Innovative
Delivery And
Unique Hormone
Profile

97.3% Effective

ANNOVERA® is designed to continuously release a novel combination of hormones for 1 year. ANNOVERA is inserted
for 21 continuous days and removed 7 days for 13 cycles1

segesterone acetate1
~150 mcg daily

ethinyl estradiol1
~13 mcg daily

 

Segesterone Acetate
A Novel Progestin That Is:

Derived from progesterone2,3

Not derived from testosterone2,3

No androgenic activity. Androgenic activity can be responsible for changes in weight and acne2-5

Of the highest anti-ovulatory potential2,3

Demonstrated
Tolerability

No Clinically Meaningful
Changes in Weight3

No Increased Risk in Vaginitis6*

In a sub-study of 110 women

ANNOVERA showed no increase in vaginitis, bacterial vaginosis, or yeast infections, and no changes in the vaginal flora after 13 cycles of use

Predictable Scheduled Bleeding7

In clinical trials of 2070 women:

98% of women had scheduled bleeding when used cyclically, with amenorrhea occurring in 2.6% to 4.9% of women per cycle

The mean number of bleeding-only days averaged 3.3 days

In clinical trials of 2308 women: 5-10% of females experienced unscheduled bleeding and/or spotting for ~1 day or less per 28-day cycle; 1.7% discontinued use due to irregular bleeding

Most Common
Adverse Reactions1

The safety of ANNOVERA® was demonstrated in 3 open-label, 13-cycle clinical trials that enrolled 2308 women.

The following adverse events include any episode occurring in ≥5% of patients in the course of the 1-year study:

  • Headache, including migraine
  • Nausea/vomiting
  • Vaginal infections
  • Abdominal pain
  • Dysmenorrhea
  • Vaginal discharge
  • UTI
  • Breast pain/tenderness/discomfort
  • Metrorrhagia
  • Diarrhea
  • Genital pruritus

Adverse reactions leading to discontinuation by greater than or equal to 1% of ANNOVERA treated subjects:

  • Metrorrhagia/menorrhagia (1.7%)
  • Headache, including migraine (1.3%)
  • Vaginal discharge/vulvovaginal infections (1.3%)
  • Nausea/vomiting (1.2%)
Contact Medical Affairs Explore the ANNOVERA
Patient Experience

References:

  1. Annovera® [Full Prescribing Information]. Boca Raton, FL: TherapeuticsMD, Inc; 2020.
  2. Kumar N, Koide SS, Tsong YY, Sundaram K. Nestorone: a progestin with a unique pharmacological profile. Steroids. 2000; 54;629-636.
  3. Nelson A. Comprehensive overview of the recently FDA-approved contraceptive vaginal ring releasing segesterone acetate and ethinyl estradiol: a new year-long, patient controlled, reversible birth control method. Expert Rev Clin Pharmacol. 2019 Oct;12(10):953-963.
  4. Refn et al. Metabolic changes during treatment with two different progestogens. Am J Obstet Gynecol. 1990;163:374-377.
  5. Darney PD. The androgenicity of progestins. Am J Med. 1995;98(Suppl1A):104S-110S.
  6. Huang Y, Merkatz RB, Hillier SL, Roberts K, Blithe DL, Sitruk-Ware R, et al. (2015) PLOS ONE. 10(8): e0134460. doi:10.1371/journal.pone.0134460.
  7. Vieira CS, Fraser IS, Plagianos MG, et al. Bleeding profile associated with 1-year use of the segesterone acetate/ ethinyl estradiol contraceptive vaginal system: pooled analysis from Phase 3 trials. Contraception. 2019;100(6):438-444. doi: 10.1016/j. contraception.2019.07.145

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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