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ethinyl estradiol and segesterone (vaginal ring)

Pronunciation: ETH in il es tra DYE ole and se JES ter one

Brand: Annovera

What is the most important information I should know about this medicine?

You should not use this medicine if you have: uncontrolled high blood pressure, heart disease, coronary artery disease, long-term diabetes (or health problems caused by diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine 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.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack.

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

What is ethinyl estradiol and segesterone?

Ethinyl estradiol and segesterone vaginal system (ring) is used as contraception to prevent pregnancy. One vaginal ring may be reused for up to 1 year.

Ethinyl estradiol and segesterone may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using this medicine?

You should not use this medicine 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 disease (coronary artery disease, a heart valve disorder, history of heart attack, stroke, or blood clot);
  • 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;
  • severe migraine headaches;
  • liver disease or liver cancer; or
  • if you have taken any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir in the past 2 weeks.

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

Do not use a 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.

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 or kidney disease;
  • depression;
  • diabetes, underactive thyroid, gallbladder disease;
  • a seizure or migraine headaches;
  • toxic shock syndrome, or easy vaginal irritation;
  • a family history of breast cancer;
  • a breast lump, fibrocystic breast disease, or an abnormal mammogram; or
  • if you have recently had a miscarriage or abortion.

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

You should not breastfeed while using this medicine.

How should I use ethinyl estradiol and segesterone?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Read and carefully follow any Instructions for Use provided with your medicine.

The 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 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 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 this medicine for a short time. Any doctor or surgeon who treats you should know that you are using the vaginal ring.

Ethinyl estradiol and segesterone 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, keep the ring in the case provided. Store at room temperature. Protect from heat, sunlight, and freezing. Follow the provided instructions for cleaning the vaginal ring when not in use.

After using this medicine 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.

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 ethinyl estradiol and segesterone is not expected to be dangerous, but may cause nausea or vaginal bleeding.

What should I avoid while using this medicine?

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.

Ethinyl estradiol and segesterone 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 ethinyl estradiol and segesterone with certain other medicines. Ask your doctor or pharmacist.

What are the possible side effects of ethinyl estradiol and segesterone?

Get emergency medical help if you have signs of an allergic reaction: 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 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 ethinyl estradiol and segesterone?

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 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.

Ethinyl estradiol and segesterone 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 ethinyl estradiol and segesterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and segesterone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2019 Cerner Multum, Inc. Version: 1.01. Revision date: 7/24/2019.

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