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."

  • Compatible with both the HomeChoice and Ultrabag systems
  • 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.

INDICATION

Extraneal (icodextrin) 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.

Extraneal 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 FOR PATIENTS

EXTRANEAL PD solution contains maltose, which can react with certain blood glucose (blood sugar) monitors and test strips.

  • Using EXTRANEAL PD solution may cause a false (incorrect) high blood sugar reading or may hide a blood sugar reading that is actually very low. This kind of false reading means that your blood sugar may really be too low even though the test says that it is normal or high. This can lead to dangerous side effects.
  • Only use a glucose-specific monitor and test strips to monitor your blood glucose when being treated with EXTRANEAL and approximately 2 weeks after stopping EXTRANEAL.
  • If you are hospitalized or go to an emergency room, take your EXTRANEAL PD Solution Patient Kit along with you and tell the hospital staff that you use EXTRANEAL PD solution so that they use the right kind of blood glucose monitor and test strips for you.
  • Taking too much insulin or waiting too long to treat low blood sugar can cause you to have serious reactions including: loss of consciousness (passing out), coma, permanent neurological problems, or death.

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

  • have a condition that affects your nutrition 
  • have low potassium levels in your blood 
  • have low magnesium levels in your blood 
  • had stomach area: 
    • surgery in the past 30 days
    • tumors
    • open wounds or an infection
    • hernia
  • have a lung or breathing problem
  • have high calcium levels in your blood
  • have 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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. The dose of certain medicines may need to be changed when you use EXTRANEAL.

Especially tell your doctor if you take:

  • insulin
  • blood pressure medicine
  • digoxin (Lanoxicaps, Lanoxin, Lanoxin Pediatric)

Know the medicines you take. Keep a list of them and show your doctor and pharmacist when you get a new medicine.

Extraneal 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:
  • 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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