HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use EXTRANEAL safely and effectively. See full prescribing information for EXTRANEAL.
EXTRANEAL(icodextrin)peritoneal dialysis solution
Initial U.S. Approval: 2002
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 inappropriateinsulin 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 dehydrogenasepyrroloquinolinequinone (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 weeksfollowing cessation of EXTRANEAL therapy. (5.1, 12.3)
Educate all patients to alert health care providers of this interactionwhenever they are admitted to the hospital. (5.1, 17)
Because of the risk of unrecognized hypoglycemia that could resultfrom drug-device interaction, EXTRANEAL is available only througha restricted program. (5.2)
INDICATIONS AND USAGE
For a single daily exchange for the long (8- to 16- hour) dwell duringcontinuous ambulatory peritoneal dialysis (CAPD) or automatedperitoneal dialysis (APD) for the management of end-stage renaldisease. (1)
To improve (compared to 4.25% dextrose) long-dwell ultrafiltration andclearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal
equilibration test (PET). (1)
DOSAGE AND ADMINISTRATION
For intraperitoneal administration only. Not for intravenous injection.
Administer as a single daily peritoneal dialysis (PD) exchange for the longdwell. Dosage should be individualized by the prescribing physicianexperienced in the treatment of end-stage renal disease with PD. (2.1)
DOSAGE FORMS AND STRENGTHS
7.5% icodextrin (75 grams icodextrin per 1000 milliliters) in an electrolytesolution containing 40 mEq/L lactate (3)
 2 L and 2.5 L AMBU-FLEX II containers (APD)
 2 L and 2.5 L ULTRABAG containers (CAPD)
CONTRAINDICATIONS
Known allergy to cornstarch or icodextrin (4.1)
Maltose or isomaltose intolerance (4.2)
Glycogen storage disease (4.2)
Pre-existing severe lactic acidosis (4.3)
WARNINGS AND PRECAUTIONS
Encapsulating peritoneal sclerosis (5.3)
Peritonitis: Initiate appropriate antimicrobial therapy. (5.3)
Hypersensitivity reactions: Serious reactions have been reported.
Discontinue use of EXTRANEAL if serious reaction is suspected. (5.4)
Monitor for lactic acidosis in patients at risk (5.5)
Monitor for electrolyte, fluid, and nutrition imbalances (5.7)
ADVERSE REACTIONS
The most common adverse reaction (incidence > 5%) was rash. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact BaxterHealthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
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