ethinyl estradiol and segesterone (vaginal ring)

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

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?

• 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.

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.

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.

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.

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.

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.

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?

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.

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?

• 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.