Use

ANNOVERA is a hormone-releasing system used by females who are able to become pregnant to prevent pregnancy. You insert ANNOVERA into your vagina. ANNOVERA is in the shape of a ring that is reusable for 1 year. The vaginal system is made of silicone and contains two female hormones that are slowly released into your vagina and then enter your blood. One hormone is an estrogen called ethinyl estradiol. The other hormone is a progestin called segesterone acetate.


ANNOVERA has not been adequately studied in moderately obese females. Ask your doctor if ANNOVERA is appropriate for you.

Important Risk Information

What is the most important information you should know about ANNOVERA?

Do not use ANNOVERA if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious heart and blood vessel (cardiovascular) side effects from hormonal birth control methods, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.

Do not use ANNOVERA if you:

  • smoke and are over 35 years old.
  • have or have had a blood clot in your arms, legs, lungs, or eyes.
  • have had a stroke.
  • have reduced blood flow to your brain (cerebrovascular disease).
  • have reduced blood flow or blockage in 1 or more of the arteries that supply blood to your heart (coronary artery disease).
  • have had a heart attack.
  • have heart rhythm or heart valve problems that increase your risk of having blood clots, such as an infection of the inner lining of the heart and heart valves or a type of irregular heartbeat called atrial fibrillation.
  • have a problem with your blood that makes it clot more than normal.
  • have high blood pressure that is not controlled with medicine or have high blood pressure with blood vessel damage.
  • have diabetes and are over 35 years old; have diabetes with high blood pressure or problems with your kidneys, blood vessels, eyes, or nerves; or have had diabetes for longer than 20 years.
  • have headaches with changes in vision, numbness or weakness, have migraine headaches with aura, or are over age 35 years old and have any type of migraine headaches.
  • have liver disease or liver tumors.
  • have or have had breast cancer or any cancer that is sensitive to the female hormones estrogen or progesterone.
  • have unexplained vaginal bleeding.
  • are allergic to segesterone acetate, ethinyl estradiol, or any of the ingredients in ANNOVERA.
  • take any Hepatitis C drug combination medicine containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme alanine aminotransferase (ALT) in the blood.

Warnings

ANNOVERA can cause serious side effects, including:

  • blood clots. Like pregnancy, hormonal contraceptives increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35.
    Or get emergency medical care right away if you have:
    • leg pain that does not go away
    • sudden shortness of breath
    • sudden changes in vision or blindness
    • severe pain or pressure in your chest
    • a sudden, severe headache unlike your usual headaches
    • weakness or numbness in an arm or leg
    • trouble speaking
  • toxic shock syndrome (TSS). Call your healthcare provider or get emergency medical care right away if you have the following symptoms:
    • sudden high fever
    • vomiting
    • diarrhea
    • fainting or feeling faint when standing up
    • a sunburn-like rash
    • muscle aches
    • dizziness
  • liver problems, including liver tumors. Tell your healthcare provider right away if you have yellowing of your skin or eyes (jaundice).
  • high blood pressure.
  • gallbladder problems or worsening of a gallbladder problem you already have. You may have an increased risk of gallbladder problems with the use of ANNOVERA if you had gallbladder problems when you were pregnant.
  • changes in the sugar and fat (cholesterol and triglycerides) levels in your blood.
  • headache. Tell your healthcare provider if you have new headaches that keep coming back, that do not go away, or are severe. Also tell your healthcare provider if your migraine headaches happen more often or are more severe than normal.
  • irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first month of using ANNOVERA, or the absence of menstrual periods (amenorrhea).
  • depression.
  • possible cancer in your cervix.
  • swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider or get emergency medical care right away if you have a swollen face, lips, mouth, tongue, or throat as this may lead to difficulty swallowing or breathing. Your risk of having angioedema is higher if you have a history of angioedema.
  • dark patches of skin on your forehead, cheeks, upper lip, and chin (chloasma). Your risk of getting chloasma with the use of ANNOVERA is higher if you had chloasma during pregnancy. Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sunlamps while using ANNOVERA. Use sunscreen if you have to be in the sunlight.

When using ANNOVERA you may have


  • headache, including migraine
  • nausea/vomiting
  • vaginal yeast infection (candidiasis)
  • lower/upper abdomen pain
  • vaginal discharge
  • painful periods
  • urinary tract infection
  • breast pain/tenderness
  • irregular vaginal bleeding
  • diarrhea
  • genital itching


The risk information provided here is not complete. To learn more, review the ANNOVERA Patient Information and talk about ANNOVERA with your healthcare provider or pharmacist. The FDA-approved product labeling, including Patient Information, can be found at www.ANNOVERA.com.



You may report side effects to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088. You may also report side effects to TherapeuticsMD®, Inc. at 1-888-228-0150

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