Discover ANNOVERA

Sign up to receive communications about health conditions, products, market research, and updates from TherapeuticsMD and its affiliated companies, including vitaCareSM Prescription Services.

Thank you for registering!

Proven patient satisfaction and
demonstrated safety & tolerability

Proven patient satisfaction.

Overall, nearly 90% of women in a clinical trial were satisfied with ANNOVERA1*

Ease-of-use:

simple insertion, simple removal, simple cleaning

Comfort:

not felt by most women while wearing

Expulsion:

not expelled while wearing or during sex

Physical effects during sexual activity:

no change in sexual pleasure or frequency

*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, ANNOVERA demonstrated:

  • High rates of adherence (94.3%)1
  • Cycle control with low rates of discontinuation due to irregular bleeding (1.7%)2†
  • No alteration of the vaginal ecosystem or increased occurrence of infections with 13 cycles of use3
  • A low daily release of 150 mcg segesterone acetate and 13 mcg ethinyl estradiol2
Adverse reactions leading to discontinuation by ≥1% Annovera treated subjects: metrorrhagia/menorrhagia 1.7%, headache/migraine 1.3%, vaginal discharge/infections 1.3%, nausea/vomiting 1.2%.

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. Annovera [Full Prescribing Information]. Boca Raton, FL: TherapeuticsMD, Inc; 2019.
  • 3.  Data on file. 300A - Microbiology Sub-Study. Population Council Inc. 2015.

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 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 is a progestin/estrogen combination hormonal contraceptive indicated for use by females of reproductive potential to prevent pregnancy.

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



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

READ FULL
Please Wait