Extraneal
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
2 DOSAGE AND ADMINISTRATION For intraperitoneal administration only. Not for intravenous or intra-arterial administration. Administer as a single daily peritoneal dialysis (PD) exchange for the long dwell. Dosage should be individualized by the prescribing physician experienced in the treatment of kidney failure in patients requiring long-term kidney replacement therapy with PD. 2.1 Basic Dosing Information EXTRANEAL is intended for intraperitoneal administration only.
Not for intravenous or intra-arterial administration. Administer as a single daily exchange for the long dwell in continuous ambulatory peritoneal dialysis or automated peritoneal dialysis. The recommended dwell time is 8 to 16 hours. Administer over a period of 10 to 20 minutes at a rate that is comfortable for the patient.
The mode of therapy, frequency of treatment, exchange volume, duration of dwell, and length of dialysis should be initiated and supervised by the prescribing physician experienced in the treatment of kidney failure in patients requiring long-term kidney replacement therapy with peritoneal dialysis. It is recommended that patients being placed on peritoneal dialysis should be appropriately trained in a program that is under supervision of a physician. 2.2 Directions for Use For complete CAPD and APD system preparation, see directions accompanying ancillary equipment.
Aseptic technique should be used throughout the peritoneal dialysis procedure. For single-dose only. Storage Store in moisture barrier overwrap and in carton until ready to use [see How Supplied/Storage and Handling] . Warming For patient comfort, EXTRANEAL can be warmed to 37°C (98.6°F). Only dry heat should be used (e.g., heating pad, warming plate).
Once the pull ring has been removed, do not reuse the solution or container. 5. Immediately attach the solution container to patient connector (transfer set) or appropriate peritoneal dialysis set. 6. For AMBU-FLEX II, continue with therapy set-up as instructed in user manual or directions accompanying tubing sets for automated peritoneal dialysis. 7.
Preparation and administration
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Basic Dosing Information EXTRANEAL is intended for intraperitoneal administration only. Not for intravenous or intra-arterial administration. Administer as a single daily exchange for the long dwell in continuous ambulatory peritoneal dialysis or automated peritoneal dialysis. The recommended dwell time is 8 to 16 hours.
Administer over a period of 10 to 20 minutes at a rate that is comfortable for the patient. The mode of therapy, frequency of treatment, exchange volume, duration of dwell, and length of dialysis should be initiated and supervised by the prescribing physician experienced in the treatment of kidney failure in patients requiring long-term kidney replacement therapy with peritoneal dialysis.
It is recommended that patients being placed on peritoneal dialysis should be appropriately trained in a program that is under supervision of a physician.
Directions for Use For complete CAPD and APD system preparation, see directions accompanying ancillary equipment. Aseptic technique should be used throughout the peritoneal dialysis procedure. For single-dose only. Storage Store in moisture barrier overwrap and in carton until ready to use [see How Supplied/Storage and Handling] .
Warming For patient comfort, EXTRANEAL can be warmed to 37°C (98.6°F). Only dry heat should be used (e.g., heating pad, warming plate). Do not immerse EXTRANEAL in water for warming. Do not use a microwave oven to warm EXTRANEAL. Do not heat above 40°C (104°F). To Open To open, tear the overwrap down at the slit and remove the solution container.
Some opacity of the plastic, due to moisture absorption during the sterilization process, may be observed. This does not affect the solution quality or safety and may often leave a slight amount of moisture within the overwrap. Inspect for Container Integrity and Solution Appearance Do not use EXTRANEAL if it is cloudy or discolored, if it contains particulate matter, or if the container is leaking.
Inspect the patient connector to ensure the pull ring is attached. Do not use if pull ring is not attached to the connector. Inspect the EXTRANEAL container for signs of leakage and check for minute leaks by squeezing the container firmly. If the container has frangible(s), inspect that they are positioned correctly and are not broken.
Do not use EXTRANEAL if the frangible(s) are broken or leaks are suspected as sterility may be impaired. For EXTRANEAL in ULTRABAG, inspect the tubing and drain container for presence of solution. Small droplets are acceptable, but if solution flows past the frangible prior to use, do not use and discard the units. Adding Medications The decision to add medication should be made by the physician after careful evaluation of the patient [see Drug Interactions, Clinical Pharmacology] .
If the re-sealable rubber plug on the medication port is missing or partly removed, do not use the product. To add a medication: 1. Put on mask. Clean and/or disinfect hands. 2. Prepare medication port site using aseptic technique. 3. Using a syringe with a 1-inch long, 25- to 19-gauge needle, puncture the medication port and inject additive. 4.
Reposition container with container ports up and evacuate medication port by squeezing and tapping it. 5. Mix solution and additive thoroughly. Preparation for Administration 1. Put on mask. Clean and/or disinfect hands. 2. Place EXTRANEAL on work surface. 3. For ULTRABAG system for manual exchanges, uncoil tubing and drain bag.
Ensure the patient transfer set is closed. Break the connector (Y-set) frangible. 4. Remove pull ring from connector of solution container. If continuous fluid flow from connector is observed, discard solution container. Once the pull ring has been removed, do not reuse the solution or container. 5. Immediately attach the solution container to patient connector (transfer set) or appropriate peritoneal dialysis set. 6.
For AMBU-FLEX II, continue with therapy set-up as instructed in user manual or directions accompanying tubing sets for automated peritoneal dialysis. 7. For ULTRABAG, follow the below steps:
Clamp solution line and then break frangible near solution bag. Hang solution container and place the drainage container below the level of the abdomen.
Open transfer set to drain the solution from abdomen. If drainage cannot be established, contact your clinician. When drainage complete, close transfer set.
Remove clamp from solution line and flush new solution to flow into the drainage container for 5 seconds to prime the line. Clamp drain line after flush complete.
Open transfer set to fill. When fill complete, close transfer set and clamp solution line.
Put on mask. Clean and/or disinfect hands.
Disconnect ULTRABAG from transfer set and apply MINICAP. Completion of Therapy 1. Following use, the drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis. 2. Discard unused portion.
Drug interactions
Check extraneal against a medication listLabel text (1 paragraph)
As with other dialysis solutions, blood concentrations of dialyzable drugs may be reduced by dialysis. Dosage adjustment of concomitant medications may be necessary. In patients using cardiac glycosides (digoxin and others), plasma levels of calcium, potassium and magnesium must be carefully monitored [see Warnings and Precautions ( 5.6 )]. Insulin: Patients with insulin-dependent diabetes may require modification of insulin dosage following initiation of treatment with EXTRANEAL. Monitor blood glucose and adjust insulin, if needed [see Warnings and Precautions ( 5.1 )] .
Contraindications
4 CONTRAINDICATIONS EXTRANEAL is contraindicated in patients with: • known hypersensitivity to icodextrin [see Warnings and Precautions ( 5.3 )] • maltose or isomaltose intolerance • glycogen storage disease • severe lactic acidosis, as EXTRANEAL contains lactate which may contribute to worsening acidosis if conversion to bicarbonate is impaired and may be associated with hyperventilation, lethargy, hypotension or irregular heart rhythms. • Known hypersensitivity to icodextrin • Maltose or isomaltose intolerance • Glycogen storage disease • Pre-existing severe lactic acidosis
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for extraneal. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary EXTRANEAL is a pharmacologically inactive solution. While there are no adequate and well controlled studies in pregnant women, appropriate administration of EXTRANEAL with monitoring of hematology, blood chemistry, and fluid status is not expected to cause fetal harm. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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