Nexplanon REMS

Frequently Asked Questions

• What are the FDA label updates for Nexplanon?

  The U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (NDA) for Nexplanon (etonorgestrel implant) in January 2026; the updated label extends the approved duration of use up to 5 years (previously 3 years). This change is supported by newer clinical trial data.

  Additionally, the updated label reflects data showing efficacy across a wide range of body mass indexes (BMIs) (including BMI of 30 kg/m² or greater) and safety/effectiveness in adolescents. In its updated January 2026 approval, the FDA also required the implementation of a REMS.

• What is a REMS, and what is the rationale for requiring one for Nexplanon?

  A REMS is required when the FDA determines that additional measures are essential to ensure that the benefits of a medication outweigh its risks. For Nexplanon, the REMS addresses rare complications related to insertion and removal, such as deep insertions and implant migration.

  A large post-marketing observational study confirmed the rarity of these events, but the FDA determined risk would be further mitigated through a REMS that ensures consistent, high-quality training. The Nexplanon REMS expands the existing clinical training program and mandates the reporting of insertion- and removal-related events.

• Do clinicians need to become Nexplanon REMS-certified?

  All clinicians who insert or remove Nexplanon must be certified under the Nexplanon REMS program. Certification is required to order, dispense (via certified pharmacies), and insert or remove the implant. Requirements differ based on prior training and recent experience.

  The deadline for currently trained clinicians to obtain REMS certification is August 23, 2026.

• What is required for REMS certification for clinicians who have been previously trained and are actively inserting Nexplanon?
  • Create a Nexplanon REMS account at https://www.nexplanonrems.com/
  • Review prescribing information and the Healthcare Provider Guide
  • Complete and submit the Healthcare Provider Knowledge Assessment (a brief seven-question quiz) and the Healthcare Provider Enrollment Form online at www.NEXPLANONREMS.com

  Certification is immediate after successful completion. The entire process takes about 10 minutes. All certified providers must immediately report any insertion- or removal-related complications to the REMS program. Consider completing the steps early to avoid missing the August 23, 2026, deadline.

• What is required for REMS certification for clinicians who have not been previously trained and/or have not inserted Nexplanon in the last 3 years?
  • Create a Nexplanon REMS account at https://www.nexplanonrems.com/
  • Review prescribing information and the Healthcare Provider Guide
  • Complete and submit the Healthcare Provider Knowledge Assessment (a brief seven-question quiz) and the Healthcare Provider Enrollment Form online at www.NEXPLANONREMS.com
  • Complete additional online didactic training
  • Attend in-person practical training (scheduled through the REMS program)
  • Pass a hands-on competency validation (checklist)

  Certification occurs after completing all steps. All certified providers must immediately report any insertion- or removal-related complications to the REMS program. Consider completing and scheduling the steps early to ensure patient access to the contraceptive implant.

• What is the deadline for receiving REMS certification?

  The deadline for currently active, previously trained providers to complete the streamlined REMS certification is August 23, 2026. After that date, all clinicians, regardless of experience and training, will need to complete full training. Failure to obtain REMS certification prior to August 23 will result in the loss of active Nexplanon provider status, with the inability to procure, insert, and remove Nexplanon. Reinstatement will require completion of the comprehensive training process.

• Where can I find additional information?

  For more information, go to www.NEXPLANONREMS.com or contact the NEXPLANON REMS Coordinating Center at 1-833-NXP-REMS (1-833-697-7367).