Delflex peritoneal dialysis solution for chronic kidney failure

Delflex is a sterile, clear peritoneal dialysis solution containing dextrose and electrolytes. It is used for the treatment of chronic kidney failure in patients undergoing peritoneal dialysis. Delivered in single-dose flexible bags, Delflex solutions provide an osmotic gradient for ultrafiltration across the peritoneal membrane to help remove waste products and excess fluid.

Delflex is indicated for use in patients with chronic kidney failure who are maintained on peritoneal dialysis therapy. It is intended for intraperitoneal administration only and should be used under medical supervision to manage renal failure.

Dextrose monohydrate; Sodium chloride; Sodium lactate; Calcium chloride; Magnesium chloride

Delflex solutions contain dextrose as the primary osmotic agent, creating a hypertonic environment in the peritoneal cavity. This osmotic gradient draws excess fluid through the peritoneal membrane by transcapillary ultrafiltration. The solution also contains electrolytes and lactate buffer to help correct acid-base and electrolyte imbalances during dialysis.

Delflex is for intraperitoneal administration only, not for intravenous or intra-arterial use. The specific dialysis regimen, including mode of therapy, frequency, solution formulation, exchange volume, dwell time, and treatment duration, should be individualized by the treating physician.

Use the solution with the lowest osmolarity that achieves the required fluid removal for each exchange. Do not store solutions that contain additives. Compatible antibiotics such as cefazolin, ceftazidime, gentamicin, and vancomycin may be added via the medication port if ordered.

Prior to use, the solution bag should be checked for leaks, clarity, correct concentration, and expiration date. Do not heat the solution in a microwave.

None specified.

• Carefully monitor patients for electrolyte, fluid, and nutritional imbalances during peritoneal dialysis, including losses of protein, amino acids, and water-soluble vitamins.
• Potassium is not included; potassium chloride may be added up to 4 mEq/L if necessary to prevent hypokalemia.
• Inspect drained dialysate for cloudiness or fibrin that may indicate peritonitis and initiate appropriate antimicrobial treatment if infection is suspected.
• Avoid infusion of air into the peritoneal cavity to reduce risk of abdominal pain and peritonitis.
• Be aware of the risk of encapsulating peritoneal sclerosis (EPS), a potentially fatal complication of long-term peritoneal dialysis.
• Monitor for lactic acidosis in at-risk patients, such as those with severe hypotension, sepsis, metabolic disorders or those receiving nucleoside/nucleotide reverse transcriptase inhibitors.
• Lactate-containing solutions should be used with caution in patients with metabolic or respiratory alkalosis or impaired lactate metabolism (e.g., severe liver insufficiency).
• Over infusion may cause abdominal distention, fullness, or shortness of breath; drain excess solution if needed.

• Peritonitis
• Catheter site infection
• Electrolyte and fluid imbalances (hypovolemia, hypervolemia)
• Hypertension or hypotension
• Disequilibrium syndrome
• Muscle cramping
• Abdominal pain, distention, or discomfort

No formal clinical drug interaction studies have been conducted. In vitro studies indicate stability with cefazolin, ceftazidime, gentamicin, and vancomycin when added to the solution.

Pregnancy

Though adequate human studies are lacking, Delflex use with appropriate monitoring of fluid, electrolyte, acid-base, and glucose balance is not expected to cause fetal harm. Animal reproduction studies have not been conducted.

Lactation

Components of Delflex solutions are excreted in human milk but are not expected to harm a nursing infant when properly administered and monitored.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Store Delflex peritoneal dialysis solutions at controlled room temperature 20°C to 25°C (68°F to 77°F), with permitted excursions between 15°C and 30°C (59°F to 86°F). Minimize exposure to temperatures above 25°C. Avoid heating in a microwave oven. Keep out of reach of children.