Effective January 16, 2026, the U.S. Food and Drug Administration (FDA) has 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.

Clinical Note:

• In 2018, the insertion location changed from the sulcus between the biceps and the triceps muscles to the current insertion site, which is 3-5 cm posterior to (below) the sulcus. This decreases the risk of migration and neurovascular injury. This 2026 label change does not change the recommended insertion location. [See “Insertion Procedure” on page 5 of the Full Prescribing Information.]

Requirements of the Nexplanon REMS program include:

• 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.

Instructions for providers to enroll and certify in the REMS program:

• Visit: nexplanonrems.com
• Following review of the updated Prescribing Information and Healthcare Provider Guide, providers are to create a Nexplanon REMS account, take a Knowledge Assessment, and complete an 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:
• Nexplanon REMS: nexplanonrems.com
• Updated FDA Full Prescribing Information
• Nexplanon Healthcare Provider REMS Flashcard