ANNOVERA®
Is Annual,
Comfortable,
Controllable

Inserted for 21 continuous days and removed 7 days for 13 cycles

Learn Why Patients
Love ANNOVERA

Proven patient satisfaction1–

~90% of women in a clinical trial were satisfied with ANNOVERA as a form of contraception, the majority of whom had no prior experience with vaginal rings.*

Women rated ANNOVERA highly for:1

  • Ease of use
  • Comfort while inserted
  • Experience during sexual activity
  • Low rate of expulsions†

*In an ANNOVERA Phase 3 study, a product acceptability questionnaire was administered and completed at the end of Cycle 3 (n=1036). Results based on data from 905 subjects in the areas of ease-of-use, expulsion, side effects, and sex/intercourse.

†In clinical trials with 2308 women, the rate of expulsion was 25%. Expulsion occurred primarily in the first few weeks as women were getting used to the product, and resulted in 1.4% discontinuation.

Designed with
HER in mind

  • Fertility and menstruation control for a full year‡
  • Soft and flexible for easy insertion and removal
  • No wider than a tampon during insertion2

‡Inserted for 21 continuous days and removed 7 days for 13 cycles.

Purposeful Design

Composed of a soft, pliable, silicone elastomer, ANNOVERA’s shape, size, and texture were designed for easy insertion
and comfortable use.

 

Is ANNOVERA Right
For Your Patients?

With just one prescription, ANNOVERA puts HER in control for a full year‡ and may be appropriate for women who:

  • Want a long-term option with no procedure
  • Are between pregnancies – don’t want the lack of flexibility of an IUD, and tired of a daily pill
  • Are always on the go and want annual birth control without monthly refills
  • Are not interested in future pregnancies and want long-lasting contraception that they control

Empower Her To
Start ANNOVERA
With Confidence

Help her get started on ANNOVERA with
Patient Education Tools.

ANNOVERA Instructions For Use ANNOVERA Anatomical Model Flashcard

Successfully starting patients on ANNOVERA3

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
HOW TO PRESCRIBE ANNOVERA guide ANNOVERA Savings & Support

References:

  1. Merkatz RB, Plagianos M, Hoskin E, et al. Acceptability of the Nestorone®/ ethinyl estradiol contraceptive vaginal ring: development of a model; implications for introduction. Contraception. 2014;90(5):514–521. doi:10.1016/j.contraception.2014.05.015.
  2. Carlin EP, Spielmann HM, inventors; The Proctor & Gamble Company, assignee. Tampon. US Patent 7,338,483 B2. March 4, 2008.
  3. Annovera® [Full Prescribing Information]. Boca Raton, FL: Mayne Pharma, Inc; 2022.

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.



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