FDA Approves Nexplanon (etonogestrel) for Prevention of Pregnancy for Up to 5 Years

Not reported in label.

Nexplanon is indicated for prevention of pregnancy in women of reproductive potential for up to 5 years.

A single Nexplanon implant is inserted subdermally just under the skin at the inner side of the non-dominant upper arm. The insertion site is overlying the triceps muscle about 8-10 cm from the medial epicondyle of the humerus and 3-5 cm posterior to the sulcus between the biceps and triceps muscles. Insertion must be performed by a healthcare professional trained in the procedure. The implant must be removed by the end of the fifth year. Timing of insertion depends on the woman's recent contraceptive history: for no preceding hormonal contraceptive use in the past month, insert between Day 1 and Day 5 of the menstrual cycle; for switching from combination hormonal contraceptives, insert on the day after the last active tablet or on the day of removal of the vaginal ring or transdermal patch; for progestin-only injectables, insert on the day the next injection is due; for minipill, insert within 24 hours after the last tablet; for contraceptive implant or IUS, insert on the same day the previous device is removed; following first trimester abortion, insert within 5 days; following second trimester abortion, insert between 21 to 28 days; postpartum not breastfeeding, insert between 21 to 28 days; breastfeeding, insert after the fourth postpartum week. Back-up contraception is not necessary if inserted as recommended; otherwise, use a barrier method for 7 days.

Trial data not available in label.

Inserting an implant more deeply than subdermally may preclude palpation and localization, making removal difficult or impossible. Healthcare professionals must receive instruction and training prior to performing insertion and/or removal.

Nexplanon is a long-acting (up to 5 years), reversible, hormonal contraceptive method. It provides an alternative to daily, weekly, or monthly contraceptive methods.