EXTRANEAL

What it is

EXTRANEAL is a peritoneal dialysis solution containing icodextrin as the active ingredient at a concentration of 7.5% w/v in an electrolyte solution. Icodextrin is an α (1-4) linked glucose polymer which contains 5–10% α (1-6) links, produced by the hydrolysis of starch and fractionated by membrane separation technology to produce material with the desired molecular weight distribution. EXTRANEAL is presented in a flexible PVC bag and is sterile, non-pyrogenic and contains no bacteriostatic or antimicrobial agents or added buffers.

Approved indications

— Use as an alternative osmotic agent in dialysis solutions for the long dwell exchange in patients treated with peritoneal dialysis

Dosing overview

Adults receive the solution by intraperitoneal administration limited to a single exchange in each 24 hour-period, as part of a Continuous ambulatory peritoneal dialysis (CAPD) or Automated Peritoneal Dialysis (APD) regimen. EXTRANEAL is recommended for use during the longest dwell period that is in CAPD usually overnight and in APD for the long daytime dwell. The recommended dwell time is between 6 and 12 hours in CAPD and 14–16 hours in APD. For adult patients of normal body size the instilled volume should not exceed 2.0 L. Use in children (less than 18 years) is not recommended.

Key safety warnings

Blood glucose management with EXTRANEAL must be done with a glucose-specific method to avoid interference resulting in unrecognised hypoglycaemia, as non-specific glucose test methods may result in loss of consciousness, neurological damage and death. Only glucose-specific monitors and test strips should be used to measure blood glucose levels; blood glucose monitoring devices using GDH-PQQ, GDO or GDH-FAD-based methods may not be used. Encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy; EPS has been reported in patients using EXTRANEAL and fatal outcomes have been reported. Patients with severe lactic acidosis should not be treated with lactate-based peritoneal dialysis solutions, and patients with conditions known to increase the risk of lactic acidosis must be monitored for occurrence before and during treatment. EXTRANEAL-associated skin reactions, including rash and pruritus, are generally mild or moderate in severity; occasionally, these rashes have been associated with exfoliation, and EXTRANEAL should be withdrawn at least temporarily depending on the severity.

Contraindications

EXTRANEAL should not be used in patients with a known allergy to starch based polymers (for example, corn starch) and/or icodextrin, in patients with maltose or isomaltose intolerance or patients with glycogen storage disease. EXTRANEAL is also contraindicated in patients with a history of abdominal surgery in the month preceding commencement of therapy or in patients with abdominal fistulae, tumours, open wounds, hernias or other conditions which compromise the integrity of the abdominal wall; pre-existing severe lactic acidosis; uncorrectable mechanical defects that prevent effective peritoneal dialysis or increase the risk of infection; or documented loss of peritoneal function or extensive adhesions that compromise peritoneal function.

Regulatory history

EXTRANEAL was first approved on 17 October 2002. Two variants are registered on the Australian Register of Therapeutic Goods: ARTG 91344 (standard single bag) and ARTG 91430 (twin bag with drainage bag), both first listed on 29 October 2002.