FDA approved Annovera (segesterone acetate/ethinyl estradiol) for Pregnancy PreventionFDA approved Annovera, a Reusable Vaginal Ring for Birth Control

Annovera is a progestin/estrogen combined hormonal contraceptive (CHC). The label does not describe the mechanism of action in detail. Not reported in label.

Annovera is indicated for use by females of reproductive potential to prevent pregnancy. Limitation of use: Annovera has not been adequately evaluated in females with a body mass index (BMI) greater than 29 kg/m2.

One Annovera vaginal system is inserted in the vagina and must remain in place continuously for 3 weeks (21 days), followed by a 1-week (7-day) vaginal system-free interval. One vaginal system provides contraception for thirteen 28-day cycles (1 year). The system is cleaned with mild soap and warm water, patted dry, and stored in its case during the dose-free interval. It is cleaned again before reinsertion. Insertion can be done lying down, squatting, or standing; the system should be entirely in the vagina and behind the pelvic bone. The day and time of insertion should be noted for removal 3 weeks later. Starting: if no hormonal contraceptive was used in the preceding cycle, insert between days 2 and 5 of menstrual bleeding; no back-up needed. If cycles are irregular or start is more than 5 days from last bleeding, use a barrier method for the first 7 days. Switching from a CHC: may start on any day of the CHC cycle without back-up, but no more than 7 hormone-free days should occur before starting. Switching from progestin-only methods: start at the time of the next POP pill, next scheduled injection, or implant/IUS removal, with a barrier method for the first 7 days. After first-trimester abortion or miscarriage: may start within 5 days without back-up; if more than 5 days, follow instructions for no prior hormonal use and use a barrier method from the event to initiation. Do not start earlier than 4 weeks after a second-trimester abortion or miscarriage. Postpartum: do not start sooner than 4 weeks, and only in females who choose not to breastfeed; use a barrier method for the first 7 days if no period has occurred. Breastfeeding females should not use until after weaning. Deviations: efficacy may be reduced if the system is out for less than 7 days (no increased risk) or other deviations.

Trial data not available in label.

The label references contraindications (section 4) and warnings and precautions (section 5.1) regarding thromboembolism risk, particularly in the postpartum period and after second-trimester abortion or miscarriage. Specific contraindications and warnings are not detailed in the provided label text. Not reported in label.

Annovera provides a reversible, user-controlled, long-acting combined hormonal contraceptive option that requires only annual replacement. It may be suitable for females who prefer a vaginal system and can adhere to the 21-day in, 7-day out schedule. Clinicians should consider the BMI limitation and the need for back-up contraception in certain initiation scenarios.