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Overview: Imvexxy is a vaginal insert used to increase estrogen levels. It is used after menopause to reduce pain during sex. The most common side effect is headache. Talk with your healthcare provider right away about any unusual vaginal bleeding or vaginal discharge.

Uses

What is Imvexxy used for?

Imvexxy is commonly used to reduce pain during sex caused by menopause symptoms.

Imvexxy may also be used for other conditions as determined by your healthcare provider.

How does Imvexxy work (mechanism of action)?

Imvexxy is an estrogen. Estrogen is a hormone that is important for the health of the vagina. Natural estrogen levels go down during menopause, which can cause the vagina to become dry and irritated. Imvexxy raises estrogen levels which may reduce these symptoms of menopause.

How is Imvexxy supplied (dosage forms)?

Imvexxy is available as 4 mcg and 10 mcg vaginal inserts.

How should I store Imvexxy?

Imvexxy should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Imvexxy?

  • Headache
  • Breast pain and tenderness
  • Nausea and vomiting

There may be other side effects of Imvexxy that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Imvexxy?

While less common, the most serious side effects of Imvexxy are described below, along with what to do if they happen.

Blood Clots. Imvexxy may cause blood clots in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the back of the eye (retinal vein occlusion), in the lungs (pulmonary embolism), or deep venous thrombosis (DVT). Stop using Imvexxy and get emergency help if you have any of the following signs of blood clots.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes 
  • Double vision

Endometrial Cancer. You may be at higher risk for cancer in the lining of your uterus (endometrial cancer) if you use Imvexxy. Call your healthcare provider right away if you have any abnormal vaginal bleeding.

Breast Cancer. You may be at higher risk for breast cancer if you use Imvexxy. Call your healthcare provider right away if you have any of the following symptoms.

  • New lump in your breast or armpit
  • Changes in the size, shape, texture, or temperature of your breast
  • Nipple changes

Ovarian Cancer. You may be at higher risk for cancer in your ovaries (ovarian cancer) if you use Imvexxy. Call your healthcare provider right away if you have any of the following symptoms.

  • Unusual vaginal discharge
  • Belly or back pain
  • Need to pee more often or urgently

Gallbladder Problems. Using Imvexxy may cause gallbladder problems, including cholecystitis and cholelithiasis (also known as gallstones). Call your healthcare provider right away if you have any of the following symptoms.

  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Fever
  • Pain in your upper stomach area
  • Stool (poop) that is clay-colored

Memory Problems. Using Imvexxy may increase your risk for memory problems (dementia), especially if you are 65 or older. Call your healthcare provider if you or friends or family notice that you are having trouble with your memory.

Increased Blood Pressure (Hypertension). Imvexxy may increase your blood pressure or worsen it if you have a history of high blood pressure. Call your healthcare provider if your blood pressure increases while using this medicine.

If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable but look out for any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heart beats

Fluid Retention (Edema). Imvexxy can cause fluid retention, also called edema. Fluid retention can cause serious issues in people with certain conditions, such as heart failure or kidney disease. Call your healthcare provider right away if you have any of the following symptoms. 

  • Chest pain
  • Irregular heartbeat
  • Shortness of breath
  • Stretched or shiny skin
  • Swollen body parts, such as the belly or ankles

Severe Allergic Reactions. Imvexxy may cause allergic reactions, which can be serious. Stop using Imvexxy and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat (angioedema)
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Imvexxy?

Allergies to Ingredients. People who are allergic to any of the following should not use Imvexxy products.

  • Estradiol
  • Imvexxy
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Imvexxy.

Blood Clots. Imvexxy should not be used if you currently have or have had blood clots in your veins, such as a deep venous thrombosis (DVT), or your lungs, such as a pulmonary embolism (PE).

Certain Cancers. Imvexxy should not be used if you have or have had breast cancer or other cancers that need estrogen to grown such as ovarian cancer and endometrial or uterine cancer. 

Stroke or Heart Attack. Do not use Imvexxy if you have had a stroke or heart attack.

Unusual Vaginal Bleeding. Do not use Imvexxy if you have abnormal bleeding from your vagina that has not been diagnosed by a healthcare provider.

Thrombophilia. Do not use Imvexxy if you have low blood levels of protein C, protein S, or antithrombin, or if you have a condition that increases your risk of developing a blood clot.

Liver Problems. Imvexxy should not be used if your liver is not working as well as it should be. If there is a concern about the health of your liver, your healthcare provider may do tests to determine if it is working well enough to use this medicine.

What should I know about Imvexxy before using it?

If you have a uterus, talk to your healthcare provider about whether adding a progestin is right for you.

Do not use Imvexxy unless it has been prescribed to you by a healthcare provider. Use it as prescribed.

Do not share Imvexxy with other people, even if they have the same condition as you. It may harm them.

Keep Imvexxy out of the reach of children.

People who are aged 65 or older can be at greater risk for some side effects from Imvexxy. Talk to your healthcare provider about your risks if you are in this age group.

Read and follow the “Instructions for Use” that come with Imvexxy. 

It is best to use the lowest dose of estrogen that works for the shortest length of time. Ask your healthcare provider how much and for how long you should use Imvexxy. 

Keep all scheduled appointments for breast exams, vaginal exams, and mammograms while using Imvexxy. 

What should I tell my healthcare provider before using Imvexxy?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Imvexxy is right for you.

In particular, make sure that you discuss any of the following.

Limited mobility. Tell your healthcare provider about any bedrest or upcoming surgery that will require you to be immobile or not be able to get up and walk around normally. Follow any instructions from your healthcare provider about when to stop and restart using Imvexxy. 

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following. 

  • Unusual vaginal bleeding or spotting after menopause
  • Cancer
  • Heart problems
  • Stroke
  • Blood clots
  • High blood pressure
  • Liver problems, including growth of abnormal blood vessels in the liver (hemangioma)
  • Asthma
  • Diabetes
  • Seizures
  • Migraines
  • Endometriosis
  • Systemic lupus erythematosus
  • Porphyria
  • Thyroid or parathyroid problems
  • Kidney problems
  • High blood calcium levels
  • Hereditary angioedema
  • Smoking
  • Gallbladder problems with estrogen use or during pregnancy

Other Medicines and Supplements. Imvexxy may interact with other medicines and supplements. Before using Imvexxy, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

High Triglyceride Levels. If you have high triglyceride levels, Imvexxy may make your triglycerides even higher. Very high triglyceride levels can lead to inflammation of the pancreas, which is called pancreatitis. Tell your healthcare provider if you have high triglyceride levels.

Pregnancy. People who can become pregnant are not usually prescribed Imvexxy. Imvexxy should not be used in pregnancy. Tell your healthcare provider if you are, think you are, or plan to become pregnant.

Breastfeeding. Estradiol passes into breast milk. Using Imvexxy can reduce the quality and quantity of milk your body makes. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Imvexxy while breastfeeding.

How can I get more information about Imvexxy?

For more information about Imvexxy, you can visit the drugmaker’s website at imvexxy.com or call them at 800-344-8661.
 

Interactions

Does Imvexxy interact with foods or drinks?

Do not eat or drink things with grapefruit or grapefruit juice in them while using Imvexxy. This could increase the estradiol levels in your blood and may cause serious side effects. 

Limit the amount of alcohol you drink while using Imvexxy. There may be increased risk for liver damage if you drink significant amounts of alcohol while using Imvexxy.

Does Imvexxy interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Imvexxy.

  • St. John’s wort, which is a supplement that may be used to treat depression
  • Phenobarbital or carbamazepine (Carbatrol, Tegretol, and others), which is a medicine to control seizures
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
  • Erythromycin (Ery-Tab and others) or clarithromycin, which is a medicine used for bacterial infections
  • Ketoconazole or itraconazole (Sporanox, Tolsura), which is a medicine used for fungal infections
  • Ritonavir, which is a medicine commonly used to treat HIV

Some other medicines may alter the blood levels of Imvexxy. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Imvexxy. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Imvexxy?

If you or someone else has used too much Imvexxy, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Imvexxy?

After starting with daily use for two weeks, Imvexxy is typically used twice a week. If you miss a dose of Imvexxy, use it as soon as you remember. You can then go back to your normal schedule or start a new two days a week schedule using this as one of your days of the week. If it is almost time for your next dose, skip the missed dose. Then use your next dose when you normally would. Do not use double or extra doses.