Annovera (segesterone acetate/ethinyl estradiol)

Annovera generic

Annovera is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics typically cost less than brand-name drugs.

Common questions about Annovera

Here are answers to some frequently asked questions about Annovera.

How does Annovera compare with NuvaRing?

Annovera and NuvaRing are both hormone-releasing vaginal rings used for birth control. With both forms, you’ll insert the ring into your vagina and leave it there for 21 days. Then you’ll take it out for 7 days.

One Annovera ring can be used for thirteen 28-day cycles (1 year). However, with NuvaRing, you’ll insert a new ring every 28 days. So you’ll need to get your prescription refilled more often than with Annovera.

Both vaginal rings contain two hormones: ethinyl estradiol (a synthetic form of estrogen) and a progestogen (synthetic form of progesterone). NuvaRing contains the progestogen etonogestrel. Annovera contains segesterone acetate, which is a newer form of progestogen. Annovera releases a slightly lower daily dose of ethinyl estradiol than NuvaRing.

Both vaginal rings are similarly effective at helping to prevent pregnancy. They can also cause similar side effects. However, Annovera may be less likely than NuvaRing to cause changes in mood.

If you’re interested in using a vaginal ring for birth control, talk with your doctor. They can help determine which form of birth control is right for you.

Can Annovera cause weight gain?

No, it’s not likely. Weight gain wasn’t reported in clinical trials of Annovera.

Weight gain is possible with some forms of birth control. According to Planned Parenthood, weight gain occurs in some people who receive the birth control shot (Depo-Provera) or have the implant (Nexplanon). However, it’s unlikely to happen with other forms.

If you’re concerned about weight gain with Annovera or other forms of birth control, talk with your doctor.

Is acne a side effect of Annovera?

No, it’s not known to be. Acne wasn’t reported in clinical trials of Annovera.

Progestogen-only forms of birth control can sometimes cause acne or make it worse. Examples include etonogestrel birth control implants (Nexplanon) and progestin-only pills such as norethindrone (Camila, Errin, Nor-QD, others). However, Annovera isn’t a progestogen-only form of birth control. It’s a combined hormonal contraceptive (CHC). CHCs often reduce acne.

If you’re concerned about how Annovera or other forms of birth control may affect your skin, talk with your doctor.

Alternatives to Annovera

Other hormonal forms of birth control are available. Some may be a better fit for you than others. If you’re interested in finding an alternative to Annovera, talk with your doctor. They can tell you about other forms of birth control that may work well for you.

Alternative birth control options

Examples of other hormonal forms of birth control include:

• other vaginal rings, such as ethinyl estradiol/etonogestrel vaginal rings (NuvaRing, Haloette, Eluryng)
• patches, such as:
  • ethinyl estradiol/norelgestromin (Xulane)
  • ethinyl estradiol/levonorgestrel (Twirla)
• combined pills (containing estrogen and progestogen), such as:
  • ethinyl estradiol/norethindrone (Junel, Loestrin Fe, Nylia, others)
  • ethinyl estradiol/drospirenone (Yaz, Loryna, Nikki, others)
  • ethinyl estradiol/levonorgestrel (Altavera, Daysee, Seasonique, others)
• progestin-only pills, such as:
  • norethindrone (Camila, Errin, Nor-QD, others)
• intrauterine devices (IUDs) that release levonorgestrel (Skyla, Kyleena, Liletta)
• medroxyprogesterone injection (Depo-Provera)
• etonogestrel implant (Nexplanon)

Annovera for birth control

The Food and Drug Administration (FDA) approves prescription drugs such as Annovera to treat certain conditions. Annovera may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Annovera is a hormone-releasing vaginal ring that’s a form of contraception (birth control). It’s FDA-approved to help prevent pregnancy in female* adults and adolescents who have started their periods.

You’ll insert Annovera into your vagina and leave it there for 21 days. Then you’ll take it out for 7 days. You’ll then repeat this cycle. Each ring can be used for thirteen 28-day cycles (1 year).

During your 7-day breaks, you’ll typically have withdrawal bleeds that are similar to your period.

Effectiveness for helping to prevent pregnancy

According to the manufacturer, Annovera is about 97% effective when used correctly. This means about three pregnancies may occur in every 100 people who use Annovera for 1 year. For information on how Annovera performed in clinical trials, see the drug’s prescribing information.

However, note that this form of birth may be used incorrectly. For example, there may be times when you forget to put the ring back in on time after your 7-day break. This can make the ring less effective.

According to Planned Parenthood, with real-world use, vaginal rings such as Annovera are about 93% effective. This means about seven pregnancies may occur in every 100 people who use Annovera for 1 year.

It’s not known whether Annovera is effective in females* who have a body mass index (BMI) above 29. (BMI is used by doctors to help determine whether you’re underweight or overweight. You can calculate your BMI here.) Annovera hasn’t been studied in people with a BMI above 29. It’s possible that it may be less effective in this group of people.

Annovera and children

Annovera can be used for birth control in female* adolescents under age 18 years who have started their periods.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Annovera side effects

The Annovera ring can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while using Annovera. These lists do not include all possible side effects.

For more information about the possible side effects of Annovera, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Annovera, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Annovera. To learn about other mild side effects, talk with your doctor or pharmacist, or view Annovera’s prescribing information.

Mild side effects of Annovera can include:

• headache or migraine
• nausea and vomiting
• vaginal yeast infection
• urinary tract infection (UTI)
• abdominal pain
• dysmenorrhea (painful periods)
• irregular periods, spotting between periods, or periods stopping altogether
• vaginal discharge or itching
• breast tenderness or pain
• diarrhea
• mild allergic reaction*

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Annovera, see “Allergic reaction” below.

Serious side effects

Serious side effects from Annovera aren’t common. However, they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Blood clots, for example, in the leg, lung, heart, brain, or eye. Symptoms can include:
  • pain, swelling, or a feeling of warmth in the leg
  • chest pain or pressure
  • sudden shortness of breath
  • sudden weakness or numbness in one side of the body
  • trouble speaking
  • sudden severe headache
  • sudden changes in vision
• Toxic shock syndrome. Symptoms can include:
  • sudden, high fever
  • diarrhea
  • vomiting
  • dizziness, feeling faint, or fainting
  • sunburn-like rash
  • muscle aches
• Liver problems, such as liver tumors. Symptoms can include:
  • jaundice
• Gallbladder problems, such as gallstones. Symptoms can include:
  • sudden pain on the right side of the body, just below the ribs, in the shoulder, or between the shoulder blades
  • nausea and vomiting
• Increased levels of sugar or fats (cholesterol or triglycerides) in the blood. Symptoms can include:
  • excessive thirst
  • urinating more than is typical
  • weight loss
• Increase in blood pressure. This doesn’t typically cause symptoms.
• Risk of serious cardiovascular problems in certain females who smoke.*
• Severe allergic reaction.†

* Annovera has a boxed warning for this side effect. This is a serious warning from the FDA. To learn more, see the “Annovera precautions” section below. Sex and gender exist on spectrums. In this article, use of the term “female” refers to sex assigned at birth.
† For details about allergic reaction and Annovera, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after using Annovera. This was a rare side effect in clinical trials of this drug.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare. However, it is possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Annovera, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Annovera cost

As with all medications, the cost of Annovera ring can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Before approving coverage for Annovera, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide whether the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Annovera, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Annovera, or if you need help understanding your insurance coverage, help is available.

A savings card is available for Annovera. For more information and to find out whether you’re eligible for support, visit the manufacturer’s website.

To learn more about saving money on prescriptions, check out this article.

Mail-order pharmacies

Annovera may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Annovera is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

How Annovera works

Annovera is a hormone-releasing vaginal ring. It’s a form of birth control used to help prevent pregnancy.

Annovera steadily releases synthetic versions of the female sex hormones estrogen and progesterone into your vagina. The hormones are absorbed into your bloodstream through the wall of your vagina.

The hormones in Annovera have three effects that help lower your risk of becoming pregnant. These are:

• preventing ovulation (release of an egg from your ovaries) from occurring each month
• thickening the mucus in your cervix, making it harder for sperm to enter your uterus
• thinning the lining of your uterus, making it harder for a fertilized egg to implant there

How long does it take to work?

How long Annovera takes to work depends on where you are in your menstrual cycle. It also depends on factors such as:

• whether you’re currently using another hormonal form of birth control
• whether you’re switching from Mirena (an intrauterine device) or another hormonal form of birth control, such as the pill, patch, injection, or implant
• whether you’ve recently given birth or had a pregnancy loss or an abortion

In some cases, Annovera may start working right away to help prevent pregnancy. However, in others, it may take up to a week.

Your doctor will recommend when you should start using Annovera. They’ll also recommend whether you need to use an extra barrier form of birth control, such as condoms, for the first 7 days after inserting Annovera.

Annovera dosage

Below is some information on Annovera’s dosage. Annovera is only available in one strength. Everyone who uses it will receive the same dosage.

Drug forms and strengths

Annovera is a hormone-releasing vaginal ring.

Each Annovera ring contains 17.4 milligrams (mg) ethinyl estradiol and 103 mg segesterone acetate.

When placed in your vagina, Annovera releases an average of 0.013 mg ethinyl estradiol and 0.15 mg segesterone acetate per day.

Dosage for helping to prevent pregnancy

You should insert Annovera into your vagina and leave it there for 21 days. Then you should remove it and leave it out for 7 days. This 28-day cycle should be repeated for 13 cycles using the same ring. After this, you’ll need to get a new Annovera ring if you want to keep using it for birth control.

You should insert, remove, and reinsert Annovera on the same day of the week at around the same time (for example, Monday at 8 a.m.).

To learn more about inserting and removing Annovera, see the “Annovera insertion and removal” section below.

Children’s dosage

Adolescents under age 18 years can be prescribed Annovera after they have started their periods. The recommended dosage is the same for adults using Annovera. This is described above.

What if I forget to remove or reinsert Annovera?

If you forget to remove Annovera after 21 days, remove it as soon as you remember. You should still be protected from pregnancy. Leave Annovera out for 7 days, then reinsert it and leave it in for 21 days.

In this case, you may have a new day and time for inserting and removing Annovera. Continue to follow this new schedule. To learn more, see the “Annovera insertion and removal” section below.

If you forget to reinsert Annovera after your 7-day break, you won’t be protected from pregnancy. Reinsert Annovera as soon as possible and leave it in for 21 days. You should abstain from sex or use a barrier form of birth control, such as condoms, until Annovera has been in your vagina for 7 continuous days.

In this case, you may have a new day and time for inserting and removing Annovera. Continue to follow this new schedule. To read more, see the “Annovera insertion and removal” section below.

If you’re late reinserting Annovera and you had sex during the time Annovera was out of your vagina, there’s a possibility you could become pregnant. Talk with your doctor or pharmacist as soon as possible.

To help make sure that you don’t forget to remove or reinsert Annovera, you may wish to download the Annovera app on your phone. You could also try using a medication reminder. This can include setting an alarm or using a timer.

What if Annovera comes out?

Annovera might sometimes come out of your vagina accidentally. For example, this could happen during sex, when removing a tampon or menstrual cup, or while straining for a bowel movement. If Annovera comes out accidentally, wash it with mild soap and water, pat it dry with a clean towel or paper towel, and reinsert it. If Annovera was out of your vagina for less than 2 hours, you should still be protected from pregnancy.

You do not need to remove Annovera during sex. However, if you want to remove it, you can. Just remember to wash, dry, and reinsert it within 2 hours. If Annovera is out of your vagina for less than 2 hours, you should still be protected from pregnancy.

However, you may not be protected from pregnancy if either of these situations arises during the 21 days that Annovera should be in your vagina:

• Annovera is out of your vagina for longer than 2 hours on any occasion.
• Annovera is out of your for vagina on several occasions that add up to more than 2 hours.

In these cases, you should not have sex or you should use an extra barrier form of birth control, such as condoms. Do this until Annovera has been in your vagina for 7 continuous days.

Will I need to use this drug long term?

Annovera is meant to be used long term to help prevent pregnancy. If you and your doctor determine that Annovera is safe and effective for you, you can use it long term.

Annovera and pregnancy

Annovera is a form of birth control used to help prevent pregnancy. You should not use Annovera if you are or could be pregnant.

It’s unlikely that you’ll become pregnant if you use Annovera correctly. However, no form of birth control is 100% effective. There’s a small risk that you could become pregnant while using Annovera.

If you think you could be pregnant while using Annovera, contact your doctor. Possible signs of pregnancy include missing a period, morning sickness, and breast tenderness. Your doctor will likely do a pregnancy test.

If you’re pregnant, you should stop using Annovera right away. If you decide to continue with the pregnancy, it shouldn’t be affected by your use of Annovera. The pregnancy should continue typically after you stop using Annovera.

Annovera is a combined hormonal contraceptive (CHC). Clinical trials haven’t found any increased risk of congenital anomalies (birth defects) in pregnancies exposed to CHC before conception or during early pregnancy.

Annovera and fertility

Annovera shouldn’t affect your fertility. After you stop using it, your ability to become pregnant should return within 6 months.

Annovera and other birth control needs

When used correctly, Annovera is very effective at helping to prevent pregnancy. However, there are certain situations that can make Annovera less effective. And in these situations, you’ll need to use a backup form of birth control to help prevent pregnancy.

Annovera may be less effective at helping to prevent pregnancy if:

• the ring is out of your vagina for longer than 2 hours on any occasion during the 21 days it should be in
• the ring is out of your vagina on several occasions that add up to more than 2 hours during the 21 days it should be in
• you forget to reinsert Annovera on time after your 7-day break

If any of these situations happen, you should use a barrier form of birth control, such as condoms, or abstain from sex. Do this until Annovera has been in your vagina continuously for 7 days.

Taking certain medications while you’re using Annovera can also make it less effective at helping to prevent pregnancy. To learn more, see the “Annovera interactions” section below.

Note that Annovera doesn’t protect you against sexually transmitted infections (STIs). To help prevent STIs, you should use condoms while using Annovera.

Annovera and breastfeeding

If you’re breastfeeding or plan to breastfeed, your doctor will likely recommend that you do not use Annovera. Talk with your doctor about other forms of birth control that may be more suitable for you.

Annovera is a combined hormonal contraceptive (CHC). CHCs can pass into breast milk. They can also decrease your body’s production of breast milk.

If you have questions about using Annovera while breastfeeding, talk with your doctor. They can advise you on the best way to feed your child.

Annovera and alcohol

Annovera isn’t known to interact with alcohol. It’s typically safe to drink alcohol while using Annovera.

If you drink alcohol, talk with your doctor about how much is safe to drink while using Annovera.

Annovera interactions

Annovera can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe. Drug-condition interactions can also cause certain effects. For information about these interactions, see the “Annovera precautions” section below.

Annovera and other medications

Below is a list of medications that can interact with Annovera. This list does not contain all drugs that may interact with Annovera.

Before using Annovera, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Types of drugs that can interact with Annovera include:

Cytochrome p450 (CYP) 3A4 inducers. Taking drugs that are CYP3A4 inducers* while using Annovera can make Annovera less effective at helping to prevent pregnancy.

If you take a CYP3A4 inducer on a long-term basis, your doctor will likely recommend using a different form of birth control than Annovera. If you take a CYP3A4 inducer while using Annovera, you should use an extra barrier form of birth control, such as condoms. You should use this while taking the interacting drug and for 28 days after stopping it.

Examples of CYP3A4 inducers include:

• certain seizure medications, such as carbamazepine (Carbatrol, Tegretol, others), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and topiramate (Topamax)
• certain HIV drugs, such as nelfinavir (Viracept), ritonavir (Norvir), darunavir (Prezista), and nevirapine (Viramune)
• certain antibacterial drugs, such as rifampin (Rifadin) and rifabutin (Mycobutin)
• the antifungal drug griseofulvin (Fulvicin)
• the antisickness drug aprepitant (Emend)

CYP3A4 inhibitors. Taking drugs that are CYP3A4 inhibitors* while using Annovera may raise your risk of side effects with Annovera. Examples of CYP3A4 inhibitors include:

• certain HIV drugs, such as atazanavir (Reyataz)
• certain antifungal drugs, such as ketoconazole, itraconazole (Sporanox, Tolsura), fluconazole (Diflucan), and miconazole (Oravig, Monistat)

Statins. Statins are drugs used to lower cholesterol. Taking certain statins while using Annovera could increase the amount of ethinyl estradiol (one of the hormones Annovera releases) in your body. This could raise the risk of its side effects. Examples of these statins include:

• atorvastatin (Lipitor)
• rosuvastatin (Crestor, Ezallor Sprinkle)

Acetaminophen (Tylenol). Acetaminophen is a mild pain reliever. Taking it while using Annovera could increase the amount of ethinyl estradiol (one of the hormones Annovera releases) in your body. This could raise your risk of its side effects.

Thyroid hormone replacement or steroid hormone replacement drugs. If you take thyroid hormones or steroid hormones, your doctor may need to increase your dosage of these hormones while you’re using Annovera.

Certain vaginal creams and suppositories. Using oil-based vaginal creams or suppositories while Annovera is in your vagina can increase the amount of hormones your body absorbs from Annovera. This could raise your risk of side effects from Annovera. If you need to treat a vaginal condition, such as a yeast infection, while using Annovera, you should use a water-based cream or oral treatment. Ask your doctor or pharmacist to recommend a suitable treatment.

* CYP3A4 is an enzyme (type of protein) in your liver that helps break down certain drugs, including the hormones released from Annovera. Drugs that are CYP3A4 inducers increase the activity of this enzyme. They can increase the breakdown of certain drugs, which can make them less effective. Drugs that are CYP3A4 inhibitors reduce the activity of this enzyme. They can cause certain drugs to build up in your body, which can raise the risk of their side effects.

Annovera and herbs and supplements

Annovera may interact with St. John’s wort and ascorbic acid, as discussed below.

There aren’t any other herbs or supplements that have been specifically reported to interact with Annovera. However, you should still check with your doctor or pharmacist before taking any of these products while using Annovera.

St. John’s wort

The herbal remedy St. John’s wort, which is a CYP3A4 inducer,* can make Annovera less effective at helping to prevent pregnancy. If you regularly take St. John’s wort, your doctor will likely recommend using a different form of birth control than Annovera.

If you take St. John’s wort while using Annovera, you should use an extra barrier form of birth control, such as condoms. You should use this while taking St. John’s wort and for 28 days after stopping it.

* CYP3A4 is an enzyme (type of protein)) in your liver that helps break down certain drugs, including the hormones released from Annovera. CYP3A4 inducers increase the activity of this enzyme. They can increase the breakdown of certain drugs, which can make them less effective.

Ascorbic acid

Ascorbic acid (vitamin C) may increase the amount of ethinyl estradiol (one of the hormones Annovera releases) in your body. This could raise your risk of its side effects.

Annovera and foods

You should avoid drinking grapefruit juice and eating grapefruit while using Annovera. Grapefruit could cause the hormones released from Annovera to build up in your body. This could increase your risk of side effects from Annovera.

There aren’t any other foods that have been specifically reported to interact with Annovera. If you have any questions about eating certain foods with Annovera, talk with your doctor.

Annovera and lubricants

You should not use vaginal lubricants that contain oil or silicone while using Annovera. These types of lubricants can affect the release of hormones from Annovera. This could make Annovera less effective or raise your risk of side effects.

If you want to use a vaginal lubricant while using Annovera, choose one that’s water-based. Water-based lubricants don’t affect Annovera.

Annovera and lab tests

If you need to have any lab tests, be sure to tell your healthcare professional that you’re using Annovera. Annovera could affect the results of certain lab tests. Examples of these include:

• coagulation factors, which are tested to check whether you have a problem with your clotting factors (proteins in your blood that help your blood clot)
• lipids (fats such as triglycerides and cholesterol)
• glucose tolerance, which is used to measure your body’s response to glucose (sugar)
• binding proteins, which may be used to test for certain hormone problems

Annovera insertion and removal

You should insert and remove Annovera according to the instructions your doctor gives you.

Typically, you’ll insert Annovera into your vagina and leave it in place for 21 days. Then you’ll remove it and leave it out for 7 days. And you’ll follow this 21 days in, 7 days out schedule for 13 cycles (1 year). After this, you’ll need to get a new Annovera ring if you want to keep using this drug for birth control.

How to insert Annovera

Before you insert the Annovera ring, wash your hands and wash the ring with mild soap and water. Then pat the ring dry with a clean towel or paper towel.

To insert the ring, get into a comfortable position. For example, this could be squatting or standing with one leg up on something. Squeeze the ring into a narrow oval shape using your finger and thumb. Then insert it into your vagina, as high up as it will go. (It’s not possible to push the ring in too far or for it to get lost in your vagina.)

You should not be able to feel the ring once it’s in place. If it’s uncomfortable, it may not be far enough in. Try pushing it in further with your index finger or inserting it again.

When to insert

When to insert Annovera for the first time and how soon it will protect you from pregnancy may depend on various factors. These include:

• where you are in your menstrual cycle
• whether or not you’re currently using another hormonal form of birth control
• whether you’re switching from Mirena (an intrauterine device) or another hormonal form of birth control, such as the pill, patch, injection, or implant
• whether you’ve recently given birth, had pregnancy loss, or an abortion

Your doctor will recommend when you should start using Annovera. They’ll also recommend whether you need to use an extra barrier form of birth control, such as condoms, for the first 7 days after inserting Annovera.

When you first insert Annovera, make a note of the day and the time (for example, Monday at 8 a.m.). When you remove Annovera after 21 days, you should do this on the same day of the week at around the same time. And when you reinsert Annovera after your 7 day-break, you should do this on the same day at around the same time.

To help make sure that you don’t forget to remove or reinsert Annovera, you may wish to download the Annovera app on your phone. You could also try using a medication reminder. This can include setting an alarm or using a timer.

How to remove Annovera

Before removing Annovera, wash and dry your hands. Then insert your index finger into your vagina and hook it through the ring. Remove the ring by gently pulling it forward and downward.

After removal, wash the ring with mild soap and water. Pat it dry with a clean towel or paper towel and store it in the case provided until it’s time to reinsert it 7 days later.

When to remove

You should remove Annovera after it’s been in your vagina for 21 days. You should do this on the same day of the week at around the same time as when you inserted it (for example, Monday at 8 a.m.).

Accessible labels and containers

If your prescription label is hard to read, talk with your doctor or pharmacist. Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist may be able to direct you to one that does.

Annovera precautions

This drug comes with several precautions. These are known as drug-condition interactions.

FDA warning: Risk of serious cardiovascular problems in certain females who smoke

This drug has a boxed warning. This is a serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Annovera is a combined hormonal contraceptive (CHC). Smoking cigarettes while using a CHC, such as Annovera, can increase your risk of blood clots that can cause serious cardiovascular problems. These may include heart attack and stroke. The risk increases with age and with the number of cigarettes smoked.

Due to this risk, females* over age 35 years who smoke should not use Annovera.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Other precautions

Before using Annovera, talk with your doctor about your health history. Annovera may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

Risk of blood clots. Annovera can cause blood clots, for example, in your leg, lungs, heart, brain, or eyes. Smoking and having certain conditions can raise your risk of blood clots with Annovera. These conditions include high blood pressure, high cholesterol, diabetes, and obesity. If you smoke or have any of these conditions, talk with your doctor about whether Annovera is right for you.

Your doctor will likely not prescribe Annovera if you have a high risk of blood clots. Ask your doctor what other forms of birth control may be better options for you. You may have a high risk of blood clots if you:

• have ever had a blood clot in your leg (deep vein thrombosis) or lung (pulmonary embolism)
• have ever had a stroke or transient ischemic attack
• have heart disease or have had a heart attack
• have heart valve disease or an irregular heart rhythm, such as atrial fibrillation
• have a blood problem that makes your blood more likely to clot
• have high blood pressure that’s not managed with medication, or high blood pressure with blood vessel damage
• have diabetes and are over age 35 years, or have had diabetes for more than 20 years
• have diabetes and also have high blood pressure or complications from diabetes such as kidney damage
• have headaches with changes in vision, numbness, or weakness
• have migraine headaches with aura (changes in vision, tingling sensations, or speech problems)
• are over age 35 years and have any type of migraine headaches

Upcoming surgery or being immobile for long periods. Having surgery can raise your risk of blood clots with Annovera. If you have surgery scheduled, your doctor will likely recommend that you stop using Annovera 4 weeks before your surgery.

Typically, you should not restart Annovera until at least 2 weeks after your surgery. Your doctor will tell you when you can restart Annovera. Being unable to move around for a long time (for example, due to an injury or severe illness) can also raise your risk of blood clots with Annovera.

If you’re unable to move around for a long time, ask your doctor whether you should stop using Annovera.

Allergic reaction. If you’ve had an allergic reaction to Annovera or any of its ingredients, your doctor will likely not prescribe Annovera. Ask your doctor what other forms of birth control may be better options for you.

Pregnancy. Annovera is used to help prevent pregnancy. Your doctor will not prescribe it if you are or could be pregnant. If you become pregnant, you should stop using Annovera. For more information, see the “Annovera and pregnancy” section above.

Breastfeeding. If you’re breastfeeding, your doctor will likely not prescribe Annovera. Ask your doctor what other forms of birth control may be better options for you. For more information, see the “Annovera and breastfeeding” section above.

Breast cancer or other hormone-sensitive cancer. If you’ve ever had breast cancer or another cancer sensitive to the hormones estrogen or progesterone, your doctor will likely not prescribe Annovera. Annovera could cause these types of cancer to get worse or come back. Ask your doctor what other forms of birth control may be better options for you.

Liver disease or liver tumors. If you have acute hepatitis (liver inflammation), severe liver cirrhosis, or a liver tumor, your doctor will likely not prescribe Annovera. It could make your liver condition worse. Ask your doctor what other forms of birth control may be better options for you.

Atypical vaginal bleeding. If you have atypical vaginal bleeding and your doctor hasn’t diagnosed the cause, they’ll likely not prescribe Annovera. Ask your doctor what other forms of birth control may be better options for you.

Gallbladder disease. If you have gallbladder disease, Annovera could make your condition worse. If you’ve had gallstones in the past, you may have a raised risk of developing gallstones with Annovera. Talk with your doctor about whether Annovera is right for you.

High blood pressure. Annovera may increase your blood pressure. If you have high blood pressure, Annovera could make your condition worse. You may also have a raised risk of blood clots with Annovera. Talk with your doctor about whether this form of birth control is right for you.

High cholesterol or triglycerides. Annovera can increase cholesterol and triglyceride levels. If you already have high cholesterol or triglycerides, Annovera could make your condition worse. If you have high cholesterol, you may also have a raised risk of blood clots with Annovera. Talk with your doctor about whether this form of birth control is right for you.

Diabetes. Annovera can increase your blood sugar level. If you have diabetes, Annovera could make it harder to manage your blood sugar. You may also have a raised risk of blood clots with Annovera. Talk with your doctor about whether this form of birth control is right for you.

Depression. If you have a history of depression, talk with your doctor about whether Annovera is right for you.

Chloasma. Annovera can sometimes cause chloasma (darker patches of skin on your face). You may have a raised risk of this side effect if you’ve ever had chloasma during a pregnancy. If you tend to get chloasma, you may wish to avoid spending a lot of time in the sun while using Annovera. It may help to regularly apply sunscreen if you’re outside a lot. It may also help to avoid using tanning beds or sunlamps.

Vaginal irritation or ulceration. If your vagina is prone to becoming irritated or having ulcers (sores), Annovera may not be the best form of birth control for you. Ask your doctor what other forms of birth control may be better options for you.

Note: For more information about the potential negative effects of Annovera, see the “Annovera side effects” section above.

Annovera overdose

Do not use more Annovera than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose. This could mean inserting more than one ring at once, or not taking the ring out for 7 days in each cycle.

What to do in case you use too much Annovera

If you think you’ve used too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number or go to the nearest emergency room right away.