WARNING

Potential for Incorrect Blood Glucose Reading

Patients using EXTRANEAL (icodextrin 7.5%) peritoneal dialysis solution 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. Glucose-specific monitors and test strips include glucose oxidase (GOD), hexokinase, glucose dehydrogenase with nicotinamide adenine dinucleotide (GDH-NAD), or glucose dehydrogenase with flavin-adenine dinucleotide (GDH-FAD) based methods.

DO NOT use monitors or test strips that utilize the enzyme glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase. Maltose interferes with these glucose monitors and test strips, which may result in a falsely elevated blood glucose reading in patients using EXTRANEAL (icodextrin 7.5%). This 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 7.5%) or glucose monitors and test strips, including glucose monitor company contact information, please see the information in the links below.

Product Labeling Important Safety Information Additional Links

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