Potential For Incorrect Blood Glucose Reading
Patients using EXTRANEAL (icodextrin) for peritoneal dialysis may have incorrect blood glucose results when using particular blood glucose monitors and testing strips.
ONLY use glucose-specific monitors and test strips on peritoneal dialysis patients using EXTRANEAL (icodextrin). Some glucose monitors are not glucose-specific and cannot tell the difference between glucose and other sugars in the blood (e.g., maltose, a metabolite of icodextrin). Use laboratory-based methods, if available or a glucose-specific monitor and test strips.
The term "glucose-specific" applies to monitors or test strips that are not affected by the presence of maltose or certain other sugars. Because EXTRANEAL (icodextrin) Peritoneal Dialysis solution results in elevated blood levels of maltose, only glucose-specific monitors and test strips must be used.
DO NOT use monitors or test strips that utilize the enzyme glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase. In addition, some but not all monitors and test strips that use glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD) must not be used. Use of these methods may result in falsely elevated blood glucose readings in patients using EXTRANEAL (icodextrin) due to maltose interference. Falsely elevated blood glucose readings may mask true hypoglycemia or lead to the erroneous diagnosis of hyperglycemia. Treatment decisions based on incorrect blood glucose readings may lead to life-threatening events.
To determine what type of method is used for monitoring glucose levels, review the labeling for BOTH the glucose monitor and the test strips used. If in doubt, contact the manufacturer of the glucose monitors and test strips to determine the method that is used.
For important information about EXTRANEAL (icodextrin) or glucose monitors and test strips, please see the links below. Details about glucose monitor manufacturers and product compatibility with EXTRANEAL (icodextrin) are included in the Country-Specific Glucose Monitor List (under “Additional Links”).
|Product Labeling||Important Risk Information||Additional Links|
Get Acrobat Reader