FDA Approves Phoxillum Renal Replacement Solution

Phoxillum solution can be used for electrolyte management during CRRT.
Phoxillum solution can be used for electrolyte management during CRRT.

The FDA has approved Phoxillum replacement solution for use during continuous renal replacement therapy (CRRT).

Phoxillum can replace plasma volume removed by ultrafiltration and correct electrolyte and acid-base imbalances. The solution also may be used in cases of drug poisoning when CRRT is selected to remove dialyzable substances.

Prescription Phoxillum is approved for both pediatric and adult patients. The product's maker, Baxter International, anticipates it will be available in the second quarter of 2015.

Phoxillum, a pre-mixed solution containing phosphate in a 5L bag, can help treat hypophosphatemia in patients receiving CRRT, such as in an intensive care environment for patients who develop acute kidney injury.

Healthcare providers need to monitor hemodynamic status and fluid, electrolyte and acid-base balance throughout the CRRT procedure. During hemofiltration or hemodiafiltration using Phoxillum solution, 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, according to the manufacturer.

While there were no controlled studies in pregnant women, use of Phoxillum solution with monitoring is not expected to cause fetal harm or affect reproductive capacity. The solution is excreted in breast milk, but should not affect nursing infants. No novel concerns have arisen from use of phoxillum in geriatric patients.

 

Sources

  1. News release, Jan 20, 2015. Baxter International Inc.
  2. Phoxillum Prescribing Information, Jan 2015.
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