Annovera Vaginal Ring

Generic name: ethinyl estradiol and segesterone (vaginal ring) (ETH in il es tra DYE ole and se JES ter one)
Brand name: Annovera
Drug class: Contraceptives

Annovera Vaginal Rings are made of silicone and contains two female hormones that are slowly released into your vagina and then enter your blood. The vaginal ring contains a combination of segesterone acetate and ethinyl estradiol.

Annovera is used by females as contraception to prevent pregnancy.

One Annovera vaginal ring may be reused for up to 1 year.

Warnings

You should not use Annovera if you have: uncontrolled high blood pressure, heart problems, coronary artery disease, reduced blood flow to your brain, long-term diabetes (or health problems caused by diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

You should not use Annovera if you smoke and are older than 35 years of age.

Do not use the Annovera vaginal ring if you are pregnant or if you have recently had a baby.

Before taking this medicine

You should not use Annovera if you are allergic to ethinyl estradiol or segesterone, or if you have:

  • uncontrolled high blood pressure (especially if you also have blood vessel damage);
  • heart problems (coronary artery disease, heart rhythm disorder, a heart valve disorder, history of heart attack, stroke, or blood clot);
  • reduced blood flow to your brain;
  • an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
  • diabetes (and you are over 35 years old, or have had diabetes longer than 20 years);
  • a diabetes-related health problem (vision problems, kidney problems, nerve damage, circulation problems);
  • a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
  • unusual vaginal bleeding that has not been checked by a doctor;
  • migraines or severe headaches with vision changes;
  • liver disease or liver cancer; or
  • if you have taken any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir in the past 2 weeks.

You should not use Annovera if you smoke and are older than 35 years of age. Using this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you smoke.

To make sure Annovera is safe for you, tell your doctor if you have ever had:

  • heart disease, high blood pressure, or if you are prone to having blood clots;
  • high cholesterol or triglycerides (a type of fat in the blood);
  • liver disease or jaundice (yellowing of your skin or eyes);
  • kidney disease;
  • diabetes, gallbladder disease;
  • depression, migraine headaches, or a seizure;
  • toxic shock syndrome, or easy vaginal irritation;
  • a family history of stroke or breast cancer;
  • a breast lump, fibrocystic breast disease, or an abnormal mammogram; or
  • if you have recently had a miscarriage or abortion.

Do not use a Annovera vaginal ring if you are pregnant, or if you had a baby within the past 4 weeks. Call your doctor if you miss a period or think you may be pregnant.

You should not breastfeed while using Annovera.

Annovera is not approved for any woman who has not yet had a menstrual period, or a woman no longer having periods.

How should I use Annovera?

Use Annovera exactly as directed by your health care professional. Follow all directions on your prescription label and read all medication guides or instruction sheets.

The Annovera vaginal ring will not prevent pregnancy if you wear it only during intercourse. You must wear the ring around-the-clock for 3 full weeks (21 days).

After 21 days, remove the ring and wait 7 full days before inserting the ring again. Try to stay on your schedule of inserting and removing the ring.

Do not leave the Annovera ring out of the vagina for longer than a total of 2 hours during the 21-day wearing time.

If a ring falls out, wash it with mild soap and warm water, pat dry with a clean cloth, and reinsert it.

You may need to use back-up birth control (condoms or spermicide, but not a female condom) for 7 days in a row:

  • if the ring has been out of the vagina for more than a total of 2 hours during the 21-day wearing time;
  • if the Annovera ring has been out of the vagina for longer than 7 days; or
  • if you recently had a baby and have not yet started having periods again.

You may have breakthrough bleeding. Tell your doctor if this bleeding continues for longer than 7 days or is very heavy.

If you need major surgery or will be on long-term bed rest, you may need to stop using Annovera for a short time. Any doctor or surgeon who treats you should know that you are using the Annovera vaginal ring.

Annovera will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom can help protect you from these diseases.

Whenever the ring is out of the vagina, wash the ring with mild soap and warm water, pat dry, and store in the case provided. Store at room temperature. Protect from heat, sunlight, and freezing. Follow the provided instructions for cleaning the Annovera vaginal ring when not in use.

After using a Annovera vaginal ring for 1 year, dispose of the used vaginal ring in the case or pouch it came in and throw it away where children and pets cannot get to it. Do not flush the ring down a toilet.

Detailed Ethinyl estradiol/segesterone dosage information

What happens if I miss a dose?

Call your doctor if you get off schedule, or if you have trouble removing a vaginal ring.

What happens if I overdose?

An overdose of Annovera is not expected to be dangerous, but may cause nausea or vaginal bleeding.

What should I avoid while using Annovera?

Avoid leaving the ring in place for longer than 3 weeks.

Do not use an oil-based vaginal product, such as a cream, gel, a suppository. You may use a water-based vaginal lubricant but not one that contains oil or silicone.

Annovera may cause dark patches on the skin of your face. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

You may need to avoid drinking grapefruit juice while using Annovera with certain other medicines. Ask your doctor or pharmacist.

Annovera side effects

Get emergency medical help if you have signs of an allergic reaction to Annovera: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • very high blood pressure - severe headache, blurred vision, pounding in your neck or ears;
  • signs of a blood clot - sudden numbness or weakness (especially on one side of the body), sudden severe headache, problems with speech or vision, stabbing chest pain, feeling short of breath, pain or numbness in one or both legs;
  • heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • toxic shock syndrome - sudden fever, body aches, skin rash, vomiting, diarrhea, and feeling dizzy or light-headed;
  • new headaches, or a change in the pattern or severity of migraine headaches;
  • jaundice (yellowing of the skin or eyes); or
  • symptoms of depression - mood changes, thoughts about hurting yourself.

Common Annovera side effects may include:

  • headache;
  • nausea, vomiting, diarrhea, stomach pain;
  • vaginal itching or discharge;
  • menstrual pain, breast tenderness;
  • irregular vaginal bleeding; or
  • pain or burning when you urinate;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Annovera?

Some drugs can make birth control less effective, which may result in pregnancy. Use a barrier form of birth control (a male condom with spermicide, but not a female condom) with the Annovera vaginal ring if you also use any of the following medicines:

  • aprepitant, bosentan, St. John's wort;
  • antifungal medicine;
  • antiviral medicine to treat hepatitis C or HIV/AIDS;
  • blood pressure medication;
  • seizure medicine;
  • steroid medicine;
  • thyroid medicine; or
  • tuberculosis medicine.

Keep using the barrier birth control for at least 28 days after your last dose of any of these medicines.

Annovera can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Some drugs can affect your blood levels of ethinyl estradiol and segesterone if you take them with grapefruit juice.

Tell your doctor about all your current medicines and any medicine you start or stop using. Many drugs can affect Annovera, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.