Estrogen and Progestin (Vaginal Ring Contraceptives)

Cigarette smoking increases the risk of serious side effects from estrogen and progestin vaginal ring, including heart attacks, blood clots, and strokes. This risk is higher for women over 35 years of age and heavy smokers (15 or more cigarettes per day). If you use estrogen and progestin, you should not smoke.

Estrogen and progestin vaginal ring contraceptives are used to prevent pregnancy. Estrogen (ethinyl estradiol) and progestin (etonogestrel or segesterone) are two female sex hormones. Estrogen and progestin are in a class of medications called combination hormonal contraceptives (birth control medications). Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). They also change the lining of the uterus (womb) to prevent pregnancy from developing and change the mucus at the cervix (opening of the uterus) to prevent sperm (male reproductive cells) from entering. Contraceptive vaginal rings are a very effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.

Estrogen and progestin vaginal ring contraceptives come as a flexible ring to place in the vagina. The estrogen and progestin vaginal ring contraceptives are usually placed in the vagina and left in place for 3 weeks. After 3 weeks using the vaginal ring, remove the ring for a 1-week break. After using the Annovera^® vaginal ring for 3 weeks, clean it with mild soap and warm water, pat it dry with a clean cloth or paper towel, and then place it in the provided case during the 1 week break. After using the NuvaRing^® vaginal ring for 3 weeks, you may dispose of it and insert a new vaginal ring after the 1 week break. Be sure to insert your vaginal ring at the end of the 1-week break on the same day and at the same time that you usually insert or remove the ring, even if you have not stopped bleeding. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use the contraceptive ring exactly as directed. Never use more than one contraceptive ring at a time and always insert and remove the ring according to the schedule your doctor gives you.

Contraceptive vaginal rings come in different brands. Different brands of contraceptive rings contain slightly different medications or doses, are used in slightly different ways, and have different risks and benefits. Be sure that you know which brand of contraceptive vaginal ring you are using and exactly how you should use it. Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient and read it carefully.

Your doctor will tell you when you should insert your first contraceptive vaginal ring. This depends on whether you were using another type of birth control in the past month, were not using birth control, or have recently given birth or had an abortion or miscarriage. In some cases, you may need to use an additional method of birth control for the first 7 days that you use the contraceptive ring. Your doctor will tell you whether you need to use backup birth control and will help you choose a method, such as male condoms and/or spermicides. You should not use a diaphragm, cervical cap, or a female condom when a contraceptive ring is in place.

If you are using the NuvaRing^® vaginal ring, insert a new ring after the 1-week break; repeat the cycle of 3 weeks of use with a 1-week break, using a new vaginal ring for each cycle.

If you are using the Annovera^® vaginal ring, re-insert the clean vaginal ring after the 1-week break; repeat the cycle of 3 weeks of use with a 1-week break for up to 13 cycles.

The contraceptive ring will usually stay in your vagina until you remove it. It may sometimes slip out when you are removing a tampon, during intercourse, or having a bowel movement. Call your doctor if your contraceptive ring slips out often.

If your NuvaRing^® contraceptive ring slips out, you should rinse it with cool or lukewarm (not hot) water and try to replace it within 3 hours. However, if your NuvaRing^® contraceptive ring slips out and it is broken, discard it and replace it with a new vaginal ring. If your ring falls out and gets lost, you should replace it with a new ring and remove the new ring at the same time you were scheduled to remove the ring that was lost. If you do not replace your NuvaRing^® vaginal ring within the appropriate time, you must use a non-hormonal backup method of birth control (e.g., condoms with spermicide) until you have had the ring in place for 7 days in a row.

If your Annovera^® contraceptive vaginal ring falls out, wash it with mild soap and warm water, rinse and pat dry with a clean cloth towel or paper towel, and try to replace it within 2 hours. If your vaginal ring is out of place for more than a total of 2 hours over the cycle of 3 weeks that the vaginal ring is to be inserted (e.g., from falling out one time or several times), you must use a non-hormonal backup method of birth control (e.g., condoms with spermicide) until you have had the ring in place for 7 days in a row.

Regularly check for the presence of the vaginal ring in the vagina before and after intercourse.

Contraceptive vaginal rings will work only as long as they are used regularly. Do not stop using contraceptive vaginal rings without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using the estrogen and progestin vaginal ring,

• tell your doctor and pharmacist if you are allergic to etonogestrel, segesterone, ethinyl estradiol, any other medications, or any of the ingredients in the estrogen and progestin vaginal ring. Ask your pharmacist for a list of the ingredients in the estrogen and progestin vaginal ring.
• tell your doctor if you are taking the combination of ombitasvir, paritaprevir, and ritonavir (Technivie) with or without dasabuvir (in Viekira Pak). Your doctor will probably tell you not to use estrogen and progestin vaginal ring if you are taking one or more of these medications.
• some medications should not be taken with estrogen and progestin vaginal ring. Other medications may cause dosing changes or extra monitoring when taken with estrogen and progestin vaginal ring. Make sure you have discussed any medications you are currently taking or plan to take before using estrogen and progestin vaginal ring with your doctor and pharmacist. Before starting, stopping, or changing any medications while using estrogen and progestin vaginal ring, please get the advice of your doctor or pharmacist..
• the following herbal product may interact with estrogen and progestin vaginal ring: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you using estrogen and progestin vaginal ring. Do not start any of these medications while using estrogen and progestin vaginal ring without discussing with your healthcare provider..
• tell your doctor if you have or have ever had breast cancer or any other cancer; cerebrovascular disease (clogging or weakening of the blood vessels within the brain or leading to the brain); a stroke or mini-stroke; coronary artery disease (clogged blood vessels leading to the heart); chest pain; a heart attack; blood clots in your legs or lungs; high cholesterol or triglycerides; high blood pressure; atrial fibrillation; an irregular heartbeat; any condition that affects your heart valves (flaps of tissue that open and close to control blood flow in the heart); diabetes and are over 35 years old; diabetes with high blood pressure or problems with your kidneys, blood vessels, eyes, or nerves; diabetes for longer than 20 years; diabetes that has affected your circulation; headaches that come along with other symptoms such as vision changes, weakness, and dizziness; migraines (if you are over 35 years old); liver tumors or liver disease; bleeding or blood clotting problems; unexplained vaginal bleeding; or hepatitis or other types of liver disease. Your doctor will probably tell you not to use an estrogen and progestin vaginal ring.
• tell your doctor if you have recently had a baby, a miscarriage, or an abortion. Also, tell your doctor if you have or have ever had jaundice (yellowing of skin or eyes); breast problems such as an abnormal mammogram or breast x-ray, breast nodules, fibrocystic breast disease; a family history of breast cancer; seizures; depression; melasma (brown patches on the face); bladder, uterus or rectum that has dropped or bulged into the vagina; any condition that makes your vagina more likely to become irritated; toxic shock syndrome (bacterial infection); hereditary angioedema (inherited condition that causes episodes of swelling in the hands, feet, face, airway, or intestines); or kidney, thyroid, or gallbladder disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while using estrogen and progestin vaginal ring, call your doctor immediately. You should suspect that you are pregnant and call your doctor if you have used the contraceptive ring correctly and you miss two periods in a row, or if you have not used the contraceptive ring according to the directions and you miss one period. You should not breast-feed while you are using the contraceptive ring.
• if you are having surgery, tell the doctor that you are using an estrogen and progestin vaginal ring. Your doctor may ask you to stop using the vaginal ring at least 4 weeks before and for up to 2 weeks after certain surgeries.

Talk to your doctor about drinking grapefruit juice while using this medication.

Every brand of contraceptive vaginal ring has specific directions to follow as to when to remove and/or insert the contraceptive ring. Carefully read the directions in the manufacturer's information for the patient that came with your contraceptive ring. If you do not insert the vaginal ring according to instructions or miss a dose, you will need to use a back-up method of birth control. Do not use more than one vaginal ring at a time. If you have any questions, call your doctor or pharmacist.

Estrogen and progestin vaginal ring may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• swelling, redness, irritation, burning, itching, or infection of the vagina
• white or yellow vaginal discharge
• vaginal bleeding or spotting when it is not time for your period
• unusual breast tenderness
• headache
• nausea
• vomiting
• diarrhea
• weight gain or loss
• breast pain, tenderness, or discomfort
• vaginal discomfort or foreign body sensation
• stomach pain
• acne
• changes in sexual desire

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them call your doctor immediately:

• pain in the back of the lower leg
• sharp, sudden, or crushing chest pain
• heaviness in chest
• sudden shortness of breath
• sudden severe headache, vomiting, dizziness, or fainting
• sudden problems with speech
• weakness or numbness of an arm or leg
• double vision, blurred vision, or other changes in vision
• dark patches of skin on forehead, cheeks, upper lip, and/or chin
• yellowing of skin or eyes; loss of appetite; dark urine; extreme tiredness; weakness; or light-colored bowel movements
• sudden high fever, vomiting, diarrhea, fainting or feeling faint when standing up, rash, muscle aches, or dizziness
• depression; difficulty sleeping or staying asleep; loss of energy; or other mood changes
• rash; swelling of the hands, feet, ankles, or lower legs; hives; or itching

Estrogen and progestin vaginal ring may increase the chance that you will develop liver tumors. These tumors are not a form of cancer, but they can break and cause serious bleeding inside the body. Talk to your doctor about the risks of using the contraceptive ring.

Estrogen and progestin vaginal ring may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from direct sunlight, excess heat and moisture (not in the bathroom). Do not refrigerate or freeze it. Discard the NuvaRing^® after the expiration date if not used in the provided sachet (foil pouch) and then into a trash can. Do not flush the vaginal ring down the toilet.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Symptoms of overdose may include:

• bleeding
• nausea
• vomiting

Keep all appointments with your doctor and the laboratory. Follow your doctor's directions for examining your breasts; report any lumps immediately.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using estrogen and progestin vaginal ring.

Do not use oil-based (including silicone-based) vaginal lubricants with the Annovera^® vaginal ring.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Annovera^® (containing Ethinyl Estradiol, Segesterone)
• NuvaRing^® (containing Ethinyl Estradiol, Etonogestrel)

• contraceptive ring