Vagifem (estradiol vaginal inserts) is a localized hormone replacement therapy (HRT) designed to alleviate vaginal symptoms of menopause, such as dryness, burning, and itching. Containing estradiol, a form of estrogen, Vagifem is inserted intravaginally to target these symptoms directly with minimal systemic absorption. This article explores Vagifem, how it works, its benefits, potential side effects, and essential information for women considering or currently using this medication.
What is Vagifem?
Vagifem is a prescription medication used to treat vaginal symptoms of menopause, such as dryness, burning, and painful intercourse. Unlike systemic hormone therapy (like oral pills or patches), Vagifem works locally-meaning it delivers vaginal estrogen tablets directly to the vaginal tissues without significantly increasing hormone levels in the rest of the body. Vagifem 10 mcg (estradiol vaginal inserts) are small, white, film-coated tablets containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. Vagifem 25 mcg (estradiol vaginal inserts) are small, white, film-coated tablets containing 25.8 mcg of estradiol hemihydrate equivalent to 25 mcg of estradiol. Each tablet of Vagifem 10 mcg and 25 mcg contains the following excipients: hypromellose, lactose monohydrate, maize starch and magnesium stearate. The film coating contains hypromellose and polyethylene glycol. Each Vagifem tablet is 6 mm in diameter and is placed in a disposable applicator. Each tablet-filled applicator is packaged separately in a blister pack.
How Vagifem Works
Estrogen is an important hormone for the health of the vagina. During menopause natural estrogen levels go down. When this happens, the vagina can become dry and irritated. Vaginal estradiol may reduce symptoms of menopause by raising estrogen levels in the vagina to improve vaginal health.
After insertion, the estradiol in Vagifem is absorbed directly into the vaginal lining. This localized action helps to restore vaginal moisture and elasticity, reducing discomfort and improving sexual function.
Benefits of Vagifem
Vagifem supports sexual health after menopause by relieving the physical discomforts caused by low estrogen. While it doesn’t directly increase libido, it helps remove common barriers to sexual enjoyment. With less dryness, irritation, and pain, it becomes easier to feel comfortable and confident. Some women experience urinary urgency, frequency, or mild leakage due to estrogen loss, which Vagifem can alleviate.
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Vagifem and Sexual Health
Low estrogen affects more than the skin and muscles in the vaginal area. It also changes how the brain processes sexual desire. Estrogen helps the body respond to sexual touch and stimulation. It increases blood flow, improves lubrication, and makes tissues more sensitive. When estrogen is low, like during or after menopause, sex can feel uncomfortable or even painful. Raising estrogen doesn’t act like an aphrodisiac, but it may help bring the sex drive and libido back to a state where desire can return naturally.
Possible Side Effects of Vagifem
Like all medications, Vagifem can cause side effects. However, because it is a localized treatment, the systemic absorption of estrogen is minimal, which often results in fewer and less severe side effects compared to systemic hormone therapy.
Common Side Effects
Common Vagifem side effects are usually mild and temporary. It is important to note that medication side effects may be underreported. Some common side effects include:
- Headache
- Back pain
- Breast pain and tenderness
- Abnormal vaginal bleeding or spotting
- Itching, irritation, or burning sensation in the vagina
- Stomach cramps, bloating, nausea, vomiting, or diarrhea
- Hair loss
- Fluid retention (edema)
- Vaginal yeast infection
Tell your healthcare provider if you have any of these side effects that bother you.
Serious Side Effects
While less common, some serious side effects are associated with vaginal estradiol. It is important to be aware of these and seek immediate medical attention if they occur.
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- Blood Clots: Vaginal estradiol 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 vaginal estradiol 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 vaginal estradiol. Call your healthcare provider right away if you have any abnormal vaginal bleeding. An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in a woman with a uterus. The reported endometrial cancer risk among unopposed estrogen users is about 2- to 12Âfold greater than in non-users, and appears dependent on duration of treatment and on estrogen dose. Most studies show no significant increased risk associated with use of estrogens for less than 1 year.
- Breast Cancer: You may be at higher risk for breast cancer if you use vaginal estradiol. 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 vaginal estradiol. 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 vaginal estradiol 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 vaginal estradiol 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. After an average follow-up of 5.2 years, 28 women in the estrogen-alone group and 19 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for CE-alone versus placebo was 1.49 (95 percent CI, 0.83-2.66). In the WHIMS estrogen plus progestin ancillary study, a population of 4,532 postmenopausal women 65 to 79 years of age was randomized to daily CE (0.625 mg) plus MPA (2.5 mg) or placebo. After an average follow-up of 4 years, 40 women in the CE plus MPA group and 21 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for CE plus MPA versus placebo was 2.05 (95 percent CI, 1.21-3.48).
- Increased Blood Pressure (Hypertension): Vaginal estradiol 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): Vaginal estradiol 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: Vaginal estradiol may cause allergic reactions, which can be serious. Stop using vaginal estradiol 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
- Toxic Shock Syndrome: Toxic shock syndrome may happen in people using an estradiol vaginal ring. Remove your estradiol vaginal ring and call your healthcare provider right away if you have any of the following serious symptoms:
- Fever
- Nausea, vomiting, or diarrhea
- Dizziness or fainting
- Muscle pain
- A rash on your face and body that looks like a sunburn
- Vaginal Sores: Sometimes using a vaginal estradiol ring can cause some of the lining of the vagina to get very thin, or for sores to develop. Remove your estradiol vaginal ring and call your healthcare provider right away if you have any of the following symptoms of vaginal thinning or sores:
- Pain or soreness of the vagina
- Vaginal bleeding
- Swelling, redness, or scapes in the vagina
Vagifem and Weight Gain
Vagifem delivers a very small amount of estrogen directly to the vaginal tissue. It doesn’t have much effect on the rest of the body, so it’s not likely to cause weight gain. Some women may gain weight during menopause for other reasons, such as changes in metabolism or lower activity levels.
Who Should (and Shouldn’t) Use Vagifem?
Vagifem is typically recommended for postmenopausal women experiencing moderate to severe vaginal symptoms due to low estrogen levels. However, it is not appropriate for everyone.
Who Should Use Vagifem?
Vagifem is appropriate for women experiencing:
- Vaginal dryness
- Burning
- Itching
- Painful intercourse due to menopause
Who Shouldn’t Use Vagifem?
Vagifem should not be used by individuals with certain medical conditions or a history thereof. These contraindications include:
- Allergies to Ingredients: People who are allergic to any of the following should not use vaginal estradiol products. Estradiol, Estrace, Estring, Vagifem, Femring, Yuvafem, Any of the ingredients in the specific product dispensed.
- Blood Clots: Vaginal estradiol should not be used if you have now or have a history of blood clots in your veins, such as a deep venous thrombosis (DVT), or your lungs, such as a pulmonary embolism (PE).
- Breast Cancer: Vaginal estradiol should not be used if you have, are being evaluated to see if you have, or have previously had breast cancer.
- Estrogen Dependent Cancer: Vaginal estradiol should not be used if you have cancer that needs estrogen to grow. Examples of these cancers include ovarian cancer and endometrial or uterine cancer.
- Stroke or Heart Attack: Vaginal estradiol should not be used if you have had a stroke or heart attack.
- Unusual Vaginal Bleeding: Vaginal estradiol should not be used if you have abnormal bleeding from your vagina that has not been diagnosed by a healthcare provider.
- Thrombophilia: Vaginal estradiol should not be used 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: Vaginal estradiol should not be used if your liver is not working as well as it should be.
- Pregnancy: Do not use vaginal estradiol if you are pregnant.
Use with Caution If You:
- Have a uterus: If you have a uterus, talk to your healthcare provider about whether adding a progestin is right for you.
- Surgery or Bedrest: 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.
- 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
- High Triglyceride Levels: If you have high triglyceride levels, vaginal estradiol may make your triglycerides even higher.
How to Use Vagifem Correctly
Using Vagifem properly ensures you get the maximum benefit while minimizing side effects. Each Vagifem tablet is supplied in a single-use disposable applicator. To use Vagifem correctly:
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- Separate the plastic wrap and remove the applicator from the plastic wrap. If after opening the package you see that the insert has come out of the applicator but has not fallen out of the package, carefully put it back into the applicator for insertion.
- Next select the best position for vaginal insertion of Vagifem vaginal inserts that is most comfortable for you.
- Using the other hand, guide the applicator gently and comfortably through the vaginal opening.
- Once the insert-filled applicator has been inserted, gently press the plunger until the plunger is fully depressed.
- After depressing the plunger, gently remove the applicator and dispose of it the same way you would a plastic tampon applicator.
Insertion may be done at any time of the day. It is advisable to use the same time daily for all applications of Vagifem vaginal inserts. The initial dose of Vagifem is one tablet, inserted vaginally, once daily for two weeks, at the same time each day. The maintenance dose is one tablet, inserted vaginally, twice weekly.
Tips for Best Results
- Follow your doctor's instructions carefully.
- Insert the tablet at the same time each day.
- If you miss a dose, use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose.
- Your doctor should check your progress on a regular basis to determine whether you should continue this treatment.
Vagifem: What to Expect in the First Few Weeks?
Vagifem, a low-dose vaginal estrogen tablet, typically begins to relieve symptoms of vaginal atrophy-such as dryness, itching, and discomfort-within a few weeks of regular use. Some women may notice improvements within a few days, but for most, noticeable relief occurs after two to four weeks.
Drug Interactions
Many drugs can interact with estradiol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Some products that may interact with Vagfem include aromatase inhibitors, fulvestrant, raloxifene, tamoxifen, or toremifene. In-vitro and in-vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4, such as St. John’s wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile.
Foods to Avoid
Grapefruit may interact with estradiol and lead to unwanted side effects. Do not eat or drink things with grapefruit or grapefruit juice in them while using vaginal estradiol. This could increase the estradiol levels in your blood and may cause serious side effects. Limit the amount of alcohol you drink while using vaginal estradiol. There may be increased risk for liver damage if you drink significant amounts of alcohol while using vaginal estradiol.
Precautions and Warnings
Vagifem is intended only for vaginal administration. Systemic absorption occurs with the use of Vagifem. Increased risks of stroke and DVT are reported with estrogen-alone therapy. Increased risks of PE, DVT, stroke, and MI are reported with estrogen plus progestin therapy.
Cancer Risks
Using this medicine over a long period of time may increase your risk of breast cancer, endometrial cancer, or uterine cancer. 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.
Cardiovascular Risks
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.
Dementia Risk
Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.
Vision Changes
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).
FAQs:
Can Vagifem cause weight gain or bloating?
Vagifem is not commonly associated with significant weight gain or bloating, but some women may experience mild fluid retention or a feeling of fullness as a side effect. These symptoms are generally uncommon and often temporary.
Is Vagifem safe for long-term use?
Vagifem is generally considered safe for long-term use at its low dose, especially when used under medical supervision. Studies suggest that vaginal estrogen poses minimal systemic absorption, reducing the risks linked with long-term hormone therapy. There’s no strict time limit for using Vagifem. Some women use it for a few months to relieve symptoms, while others continue longer-term. Because Vagifem is a low-dose local therapy, it’s considered safer than other forms of hormone replacement. A doctor may recommend using it regularly for as long as symptoms remain bothersome.
Can I use Vagifem along with other medications?
Tell your doctor all medications you are taking. Many drugs can interact with estradiol.
Is a Prescription required for Vagifem?
Yes, Vagifem is a prescription medication.
Can Vagifem increase the risk of cancer?
Using Vagifem can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries.
What should I do if I miss a dose of Vagifem?
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose.