August 13, 2022

Side effects, alternatives, dosage, uses, etc.

Imvexxy can cause mild or serious side effects. The following lists contain some of the main side effects that can occur when taking Imvexxy. These lists do not include all possible side effects.

For more information about the possible side effects of Imvexxy, talk to your doctor or pharmacist. They can give you advice on how to deal with side effects that may be worrying or bothersome.

To note: The Food and Drug Administration (FDA) tracks the side effects of drugs it has approved. If you would like to notify the FDA of a side effect you have had with Imvexxy, you can do so via MedWatch.

Mild side effects

Mild side effects * of Imvexxy may include:

  • headache
  • breast pain or tenderness
  • nausea or vomiting
  • fluid retention (accumulation of fluid in your body)

Most of these side effects can go away within days or weeks. But if they get worse or don’t go away, talk to your doctor or pharmacist.

* This is a partial list of mild side effects of Imvexxy. To find out more about other mild side effects, talk to your doctor or pharmacist, or see Imvexxy patient information.

Serious side effects

Serious side effects of Imvexxy are not common, but they can happen. Call your doctor immediately if you experience serious side effects. Call 911 or your local emergency number if your symptoms are life-threatening or if you think you have a medical emergency.

Serious side effects and their symptoms can include:

  • Gallbladder problems that may require surgery. Symptoms may include:
    • stomach pain, usually in the middle or upper right area
    • jaundice (yellowing of the skin or the whites of the eyes)
  • Vision problems. Symptoms may include:
    • papillary edema (a condition that causes sudden vision loss and can become permanent if left untreated)
  • Changes in some blood test results. These may include:
    • increased level of proteins that bind to natural corticosteroids and sex hormones in your body
  • Changes in your lipid (fat) levels, including cholesterol and triglycerides.
  • Impaired glucose tolerance (a condition in which your blood sugar level may be increased, but it is not high enough to be diagnosed as type 2 diabetes).
  • Breast or uterine cancer. * †
  • Cardiovascular problems. * †
  • Dementia.*†
  • Allergic reaction. *

* For more information about this side effect, see “Side effect details” below.
?? Imvexxy has a boxed warning regarding the risk of these side effects. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients to the effects of drugs that can be dangerous.

Details of side effects

Here are some details about some serious side effects this medication can cause.

Breast or uterine cancer

Imvexxy contains the active drug estradiol, which is a form of estrogen. It is a type of hormone replacement therapy (HRT) that replaces your body’s natural estrogen in your vaginal area.

Imvexxy is an estrogen-only treatment, which means it is a type of HRT in which estrogen is taken on its own, without progesterone. (For more information on using Imvexxy, see the “Uses of Imvexxy” section below.)

Even though Imvexxy is only used in the vaginal area, estrogen may be absorbed into the bloodstream. In rare cases, this can lead to an increased risk of certain cancers. *

Using estrogen-only therapy, such as Imvexxy, may increase your risk for uterine cancer. Specifically, it can increase the risk of endometrial cancer. This is a type of cancer that affects the lining of the uterus.

Some to research suggests that adding progesterone to estrogen therapy helps reduce the risk of uterine cancer. But other research shows that the combination of progesterone and estrogen can increase your risk of developing breast cancer.

After starting Imvexxy, call your doctor immediately if you have any dark, red, or bloody vaginal spotting, bleeding, or discharge. These can be early signs of endometrial cancer, and they shouldn’t be ignored. Also, call your doctor right away if you find any new breast lumps or have any other bothersome unusual symptoms.

Most forms of cancer are easier to treat if caught early. It is therefore very important that you follow your doctor’s advice for getting routine checkups and tests while you are taking Imvexxy. These may include:

If you have any questions about the risk of cancer with Imvexxy, talk to your doctor. They may suggest other ways to lower your risk. To help lower your risk of developing these cancers, it is best to limit your use of Imvexxy to the lowest possible dose for the shortest possible time.

* Imvexxy has a boxed warning regarding the risk of this side effect. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients to the effects of drugs that can be dangerous.

Cardiovascular problems

Although Imvexxy is a estrogen therapy which is only used in the vaginal area, estrogen may be absorbed into the bloodstream. In rare cases, this can lead to an increased risk of cardiovascular problems * such as stroke and deep vein thrombosis (DVT). (A DVT is a type of blood clot that can lead to a heart attack or stroke.)

Estrogen therapy, with or without progesterone, should not be used to prevent cardiovascular problems. In fact, using estrogen with progesterone can increase your risk for stroke, DVT, heart attack, or pulmonary embolism (PE). (A PE is a type of blood clot in your lungs.)

To assess your risk for cardiovascular problems, think about your current health by reading the following questions:

For every question you answered “yes” to, your risk of cardiovascular disease is increased. If you are considering using Imvexxy, talk to your doctor about ways to reduce these risk factors for cardiovascular disease.

Tell your doctor if you develop any of the following symptoms:

  • changes in your vision or ability to speak
  • sudden and severe headache
  • severe pain in the chest or legs
  • feel weak
  • difficulty in breathing

But if your symptoms are severe or life threatening, call 911 or your local emergency number.

If you have any questions about your risk for cardiovascular disease with Imvexxy, talk to your doctor.

* Imvexxy has a boxed warning regarding the risk of this side effect. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients to the effects of drugs that can be dangerous.

Dementia

Using estrogen therapy may increase the risk of dementia * (memory loss) in women † aged 65 and over who have gone through menopause. Treatment with estrogen, with or without progesterone, should not be used to prevent dementia.

You should not take estrogen, including Imvexxy, if you are an elderly person and have symptoms of dementia, such as:

  • recent memory loss
  • difficulty completing tasks that you did easily
  • speech problems
  • get lost in places that were familiar
  • misplace things
  • loss of interest
  • mood swings

If you or someone in your household notice that you have the above symptoms, talk to your doctor. Your doctor will likely ask you to stop any hormone therapy you are taking and possibly recommend other treatment options.

* Imvexxy has a boxed warning regarding the risk of this side effect. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients to the effects of drugs that can be dangerous.
† Sex and gender exist on spectra. The use of the term “female” in this article refers to the sex assigned at birth.

Allergic reaction

As with most medicines, some people may have a allergic reaction after using Imvexxy. It is not known how often an allergic reaction has occurred in Clinical studies drug.

Symptoms of a mild allergic reaction can include:

  • itchy skin
  • itching
  • flushing (temporary warmth, redness, or deepening of skin color)

A more serious allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under the skin, usually on the eyelids, lips, hands or feet
  • swelling of the tongue, mouth, or throat
  • difficulty in breathing

Call your doctor right away if you have an allergic reaction to Imvexxy, as the reaction could get serious. Call 911 or your local emergency number if your symptoms are life-threatening or if you think you have a medical emergency.


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