Drug Class: Contraceptives
Usual Adult Dose for Contraception
Insert vaginal system into vagina and allow it to remain in vagina continuously for 21 days, then remove for a 1-week dose-free interval
- Repeat on a 21/7 days in/out schedule
Timing of Initiation:
- For females who have not used hormonal contraceptive in the preceding cycle or after copper IUD removal: Insertion should occur between days 2 and 5 of regular menstrual bleeding and no back-up contraception will be needed; if menstrual cycle is irregular or if more than 5 days from last menstrual bleeding, an additional barrier method is recommended during coitus for the first 7 days (e.g., male condom or spermicide).
- Switch from another CHC (assuming prior CHC has been used consistently): Switch may occur on any day of the CHC cycle without need for back-up contraception; however, no more than 7 hormone-free days should occur before starting on this drug.
- Switch from a progestin-only method: Switch should occur at time of next pill, injection, implant or intrauterine system; in all cases, an additional barrier method is recommended during coitus for the first 7 days (e.g., male condom or spermicide).
- For use after abortion or miscarriage: May begin within the first 5 days following a complete first trimester abortion or miscarriage without back up contraception; if more than 5 days have elapsed, follow instructions for use in females who have not used hormonal contraceptive in the preceding cycle using a barrier method from the time of abortion or miscarriage to initiation of this drug.
- This drug should start no sooner than 4-weeks after a second trimester abortion or miscarriage due to increased risk of thromboembolism.
- This drug should start no sooner than 4-weeks postpartum and only in females who choose not to breastfeed; if started 4 weeks or more postpartum, an additional method of contraception during coitus is recommended if the women has not had a period (e.g., male condom or spermicide).
Comments:
- Prior to starting therapy, consider the possibility of ovulation and conception.
- For maximum effectiveness, the system is to remain in the vagina continuously for 21 days; removed for a 1-week dose-free interval (during which time a withdrawal bleed usually occurs), and cycle is repeated.
- This drug has not been adequately studied in females with a BMI greater than 29 kg/m2.
Use: For use by females of reproductive potential to prevent pregnancy.
Usual Pediatric Dose for Contraception
Insert vaginal system into vagina and allow it to remain in vagina continuously for 21 days, then remove for a 1-week dose-free interval
- Repeat on a 21/7 days in/out schedule
Timing of Initiation:
- For females who have not used hormonal contraceptive in the preceding cycle or after copper IUD removal: Insertion should occur between days 2 and 5 of regular menstrual bleeding and no back-up contraception will be needed; if menstrual cycle is irregular or if more than 5 days from last menstrual bleeding, an additional barrier method is recommended during coitus for the first 7 days (e.g., male condom or spermicide).
- Switch from another CHC (assuming prior CHC has been used consistently): Switch may occur on any day of the CHC cycle without need for back-up contraception; however, no more than 7 hormone-free days should occur before starting on this drug.
- Switch from a progestin-only method: Switch should occur at time of next pill, injection, implant or intrauterine system; in all cases, an additional barrier method is recommended during coitus for the first 7 days (e.g., male condom or spermicide).
- For use after abortion or miscarriage: May begin within the first 5 days following a complete first trimester abortion or miscarriage without back up contraception; if more than 5 days have elapsed, follow instructions for use in females who have not used hormonal contraceptive in the preceding cycle using a barrier method from the time of abortion or miscarriage to initiation of this drug.
- This drug should start no sooner than 4-weeks after a second trimester abortion or miscarriage due to increased risk of thromboembolism.
- This drug should start no sooner than 4-weeks postpartum and only in females who choose not to breastfeed; if started 4 weeks or more postpartum, an additional method of contraception during coitus is recommended if the women has not had a period (e.g., male condom or spermicide).
Comments:
- Prior to starting therapy, consider the possibility of ovulation and conception.
- For maximum effectiveness, the system is to remain in the vagina continuously for 21 days; removed for a 1-week dose-free interval (during which time a withdrawal bleed usually occurs), and cycle is repeated.
- This drug has not been adequately studied in females with a BMI greater than 29 kg/m2.
Use: For use by females of reproductive potential to prevent pregnancy.
Renal Dose Adjustments
Not recommended in renal impairment
Liver Dose Adjustments
Contraindicated in patients with liver tumors, acute hepatitis, or severe (decompensated) cirrhosis
Discontinue use if jaundice develops; investigate acute liver test abnormalities as they may necessitate therapy discontinuation
Dose Adjustments
Use of CHC (those containing estrogen) for emergency contraception is not recommended while using this drug
Deviations from the Recommended Regimen:
- If system is out of vagina for more than 7 days, the risk of pregnancy increases; back-up contraception is recommended
- Deviations from the recommended regimen may result in a new vaginal system change day
Inadvertent Removal or Expulsion:
- Accidental expulsion may occur while removing a tampon, during coitus, or with straining during a bowel movement
- If expelled and replaced within 2 hours, contraceptive efficacy should be maintained
- If expelled and not replaced within 2 hours or if more than 2 cumulative hours in 21-days of continuous use (multiple inadvertent removals or expulsions adding up to 2 hours): Back-up contraception should be used until the vaginal system has been in the vagina for 7 consecutive days
Prolonged Vaginal System Free Interval:
- If the vaginal system free interval is prolonged, consider the possibility of pregnancy; back-up contraception should be used during coitus until the vaginal system has been in the vagina for 7 consecutive days
Prolonged Use of Vaginal System:
- If the vaginal system is in the vagina for more than 21 days, it should be removed for 7 days, then reinserted for 21 days to resume 21/7 days in/out schedule
Concomitant Use with Enzyme Inducers:
- Back-up or alternative method of contraception is recommended when enzyme Inducers are used with CHCs
Precautions
US BOXED WARNINGS: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS:
- Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly those over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs should not be used by females over the age of 35 years who smoke.
CONTRAINDICATIONS:
- Hypersensitivity to the active components or to any of the ingredients
- Smokers over 35 years of age
- Deep vein thrombosis or pulmonary embolism, now or in the past
- Cerebrovascular disease
- Coronary artery disease
- Thrombogenic valvular or thrombogenic rhythm diseases of the heart (e.g., subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
- Inherited or acquired hypercoagulopathy
- Uncontrolled hypertension or hypertension with vascular disease
- Diabetes mellitus and over 35 years of age
- Diabetes mellitus with hypertension, vascular disease, or other end-organ damage
- Diabetes mellitus of over 20 years duration
- Headaches with focal neurological symptoms
- Migraine headaches with aura
- Migraine headaches (any type) and over 35 years of age
- Breast cancer or other estrogen or progestin sensitive cancer, now or in the past
- Liver tumors, acute hepatitis, or severe (decompensated) cirrhosis
- Undiagnosed abnormal uterine bleeding
- Concomitant use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
Safety and efficacy have been established in females of reproductive age including postpubertal adolescents under the age of 18 years
Safety and efficacy have not been established in females who have reached menopause.
Consult WARNINGS section for additional precautions.
Dialysis
Not recommended
Other Comments
Administration advice:
- For vaginal use only
- Vaginal system should remain in the vagina continuously for 21 days then removed for 7 days, this cycle (21/7 days in/out) is repeated every 28 days; each system is designed to be used for 13 cycles (1 year)
- Insertions and removal should be at about the same time of day
- Prior to each insertion, wash vaginal system with mild soap and water, rinse and pat dry
- Hold ring between thumb and index finger; press sides together to make narrow
- Choose a comfortable position for insertion; gently insert the folded ring into vagina; push into vagina using index finger
- Ring should be pushed in as far as possible; it does not need to be in an exact position to work; proper insertion should be entirely in the vagina and behind the pelvic bone
- If the system feels uncomfortable, it may not be in far enough
- To remove, hook index finger into the vaginal system and gently pull
- The manufacturer product labeling may be consulted for further instructions and illustrations
Storage requirements:
- Protect from direct sunlight; do not refrigerate or freeze; avoid excessive heat
General:
- There is no danger of the vaginal system being pushed too far up in the vagina or getting lost.
- After placing system in vagina, the patient should not feel it, however, some women and partners report being aware of it during intercourse.
- This drug is compatible with male condoms made with natural rubber latex, polyisoprene, and polyurethane.
- Oil-based (including silicone-based) vaginal lubricants will alter the vaginal system and/or exposure to ethinyl estradiol and segesterone and should not be used; water based vaginal lubricants have no effect on the vaginal system.
Monitoring:
- Monitor blood pressure during routine visits
- Monitor glucose in pre-diabetic and diabetic patients
- Rule out pregnancy if a scheduled period is missed and/or symptoms of pregnancy are present
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
- Patients should understand that this drug does not protect against HIV infection and other sexually transmitted infections
- Patients should be instructed to speak with their healthcare provider regarding any changes in prescription or over the counter products as other drugs may make this drug less effective.
- Patients should receive proper instructions on use and understand what situations will require use of back-up contraception.
- Patients should be instructed to get emergency medical care if they experience signs or symptoms of blood clots.
- Patients should understand that this product may be used for up to 1 year and then discarded; whenever possible, it is best to discard via a take-back option if one is available, if not, discard in trash; the vaginal system should not be flushed.
Frequently asked questions
- How do you use Annovera for birth control?
