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.
WHAT IS EXTRANEAL?
EXTRANEAL solution is a non-glucose, 7.5% icodextrin solution for the long dwell, widely used by nephrologists for 20+ years.
The long dwell
The dwell time is the prescribed period of time the dialysis fluid stays in the patient’s abdomen.
Continuous Ambulatory Peritoneal Dialysis
Extraneal is indicated for a single daily exchange for the long dwell during continuous ambulatory peritoneal dialysis (CAPD), exchanges are performed manually and the long dwell is usually during the night.
Automatic Peritoneal Dialysis
During automated peritoneal dialysis (APD) where a cycler assists the patient by automating a number of exchanges, the long dwell usually occurs during the day.
- The challenge with using a glucose-based PD solution during the long dwell may lead to gradual fluid reabsorption from the peritoneal cavity over time.1-4
- Patient benefits of the long dwell
The long dwell may reduce the potential need for multiple mid-day exchanges, meaning patients may plan and enjoy longer, uninterrupted daytime activities.
Learn more about the composition and mechanism of action of Extraneal PD Solution as an osmotic agent.
Extraneal (icodextrin) functions irrespective of transport type
Temporal profile of net ultrafiltration in the four standard transport
categories with the use of 2.5% dextrose solution and 7.5% icodextrin solution5
ONE BAG. MULTIPLE BENEFITS.
Compared to dextrose PD solutions, prescribing one bag of EXTRANEAL (icodextrin) Peritoneal Dialysis Solution FROM THE START OF PD therapy may bring the following benefits to patient outcomes:
LESS GLUCOSE FROM THE START
Prescribing PD patients with icodextrin solution, such as EXTRANEAL (7.5% icodextrin) Solution for Peritoneal Dialysis from the start, limits glucose exposure during PD therapy.1,4,6-10
LESS TREATMENT COMPLICATIONS FROM THE START
Icodextrin solution, such as EXTRANEAL (7.5% icodextrin) Solution for Peritoneal Dialysis may improve clinical outcomes by increasing ultrafiltration and maintaining fluid balance.4,11-19
LESS POTENTIAL RISK FOR PD DROPOUT
When prescribed from the onset of PD, one daily bag of icodextrin solution such as EXTRANEAL (7.5% icodextrin) Solution for Peritoneal Dialysis for the long dwell, may increase patient time on therapy.1,19,20
The International Society for Peritoneal Dialysis (ISPD) guidelines recommend “high-quality goal-directed peritoneal dialysis.”21
Individualization of the prescription is a key component of this high quality dialysis therapy, and can be achieved through a combination of Icodextrin and glucose based solutions.21
This is contrary to the prevalent notion that only glucose solutions should be used at the beginning of PD therapy.
Upon completion of this session, you will be able to:
- Discuss the evolution of the peritoneal membrane with prolonged exposure to glucose
- Understand the mechanism of action of EXTRANEAL
- Review the latest ISPD recommendations on the use of Icodextrin
- Discuss Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) current practice patterns
- Understand the clinical benefits of using EXTRANEAL for the management of the long-dwell
INDICATIONS AND IMPORTANT RISK INFORMATION (IRI)
INDICATIONS:
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).
IMPORTANT RISK INFORMATION:
- 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 GDH-FAD-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.
Click here full Prescribing Information for Extraneal PD Solution.