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Approved Risk Evaluation and Mitigation Strategies (REMS)

Nexplanon (etonogestrel implant)
NDA #021529
REMS last update: 04/20/2026



What is the purpose of the REMS?

The goal of the NEXPLANON REMS is to mitigate complications due to improper insertion and removal.

Objective:

  1. Healthcare providers who perform NEXPLANON procedures demonstrate proper insertion and removal techniques for NEXPLANON prior to first use.

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). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare providers who dispense NEXPLANON for insertion must:

To become certified to dispense for insertion
  • Review the Prescribing Information, including the Instructions for Use.
  • Review the Healthcare Provider Guide.
  • Successfully complete the Healthcare Provider Knowledge Assessment and submit it to the REMS.
  • Successfully complete the Didactic Training.
  • Take the in-person practical training provided by Organon.
  • Successfully complete the Competency Checklist.
  • Enroll by completing and submitting the Healthcare Provider Enrollment Form to the REMS.
After insertion
  • Assess the patient for complications due to insertion and need for removal of NEXPLANON.
  • For patients who experience complications due to insertion: Document and submit to the REMS using the Insertion and Removal-Related Events Documentation Form.
After removal
  • Assess the patient for complications due to insertion or removal of NEXPLANON.
  • For patients who experience complications due to insertion or removal: Document and submit to the REMS using the Insertion and Removal- Related Events Documentation Form.
To maintain certification to dispense for insertion after any three-year period of inactivity of performing procedures with NEXPLANON
  • Review the Healthcare Provider Guide.
  • Successfully complete the Healthcare Provider Knowledge Assessment and submit it to the REMS.
At all times
  • Not transfer NEXPLANON except to certified healthcare providers.
  • Not distribute, loan, or sell NEXPLANON.
  • Report complications due to insertion or removal of NEXPLANON to the REMS using the Insertion and Removal-Related Events Documentation Form.

Pharmacies that dispense NEXPLANON must:

To become certified to dispense
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
  • Have the authorized representative review the Pharmacy Guide.
  • Have the authorized representative enroll in the REMS by completing and submitting the Pharmacy Enrollment Form to the REMS.
  • Train all relevant staff involved in dispensing NEXPLANON on the REMS requirements.
  • Establish processes and procedures to verify that NEXPLANON is dispensed only to certified healthcare providers.
Before dispensing
  • Verify that NEXPLANON is dispensed only to certified healthcare providers through the processes and procedures established as a requirement of the REMS.
To maintain certification to dispense
  • Have any new authorized representative enroll by completing and submitting the Pharmacy Enrollment Form to the REMS.
At all times
  • Not distribute, transfer, loan, or sell NEXPLANON except to certified pharmacies.
  • Maintain records of staff training.
  • Maintain records of all processes and procedures including compliance with those processes and procedures.
  • Comply with audits carried out by Organon or a third party acting on behalf of Organon to ensure that REMS processes and procedures are in place and are being followed.

Wholesalers-distributors that distribute NEXPLANON must:

To be able to distribute
  • Establish and maintain processes and procedures to ensure that NEXPLANON is distributed only to certified pharmacies and certified healthcare providers.
  • Train all relevant staff involved in distributing NEXPLANON on the REMS requirements.
At all times
  • Distribute only to certified pharmacies and certified healthcare providers.
  • Maintain and submit records of all shipments of NEXPLANON.
  • Comply with audits carried out by Organon or a third party acting on behalf of Organon to ensure that REMS processes and procedures are in place and are being followed.

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.

Material Name Material Name Link
Competency Checklist (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nexplanon_2026_04_20_Competency_Checklist.pdf
Didactic Training (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nexplanon_2026_04_20_Didactic_Training.pdf
Healthcare Provider Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nexplanon_2026_04_20_Healthcare_Provider_Enrollment_Form.pdf
Healthcare Provider Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nexplanon_2026_04_20_Healthcare_Provider_Guide.pdf
Healthcare Provider Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nexplanon_2026_04_20_Healthcare_Provider_Knowledge_Assessment.pdf
In Person Training Slide Deck with Videos (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nexplanon_2026_04_20_In_Person_Training_Slide_Deck_with_Videos.pdf
Insertion and Removal-Related Events Documentation Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nexplanon_2026_04_20_Insertion_and_Removal-Related_Events_Documentation_Form.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nexplanon_2026_04_20_Pharmacy_Enrollment_Form.pdf
Pharmacy Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nexplanon_2026_04_20_Pharmacy_Guide.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nexplanon_2026_04_20_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nexplanon_2026_04_20_REMS_Full.pdf
REMS Website (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nexplanon_2026_04_20_REMS_Website.pdf
Assessment Plan
Nexplanon REMS Assessment Plan

This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date Summary of change
04/20/2026 Revised to make editorial changes
01/16/2026 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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