Dianeal PD-4

What it is

DIANEAL PD-4 is a peritoneal dialysis solution containing sodium chloride, glucose monohydrate, sodium lactate, magnesium chloride hexahydrate and calcium chloride dihydrate. The solution is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents or added buffers. It is presented as a clear, slightly coloured peritoneal dialysis solution.

Approved indications

— Chronic renal failure patients being maintained on continuous ambulatory peritoneal dialysis (CAPD)

Dosing overview

DIANEAL PD-4 is intended for intraperitoneal administration only. The mode of therapy, frequency of treatment, formulation, exchange volume, duration of dwell and length of dialysis should be selected by the physician responsible for and supervising the treatment of the individual patient. To avoid severe dehydration and hypovolaemia and to minimise protein loss, the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements should be selected. Typically the majority of exchanges will utilise DIANEAL 1.5% and 2.5% glucose solutions, with DIANEAL 4.25% glucose solutions being used when extra fluid removal is required.

Key safety warnings

Encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy that has been reported in patients using DIANEAL solutions. Infrequently, fatal outcomes of EPS have been reported with DIANEAL solutions. Solutions containing glucose should be used with caution in patients with a known allergy to corn or corn products, as hypersensitivity reactions such as those due to corn starch allergy, including anaphylactic and anaphylactoid reactions, may occur. The infusion should be stopped immediately and the solution drained from the peritoneal cavity if any signs or symptoms of a suspected hypersensitivity reaction develop. Patients with conditions known to increase the risk of lactic acidosis (such as severe hypotension or sepsis associated with acute renal failure, inborn errors of metabolism, or treatment with metformin and nucleoside/nucleotide reverse transcriptase inhibitors) must be monitored for occurrence of lactic acidosis before and during treatment with lactate-based peritoneal dialysis solutions. Azotaemic diabetics require careful monitoring of insulin requirements during and following dialysis. In diabetic patients, blood glucose levels should be regularly monitored, and the dosage of insulin or other treatments for hyperglycaemia should be adjusted.

Contraindications

DIANEAL PD-4 should not be administered unless the solution is clear and the seal is intact. The solution is contraindicated in patients with pre-existing severe lactic acidosis, uncorrectable mechanical defects that prevent effective peritoneal dialysis or increase the risk of infection, and documented loss of peritoneal function or extensive adhesions that compromise peritoneal function.

Regulatory history

DIANEAL PD-4 was first approved on 30 September 1991. Multiple ARTG registrations were established for DIANEAL PD-4 variants between 1991 and 1995, including low calcium formulations with varying glucose concentrations and packaging configurations.