Annovera 0.15 mg-0.013 mg/24 hr vaginal ring

Generic name:
Segesterone/ethinyl estradiol ring - vaginal

Pronunciation
(se-JES-ter-one/ETH-i-nil ES-tra-DYE-ol)

Brand name(s)
Annovera

Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, patch, ring). The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.

This product is a vaginal ring containing combination hormone medication and is used to prevent pregnancy. It contains 2 hormones: a progestin (segesterone) and an estrogen (ethinyl estradiol).

Using this product does not protect you or your partner against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method (latex or polyurethane condom/dental dams) during all sexual activity.

Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information on how to properly use, store, and dispose of the vaginal ring. If you have any questions, ask your doctor or pharmacist.

This product is for vaginal use only. The vaginal ring is reusable for up to 1 full year (13 cycles). Before use, wash and dry your hands. Remove the ring from the pouch. Wash the ring with mild soap and water, then rinse and pat dry with a clean cloth or paper towel before each insertion and at each removal. Press the sides of the ring together and gently push it into your vagina as directed, until it feels comfortable. Although some women may be aware of the ring in the vagina, most women do not feel it once it is in place; it will not interfere with sexual intercourse (though your partner may be able to feel the ring). Unlike a diaphragm, the ring's exact position in the vagina does not affect how well it works. Once inserted, keep the ring in place for 3 weeks in a row.

If this is the first time you are using the ring, start using the ring between days 2 and 5 of your period. You do not need to use a backup form of non-hormonal birth control (such as condoms, spermicide). If your periods are not regular or if your start day is more than 5 days from the first day of your period, use backup non-hormonal birth control for the first 7 days to prevent pregnancy until the ring has enough time to work. Do not use a diaphragm, female condom, or cervical cap for backup birth control since the ring may interfere with proper placement.

After using the ring for 3 weeks, remove it on the same day of the week and about the same time that you placed it. If you have pain/bleeding when trying to remove the ring, or if you cannot remove it, tell your doctor right away. After removing the ring, store it in the container provided by the manufacturer.

Next, do not wear the ring for 1 week (7 days). You should have your period within 2 to 3 days after the ring is removed. After 1 ring-free week, re-insert the ring on the same day of the week that it was removed, whether or not you have your period. If you do not get your period, consult your doctor. Do not go longer than 7 days without a ring. Doing so will increase your risk of pregnancy.

Regularly check that the ring is in your vagina, such as before and after sexual intercourse. The ring may accidentally fall out during sexual intercourse, during a bowel movement, or while removing a tampon. If this happens and the ring has been out of your vagina for less than 2 hours, wash it with mild soap and warm water, rinse and pat dry with a clean cloth or paper towel, and re-insert the ring as soon as possible. If the ring has been out longer than 2 hours, you could become pregnant. Re-insert it as directed and use a backup form of non-hormonal birth control (such as condoms, spermicide) for the next 7 days to prevent pregnancy.

It is very important to follow the schedule every cycle. If you are more than 1 or 2 days off schedule for insertion, you will need to use a new schedule for the remaining cycles of use. Read the manufacturer's information for details, and ask your doctor or pharmacist if you have any questions.

Ask your doctor or pharmacist about how to switch from other forms of hormonal birth control (such as birth control pills) to this product. If any information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

Vaginal discomfort/irritation, nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. Vaginal bleeding between periods (spotting) may occur, especially during the first few months of use. If any of these effects last or get worse, tell your doctor or pharmacist promptly. If you miss 2 periods in a row (or 1 period if the ring has not been used properly), contact your doctor about a pregnancy test.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• lumps in the breast
• mental/mood changes (such as new/worsening depression)
• severe stomach/abdominal pain
• unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods)
• dark urine
• yellowing eyes/skin

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have:

• chest/jaw/left arm pain
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• trouble speaking
• shortness of breath/rapid breathing
• sudden/severe headaches
• unusual sweating
• weakness on one side of the body
• sudden vision changes

Rarely, a very serious (possibly fatal) bacterial infection (toxic shock syndrome-TSS) has occurred in women using vaginal rings. Remove this product and get medical help right away if you develop symptoms of toxic shock syndrome, including:

• sudden high fever
• severe/sudden dizziness
• fainting
• unusual muscle pain
• sunburn-like rash

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using this product, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or segesterone; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood clots (for example, in the legs, eyes, lungs)
• blood clotting disorders (such as protein C or protein S deficiency)
• high blood pressure
• abnormal breast exam
• cancer (especially endometrial or breast cancer)
• high cholesterol or triglyceride (blood fat) levels
• depression
• diabetes
• family or personal history of a certain swelling disorder (angioedema)
• gallbladder problems
• severe headaches/migraines
• heart problems (such as heart valve disease, irregular heartbeat, previous heart attack)
• history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch)
• liver disease (including tumors)
• obesity
• stroke
• swelling (edema)
• thyroid problems
• vaginal conditions (such as unexplained vaginal bleeding, vaginal stenosis, prolapsed uterus)

If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using hormonal birth control. You may need to stop this medication for a time or take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.

A small amount of this medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• aromatase inhibitors (such as anastrozole, exemestane)
• fezolinetant
• ospemifene
• tamoxifen
• tizanidine
• tranexamic acid
• certain combination products used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir with or without dasabuvir)

Do not use oil-based (including silicone-based) vaginal lubricants or medications while using this product. These may make this product work less well. Water-based vaginal products will not affect this product. Ask your doctor or pharmacist if you have questions.

Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), ritonavir, St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine), among others.

Tell your doctor when you start any new drug, and discuss if you should use reliable non-hormonal backup birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with many lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this medication.

This product may be harmful if swallowed. Overdose with this product is highly unlikely. Do not use more than one ring at a time. If someone has overdosed, remove the ring if possible. For serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Keep all regular medical and lab appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, pap smear. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Consult your doctor for more details.

Refer to the product package information for instructions. You may need to use backup birth control (such as condoms, spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.

If you have trouble remembering to remove and reinsert the ring as directed, or if it falls out repeatedly, contact your doctor to discuss switching to another form of birth control.

Store this product at room temperature away from direct sunlight and high heat. Do not refrigerate or freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.