|—Annovera（醋酸庚酯和乙炔雌二醇[segesterone acetate and ethinyl estradiol vaginal system]）阴道系统-为全球第一种也是唯一一种避孕新药|
2018年8月10日，美国食品和药物管理局（FDA）批准Annovera（醋酸硒醋酸酯和乙炔雌二醇[segesterone acetate and ethinyl estradiol vaginal system]）阴道系统，这是第一种也是唯一一种在完全受女性控制的情况下提供全年保护以防止意外怀孕的避孕药。该批准是给扩大妇女避孕新选择。
Annovera(segesterone acetate and ethinyl estradiol vaginal system)
ANNOVERA™ is indicated for use by females of reproductive potential to prevent pregnancy.
Limitation Of Use
ANNOVERA™ has not been adequately studied in females with a BMI >29 kg/m2.
Dosage Forms And Strengths
Vaginal system: Each ANNOVERA™ releases an approximate average 0.15 mg/day of segesterone acetate (SA) and 0.013 mg/day of ethinyl estradiol (EE) when placed in the vagina over a period of 21 days of each cycle for up to 13 cycles (total of 273 days). Each cycle of use is 28 days with 21 days in and 7 days out.
ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) is a toroidal-shaped (ring), nonbiodegradable, flexible, opaque white, contraceptive vaginal system containing 103 mg of SA and 17.4 mg EE.
ANNOVERA™ is 56 mm in overall diameter and 8.4 mm in cross-sectional diameter. It contains 2 channels of approximately 3.0 mm diameter and 27 mm length into which steroid-containing cores are inserted. The cores are 3 mm in diameter with one releasing SA alone and the other releasing both SA and EE.
Each ANNOVERA™ is designed to be used for up to 13 cycles (1 year).
ANNOVERA™ is not made with natural rubber latex.
Storage And Handling
ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) is a toroidal-shaped (ring), nonbiodegradable, flexible, opaque white vaginal system. The vaginal system body has an overall diameter of 56 mm and a cross-sectional diameter of 8.4 mm. When placed inside the vagina, each ANNOVERA™ releases an approximate average 0.15mg/day of segesterone acetate and 0.013 mg/day of ethinyl estradiol over 21-day in-use period of each cycle for up to 13 cycles (total 273 days). Each cycle is 28 days, with 21 days in and 7 days out.
Each ANNOVERA™ is individually packaged in an aluminum pouch. The pouch consists of a laminate from outside to inside of polyester, aluminum foil, and polyethylene.
A black compact case is provided with the drug product for storage of ANNOVERA™ by patients during each 7-day vaginal system-out interval.
The vaginal system should be placed in the compact case after 13 cycles of use and discarded via a drug take-back option if one is available. If a take-back option is unavailable, then discard in the waste receptacle out of reach of children and pets. The vaginal system should NOT be flushed down the toilet. See www.fda.gov/drugdisposal for more information about disposal of medicines.
Each box contains 1 pouch. NDC 72468-313-01
Prior to dispensing ANNOVERA™ to the user, store ANNOVERA™ at 25 °C (77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature].
Protect ANNOVERA™ from direct sunlight.
Do not refrigerate or freeze, and avoid excessive heat.
Manufactured for: Population Council One Dag Hammarskjold Plaza New York, NY 10017 United States. Revised: Aug 2018
There have been no reports of serious ill effects from overdose of CHCs. Overdosage may cause withdrawal bleeding in females and nausea. In case of suspected overdose, all ANNOVERA™ vaginal systems should be removed and symptomatic treatment given.
(segesterone acetate and ethinyl estradiol vaginal system)
Read this Patient Information carefully before you decide if Annovera™ is right for you. This information does not take the place of talking with your gynecologist or other health-care provider who specializes in women’s health. If you have any questions about Annovera™, ask your health-care provider. You should also learn about other birth control methods to choose the one that is best for you.
What is the most important information I should know about Annovera™?
Do not use Annovera™ if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious heart and blood vessel (cardiovascular) side effects from hormonal birth control methods, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.
Annovera™does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
What is Annovera™?
Annovera™ is a hormone-releasing system used by females who are able to become pregnant to prevent pregnancy. You insert Annovera™ into your vagina. Annovera™ is in the shape of a ring that is reusable for 1 year. The vaginal system is made of silicone and contains two female hormones that are slowly released into your vagina and then enter your blood. One hormone is an estrogen called ethinyl estradiol. The other hormone is a progestin called segesterone acetate.
How well does Annovera™ work for contraception?
Your chance of getting pregnant depends on how well you follow the directions for using the vaginal system. The more carefully you follow the directions, the less chance you have of getting pregnant.
Based on the results of two clinical studies that lasted 12 months, about 2 to 4 women out of 100 women may get pregnant during the first year they use Annovera™. Annovera™ was designed to be reused for 1 year. Replace Annovera™ at the end of 1 year if you choose to continue using Annovera™. There is not enough hormone left in the vaginal system to provide you effective birth control after 1 year of use.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in how well they work to prevent pregnancy. The most effective methods are at the top of the chart. The box at the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
简介： Annovera（醋酸庚酯和乙炔雌二醇[segesterone acetate and ethinyl estradiol vaginal system]）阴道系统-为全球第一种也是唯一一种避孕新药2018年8月10日，美国食品和药物管理局（FDA）批准Annovera（醋 ...