Ethinyl Estradiol Segesterone Vaginal Ring

Ethinyl Estradiol and Segesterone Vaginal Ring is a combination prescription medication used as a contraception to prevent pregnancy.

• Ethinyl Estradiol and Segesterone Vaginal Ring are available under various brand names: Annovera

Common side effects of Ethinyl Estradiol and Segesterone Vaginal Ring include:

headache

• nausea, vomiting, diarrhea, stomach pain
• vaginal itching or discharg
• menstrual pain, and breast tenderness
• irregular vaginal bleeding; or
• pain or burning while urinating.

Serious side effects of Ethinyl Estradiol and Segesterone Vaginal Ring include:

• hives
• difficult breathing
• swelling of the face, lips, tongue, or throat
• very high blood pressure--severe headache, blurred vision, pounding in the 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 the 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.

Rare side effects of Ethinyl estradiol and segesterone include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

• Silicone elastomer vaginal system
• 103 mg/17.4 mg

Contraception

Adult and pediatric dosage

• Place one vaginal system in the vagina and it should remain in place continuously for 21 days (3 complete weeks)
• After 3 weeks, remove the vaginal system for 1 week for a dose-free interval, during which a withdrawal bleed usually occurs
• Following the dose-free interval, reapply the removed and cleaned vaginal system for another 21 continuous days (3 complete weeks); this pattern of use made up of 3 weeks in and 1 week out is a cycle of use, which provides contraception for 13 cycles

Limitation of use

• The vaginal system has not been adequately studied in females with a BMI above 29 kg/m²

Dosage Considerations – Should be Given as Follows: 

• See “Dos0ages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ethinyl Estradiol and Segesterone Vaginal Ring have severe interactions with no other drugs.
• Ethinyl Estradiol and Segesterone Vaginal Ring have serious interactions with the following drugs:
  • belzutifan
  • elagolix
  • mavacamten
• Ethinyl Estradiol and Segesterone Vaginal Ring have moderate interactions with the following drugs:
  • fostemsavir
  • istradefylline
  • lamotrigine
  • levoketoconazole
  • lonapegsomatropin
  • mifepristone
  • warfarin
• Ethinyl Estradiol and Segesterone Vaginal Ring have minor interactions with the following drugs:
  • ruxolitinib topical

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to Ethinyl estradiol or segesterone, 
• 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.
• Smoking and are older than 35 years

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ethinyl Estradiol and Segesterone Vaginal Ring?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ethinyl Estradiol and Segesterone Vaginal Ring?”

Cautions

• 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.
• 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.
• 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.

Pregnancy and Lactation

• 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.
• Lactation
  • You should not breastfeed while using Ethinyl estradiol and segesterone.