Generic name: Ethinyl estradiol and segesterone (vaginal ring)
Pregnancy & Lactation: Risk data not available
What is Annovera?
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.
Warnings
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 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 this medicine 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.
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 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 this medicine.
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 Annovera
Use Annovera (Ethinyl Estradiol And Segesterone (Vaginal Ring)) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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, 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 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.
Call your doctor if you get off schedule, or if you have trouble removing a vaginal ring.
Annovera side effects
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 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.
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.