FDAnews
www.fdanews.com/articles/169714-fda-approves-baxters-dialysis-solution-phoxillum

FDA Approves Baxter’s Dialysis Solution Phoxillum

January 27, 2015

Baxter plans to roll out two of its Phoxillum solutions for continuous renal replacement therapy in the second quarter of this year, following FDA approval earlier this month.

The BK4/2.5 and B22K4/0 solutions are the first premixed phosphate solutions in a 5L bag to receive FDA approval, the company claims, adding they allow for the use of a single type of solution across a large swath of acute kidney injury patients.

The solutions are indicated to correct electrolyte and acid/base imbalances, such as hypophosphatemia, in adults and children requiring dialysis due to acute kidney injury, as well as to reverse drug poisoning that can be helped with dialysis.

Baxter recommends monitoring patients’ electrolyte, fluid and acid-base levels throughout the treatment, as abnormalities in potassium, calcium, magnesium and phosphate levels may develop.

The FDA has designated Phoxillum an orphan drug for use in continuous renal replacement therapy. — Lena Freund