What is Vagifem (Estradiol)?

Vagifem is an estrogen derivative estradiol vaginal insert that is used for the localized treatment of menopause-related changes around and in the vagina, such as irritation, burning, or vaginal dryness that occur after a patient has experienced menopause. It may also help alleviate symptoms such as soreness, painful urination, and bleeding or pain that occur during intercourse. It may be used alongside additional medications or by itself.

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Estradiol (Generic)
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Estradiol (Generic)
Estradiol
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Estradiol (Generic)
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Product of Canada.

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Prescription Required.Product of Canada.Shipped from Canada.

What is Vagifem (Estradiol)?

Vagifem is an estrogen derivative estradiol vaginal insert that is used for the localized treatment of menopause-related changes around and in the vagina, such as irritation, burning, or vaginal dryness that occur after a patient has experienced menopause. It may also help alleviate symptoms such as soreness, painful urination, and bleeding or pain that occur during intercourse. It may be used alongside additional medications or by itself.

How is Vagifem Used?

Vagifem is a vaginal insert that releases estradiol in the localized area of the pelvic region. Due to estrogen’s tendency to cause more side effects and/or side effects that are more serious when orally consumed, it is instead a vaginally-inserted treatment option to reduce these risks.

When using Vagifem, patients will typically insert the medication once each day for a period of two weeks before decreasing the frequency of insertion to only twice per week. It consists of a tampon-like applicator that contains one tablet of the medication. The applicator should be inserted vaginally, and the plunger should then be pressed to insert the tablet inside the vagina.

If the tablet dislodges or falls out of the applicator before use, patients using this medication should dispose of the tablet and the applicator and use new ones to avoid contamination and any infection risk.

Patients should use Vagifem exactly as directed by their doctor for maximum efficacy and safety. Instructions for use may vary amongst individuals due to any preexisting comorbid health conditions.

Storage

Vagifem should be stored at an average temperature of 77°F (25°C) and should not be refrigerated. It may be allowed to reach temperatures as low as 59°F (15°C) or as high as 86°F (30°C).

Keep this medication out of the reach of children and pets at all times.

Uses

Vagifem is prescribed for the treatment of menopause-related changes occurring in or around the vagina in those who have already been through menopause. Its use typically helps to alleviate postmenopausal symptoms such as burning, soreness, irritation, painful urination, vaginal dryness, and discomfort, pain, or bleeding that occur during intercourse.

Patients with a uterus are recommended to also use progestin to help prevent endometrial cancer from developing while using Vagifem. Patients that no longer have a uterus do not require the use of progestin to reduce such risks. Regardless, the lowest dose of Vagifem should be used in all patients to help manage their symptoms while reducing all of the associated risks of estrogen therapy.

How Does Vagifem Work?

After menopause, an individual’s ovaries will stop producing estrogen and progestin. This significant reduction in estrogen causes a person’s overall estrogen levels to drop entirely, and this can result in a condition referred to as vaginal atrophy, which involves the tissues of the vagina shrinking and becoming dried out.

When a patient uses a vaginally inserted form of estrogen therapy such as Vagifem, the missing hormones are directly placed within the vagina in tablet form to dissolve and restore vaginal tissues to their pre-menopausal state and alleviate the adverse symptoms of low estrogen. Changes in the tissues typically occur within two to three weeks after beginning such treatment.

Dosage

Vagifem consists of an applicator that contains one tablet of estradiol. This medication is available in the following strength:

  • 10 mcg

Overdose

If a patient has somehow overdosed on Vagifem, this may result in various side effects, such as the following: bleeding, breast tenderness, fluid retention, nausea, headache, fatigue, vomiting, and drowsiness. Treatment for an overdose of estrogen typically consists of managing the symptoms of the overdose and discontinuing the use of estrogen therapy until those symptoms resolve.

If you or someone else have overdosed on Vagifem, you may also contact your local Poison Control Center or physician for further assistance.

Side Effects

As a hormonal medication, it is associated with a number of different side effects that will vary amongst individual patients.

The most common side effects of taking Vagifem are as follows:

  • bloating
  • breakthrough bleeding
  • breast pain or tenderness
  • changes in the menstrual cycles
  • hair loss
  • headaches
  • nausea
  • stomach cramps
  • swelling of the feet or hands
  • weight gain
  • vaginal discharge
  • vaginal itching
  • vomiting
  • yeast infection

Some of the more serious following side effects may also occur when using Vagifem, and these should be discussed with your doctor as soon as possible:

  • balance issues
  • bone pain
  • changes in behavior
  • chest pain
  • confusion
  • constipation
  • coughing up blood
  • diarrhea
  • dizziness
  • fainting
  • fever with nausea
  • formation of a lump in the breast
  • increased thirst
  • increased urination
  • jaundice (yellowing of the eyes or skin)
  • lack of energy
  • memory problems
  • muscle pain
  • muscle weakness
  • pelvic pain
  • skin rash that is similar to sunburn
  • shortness of breath
  • slurred speech
  • stabbing chest pains
  • stomach pain or tenders
  • sudden severe headache
  • sudden vision loss
  • sweating
  • unusual vaginal bleeding
  • vision changes or difficulties
  • vomiting
  • warmth or pain in the legs

Warnings & Precautions

Estrogen therapy, which includes medications such as Vagifem, is closely associated with a number of different health conditions in those using hormonal treatments. Please discuss all preexisting health conditions and current medications with your doctor before beginning treatment with Vagifem, and be sure to receive regular checkups to monitor your overall health when using this medication.

Breast Cancer

High levels of estradiol within a person’s blood have been linked to an increased risk of developing breast cancer in those who are postmenopausal. As Vagifem is a vaginal insert containing estradiol, this places patients using the medication at a higher risk of breast cancer compared to those not using such products. Patients that are using Vagifem should not skip any yearly checkups involving breast exams and mammograms due to this significant risk factor.

Cardiovascular Disorders

Estrogen-only medications, such as Vagifem, have been linked to an increased risk of multiple cardiovascular conditions. This includes coronary heart disease and significant cardiovascular events such as deep vein thrombosis and stroke. Individuals with risk factors for the development of these conditions should exercise caution when using Vagifem. Some of the notable risk factors include diabetes, obesity, hypertension, tobacco use, lupus, and a family or personal history of venous thromboembolism. If any cardiovascular events are suspected or occur while using Vagifem, the patient should stop using the medication immediately.

Endometrial Cancer

Endometrial cancer is associated with prolonged use of estrogen therapy, such as Vagifem, in those who have a uterus. Those who use Vagifem are at a 2 to 12 times greater risk of developing endometrial cancer compared to those who do not use any form of estrogen therapy. The risks appear to increase the longer an individual uses Vagifem, and higher doses of estrogen in the body have been shown to increase this risk as well. A patient’s level of risk associated with estrogen use and endometrial cancer will remain high for up to 15 years, even after such hormone therapy has ceased.

Endometriosis

Patients with endometriosis are likely to experience a worsening of the inflammation and pain associated with their condition when using any estrogen products, such as Vagifem. In postmenopausal patients, the natural decrease in their estrogen levels tends to alleviate the symptoms of endometriosis. However, when using this medication or any other forms of hormone therapy to manage the symptoms of low estrogen after going through menopause, this may likely reactivate the endometriosis still remaining within their bodies and contribute to the development of malignancies associated with endometriosis.

Gallbladder Disease

Estrogen therapy, such as the use of Vagifem, in postmenopausal patients is a risk factor in those patients developing gallbladder disease. This risk remains increased even after the medication has been discontinued.

Hypercalcemia

Patients with bone metastases and breast cancer may experience severe hypercalcemia, or dangerously high levels of calcium in the blood, when using Vagifem. This is due to the fact that estrogen-based therapies, when used in patients that are postmenopausal, have these hormones impact their parathyroid function and significantly increase PTH levels, resulting in hypercalcemia.

Hypothyroidism

Patients using thyroid hormone replacement therapy to manage their hypothyroidism may require adjustments to their thyroid medications to balance out the effects of Vagifem on TBG levels. Those using Vagifem while managing hypothyroidism should have their thyroid function monitored during treatment to avoid any adverse side effects.

Ovarian Cancer

Patients using Vagifem and other similar estrogen-related products have been shown to have an increased risk of developing ovarian cancer. The risk of ovarian cancer appears to be higher in those using it and other such products for five years or more, but the studies and their findings related to estrogen products and ovarian cancer development have not been consistent enough to provide solid statistics.

Ocular Changes

Estrogen therapies, like Vagifem, have been linked to serious eye-related conditions such as retinal vascular thrombosis (or retinal vein occlusion). Patients using such medications may experience a sudden onset of migraine, double vision, proptosis (bulging of the eyes), or a sudden loss of vision that may be partial or complete. In these instances, medical attention should be sought immediately. If a patient has developed vascular lesions or papilledema, they should stop using Vagifem indefinitely.

Worsening of Other Medical Conditions

Vagifem may also result in changes to or worsening of the following conditions:

  • angioedema
  • asthma
  • cardiac or renal dysfunction
  • cholestatic jaundice
  • diabetes
  • epilepsy
  • hepatic hemangiomas
  • hepatic impairment
  • high blood pressure
  • hypocalcemia
  • hypoparathyroidism
  • lupus
  • migraines
  • porphyria

Drug Interactions

Speak to your doctor about any medications or herbal supplements you are currently taking before beginning treatment with Vagifem. Discuss any concerns you may have with your doctor or a trusted pharmacist.

Drugs That Amplify the Risk of Vagifem Side Effects

These medications and substances are known to interact with Vagifem and may increase your chances of experiencing adverse Vagifem side effects:

  • clarithromycin
  • erythromycin
  • grapefruit juice
  • itraconazole
  • ketoconazole
  • ritonavir

Drugs That May Make Vagifem Less Effective

The following medications and substances are likely to affect the metabolism of Vagifem and result in decreased efficacy or changes in the menstrual cycle:

  • carbamazepine
  • phenobarbital
  • rifampin
  • John’s wort

Alternative Medications

For patients who are unable to take Vagifem or experiencing significant adverse side effects, alternative medications may be used to treat some of the associated conditions for which this medication is commonly prescribed:

  • Estrace (estradiol vaginal cream)
  • Estring (estradiol vaginal ring)
  • Femring (estradiol acetate vaginal ring)
  • Premarin (conjugated estrogen tablets)
  • Vagirux (estradiol hemihydrate vaginal tablets)
  • Yuvafem (estradiol vaginal inserts)

Frequently Asked Questions

Vagifem is a form of hormone replacement therapy that is referred to as “local estrogen therapy.” This allows the estrogen within the medication to work within the pelvic region to alleviate postmenopausal symptoms, especially those affecting the vagina. Other forms of estrogen or hormone replacement therapy, regardless of their method of administration, result in estrogen circulating within the entire body rather than just a localized area, which can result in far more side effects associated with estrogen therapy.

Vagifem begins to dissolve and increase estrogen levels right after it has been inserted, but most patients using the medication do not notice a significant improvement in their postmenopausal symptoms until nearly 8 to 12 weeks after beginning treatment.

Most weight gain that occurs with the use of Vagifem can be attributed to bloating or swelling (fluid retention). However, due to the hormonal changes that will be occurring within the patient’s body, it is possible for weight gain to occur.

It is currently suggested that patients remain using Vagifem to manage their symptoms for as long as needed. However, the average duration of treatment tends to be 12 months. Prolonged use of estrogen-based products may result in higher risks of serious conditions developing if estrogen levels become too high. Patients should be monitored throughout the duration of their treatment to avoid serious risks.

Low levels of estrogen contribute to individuals experiencing genital and bladder changes that result in incontinence and urinary frequency. When using Vagifem to increase estrogen levels in the vagina and pelvic region, this can help alleviate the symptoms of certain urinary conditions, including issues such as nocturia (nighttime urination urges), urinary incontinence, urinary urgency, and urinary frequency.

Estradiol, including Vagifem, is known to cause changes in a person’s mood. Individuals using this drug may experience mood-related symptoms such as mood swings, depression, anger, irritability, and issues with memory loss.

Unlike estrogen creams and other vaginal hormone replacement therapy options, Vagifem does not tend to cause any sensation of leaking out of the vagina after use. It simply dissolves after insertion and does not cause any type of mess.

There are no specific requirements regarding what time of day a person should insert and use Vagifem. However, the patient should be sure that the medication is used at the same time each day when administering their scheduled dose.

High levels of estrogen are associated with fibroid growth and development. Oral estrogen and other forms are likely to increase the body’s overall levels of estrogen and result in such a risk. Due to Vagifem’s local absorption that avoids significant amounts of estrogen making it into the bloodstream, using this medication is unlikely to result in fibroid growth.

Due to Vagifem being vaginally absorbed, the amount of estrogen that makes its way into a patient’s bloodstream is minimal compared to those who use oral or injectable forms of estrogen.

Vagifem requires a prescription from your doctor and is not available over the counter. Due to the health risks of using this medication, a doctor is required to monitor patients using this medication to ensure that the treatment is both safe and effective.

While estradiol by itself is a type of estrogen that is naturally produced within the body, the estradiol that is found in Vagifem is simply produced in a lab. Otherwise, Vagifem and estradiol are essentially the same.

Vagifem’s primary active ingredient is estradiol. The tablets also contain the following ingredients: magnesium stearate, maize starch, lactose monohydrate, polyethylene glycol, and hypromellose.

One of the potential side effects of using Vagifem is the development of vaginal yeast infections (thrush). If a patient develops thrush and requires the use of vaginal medications to alleviate such an infection, they may need to stop using it until the condition has resolved. Patients that develop thrush or symptoms of a vaginal yeast infection should report these changes to their doctor.

After insertion has occurred, Vagifem tablets take several hours to completely dissolve and be absorbed by the body.

Yes. Vaginal atrophy is a common condition in almost 60% of those who have gone through menopause or are perimenopausal.

As soon as Vagifem is inserted and begins to be absorbed into the patient’s tissue, it begins to work. However, it may take between 8 to 12 weeks to rebalance an individual’s hormone levels and show significant improvement in their symptoms.

Since some patients may have stopped using Vagifem after it already alleviated their post-menopausal symptoms once before, they are still perfectly safe beginning treatment with the medication again if those same symptoms return.

If the tablet falls out of the applicator after it has been removed from the packaging, it should be disposed of due to the risk of contamination. However, if the Vagifem tablet becomes dislodged from the applicator while still in the sealed packaging, patients should handle the medication with clean and dry hands or with sterile gloves and carefully place the medication back into the applicator. This should only be done if the Vagifem tablet has fallen out within the packaging and has not become contaminated.

Vagifem applicators are a one-time-use item. These applicators are intended to be used only once and then disposed of in the same manner as one would do with a tampon applicator. They should not be reused.

Dosing requirements may vary during the first few weeks of use, so patients that have missed a dose or suspect they may be likely to miss a dose at some point should discuss how to handle such an issue with their prescribing physician.

As a form of local estrogen therapy, the medication is inserted directly into the vagina itself to provide direct treatment to the affected areas. This reduces the risks of full-body exposure to estrogen that other forms of estrogen therapy cause, making Vagifem a safe and effective option specifically for the treatment of vaginal symptoms.

As with any type of hormone-related therapy or medication, the safety and efficacy of these treatment methods have been studied and deemed safe for most individuals. However, patients are encouraged to review the safety information available and discuss their medical history, current medications, and any potential risk factors that may affect their treatment plan with their physician. Estrogen therapy may not be suitable for all patients.

Vagifem is used by inserting the applicator into the vagina and pressing down on the plunger to insert the medication directly into the localized area for treatment that avoids negatively impacting the rest of the body. By doing this once to twice per week, the patient will be able to reverse some of the hormonal changes that have taken place within the vagina and pelvic region directly.

Vagifem works by dissolving into the patient’s vaginal tissues to restore proper balance to the individual’s hormone levels and reduce the symptoms of low estrogen, such as vaginal atrophy.

As Vagifem causes changes in the hormone levels within a patient’s body, changes in weight may occur when using this medication. However, most weight gain while taking Vagifem can simply be attributed to fluid retention (swelling or bloating).

Vagifem is capable of causing changes in a patient’s moods while using this medication, as this is a common side effect of using any medication that includes estradiol. These changes may include memory loss, irritability, anger, mood swings, or depression. If you are experiencing significant changes in mood and personality while using Vagifem, please discuss these changes with your prescribing physician.

Using Vagifem can result in an increased risk of a patient developing blood clots. This is due to the fact that estrogen causes an increase in the body’s clotting factors and increases coagulation when it occurs, thereby resulting in a higher risk of blood clots forming.

Vagifem has not been reported to cause any sensation of the medication leaking out from the vagina after it has been inserted. It is designed to simply dissolve into the vaginal tissues, unlike some of the other vaginal hormone replacement medications (such as creams), which are more likely to be messy.

Vagifem is less likely to result in fibroid growth as the hormone treatment is localized due to the act of vaginal insertion. When taking oral medications that include estrogen or otherwise affect a person’s hormone levels, these types of medication are much more likely to increase the amount of estrogen present throughout the patient’s entire body, and this is what is most associated with a higher risk of fibroid growth.

Vagifem is a form of estrogen therapy, and this type of hormone-related treatment has been associated with an increased risk of developing conditions such as dementia, especially in older patients that may be using such medications.

The active ingredient in Vagifem is estradiol. Vagifem tablets contain the following inactive ingredients as well: hypromellose, polyethylene glycol, lactose monohydrate, magnesium stearate, and maize starch.

As the use of tobacco products can cause an increased risk of high blood pressure, blood clots, stroke, and heart attack when used alongside medications that include estrogen, it is strongly advised to avoid smoking or otherwise using tobacco while also using Vagifem.