Important Risk Information regarding EXTRANEAL (icodextrin) Peritoneal Dialysis Solution
Dangerous Drug – Device Interaction
Important Risk Information for EXTRANEAL (icodextrin) Peritoneal Dialysis Solution
WARNING: UNRECOGNIZED HYPOGLYCEMIA RESULTING FROM DRUG-DEVICE INTERACTION
- 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.