Warning and Precaution

Potential for Incorrect Blood Glucose Reading

Patients using EXTRANEAL (icodextrin 7.5%) solution for peritoneal dialysis therapy may have incorrect blood glucose results when using particular blood glucose monitors or test strips.

ONLY use glucose-specific monitors and test strips.These methods are common in clinical laboratories.

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 7.5%) peritoneal dialysis solution results in elevated blood levels of maltose, only glucose-specific monitors and test strips should be used.

DO NOT use monitors or test strips that utilize the enzyme glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase methods. In addition, some but not all monitors or test strips that utilize a glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD) method should not be used. Use of these methods may result in falsely elevated blood glucose readings in patients using EXTRANEAL (icodextrin 7.5%). due to maltose interference. Falsely elevated blood glucose readings may mask true hypoglycemia or lead to the erroneous diagnosis of hyperglycemia, leading to life-threatening events.

To determine what type of method is used for monitoring glucose levels, review the labelling for BOTH the glucose monitor and the test strips used. If in doubt, contact manufacturer of the glucose monitors and test strips to determine the specific type of testing that is used.

For important information about EXTRANEAL (icodextrin 7.5%) and glucose monitors and test strips, please see the links below. Details about glucose monitor manufacturers and product compatibility with EXTRANEAL (icodextrin 7.5%) are included in the Country-Specific Glucose Monitor List (under "Additional Links").

Product Labeling Important Safety Information Additional Links

Get Acrobat Reader
download adobe reader