FDA Approves Updated Nexplanon® Label and Launches New REMS: What to Know from ReproHH

Updates from ReproHH

The latest updates, announcements, and clinical information from the Reproductive Health Hotline

FDA Approves Updated Nexplanon® Label and Launches New REMS: What to Know from ReproHH

ReproHH Staff

Effective January 16, 2026, the U.S. Food and Drug Administration (FDA) approved the Supplemental New Drug Application (sNDA) for Nexplanon® (68 mg etonogestrel implant), extending its approved use from 3 years to up to 5 years for pregnancy prevention.

  • Full Prescribing Information (for clinicians) and Patient Labeling have been updated accordingly.
  • Clinical trial data (NCT04626596) showed zero pregnancies during years 4–5 and no new safety concerns across BMI ranges of 17.2 to 64.3 kg/m², including 38% with BMI ≥30 kg/m².

All clinicians performing Nexplanon insertions or removals must now complete FDA-required Risk Evaluation and Mitigation Strategy (REMS) certification.

  • Healthcare providers must certify with the program by enrolling and completing training on the proper insertion and removal of Nexplanon prior to first use.
  • Wholesalers and distributors must be registered with the program and must only distribute to certified pharmacies and certified healthcare providers.

We clinicians at ReproHH trialed this for you, and it took our clinicians who are familiar with the prescribing information LESS than 10 minutes to complete! 

Here's a step-by-step guide on how to do it:

  • Visit: https://www.nexplanonrems.com/
  • You do not need to go to the pink “Login” button (that login screen is only for people who already have an existing account). Instead, go to “Healthcare Providers → Learn More,” which can be directly accessed at: https://www.nexplanonrems.com/healthcareproviders 
  • Register an account (you need your NPI and license), and then follow the email to register and log in.
  • Review Prescribing Information (31 pages) and Healthcare Provider Guide (2-page summary of the REMS):
    • There is a notable change regarding reporting and documentation: “Potential insertion and removal-related events (IRREs) must be reported immediately to the NEXPLANON REMS using the Insertion and Removal-Related Events Documentation Form or by calling 1-833-NXP-REMS (1-833-697-7367).”
  • Providers then complete a Knowledge Assessment (7 short questions) and Enrollment Form to obtain REMS certification.
  • The REMS enrollment period is February 23, 2026, through August 23, 2026.
    • Providers who do not enroll during this time period will not be able to purchase Nexplanon after the end of this 6-month certification period. 
    • Providers who have not been previously trained by Organon – or those who did not complete the 2018 re-training – can visit the Nexplanon REMS website to enroll in the REMS program and receive information on the required training.
    • All health care providers must receive instruction and training prior to performing insertion and/or removal of Nexplanon.

Resources: 

Have questions about Nexplanon, the new REMS, or anything else related to sexual and reproductive health (SRH) clinical care? Call us at the Reproductive Health Hotline, call 1-844-ReproHH (844-737-7644) after reading our Terms of Service!