Discover ANNOVERA®

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Long-Lasting,
Procedure-Free, And
Designed To Empower Women1

Created for her control1

  • As effective as a pill
  • Fertility and menstruation control for 1 year (13 cycles)
  • Inserted for 21 continuous days and removed for 7 days each cycle

Created for her comfort1,2*

  • Soft and flexible for easy insertion and removal
  • Comfortable throughout daily activities including sex

No wider than a tampon
during insertion1,3

*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.

Created with a novel hormonal profile

ANNOVERA was purposefully designed to release a novel combination of hormones for 13 cycles.1

Non-androgenic segesterone acetate1,4

~150 mcg daily for 1 year

  • Has high anti-ovulatory potency
  • Unlike other progestins, segesterone acetate demonstrates no androgenic, estrogenic, or glucocorticoid activity

Low-dose ethinyl
estradiol1

~13 mcg daily for 1 full year

  • One of the lowest-dose estrogen contraceptive products on the market
Based on pharmacological studies in animals and in vitro studies. The clinical significance of these data is not known.

References:

  • 1. Annovera® [Full Prescribing Information]. Boca Raton, FL: TherapeuticsMD, Inc; 2020
  • 2. 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.
  • 3. Carlin EP, Spielmann HM, inventors; The Proctor & Gamble Company, assignee. Tampon. US Patent 7,338,483 B2. March 4, 2008.
  • 4. Kumar N, Koide SS, Tsong YY, Sundaram K. Nestorone®: a progestin with a unique pharmacological profile. Steroids. 2000;65:629–636.

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.


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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