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1/3/2003

Extraneal Peritoneal Dialysis Solution Earns FDA Approval

Kate Traynor

The Food and Drug Administration on Dec. 20, 2002, approved the marketing of Baxter Healthcare Corp.'s Extraneal, a 7.5 percent icodextrin peritoneal dialysis solution, for the management of chronic renal failure.

According to the product's labeling (PDF), the solution should be used once daily for the eight- to16-hour, or long-dwell, exchange in peritoneal dialysis. Patients undergoing continuous ambulatory peritoneal dialysis should conduct this exchange at night, and those using a cycler for automated peritoneal dialysis should conduct the exchange during the daytime.

Because icodextrin is metabolized to various sugars including maltose, patients with diabetes mellitus should use a glucose-specific method to monitor their blood glucose level to avoid erroneous readings. The product's labeling notes that patients with type 1 diabetes mellitus may need to adjust their insulin dosage when using icodextrin solution for peritoneal dialysis.

During the clinical studies, the adverse event most commonly related to the use of icodextrin solution for peritoneal dialysis was a rash that typically appeared during the first three weeks of treatment and resolved when therapy ended.

Extraneal is supplied in flexible containers holding 1.5 L, 2.0 L, or 2.5 L of solution. Each liter of solution contains 75 g of icodextrin, 132 meq of sodium, 96 meq of chloride, 40 meq of lactate, 3.5 meq of calcium, and 0.5 meq of magnesium.