Discover ANNOVERA

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Highly effective,
completely controlled by her.1

Where ANNOVERA fits among birth control options.

Short-acting contraceptives2

(such as daily pills)

Daily dose

No long-acting benefits

 

ANNOVERA

Patient-directed control over fertility and menstruation1

Long-term birth control for 13 cycles1

Procedure-free insertion and removal1

Long-acting contraceptives2

(such as IUDs and implants)

Require a procedure by a healthcare provider for insertion and removal

3-10 years of use3,4

Short-acting contraceptives2

(such as daily pills)

Daily dose

No long-acting benefits

 

ANNOVERA

Patient-directed control over fertility and menstruation1

Long-term birth control for 13 cycles1

Procedure-free insertion and removal1

Long-acting contraceptives2

(such as IUDs and implants)

Require a procedure by a healthcare provider for insertion and removal

3-10 years of use3,4

ANNOVERA gives today's women more of what they want.

Control for the long-term

  • ANNOVERA delivers month-to-month birth control for an entire year (13 cycles)1

    For each cycle, ANNOVERA is inserted for 21 continuous days and then removed for 7 days1
  • Patient-directed insertion and removal provides women with control over their fertility and menstruation1

Convenience

  • 1 prescription provides 1 year (13 cycles) of birth control, eliminating the hassle of monthly pharmacy visits1
  • Reversible by the patient at any time with no healthcare visit for a procedure required1
  • Easy to maintain and does not require refrigeration1

Comfort*

  • Soft and flexible for easy insertion and removal1,5
  • Not felt by most women while wearing5
  • Entirely procedure free1
  • No change in sexual pleasure or frequency5
*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.

The ANNOVERA ring

The soft, flexible ring delivers a sustained daily release of hormones vaginally, bypassing the first-pass metabolism1:

150 mcg/
day
of segesterone acetate1

Segesterone acetate is a novel progestin that does not bind to androgen or estrogen receptors, and has no glucocorticoid effects at contraceptive doses.

13 mcg/
day
of ethinyl estradiol1

ANNOVERA is one of the lowest dose estrogen products on the market.

Based on pharmacological studies in animals and in vitro studies. The clinical significance of these data is not known.6

References:

  • 1. Annovera [Full Prescribing Information]. Boca Raton, FL: TherapeuticsMD, Inc; 2019.
  • 2. Tibaijuka L, Odongo R, Welikhe E, et al. Factors influencing use of long-acting versus short acting contraceptive methods among reproductive-age women in a resource-limited setting. BMC Women’s Health. 2017;17(1):25. doi:10.1186/s12905-017-0382-2.
  • 3. Skyla® [Full Prescribing Information] Whippany, NJ. Bayer, 2018.
  • 4. Mirena® [Full Prescribing Information] Whippany, NJ. Bayer. 2018.
  • 5. 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.
  • 6. 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.

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.

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