ntribute to worsening acidosis if conversion to bicarbonate is impaired and may be associated withhyperventilation, lethargy, hypotension or irregular heart rhythms.
5. WARNINGS AND PRECAUTIONS
5.1 Unrecognized Hypoglycemia Resulting From Drug-Device Interaction
Only use glucose-specific monitors and test strips to measure blood glucose levels in patients using EXTRANEAL(icodextrin) Peritoneal Dialysis Solution. Blood glucose monitoring devices using glucose dehydrogenasepyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase (GDO)-based methods must not be used. In addition, some blood glucose monitoring systems using glucose dehydrogenase flavin-adenine dinucleotide (GDHFAD)-basedmethods must not be used. Use of GDH-PQQ, GDO, and GDH-FAD-based glucose monitors and teststrips has resulted in falsely elevated glucose readings (due to the presence of maltose). Falsely elevated glucosereadings have led patients or health care providers to withhold treatment of hypoglycemia or to administer insulininappropriately. Both of these situations have resulted in unrecognized hypoglycemia, which has led to loss ofconsciousness, coma, permanent neurological damage, and death. Plasma levels of EXTRANEAL (icodextrin) andits metabolites return to baseline within approximately 14 days following cessation of EXTRANEAL (icodextrin)administration. Therefore falsely elevated glucose levels may be measured up to two weeks following cessation ofEXTRANEAL (icodextrin) therapy when GDH-PQQ, GDO, and GDH-FAD-based blood glucose monitors and teststrips are used.
Because GDH-PQQ, GDO, and GDH-FAD-based blood glucose monitors may be used in hospital settings, it iimportant that the health care providers of all peritoneal dialysis patients using EXTRANEAL (icodextrin) carefullyreview the product information of the blood glucose testing system, including that of test strips, to determine if thesystem is appropriate for use with EXTRANEAL (icodextrin).
To avoid improper insulin administration, educate all patients to alert health care providers of this interactionwhenever they are admitted to the hospital.
The manufacturer(s) of the monitor and test strips should be contacted to determine if icodextrin or maltose causesinterference or falsely elevated glucose readings. For a list of toll free numbers for glucose monitor and test stripmanufacturers, please contact the Baxter Renal Clinical Help Line 1-888-RENAL-HELP or visit
www.glucosesafety.com.
5.2 REMS Program for EXTRANEAL
Because of the risk of unrecognized hypoglycemia resulting from a drug-device interaction, EXTRANEAL isavailable only through a restricted program under a REMS [see Warnings and Precautions (5.1)].
Requiredcomponents of the EXTRANEAL REMS Program include the following:
Dialysis clinic staff must be trained about the risk of undetected hypoglycemia resulting from a drug-deviceinteractions involving EXTRANEAL in order to manage the treatment of patients prescribedEXTRANEAL.
Patients must be educated at a trained dialysis center before their initial EXTRANEAL treatment.
Further information, including a listing of blood glucose monitor compatibility information provided by themanufacturers of blood glucose monitors, is available by visiting www.glucosesafety.com or by calling BaxterRenal Clinical Help Line 1-888-RENAL-HELP.
5.3 Peritonitis and Encapsulating Peritoneal SclerosisInfectious a |
