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WARNING AND PRECAUTION

Potential for Incorrect Blood Glucose Reading

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

To avoid interference by maltose or other metabolites of EXTRANEAL (icodextrin), ONLY use glucose monitors and test strips that are glucose-specific. 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) 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 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) 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 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) and 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 Safety Information
Additional Links

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