Extraneal PD Solution

Start Smart. Stay Strong. Make a move to protect the choice of PD with Extraneal Peritoneal Dialysis (PD) Solution.

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).

Please read the accompanying Important Risk Information and full Prescribing Information.

PD is Growing as the Therapy of Choice for ESRD Patients and their Nephrologists. Why Do Nephrologists Prescribe Extraneal (Icodextrin) PD Solution?

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Help Manage Fluid Balance

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Optimize the PD Prescription

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Start & Sustain a Glucose-Sparing Rx

Extraneal Solution Has Been Proven to Help Improve Retention and Address Causes of PD Dropout

*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

**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.

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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

When starting and sustaining a glucose-sparing prescription

When the PET results suggest a need to modify the prescription

When protecting your patient from fluid overload

When more dialysis requires a midday exchange, use a glucose-sparing solution like EXTRANEAL for the long dwell

When ultrafiltration targets are becoming harder to achieve, requiring additional exchanges or higher dextrose solutions, particularly in patients with high average or greater transport characteristics

When your patient is experiencing lifestyle challenges and struggling with managing additional or daytime exchanges

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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.

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

Please click here for full Prescribing Information