Discover ANNOVERA®

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Annovera®
Meets The Needs
Of Today’s Women

With just 1 prescription and 1 trip to the
pharmacy, ANNOVERA
may be appropriate for women who1:

  • Want a long-term option with no procedure
  • Struggle with daily pill reminders
  • Are always on the go
  • Are between pregnancies and want the option to return to fertility without a procedure
  • Travel frequently and don’t have easy access to a pharmacy
  • Are looking for a low-dose option
  • Are approaching menopause and still want contraception

Simple insertion and removal1

Inserting the ring: With clean hands, the patient can choose a comfortable position and press the sides of the ring together for insertion into the vagina. When properly inserted, the ring should be entirely in the vagina and behind the pelvic bone. The date and time of insertion should be noted so that the ring can be removed 21 days later at about the same time.

Removing the ring: ANNOVERA can be removed by hooking the index finger on the ring inside the vagina and gently pulling it out. The patient should clean the ring with mild soap and water and then pat dry with a clean towel. It can be stored in the case provided between uses.

Successfully starting patients on ANNOVERA1

Women not currently using birth control or after copper IUD removal

Women should 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, such as a male condom or spermicide, for the first 7 days of ANNOVERA use.

Women switching from 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 switching from a progestin-only* contraceptive

Women that remain on schedule with their current birth control and have no contraindication to ethinyl estradiol can successfully switch to ANNOVERA from:

Progestin-only pills:

at the time of their next pill

Injection:

at the time of their next scheduled injection

Implant or an IUS:

at the time of their implant or IUS removal

In all cases, an additional barrier method such as a condom or spermicide should be used during coitus for the first 7 days of ANNOVERA use.

*Progestin-only pills (POP), progestin injection, progestin implant, progestin intrauterine system (IUS).

Reference:

  • 1. Annovera® [Full Prescribing Information]. Boca Raton, FL: TherapeuticsMD, Inc; 2020

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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