Important Safety Information:
Peritoneal Dialysis Patients and
Blood Glucose Monitoring

Baxter Healthcare Corporation has recently received FDA approval to market and sell EXTRANEAL (icodextrin), a new solution for peritoneal dialysis. Because of its unique properties, EXTRANEAL is expected to receive wide interest and use in the nephrology community.

Patients receiving EXTRANEAL (icodextrin) for peritoneal dialysis therapy may have falsely elevated blood glucose results when using particular blood glucose monitoring systems. Blood glucose monitoring systems using the enzyme glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) will result in a falsely elevated glucose reading. These

particular glucose monitors must not be used for patients receiving EXTRANEAL. Patients receiving EXTRANEAL (icodextrin) for peritoneal dialysis therapy have elevated maltose levels. This high level of maltose is an expected and normal response in EXTRANEAL patients. These elevated levels have been observed to interfere with the GDH-PQQ enzyme pathway and lead to a falsely elevated blood glucose reading. Blood glucose measurements must be determined with a glucose specific method (monitor and test strips) to avoid interference by maltose release from EXTRANEAL. GDH-PQQ methods must not be used.

Baxter Healthcare Corporation recommends that we consult the product information included with our glucose monitors and test strips to verify if the monitor and/or test strip measures only glucose.

Reference:

Letter from Baxter Healthcare Corporation dated March 20, 2003 from Salim Mujais, M.D., Vice President, Global Medical Affairs

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