Dosage & Administration
One ANNOVERA is inserted in the vagina. The vaginal system 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).
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Annovera Prescribing Information
Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs should not be used by females who are over 35 years of age and smoke[See Contraindications and Warnings and Precautions ].
ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy.
Limitations of Use
ANNOVERA has not been adequately studied in females with a BMI >29 kg/m2.
How to Use ANNOVERA
Instruct patients that ANNOVERA should be used as directed [see How to Start ANNOVERA ]. One ANNOVERA should be placed in the vagina. For maximum contraceptive effectiveness, ANNOVERA is to remain in the vagina continuously for 21 days (3 complete weeks). It is removed for a 1-week dose-free interval, and during this time a withdrawal bleed usually occurs. The removed vaginal system should be cleaned with mild soap and warm water, patted dry with a clean cloth towel or paper towel, and placed in its case during the 1-week dose- free interval. At the end of the dose-free interval, the vaginal system should be cleaned prior to being placed back in the vagina for another 21 continuous days (3 complete weeks). This pattern of ANNOVERA use made up of 3-weeks in and 1-week out is a cycle of use; one ANNOVERA vaginal system will provide contraception for 13 cycles.
With clean hands, the user can choose an insertion position that is comfortable, such as lying down, squatting, or standing. The sides of the vaginal system are pressed together for insertion into the vagina. When properly inserted, the vaginal system should be entirely in the vagina and behind the pelvic bone. The day and time of insertion should be noted so that the vaginal system can be removed 3 weeks later on the same day and at about the same time.
ANNOVERA can be removed by hooking an index finger into the vaginal system inside the vagina and gently pulling the vaginal system.
For patient instructions regarding cleaning the vaginal system, see FDA-approved Patient Information.
How to Start ANNOVERA
IMPORTANT: Consider the possibility of ovulation and conception prior to the first use of ANNOVERA.
No Hormonal Contraceptive Use in the Preceding Cycle and after Copper IUD Removal:
The woman should insert ANNOVERA between days 2 and 5 of her regular menstrual bleeding; no back-up contraception is needed. If menstrual cycles are irregular or if the start is more than 5 days from the last menstrual bleeding, the woman should use an additional barrier method during coitus, such as a male condom or spermicide, for the first 7 days of ANNOVERA use.
Switching from a CHC:
A woman who has been using her CHC method consistently and correctly, and who you are reasonably certain is not already pregnant, may switch from her previous CHC to ANNOVERA on any day of the CHC cycle (Day 1-28), without the need for back-up contraception, but no more than 7 hormone-free days should occur before starting ANNOVERA.
Switching from a Progestin-Only Method [Progestin-only pills (POP), Progestin Injection, Progestin Implant, Progestin Intrauterine System (IUS)]:
If a woman has no contraindications to the use of ethinyl estradiol (EE), she may elect to switch from a progestin-only method to ANNOVERA. If switching from progestin-only pills, she should begin ANNOVERA at the time she would have taken her next POP pill. If switching from an injection, she should begin ANNOVERA at the time of her next scheduled injection. If switching from an implant or an IUS, she should begin ANNOVERA at the time of implant or IUS removal. In all of these cases, the woman should use an additional barrier method during coitus, such as a male condom or spermicide, for the first 7 days of ANNOVERA use.
Use after Abortion or Miscarriage:
If a woman has no contraindications to the use of EE, ANNOVERA may be initiated for contraception within the first 5 days following a complete first trimester abortion or miscarriage without additional back-up contraception. If more than 5 days have elapsed from the first trimester abortion or miscarriage, then follow the instructions for “No Hormonal Contraceptive Use in the Preceding Cycle” and a barrier method should be used from the time of the first trimester abortion or miscarriage to the initiation of ANNOVERA.
ANNOVERA should not be started earlier than 4 weeks after a second trimester abortion or miscarriage due to the increased risk of thromboembolism [see Contraindications and Warnings and Precautions ].
Following Childbirth:
ANNOVERA should not be started sooner than 4 weeks postpartum and only in females who choose not to breastfeed. Prior to 4 weeks postpartum there is an increased risk of thromboembolism [see Contraindications and Warnings and Precautions ].
The initiation of ANNOVERA 4 weeks or more postpartum should be accompanied by an additional method of contraception during coitus, such as male condoms or spermicide, for the first 7 days if the woman has not yet had a period. Consider the possibility of ovulation and conception occurring prior to initiating ANNOVERA.
Females who are breastfeeding should not use ANNOVERA until after weaning.
Deviations from the Recommended Regimen
Contraceptive efficacy of ANNOVERA may be reduced if a woman deviates from the recommended use. ANNOVERA should remain in the vagina for a continuous period of 21 days (3 weeks); then ANNOVERA should be taken out of the vagina for 7 days. In a 28-day cycle, a deviation that involves ANNOVERA being out of the vagina for less than 7 days will not increase pregnancy risk. In a 28-day cycle, a deviation that involves ANNOVERA being out of the vagina for more than 7 days will increase pregnancy risk and back-up contraception is recommended in these instances. Deviations from the recommended regimen may result in a new vaginal system change day [See FDA-approved Patient Information].
Inadvertent Removal or Expulsion
ANNOVERA can be accidently expelled. Accidental expulsion could occur while removing a tampon, during coitus, or with straining during a bowel movement. If the vaginal system is accidentally expelled once during the 21 days of intravaginal use and is replaced within 2 hours, contraceptive efficacy should not be reduced and no back-up contraception is needed. If the vaginal system is accidently expelled, wash it with mild soap and warm water, rinse and pat dry with a clean cloth towel or paper towel, and replace it as soon as possible.
During the 21 days of continuous use, if ANNOVERA is out of the vagina for more than 2 continuous hours or more than 2 cumulative hours (multiple inadvertent removals or expulsions adding up to 2 hours), then back-up contraception, such as male condoms or spermicide, should be used until the vaginal system has been in the vagina for 7 consecutive days. The use of combined hormonal contraceptives (those containing an estrogen) for emergency contraception during use of ANNOVERA is not recommended.
Prolonged Vaginal System Free Interval
If the vaginal system free interval is prolonged, consider the possibility of pregnancy and have the woman use back-up contraception, such as male condoms or spermicide, during coitus until the vaginal system has been in the vagina for 7 consecutive days. The use of combined hormonal contraceptives (those containing an estrogen) for emergency contraception during use of ANNOVERA is not recommended.
Prolonged Use of ANNOVERA
If ANNOVERA is left in the vagina for more than 21 days, it should be removed for 7 days and then reinserted for 21 days to resume a 21/7 schedule.
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.
Pregnancy
Risk Summary
Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
Discontinue ANNOVERA if pregnancy occurs, because there is no reason to use CHCs during pregnancy.
Data
Human Data
No studies have been conducted of the use of ANNOVERA in pregnant females.
Lactation
Risk Summary
Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well established. Advise the nursing female to use another method of contraception until she discontinues breastfeeding [see Dosage and Administration ].
Data
Human Data
No studies have been conducted of the use of ANNOVERA in breastfeeding females. Two studies have been conducted in breastfeeding females of segesterone acetate implants delivering lower levels of segesterone acetate than ANNOVERA. Maternal serum levels of up to 141 pg/mL were associated with infant exposure of up to 7 pg/mL. No safety signals in feeding, growth, and development were observed in the infants between the segesterone acetate implant group and the control group.
Pediatric Use
Safety and efficacy of ANNOVERA have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of ANNOVERA before menarche is not indicated.
Geriatric Use
ANNOVERA has not been studied in females who have reached menopause and is not indicated in this population.
Hepatic Impairment
No studies have been conducted to evaluate the effect of hepatic impairment on the disposition of ANNOVERA. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of CHC use until markers of liver function return to normal and CHC causation has been excluded [see Contraindications and Warnings and Precautions ].
Renal Impairment
No studies were conducted in subjects with renal impairment; ANNOVERA is not recommended in patients with renal impairment.
Body Mass Index (BMI)/Body Weight
The safety and efficacy of ANNOVERA in females with a BMI >29 kg/m2 have not been adequately evaluated because this subpopulation was excluded from the clinical trials after 2 VTEs occurred in females with a BMI > 29 kg/m2[see Adverse Reactions and Clinical Studies ]. Higher body weight is associated with lower systemic exposure of SA and EE [see Clinical Pharmacology ].
ANNOVERA is contraindicated in females who are known to have or develop the following conditions:
- A high risk of arterial or venous thrombotic diseases. Examples include females who are known to:
-Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ].
-Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions ].
-Have cerebrovascular disease [see Warnings and Precautions ].
-Have coronary artery disease [see Warnings and Precautions ].
-Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular
disease, or atrial fibrillation) [see Warnings and Precautions ].
-Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ].
-Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions ].
-Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease, or other end-organ damage, or diabetes
mellitus of >20 years duration [see Warnings and Precautions , ].
-Have headaches with focal neurological symptoms, migraine headaches with aura, or are over age 35 with any migraine headaches [see
Warnings and Precautions ].
- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions ].
- Liver tumors, acute hepatitis, or severe (decompensated) cirrhosis [see Warnings and Precautions and Use in Specific Populations ].
- Undiagnosed abnormal uterine bleeding [see Warnings and Precautions ].
- Hypersensitivity to any of the components of ANNOVERA. Hypersensitivity reactions reported include: throat constriction, facial edema, urticaria, hives, and wheezing [see Adverse Reactions ].
- Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine transaminase (ALT) elevations [see Warnings and Precautions ].