22K4/0).

Baxter anticipates Phoxillum phosphate-containing solutions, primarily for acute kidney injury (AKI) patients, will be available in the United States in the second quarter of 2015.

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The drug serves 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. FDA has granted Phoxillum orphan drug designation for use in CRRT.

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"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, MD, vice president and renal therapeutic area lead with Baxter.

Phoxillum is the only FDA-approved, pre-mixed solution containing phosphate in a 5-L 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 AKI patients, according to Baxter.

The approval includes Phoxillum formulations containing different bicarbonate concentrations.

Healthcare professionals are advised to 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,” according to a Baxter statement. “These abnormalities may be corrected by changing the formulations of replacement solution or by supplementation.”

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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.

Because of its continuous nature, CRRT slowly corrects these abnormalities over time, allowing for treatment to be provided for unstable patients in the intensive care unit, according to Baxter.

“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,” according to the Baxter statement.