Extraneal (icodextrin) PD solution: A solution for the long dwell

The information provided is not intended to be a substitute for professional medical advice. A licensed healthcare professional should be consulted for diagnosis and treatment of any and all medical conditions.

Your doctor may prescribe Extraneal (icodextrin) PD solution as one of your solutions for Peritoneal Dialysis (PD). Extraneal PD solution is different from other solutions because it's used just once per day and it stays in your peritoneal cavity for 8 to 16 hours - otherwise known as the "long dwell."

  • Helps reduce fluid overload
  • Compatible with both the HomeChoice and Ultrabag systems
  • Can be an alternative if you have fluid management challenges
  • An option for patients requiring increased ultrafiltration. Extraneal PD solution improves ultrafiltration and clearance of creatinine and urea nitrogen in patients with high-average or greater transport characteristics.

Indications

Extraneal (icodextrin) Peritoneal Dialysis (PD) solution 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 (ESRD). Extraneal PD solution 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

Do not use Extraneal PD solution if you:

  • have a glycogen storage disease
  • cannot tolerate maltose or isomaltose
  • have severe lactic acidosis
  • are allergic to cornstarch or icodextrin 

Extraneal PD solution may not be right for you. Before using Extraneal PD solution, tell your doctor about all your medical conditions, including if you have:

  • a condition that affects your nutrition 
  • low potassium levels in your blood 
  • low magnesium levels in your blood 
  • had stomach area: 
    • surgery in the past 30 days
    • tumors
    • open wounds or an infection
    • hernia
  • a lung or breathing problem
  • high calcium levels in your blood
  • had recent aortic graft surgery
  • have certain bowel conditions including: 
    • colostomy or ileostomy
    • frequent episodes of diverticulitis
    • inflammatory bowel disease 
  • are pregnant or plan to become pregnant. It is not known if Extraneal PD solution will harm your unborn baby
  • are breast-feeding. It is not known if Extraneal PD solution passes into your breast milk

Extraneal PD solution can cause serious side effects, including:

  • Serious allergic reactions. Tell your doctor or get medical help right away if you get any of these symptoms of a serious allergic reaction during treatment with Extraneal PD solution;
    • swelling of your face, eyes, lips, tongue or mouth
    • trouble swallowing or breathing
    • skin rash, hives, sores in your mouth, on your eyelids, or in your eyes
    • your skin blisters or peels

Common side effects of Extraneal PD solution include:

  • Peritonitis, an infection in the peritoneal (abdominal) cavity, which is common in people on peritoneal dialysis. Tell your doctor right away if you have any pain, redness, fever, or cloudy drained fluid
  • High blood pressure, nausea, headache, swelling, stomach area (abdomen) pain, chest pain, increased cough, upset stomach, flu-like symptoms, high blood sugar

These are not all the possible side effects of Extraneal PD solution. For more information, ask your doctor or dialysis center. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

For additional information please see the Extraneal PD Solution Medication Guide.

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Material Safety Data Sheet

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