Indications and Usage
EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour ) dwell during continuous ambulatory peritoneal dialysis (CAPD ) or automated peritoneal dialysis (APD) for the management of end-stage renal disease. EXTRANEAL is also indicated to improve (compared to 4 .25 % dextrose ) long-dwell ultraﬁltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as deﬁned using the peritoneal equilibration test (PET).
PD is Growing as the Therapy of Choice for ESRD Patients and their Nephrologists.10 Why Do Nephrologists Prescribe Extraneal (Icodextrin) PD Solution?
Help Manage Fluid Balance
Optimize the PD Prescription
Start & Sustain a Glucose-Sparing Rx
Extraneal Solution Has Been Proven to Help Improve Retention and Address Causes of PD Dropout
12% LOWER LIKELIHOOD OF TECHNIQUE FAILURE in a patient’s first year of therapy vs. not using Extraneal5,6*
*In a subpopulation of the multicenter cohort study of the ANZDATA registry including 8,960 patients who initiated PD therapy between 2007 and 2014, of whom 2,124 developed technique failure within the first year, a competing-risk regression analysis demonstrated that icodextrin solution use was associated with a 12% lower likelihood of technique failure in the first year of PD.5,6
INCREASE TIME ON THERAPY BY 1.21 YEARS in patients with refractory
**A prospective open-label study of 39 patients experiencing refractory fluid overload measured the effect of prescription of icodextrin on peritoneal dialysis (PD) technique survival.7
Selected Risk Information: Monitor electrolytes and blood chemistry periodically. Monitor fluid status to avoid hyper- or hypovolemia and potentially severe consequences including congestive heart failure, volume depletion, and hypovolemic shock. Abnormalities in any of these parameters should be treated promptly under the care of a physician.
Optimize the PD Prescription by Including Extraneal Solution
and Help Reduce PD Dropout by Keeping Your Patients on PD Therapy as Long as Possible.
When to Consider Making a Move to Optimize the PD Rx
Did you know that ISPD has updated recommendations on the use of Icodextrin?
A faster peritoneal solute transfer rate (PSTR) is associated with lower survival on PD (GRADE 1A) in part due to lower UF and increased net fluid reabsorption. ISPD recommends several prescription management strategies including the use of Icodextrin (GRADE 1A). Compared to glucose, use of Icodextrin can translate into improved fluid status and fewer episodes of fluid overload (GRADE 1A).8 Click here to read the publication.
Ultrafiltration (UF) is associated with overall and technique survival. ISPD recommends Icodextrin to improve UF independent of the Dialysate/Plasma (D/P) creatinine.9 (Practice Point) Click here to read the publication.
Manage Your Patients' Long Dwell with Extraneal
Extraneal PD Solution improves long-dwell ultrafiltration compared with glucose solutions, particularly in high and high-average transporters, as defined by using a PET test.
Randomized controlled trials showed that Extraneal PD Solution improves long-dwell net UF compared with 4.25% dextrose in high or high-average transporters treated with APD1 and compared with 2.5% dextrose in high or high-average transporters treated with CAPD.2,3,4
Extraneal (Icodextrin) PD Solution Mechanism of Action
Learn more about the composition and mechanism of action of Extraneal PD Solution as an osmotic agent.
EXTRANEAL (icodextrin) Peritoneal Dialysis Solution Important Risk Information (IRI)
EXTRANEAL is contraindicated in patients with a known allergy to cornstarch or icodextrin, in patients with maltose or isomaltose intolerance, in patients with glycogen storage disease, and in patients with severe lactic acidosis.
When measuring blood glucose levels in patients using EXTRANEAL, do not use blood glucose monitoring devices using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ)-, glucose-dye oxidoreductase (GDO)-, and some glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD) based methods because these systems may result in falsely elevated glucose readings (due to the presence of maltose). Falsely elevated glucose readings have led patients or health care providers to withhold treatment of hypoglycemia or to administer insulin inappropriately leading to unrecognized hypoglycemia. Falsely elevated glucose levels may be measured up to two weeks following cessation of EXTRANEAL therapy when GDH-PQQ, GDO, and GDHFAD-based blood glucose monitors and test strips are used. Additionally, other glucose-measuring technologies, such as continuous glucose monitoring systems, may or may not be compatible with EXTRANEAL. Always contact the device manufacturer for current information regarding compatibility and intended use of the device in the dialysis patient population.
EXTRANEAL is intended for intraperitoneal administration only. Not for intravenous or intra-arterial administration. Aseptic technique should be used throughout the peritoneal dialysis procedure.
Encapsulating peritoneal sclerosis (EPS), sometimes fatal, is a complication of peritoneal dialysis therapy and has been reported in patients using EXTRANEAL.
Serious hypersensitivity reactions to EXTRANEAL have been reported such as toxic epidermal necrolysis, angioedema, serum sickness, erythema multiforme and vasculitis. Anaphylactic or anaphylactoid reactions may occur. If a serious reaction is suspected, discontinue EXTRANEAL immediately and institute appropriate therapeutic countermeasures.
Overinfusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominal distention, feeling of fullness and/or shortness of breath. Drain the peritoneal dialysis solution from the peritoneal cavity to treat overinfusion.
Patients with insulin-dependent diabetes may require modification of insulin dosage following initiation of treatment with EXTRANEAL. Monitor blood glucose and adjust insulin, if needed.
Peritoneal dialysis may affect a patient’s protein, water-soluble vitamin, potassium, sodium, chloride, bicarbonate, and magnesium levels and volume status. Monitor electrolytes and blood chemistry periodically. Monitor fluid status to avoid hyper- or hypovolemia and potentially severe consequences including congestive heart failure, volume depletion, and hypovolemic shock. Abnormalities in any of these parameters should be treated promptly under the care of a physician.
In clinical trials, the most frequently reported adverse events occurring in > 10% of patients and more common in EXTRANEAL PD solution patients than in control patients, were peritonitis, upper respiratory infection, hypertension, and rash. The most common treatment-related adverse reaction for EXTRANEAL PD solution patients was skin rash.
For a list of toll free numbers for glucose monitor and test strip manufacturers, please contact the Baxter Renal Clinical Help Line 1-888-RENAL-HELP or visit www.glucosesafety.com