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FREQUENTLY ASKED QUESTIONS AND
IMPORTANT INFORMATION ABOUT IMVEXXY

ABOUT IMVEXXY

Is IMVEXXY a hormone replacement therapy?

Yes, IMVEXXY is a softgel vaginal insert that contains an estrogen hormone. It is a bio-identical estrogen product, which means that IMVEXXY is similar to the estrogen your body produces naturally.* The estrogen hormone in IMVEXXY is absorbed in the tissues in and around the vagina. In this way, IMVEXXY is used to treat moderate to severe pain associated with sexual activity, a symptom of changes in and around your vagina, due to menopause.

IMVEXXY is not for everyone as there are risks associated with hormone replacement therapy. See “What is the most important information I should know about IMVEXXY?” below. Professional medical guidelines state that low-dose vaginal estrogen therapies, such as IMVEXXY, are effective treatments for vaginal symptoms due to menopause.

*IMVEXXY is bio-identical estradiol that is structurally identical to the estrogen produced in the body. The relevence of risks associated with the use of synthetic hormones compared to bio-identical hormones is not known but cannot be excluded.

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Does hormone replacement therapy seem like it might be right for you?

What is the most important information I should know about IMVEXXY?
  • Using estrogen alone may increase your chance of getting cancer of the uterus (womb)
  • Report any unusual vaginal bleeding right away while you are using IMVEXXY. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause
  • Do not use estrogen alone to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function)
  • Using estrogen alone may increase your chance of having strokes or blood clots
  • Using estrogen alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • Do not use estrogen with progestins to prevent heart disease, heart attacks, strokes, or dementia
  • Using estrogens with progestins may increase your chance of having heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • You and your healthcare provider should talk regularly about whether you still need treatment with IMVEXXY

WHO SHOULD NOT USE IMVEXXY?

Do not start using IMVEXXY if you:

  • Have unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb)
  • Currently have or have had certain cancers. Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus (womb). If you have or have had cancer, talk with your healthcare provider about whether you should use IMVEXXY
  • Currently have or have had blood clots
  • Had a stroke or heart attack
  • Currently have or have had liver problems
  • Have been diagnosed with a bleeding disorder
  • Are allergic to IMVEXXY or any of its ingredients
  • Think you may be pregnant. IMVEXXY is not for pregnant women

BEFORE USING IMVEXXY

Before you use IMVEXXY, tell your healthcare provider about all of your medical conditions, including if you:

  • Have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding or spotting to find out the cause
  • Have certain medical conditions. Your healthcare provider may need to examine you more carefully if you have certain medical conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of the face and tongue), problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood
  • Are going to have surgery or will be on bed rest. You may need to stop using IMVEXXY
  • Are breastfeeding. The hormone in IMVEXXY can pass into your breast milk

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medications, vitamins, and herbal supplements. IMVEXXY may affect the way other medicines work and other medicines may affect how IMVEXXY works.

USING IMVEXXY

What is IMVEXXY used for?

IMVEXXY is used after menopause to treat moderate to severe painful intercourse, a symptom of changes in and around your vagina, due to menopause.

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Questions about IMVEXXY or other treatments for painful sex due to menopause?

How should I use IMVEXXY?

For detailed instructions, see the step-by-step Instructions for Use for IMVEXXY.

  • Use IMVEXXY exactly as your healthcare provider tells you to use it
  • IMVEXXY is a vaginal insert that you place in your vagina
  • IMVEXXY is only for use in the vagina. Do not take IMVEXXY by mouth (orally)
  • Estrogens should be used at the lowest dose possible for your treatment and for only as long as needed
  • Place 1 IMVEXXY insert inside your vagina, once a day at about the same time for the first 2 weeks
  • Then place 1 IMVEXXY insert into your vagina 2 times a week, every 3 to 4 days (for example, Monday and Thursday), for as long as you use IMVEXXY
  • You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are using and whether you still need treatment with IMVEXXY

HOW TO INSERT IMVEXXY

  • STEP 1: HOLD

    Push one IMVEXXY insert through the foil of the blister pack and hold the IMVEXXY insert with the larger end between your fingers. Remember to wash and dry your hands before handling IMVEXXY.

  • STEP 2: INSERT

    You can insert IMVEXXY lying down or standing. Select the position that is most comfortable for you, and then with the smaller end facing up, use your finger to place the insert about two inches into your vagina.

  • STEP 3: RETURN
    TO ACTIVITIES
    RIGHT AFTER USE

    Once IMVEXXY is inserted, there’s no downtime.

  • IMVEXXY IS EASY
    TO USE

    For a visual guide and detailed instructions about placing IMVEXXY in your vagina, see the Instructions for Use.

WHAT DO I NEED TO KNOW ABOUT THE SIDE EFFECTS OF IMVEXXY?

What are the possible side effects of IMVEXXY?

See “What is the most important information I should know about IMVEXXY (an estrogen hormone)?” above.

Side effects are grouped by how serious they are and how often they happen when you are treated. Serious, but less common side effects could include:

  • Heart attack
  • Cancer of the ovary
  • Dementia
  • Changes in vision
  • Liver problems
  • Low blood calcium (hypocalcemia)
  • Worsening of angioedema (swelling of the face and tongue)
  • Stroke
  • Breast cancer
  • Gallbladder disease
  • High blood pressure
  • Low thyroid levels in your blood
  • Changes in certain laboratory test results
  • Blood clots
  • Cancer of the lining of the uterus (womb)
  • High blood calcium (hypercalcemia)
  • High triglyceride (fat) levels in your blood
  • Fluid retention
  • Enlargement of benign tumors of the uterus (“fibroids”)

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

  • New breast lumps
  • Unusual vaginal bleeding
  • Changes in vision or speech
  • Sudden, new, severe headaches
  • Severe pains in your chest or legs with or without shortness of breath, weakness, and fatigue

The most common side effects of IMVEXXY include:

  • Headache
  • Breast tenderness or pain
  • Nausea and vomiting

These are not all of the possible side effects of IMVEXXY. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

You may also report side effects to TherapeuticsMD at 1-888-228-0150.

What can I do to lower my chances of a serious side effect with IMVEXXY?
  • Talk with your healthcare provider regularly about whether you should continue using IMVEXXY
  • If you have a uterus (womb), talk with your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus
  • See your healthcare provider right away if you get vaginal bleeding while using IMVEXXY
  • Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have had breast lumps or an abnormal mammogram, you may need to have breast exams more often
  • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance of getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart disease
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Questions about the safety of IMVEXXY or other treatments for painful sex due to menopause?

WHAT ARE THE INGREDIENTS IN IMVEXXY?

ACTIVE INGREDIENT: IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped inserts that contain estradiol.

INACTIVE INGREDIENTS: Each insert also contains medium chain triglycerides, polyethylene glycol stearates, ethylene glycol palmitostearate, gelatin, hydrolyzed gelatin, sorbitol-sorbitan solution, water, glycerin, FD&C Red #40, ethanol, ethyl acetate, propylene glycol, titanium dioxide, polyvinyl acetate phthalate, isopropyl alcohol, polyethylene glycol, ammonium hydroxide, and lecithin. IMVEXXY is supplied in blister cartons of 18 or 8 vaginal inserts.

USE

IMVEXXY® is a prescription medicine that contains an estrogen hormone in a vaginal insert. It is used after menopause to treat moderate to severe painful intercourse, a symptom of changes in and around your vagina, due to menopause.


Important Risk Information

MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT IMVEXXY(an estrogen hormone)

  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
  • Report any unusual vaginal bleeding right away while you are using IMVEXXY. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • Do not use estrogen-alone or with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
  • Using estrogen-alone or with progestin may increase your chances of getting strokes or blood clots.
  • Using estrogen-alone or with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
  • Using estrogens with progestins may increase your chances of getting heart attacks or breast cancer.
  • Talk to your doctor regularly about whether you still need treatment with IMVEXXY.

Do not use if you

  • have unusual vaginal bleeding.
  • currently have or have had certain cancers.
  • currently have or have had blood clots.
  • had a stroke or heart attack.
  • currently have or have had liver problems.
  • have been diagnosed with a bleeding disorder.
  • are allergic to IMVEXXY or any of its ingredients.
  • think you may be pregnant.

Warnings

Tell your healthcare provider about all of your medical conditions, including if you:

  • have any unusual vaginal bleeding.
  • have asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
  • are going to have surgery or will be on bed rest. You may need to stop using IMVEXXY.
  • are breast feeding.

Tell your healthcare provider about all the medicines you take. IMVEXXY may affect the way other medicines work, and other medicines may affect how IMVEXXY works.

When using IMVEXXY you may have


  • headache
  • breast tenderness or pain
  • nausea and vomiting


The risk information provided here is not complete. To learn more, talk about IMVEXXY with your healthcare provider or pharmacist. The FDA-approved product labeling can be found here.



You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088. You may also report side effects to TherapeuticsMD at 1-888-228-0150

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