Full Prescribing Information

Full Prescribing Information

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WITH THIS RING…

it’s easy to start your patients

Successfully starting patients on ANNOVERA1

Women who have not used a hormonal contraceptive in the preceding cycle or after copper IUD removal

  • Insert ANNOVERA between days 2 and 5 of their 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, women should use an additional barrier method for the first 7 days of ANNOVERA use

Women using a combination hormonal contraceptive (CHC)

  • Women who are not pregnant and are consistently and correctly using a CHC can successfully switch to ANNOVERA on any day of the CHC cycle (Day 1-28) without back-up contraception as long as no more than 7 hormone-free days occur before starting ANNOVERA

Women using a progestin-only contraceptive

  • Women who remain on schedule with their current birth control and have no contraindication to ethinyl estradiol can successfully switch to ANNOVERA from:

Pills: at the time of their next pill
Injection: at the time of their next scheduled injection
Implant or an IUD: at the time of their implant or IUS removal

  • After switching from a progestin-only method, an additional barrier method should be used for initial 7 days of ANNOVERA use

Starting your Patients on ANNOVERA Guide

With this ring…

is an easy option for your patients to use1

step 1:

clean the ring

First, wash and dry your hands then remove ANNOVERA from the package. Wash the ring with mild soap and lukewarm water. Pat it dry with a clean cloth, towel or paper towel. At the beginning of each cycle, ANNOVERA should be washed and dried this way, before insertion.

step 2:

prepare to insert

Using your thumb and index finger, as shown here, squeeze the ANNOVERA ring into a narrow, oval shape.

step 3:

GET COMFORTABLE

Choose a comfortable position. The ANNOVERA ring can be inserted while lying down, squatting or standing with 1 leg raised on the toilet, bathtub, bed, etc.

step 4:

INSERTING ANNOVERA

The ANNOVERA ring should be inserted as far as possible into the vagina, and should not be felt. If the ring feels uncomfortable, it may not have been inserted far enough. ANNOVERA does not need to be in an exact position to work. It’s not possible for ANNOVERA to be pushed up too far in the vagina or for it to get lost.

NOTE: Be sure to record the date of insertion.

step 5:

ENSURE ANNOVERA IS IN PLACE

Once in place, ANNOVERA sits in the vagina without obstructing the vaginal canal.

Illustrated diagram showing how to insert ANNOVERA into the vagina.

step 6:

REMOVING ANNOVERA

Wash and dry your hands and assume a comfortable position like you did in step 3. Then reach into your vagina, hook the ring with your index finger as shown here, and pull downward and forward to remove it. Wash the ring with mild soap and lukewarm water and pat it dry  with a clean paper towel or cloth, and store it in the case provided. Store ANNOVERA away from children, pets and extreme temperatures.

NOTE: Be sure to record the date of removal.

With this ring…

is an easy option for your patients to use1

Illustrated diagram of woman cleaning an ANNOVERA ring in a bathroom sink.

step 1:

clean the ring

First, wash and dry your hands then remove ANNOVERA from the package. Wash the ring with mild soap and lukewarm water. Pat it dry with a clean cloth, towel or paper towel. At the beginning of each cycle, ANNOVERA should be washed and dried this way, before insertion.

Illustrated diagram of hand squeezing an ANNOVERA birth control ring, preparing to insert.

step 2:

prepare to insert

Using your thumb and index finger, as shown here, squeeze the ANNOVERA ring into a narrow, oval shape.

Illustrated diagram of a woman laying down getting comfortable to insert an ANNOVERA ring.

step 3:

GET COMFORTABLE

Choose a comfortable position. The ANNOVERA ring can be inserted while lying down, squatting or standing with 1 leg raised on the toilet, bathtub, bed, etc.

Illustrated diagram showing how to remove ANNOVERA from the vagina.

step 4:

inserting annovera

The ANNOVERA ring should be inserted as far as possible into the vagina, and should not be felt. If the ring feels uncomfortable, it may not have been inserted far enough. ANNOVERA does not need to be in an exact position to work. It’s not possible for ANNOVERA to be pushed up too far in the vagina or for it to get lost.

NOTE: Be sure to record the date of insertion. You can also download our ANNOVERA Birth Control Tracker App in the App Store or Google Play.

Illustration of woman standing with legs apart, ensuring her ANNOVERA birth control ring is in place.

step 5:

ENSURE ANNOVERA IS IN PLACE

Once in place, ANNOVERA sits in the vagina without obstructing the vaginal canal.

Illustrated diagram showing how to insert ANNOVERA into the vagina.

step 6:

removing annovera

Wash and dry your hands and assume a comfortable position like you did in step 3. Then reach into your vagina, hook the ring with your index finger as shown here, and pull downward and forward to remove it. Wash the ring with mild soap and lukewarm water and pat it dry  with a clean paper towel or cloth, and store it in the case provided. Store ANNOVERA away from children, pets and extreme temperatures.

NOTE: Be sure to record the date of removal.

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© 2025 Mayne Pharma Commercial LLC. All rights reserved. MAYNE PHARMA and the MAYNE PHARMA logo are registered trademarks of Mayne Pharma International Pty Ltd. ANNOVERA is a registered trademark of The Population Council, Inc. PM-US-ANVA-0123

IMPORTANT SAFETY INFORMATION

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

See full prescribing information for complete boxed warning.

  • Females over 35 years old who smoke should not use ANNOVERA.
  • Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.

CONTRAINDICATIONS

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) 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.

WARNINGS AND PRECAUTIONS

  • Stop ANNOVERA if a thrombotic or thromboembolic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Start ANNOVERA no earlier than 4 weeks after delivery, in females who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years.
  • Discontinue if jaundice occurs.
  • Stop ANNOVERA prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir. ANNOVERA can be restarted 2 weeks following completion of this regimen.
  • Do not prescribe ANNOVERA for females with uncontrolled hypertension or hypertension with vascular disease. Monitor blood pressure and stop use if blood pressure rises significantly in females with well-controlled hypertension.
  • Monitor glucose in pre-diabetic or diabetic females taking ANNOVERA. Consider an alternate contraceptive method for females with uncontrolled dyslipidemias.
  • Patients using ANNOVERA who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated. ANNOVERA should be discontinued if indicated.
  • Other warnings include: gallbladder disease; depression; cervical cancer; increased serum concentrations of binding globulins; hereditary angioedema; chloasma (females who tend to develop chloasma should avoid exposure to the sun or UV radiation while using ANNOVERA); toxic shock syndrome (TSS) (if a patient exhibits symptoms of TSS, remove ANNOVERA, and initiate appropriate medical treatment); vaginal use (ANNOVERA may not be suitable for females with conditions that make the vagina more susceptible to vaginal irritation or ulceration).

adverse reactions

The most common adverse reactions reported in at least 5% of women who received ANNOVERA were: headache/migraine, nausea/vomiting, vulvovaginal mycotic infection/candidiasis, lower/upper abdominal pain, dysmenorrhea, vaginal discharge, urinary tract infection, breast pain/tenderness/discomfort, bleeding irregularities including metrorrhagia, diarrhea, and genital pruritus.

drug interactions

Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of ANNOVERA or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with ANNOVERA.

indication

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) is a progestin/estrogen combination hormonal contraceptive indicated for use by females of reproductive potential to prevent pregnancy.

Limitations of Use: ANNOVERA has not been adequately studied in females with a body mass index >29 kg/m2.

Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING.

References:

  1. Annovera® [Full Prescribing Information]. Raleigh, NC: Mayne Pharma, Inc; 2023. Accessed 2025.