INDICATION
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
WARNING: 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 dehydrogenase pyrroloquinolinequinone (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 (GDH-FAD)-based methods must not be used. Use of GDHPQQ, GDO, and GDH-FAD-based glucose monitors and test strips has resulted 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. Both of these situations have resulted in unrecognized hypoglycemia, which has led to loss of consciousness, coma, permanent neurological damage, and death. Plasma levels of EXTRANEAL (icodextrin) and its 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 of EXTRANEAL (icodextrin) therapy when GDH-PQQ, GDO, and GDH-FAD-based blood glucose monitors and test strips are used.
- To avoid improper insulin administration, educate all patients to alert health care providers of this interaction particularly in hospital settings.
- The manufacturer(s) of the monitor and test strips should be contacted to determine if icodextrin or maltose causes interference or falsely elevated glucose readings. 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.
- Because of the risk of unrecognized hypoglycemia that could result from a drug-device interaction, EXTRANEAL is available only through a restricted program.
- EXTRANEAL (icodextrin) 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.
- EXTRANEAL is intended for intraperitoneal administration only. Not for intravenous injection. 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.
Please see www.glucosesafety.com or www.baxterpi.com for Full Prescribing Information.