The U.S. Food and Drug Administration has approved Annovera® (segesterone acetate and ethinyl estradiol vaginal system), which is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.
Description
Annovera combines a new progestin (segesterone acetate) with a widely used estrogen (ethinyl estradiol) into a single reusable ring. It is a soft, reusable flexible silicone ring (2¼ inches diameter) that can be inserted and removed by a woman herself. Left in place for 21 days and removed for 7 days, at which time the woman may experience a period (a withdrawal bleed). This schedule is repeated every four weeks for one year (thirteen 28-day menstrual cycles).
Annovera is indicated to prevent pregnancy for up to a year and does not require refrigeration, which is particularly important for distribution and use in low-resource settings. It is washed and stored in a compact case for the seven days not in use; does not require refrigeration prior to dispensing and can withstand storage temperatures up to 30°C (86°F).
Efficacy & safety considerations
The efficacy and safety of Annovera were studied in three, open label clinical trials with healthy women ranging from 18 to 40 years of age. Based on the results, about two to four women out of 100 women may get pregnant during the first year they use Annovera. Annovera has not been adequately evaluated in women with a body mass index (BMI) greater than 29 kg/m²
All hormonal contraception carries serious risks. Similar to other combined hormonal contraceptives, Annovera has a boxed warning regarding cigarette smoking and serious cardiovascular events. Women over 35 who smoke should not use Annovera. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.
Annovera is contraindicated and should not be used in women with:
- A high risk of arterial or venous thrombotic diseases;
- Current or history of breast cancer or other estrogen- or progestin-sensitive cancer;
- Liver tumors, acute hepatitis, or severe (decompensated) cirrhosis;
- Undiagnosed abnormal uterine bleeding;
- Hypersensitivity to any of the components of Annovera; and
- Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
The most common side effects in women using Annovera are similar to those of other combined hormonal contraceptive products and include headache/migraine, nausea/vomiting, yeast infections, abdominal pain, dysmenorrhea (painful menstruation), breast tenderness, irregular bleeding, diarrhea and genital itching.
Full prescribing information available at www.annovera.com/pi.pdf