Extraneal: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• EXTRANEAL is a sterile peritoneal dialysis solution used in patients whose kidneys are not working properly. It removes waste products and water from the blood. EXTRANEAL can be used up to 12 hours for continuous peritoneal dialysis in mobile patients or 14 and up to 16 hours for automated peritoneal dialysis procedures.

What it does:

EXTRANEAL contains icodextrin, which is made from cornstarch. It draws fluid and wastes from your blood stream into your peritoneal cavity (the space inside your abdomen). The fluids and wastes are removed from your body when the EXTRANEAL solution is drained.

When it should not be used:

Do not use EXTRANEAL:

• If you have been treated for acute renal failure
• If a doctor has ever told you that you have a glycogen storage disease
• If you are allergic to cornstarch or have had an allergic reaction to icodextrin
• If you have maltose or isomaltose intolerance
• If a doctor has told you that you have pre-existing severe lactic acidosis
• If you have had abdominal surgery within the last month
• If you are allergic to any of the nonmedicinal ingredients (see What the nonmedicinal ingredients are:)
• If you have impaired respiratory function or potassium deficiency

• If you are told having a surgically uncorrectable problem affecting your abdominal wall or cavity or uncorrectable

  • such as abdominal fistulae, tumors, open wounds, herniae or other conditions until healing is complete
  • If you have documented loss of peritoneal function due to severe peritoneal scarring

  • If you are pregnant or plan to become pregnant

  • If you are breastfeeding

What the medicinal ingredients are:

Icodextrin

Sodium Chloride

Sodium Lactate

Calcium Chloride

Magnesium Chloride

What the nonmedicinal ingredients are:

Hydrochloric acid (For pH adjustment)

Sodium Hydroxide (For pH adjustment)

Water for Injection

What dosage forms it comes in:

EXTRANEAL is available in Viaflex^® Single or TwinBag containers holding 2000 mL or 2500 mL.

WARNINGS AND PRECAUTIONS

If you monitor your blood glucose, you must use a glucose specific monitor and test strips. If your glucose monitor or test strips use a GDH-PQQ*GDO**or GDH-FAD***-based method, using EXTRANEAL may cause a falsely high glucose reading or may mask a very low actual glucose reading. A false high blood glucose reading could cause you to give more insulin than you need. Getting more insulin than you need can cause serious reaction including loss of consciousness, coma, neurological damage and death. If you have true low blood sugar but are using a monitor that is not specific, you may inadvertently delay taking appropriate measure to correct the low blood sugar. A false elevated reading may be measured up to two weeks following the discontinuance of EXTRANEAL .

*GDH-PQQ: glucose dehydrogenase pyrroloquinolinequinone

**GDO: glucose-dye-oxidoreductase

***GDH-FAD: glucose dehydrogenase flavin-adenine dinucleotide

If you are ever hospitalized or admitted to the emergency room, notify the hospital staff that you are using EXTRANEAL and that icodextrin and maltose may give a false high glucose reading with some types of glucose monitors or test strips.

Tell your doctor if you:

• Use cardiac glycosides, such as digoxin. Your doctor may need to monitor your blood levels of calcium, potassium and magnesium
• Have recently had surgery to repair a weakness in an abdominal artery
• Suspect you are having an allergic reaction to EXTRANEAL or any ingredient in EXTRANEAL

Patients on EXTRANEAL may experience high or low levels of potassium, calcium, or magnesium in their blood. Your doctor will monitor your blood test results.

Tell your doctor about any other conditions you have that may affect the inside, outside or the wall of your abdomen.

If you are allergic to corn or corn products, undesirable allergic reactions, including development of rash, hives, throat and/or facial swelling, wheezing, shortness of breath, low blood pressure, and other anaphylactic/anaphylactoid reactions, may occur. Stop the infusion immediately and drain the solution from the peritoneal cavity if any signs or symptoms of a suspected allergic reaction develop and contact your doctor immediately.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist all the medications you are taking including all prescription, non-prescription and natural health products.

The blood concentration of drugs that can be removed from the body using dialysis may be reduced by peritoneal dialysis.

Talk with your doctor about any drugs prescribed as an additive to EXTRANEAL .

Tell your doctor about all the medicines you take, including insulin and blood pressure medicines. Your dose of these medicines may need to be changed when you use EXTRANEAL .

PROPER USE OF THIS MEDICATION

Usual dose

• EXTRANEAL is used for the long dwell exchange, up to 12 hours, in CAPD. EXTRANEAL is used for the long dwell exchange (14 to 16 hours) in APD. Do not perform more than one exchange in 24 hours.

• To do your EXTRANEAL exchange, it is very important that you follow the steps shown to you in your peritoneal dialysis training. All surfaces and connecting parts must be clean to avoid serious infection. If you need more help

  • center or doctor.
  • Before use, always check to make sure the bags are not leaking and the date for using the solution (expiration date) has not passed. Do not use EXTRANEAL after the expiration date shown on the carton and product label.
  • Make sure the solution is clear and does not contain particles. Do not use bags that are cloudy, leaking or that contain particles.
  • EXTRANEAL is for single use only. Discard any unused remaining solution.
  • EXTRANEAL is only for intraperitoneal administration.
  • Sometimes, too much EXTRANEAL can get into your peritoneal cavity. If you experience abdominal distention, feeling of fullness and, or shortness of breath, contact your doctor or peritoneal dialysis unit.
  • To make using EXTRANEAL more comfortable, you can warm it to 37^oC (98.6^oF) before use. This should only be done using dry heat, such as a heating pad.
  • To avoid increased risk of infection, do not place EXTRANEAL in water to heat the bags.
  • Do not microwave EXTRANEAL.
  • EXTRANEAL should be infused based on your need for adequate dialysis, as determined by your doctor. When draining the fluid after the dwell, always check your drained fluid for cloudiness or fibrin. Fibrin looks like clumps or stringy material in the drained solution. Cloudy drained fluid or fibrin may mean you have an infection. Call your doctor if your drained fluid is cloudy or contains fibrin.
  • Carefully monitor your fluid balance. Keep an accurate fluid record. Carefully monitor your body weight to avoid too much or too little fluid in your body (over or under hydration) which may have serious effects.
  • Talk to your doctor before adding any other medicines to EXTRANEAL.

Overdose

There is no information available on the effects of overdosage. Only one exchange is recommended in a 24-hour period. Contact your doctor if a suspected overdosage has been administered.

Rash is the most common side effect of EXTRANEAL. It usually appears during the first 3 weeks of treatment and goes away when treatment stops.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

In case of a suspected drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

This is not a complete list of side effects. For any unexpected effects while taking EXTRANEAL, contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature (15 - 25°C). Do not store below 4^oC. Do not use unless the solution is clear and the container undamaged. Any unused portion of the solution should be discarded.

Keep out of reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    • Health Canada, Postal Locator 0701E
    • Ottawa, ON
    • K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

NOTE: Contact your health professional if you need information about how to manage your side effects. . The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

If you want more information about EXTRANEAL :

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc-gc.ca/index-eng.php); or by contacting the sponsor, Vantive ULC, at:1-800-387-8399

Mississauga ON L5N 5M4.

Vantive and Extraneal are trademarks of Vantive Health Inc. or its subsidiaries.

Viaflex is a trademark of Baxter International Inc. or its subsidiaries.

Last revised: APR 12, 2024