Annovera

Annovera is a birth control medication used to prevent pregnancy. It is a single product containing 2 kinds of female hormones: segesterone acetate, a progestin, and ethnyl estradiol, an estrogen. Annovera works by preventing ovulation (the release of an egg from the ovaries). It also changes the lining of the uterus (womb) to prevent pregnancy from developing and changes the mucus at the cervix (opening of the uterus) to prevent sperm from entering.

This medication comes as a flexible vaginal ring and is inserted and left in place for 3 weeks. After three weeks, it is removed for a 1-week break, then the same ring is reinserted for up to 1 full year (1 year includes 13 cycles; each cycle is 28 days).

Common side effects of Annovera include headache, nausea/vomiting, and vaginal yeast infection. 

Annovera is a prescription birth control medication used to prevent pregnancy. 

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

Serious side effects have been reported with Annovera. See the "Annovera Precautions" section. 

Common side effects of Annovera include the following:

• headache, including migraine
• nausea/vomiting
• vaginal yeast infection (candidiasis)
• lower/upper abdomen pain
• painful periods
• vaginal discharge
• urinary tract infection
• breast pain/tenderness
• irregular vaginal bleeding
• diarrhea
• genital itching

This is not a complete list of Annovera side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines and herbal products may make hormonal birth control less effective, including, but not limited to:

• certain anti-seizure medicines (such as barbiturates, carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide, topiramate)
• medicine to treat fungal infections (griseofulvin)
• certain combinations of HIV medicines (such as nelfinavir, ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir)
• certain hepatitis C (HCV) medicines (such as boceprevir, telaprevir)
• non-nucleoside reverse transcriptase inhibitors (such as nevirapine)
• medicine to treat tuberculosis (such as rifampicin and rifabutin)
• medicine to treat high blood pressure in the vessels of the lung (bosentan)
• medicine to treat chemotherapy-induced nausea and vomiting (aprepitant)
• St. John's Wort

Talk to your healthcare provider if you take any of the medicines listed above to see if the specific medicine you take may make hormonal contraceptives less effective. Use a back-up or another birth control method when you take medicine that may make hormonal contraceptives less effective and for 28 days after stopping the medicine.

Do not use any vaginal products such as oil-based suppositories, oil-based creams, or oil-based gels while the vaginal system is in your vagina. Do not use any vaginal lubricants that have silicone or oil in them. Water-based lubricants are ok to use. Be sure to read the ingredients on the label carefully before you buy a vaginal lubricant.

Some medicines and grapefruit juice may increase the level of ethinyl estradiol in your blood if used together, including:

• the pain reliever acetaminophen
• ascorbic acid (vitamin C)
• types of medicines used to treat fungal infections
• HIV medicines
• non-nucleoside reverse transcriptase inhibitors
• medicines to lower cholesterol

Annovera may affect the way that lamotrigine (a medicine used to treat seizures) works and may increase the risk of seizures. Your healthcare provider may need to adjust your dose of lamotrigine.

Females who take thyroid hormone replacement medicine or corticosteroid replacement medicine may need increased doses of their thyroid hormone or cortisol medicines.
Ask your healthcare provider if you are not sure if you take any of the medicines listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Talk to your healthcare provider before you start taking a new medicine.

This is not a complete list of Annovera drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Annovera including the following:

• blood clots. Like pregnancy, hormonal contraceptives increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking hormonal contraceptives and when you restart the same or different hormonal contraceptive after not using it for 4 weeks or more.

It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

• legs (deep vein thrombosis) 
• lungs (pulmonary embolus) 
• eyes (loss of eyesight)
• heart (heart attack)
• brain (stroke)

Call your healthcare provider or get emergency medical care right away if you have:

• leg pain that does not go away 
• sudden shortness of breath
• sudden changes in vision or blindness
• severe pain or pressure in your chest
• a sudden, severe headache unlike your usual headaches 
• weakness or numbness in an arm or leg
• trouble speaking
• toxic shock syndrome (TSS). Some symptoms of TSS are the same as flu symptoms, but they can become serious very quickly. Call your healthcare provider or get emergency medical care right away if you have the following symptoms:
  • sudden high fever
  • vomiting
  • diarrhea
  • fainting or feeling faint when standing up
  • a sunburn-like rash 
  • muscle aches
  • dizziness
• liver problems, including liver tumors. Tell your healthcare provider right away if you have yellowing of your skin or eyes (jaundice)
• high blood pressure.
• gallbladder problems or worsening of a gallbladder problem you already have. You may have an increased risk of gallbladder problems with the use of Annovera if you had gallbladder problems when you were pregnant.
• changes in the sugar and fat (cholesterol and triglycerides) levels in your blood.
• headache. Tell your healthcare provider if you have new headaches that keep coming back, that do not go away, or are severe. Also tell your healthcare provider if your migraine headaches happen more often or are more severe than normal.
• irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first month of using Annovera, or the absence of menstrual periods (amenorrhea).
• depression.
• possible cancer in your cervix.
• swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider or get emergency medical care right away if you have a swollen face, lips, mouth, tongue, or throat as this may lead to difficulty swallowing or breathing. Your risk of having angioedema is higher if you have a history of angioedema.
• dark patches of skin on your forehead, cheeks, upper lip, and chin (chloasma). Your risk of getting chloasma with the use of Annovera is higher if you had chloasma during pregnancy. Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sunlamps while using Annovera. Use sunscreen if you have to be in the sunlight.

Do not use Annovera if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious heart and blood vessel (cardiovascular) side effects from hormonal birth control methods, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.

Do not use Annovera if you:

• smoke and are over 35 years old. See above.
• have or have had a blood clot in your arms, legs, lungs, or eyes.
• have had a stroke.
• have reduced blood flow to your brain (cerebrovascular disease).
• have reduced blood flow or blockage in 1 or more of the arteries that supply blood to your heart (coronary artery disease).
• have had a heart attack.
• have heart rhythm or heart valve problems that increase your risk of having blood clots, such as an infection of the inner lining of the heart and heart valves or a type of irregular heartbeat called atrial fibrillation.
• have a problem with your blood that makes it clot more than normal.
• have high blood pressure that is not controlled with medicine or have high blood pressure with blood vessel damage.
• have diabetes and are over 35 years old; have diabetes with high blood pressure or problems with your kidneys, blood vessels, eyes, or nerves; or have had diabetes for longer than 20 years.
• have headaches with changes in vision, numbness or weakness, have migraine headaches with aura, or are over age 35 years old and have any type of migraine headaches.
• have liver disease or liver tumors.
• have or have had breast cancer or any cancer that is sensitive to the female hormones estrogen or progesterone.
• have unexplained vaginal bleeding.
• are allergic to segesterone acetate, ethinyl estradiol, or any of the ingredients in Annovera.
• take any Hepatitis C drug combination medicine containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme alanine aminotransferase (ALT) in the blood.

Grapefruit and grapefruit juice may interact with the female hormones in Annovera and may lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before using Annovera, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have any of the conditions listed in the "Precautions" section.
• smoke.
• are pregnant or think you are pregnant.
• recently had a baby, miscarriage, or abortion.
• have breast problems such as an abnormal mammogram or breast x-ray, breast nodules, fibrocystic breast disease, or a family history of breast cancer.
• have any medical condition, especially migraine headaches, depression, seizures, diabetes, high blood pressure, high cholesterol or triglycerides, gallbladder disease, liver disease, heart disease, or kidney disease.
• have a family history of blood clots or stroke.
• have yellowing of the skin or eyes (jaundice).
• have a condition that makes your vagina become irritated easily.
• have a history of toxic shock syndrome.
• had gallbladder problems when you were pregnant.
• are scheduled for surgery. The hormones in Annovera may increase your risk of blood clots after surgery. You should stop using Annovera at least 4 weeks before you have surgery and not restart until at least 2 weeks after your surgery.
• are scheduled for any laboratory tests. Certain blood tests may be affected by hormonal birth control methods.
• are breastfeeding or plan to breastfeed. You should not use Annovera if you are breastfeeding. The hormones in Annovera may decrease your milk production. The hormones in Annovera pass into your breast milk. Talk with your healthcare provider about the best birth control method for you while breastfeeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Use of Annovera during pregnancy can cause babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. This medication should never be used or be needed by pregnant women. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

The effects of this medication in nursing mothers have not been established and are unknown. When possible, the nursing mother should be advised to use other forms of contraception until she has completely weaned her child. Combination hormonal contraceptives can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however it can occur at any time in some women. Small amounts of contraceptive steroids and/or metabolites are present in breast milk.

Use Annovera exactly as prescribed. Annovera is reused up to a total of 13 cycles (up to 1 year). After this time, the ring must be discarded and replaced with a new system.

Insertion: The ring will be inserted for 21 days (3 weeks) of each cycle. Do not deviate from the recommended regimen. The day and time of insertion should be noted and followed consistently every cycle.

Removal: The ring is removed for a 1-week dose-free interval during each cycle, during which a withdrawal bleed occurs within 2-3 days, The ring can be removed by hooking an index finger into the vaginal system inside the vagina and pulling gently on the ring. If the ring has been left in place for more than 21 days, remove the the ring for 7 days and then reinsert for 21 days to resume schedule. 

Cleaning and storage during 1-week dose-free interval: Removed ring should be cleaned wtih mild sopa and warm water, dried wtih a clean cloth or paper towel, and placed in its case for storage during that week. At the end of the dose-free week interval, the ring shoulld be cleaned again prior to reinsertion for next cycle.

Reinstertion: the ring is inserted 1 wewek after the last ring was removed, on the same day and at about the same time. The ring should be inserted even if withdrawal bleeding has no stopped. 

You do not have to take out Annovera when you have sex. If you decide to remove it, remember to insert it within 2 hours after removing it or your may not be protected from pregnancy. 

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

One Annovera is inserted in the vagina. The vaginal system must remain in place continuously for 3 weeks (21 days) followed by a 1-week (7-day) vaginal system-free interval. One vaginal system provides contraception for thirteen 28-day cycles (1 year).

A is a silicone elastomer vaginal system containing 103 mg segesterone acetate (SA) and 17.4 mg ethinyl estradiol (EE), which releases on average 0.15 mg/day of segesterone acetate and 0.013 mg/day of ethinyl estradiol.

There have been no reports of serious ill effects from overdose of combination hormonal contraceptives (CHCs). Overdosage may cause withdrawal bleeding and nausea. In case of suspected overdose, remove the Annovera vaginal ring and contact your healthcare provider.

• Store Annovera in the supplied case at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect Annovera from direct sunlight.
• Do not refrigerate or freeze Annovera.
• Avoid storing Annovera in extreme heat.
• Keep Annovera and all medicines out of the reach of children and pets.

Disposal:

• After 13 cycles of use, place Annovera in the case that comes with it.
• Dispose of Annovera at a drug take-back location, if available. If a drug take-back location is not available, dispose of Annovera in the trash, out of the reach of children and pets.
• Do not throw away Annovera in the toilet.

Cigarette smoking and serious cardiovascular events

Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in females >35 years, and with the number of cigarettes smoked. For this reason, CHCs should not be used by females who are >35 years and smoke.