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Imvexxy (Vaginal)

Generic name: estradiol [ es-tra-DYE-ol ]
Brand names: Estrace, Estring, Femring, Imvexxy, Vagifem
Drug class: Estrogens

Medically reviewed by Drugs.com. Last updated on Jan 18, 2024.

Vaginal route(Insert, Extended Release;Cream)

Estrogen Alone Therapy

Endometrial Cancer - There is an increased risk of cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding .Cardiovascular Disorders and Probable Dementia - The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo .Cardiovascular Disorders and Probable Dementia - The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women .Cardiovascular Disorders and Probable Dementia - Do not use estrogen and progestin therapy for the prevention of cardiovascular disease or dementia .Cardiovascular Disorders and Probable Dementia - Only daily oral 0.625 mg CE was studied in the estrogen -alone substudy of the WHI. Therefore, thee relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile .Cardiovascular Disorders and Probable Dementia - In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.

Cardiovascular Disorders and Probable Dementia - Prescribe estrogens with or without progestins at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman .Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia - The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with combined medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo .Cardiovascular Disorders and Probable Dementia - The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women .Cardiovascular Disorders and Probable Dementia - Do not use estrogen and progestin therapy for the prevention of cardiovascular disease or dementia .Breast Cancer - The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer .Breast Cancer - Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile .Breast Cancer - Prescribe estrogens with or without progestins at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman .

Vaginal route(Insert, Extended Release)

Use of unopposed estrogens increases the risk of endometrial cancer, while addition of a progestin decreases the risk of endometrial hyperplasia. Rule out malignancy if abnormal vaginal bleeding develops. Do not use estrogen alone or in combination with progestin to prevent cardiovascular disease or dementia. There is an increased risk of cardiovascular disorders (ie, DVT, pulmonary embolism, stroke, myocardial infarction) with combination therapy in women 50 years or older, and an increased risk of dementia in women 65 years or older with estrogen monotherapy or combination therapy. Combination therapy also increases the risk of invasive breast cancer. Prescribe estrogens with or without progestins at the lowest effective dose and for the shortest duration consistent with risks and treatment goals .

Uses for Imvexxy

Estradiol vaginal gel, insert, and ring are used to treat changes in and around the vagina (such as vaginal dryness, itching, and burning) caused by low estrogen levels or menopause.

Estradiol vaginal gel and ring are also used to treat moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen. The hormone from the vaginal gel or ring is absorbed through your vagina. It works by preventing symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (hot flashes) in women during menopause.

Estradiol vaginal insert is also used to treat moderate to severe painful sexual intercourse caused by menopause.

This medicine is available only with your doctor's prescription.

Before using Imvexxy

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of estradiol vaginal gel, insert, or ring in the pediatric population. Use of estradiol vaginal gel, insert, or ring is not indicated for use in children.

Geriatric

Although appropriate studies on the relationship of age to the effects of estradiol vaginal gel, insert, or ring have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have breast cancer, strokes, or dementia, which may require caution in patients receiving estradiol vaginal gel, insert, or ring.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Proper use of Imvexxy

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

This medicine is to be used only in the vagina. Use it at bedtime unless your doctor tells you otherwise.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the vaginal ring:

To use the Imvexxy™ vaginal insert:

To use the Vagifem® vaginal insert:

To use the Divigel®:

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Wrap the used vaginal ring in tissue or toilet paper and throw it in the trash can. Do not flush it down the toilet.

Precautions while using Imvexxy

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits may be every 3 to 6 months. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine over a long period of time may increase your risk of breast cancer, endometrial cancer, or uterine cancer. Talk with your doctor about this risk. If you still have your uterus (womb), ask your doctor if you should also use a progestin medicine. Check with your doctor immediately if you experience abnormal vaginal bleeding.

Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.

Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes, or if you are overweight or smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.

Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine. This medicine may also affect the results of certain medical tests.

Check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Tell your doctor about any problems with your vagina, (eg, having an unusually shaped or narrow vagina). Tell your doctor if you have problems with your reproductive organs, bladder, rectum, or pelvic area.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of Imvexxy

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Incidence not known

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Commonly used brand name(s)

In the U.S.

Available Dosage Forms:

Therapeutic Class: Female Reproductive Agent

Pharmacologic Class: Estrogen

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.