EXTRANEAL (icodextrin) peritoneal dialysis solution Label

WARNING: UNRECOGNIZED HYPOGLYCEMIA RESULTING FROM DRUG-DEVICE INTERACTION See full prescribing information for complete boxed warning • Use of non-specific glucose monitors has resulted in falsely elevated glucose readings due to maltose interference leading to inappropriate insulin administration or withholding of hypoglycemia treatment. Permanent neurological damage and death have been reported. (5.1) • Only use glucose-specific monitoring systems in patients using EXTRANEAL (see glucosesafety.com). (5.1) • Blood glucose monitoring devices using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ), glucose-dye-oxidoreductase (GDO), or some glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD)-based methods must not be used. (5.1) • Falsely elevated glucose levels may be measured up to two weeks following cessation of EXTRANEAL therapy. (5.1, 12.3) • Educate all patients to alert health care providers of this interaction whenever they are admitted to the hospital. (5.1, 17) • Because of the risk of unrecognized hypoglycemia that could result from drug-device interaction, EXTRANEAL is available only through a restricted program. (5.2)