Approved Risk Evaluation and Mitigation Strategies (REMS)

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Extraneal (icodextrin)
NDA #021321
REMS last update: 10/24/2016



What is the purpose of the REMS?

To mitigate the risk of morbidity and mortality associated with the use of non-specific glucose monitors and test strips in patients using EXTRANEAL by:

  1. Informing the dialysis clinic staff managing the patient’s treatment (such as peritoneal dialysis nurses) about the drug-device interaction and the potential for falsely elevated blood glucose readings in patients using EXTRANEAL.
  2. Informing patients of the drug-device interaction and the need to alert health care providers of this interaction whenever they receive treatment outside of a dialysis clinic.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers).

Dialysis clinic staff who treat patients on Extraneal must

To become certified to treat patients
  • Receive training provided by Baxter.
Before treatment initiation
  • Counsel the patient using the REMS training tools.
At all times
  • Review the REMS Training Tools every time staff have not managed a patient using Extraneal within six months of completing the training.

Patients who are prescribed Extraneal

Before the first treatment
  • Receive counseling from the prescriber on drug-device interaction.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Extraneal REMS, see the DailyMed link(s).
Material Name Material Name Link
Patient Kit (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2016-10-24_Patient_Kit .pdf
Patient Training Tool (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2016-10-24_Patient_Training_Tool.pdf
PD Nurse Training Tool (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2016_10-24_PD_Nurse_Training_Tool.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2016-10-24_REMS_Document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Extraneal_2016-10-24_Full.pdf

What updates have been made to the REMS?

Date Summary of change
10/24/2016 Modified to:

  1. Add two new glucose monitor manufacturing companies to the REMS materials.
  2. Remove the reference to patient surveys from the REMS document.
  3. Update the version number on the REMS materials.
10/16/2015 Modified to align the REMS with the revised label approved in the December 9, 2014, Supplement Approval letter (S-028) for the conversion of the Extraneal label to the Physician’s Labeling Rule (PLR) in the Extraneal REMS and appended materials.
02/25/2014 Modified to:

  1. Add language to update the U.S. specific glucose monitor website (www.glucosesafety.com) every six months to the REMS document.
  2. Show a new address for Baxter Healthcare Corporation on the REMS document and relevant appended materials.
03/09/2011 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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