Imvexxy
Imvexxy (estradiol vaginal insert) is used to treat pain during sex due to vaginal thinning caused by menopause. It contains estradiol, a type of estrogen, which helps restore the vaginal tissues and reduce discomfort during sex. Imvexxy comes as a small softgel insert that's placed directly into the vagina without an applicator. It's available in a starter pack and a maintenance pack. You’ll typically use one insert twice a week after using it daily for the first 2 weeks. The most common side effect is headache.
What is Imvexxy?
What is Imvexxy used for?
- Moderate to severe painful sex due to vaginal thinning from menopause
How Imvexxy works
Imvexxy is an estrogen replacement. It replaces the natural estrogen your body loses during menopause. The medication works by raising estrogen levels in the vagina, which helps restore the vaginal lining and relieve pain during sex.
Drug facts
Side effects of Imvexxy
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (3-4%)
Less Common Side Effects
- Vaginal discharge
Imvexxy serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Blood clot in arm or leg: swelling, pain, or tenderness in the arm or leg; skin that's warm to the touch
- Blood clot in the lung: trouble breathing, chest pain
- Heart attack: chest pain, arm pain, shortness of breath, cold sweat, lightheadedness
- Stroke: sudden weakness on one side of the body, drooping face, changes in your speech or vision, confusion, bad headache
- Unusual or heavy vaginal bleeding
More on Imvexxy side effects
The following Imvexxy side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
- Breast tissue changes, new lumps, redness, pain, or discharge from the nipple
- Change in vision
- Gallbladder problems—severe stomach pain, nausea, vomiting, fever
- Increase in blood pressure
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
- Unusual vaginal discharge, itching, or odor
- Vaginal bleeding after menopause, pelvic pain
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
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Pros and cons of Imvexxy
Pros
- FDA approved for pain during sex due to menopause
- Comes in two different strengths
- Can use it at any time of the day
Cons
- Not taken daily, so can be easy to forget a dose
- Doesn't treat other menopause symptoms like hot flashes or night sweats
- Must take a progestin if you have a uterus to lower your risk of uterine cancer
Pharmacist tips for Imvexxy
- You'll typically use Imvexxy daily for 2 weeks, then twice a week (every 3 to 4 days) after that. Choose two days a week and mark them on your calendar to help you remember to take your dose.
- You can insert Imvexxy at any time of day, but try to use it around the same time each day. This helps keep your routine consistent.
- Each applicator contains one tablet that will be placed in the vagina. Never take Imvexxy by mouth.
- Imvexxy has some serious risks like heart attacks and strokes. Because of this, use it for the shortest time needed and check in with your prescriber regularly to see if you still need it.
- Tell your prescriber right away if you notice unusual vaginal bleeding, breast lumps, vision changes, or severe headaches after starting Imvexxy. These aren’t typical side effects and could be signs of a more serious problem.
How to use Imvexxy
- Wash your hands with warm water and soap before and after using Imvexxy. Make sure to dry them well before touching the softgel.
- While lying back or standing, insert the softgel's smaller end first about 2 inches into your vagina using your finger.
Common questions about Imvexxy
No, Imvexxy isn't made from horse urine. Instead, it's made in a lab to work like the natural estrogen your body makes.
Estrogen products like Imvexxy might raise your risk for certain cancers including uterine (endometrial) cancer and breast cancer. But vaginal estrogen is absorbed less into the body than estrogen taken by mouth. It isn't fully clear how the small amount that is absorbed affects your cancer risk, but one large study suggests that vaginal estrogen likely doesn't raise your risk of cancer. Talk with your prescriber about the risks and benefits of using this medication.
While exact time can vary from person to person, studies show that most of Imvexxy dissolves within 15 minutes. The softgel is typically fully dissolved within 6 hours.
Hair loss wasn’t a common side effect reported in studies of Imvexxy. If you notice more hair falling out than usual, reach out to your prescriber. They can help you figure out the cause of your hair loss and recommend next steps.
The length of time you take Imvexxy should be a decision you make together with your prescriber. They might recommend continuing the medication as long as it helps with your symptoms and you're not having side effects. But keep in mind that using this medication long term might raise your risk for serious side effects. Be sure to check in with your prescriber regularly so they can help you decide if you still need it.
People taking Imvexxy in studies didn't commonly report yeast infections as a side effect. But yeast infections have been linked with other vaginal estrogen products.Talk to your prescriber if you have symptoms of a yeast infection including vaginal itching and thick, white discharge.
Both Vagifem and Imvexxy are vaginal inserts that contain estradiol, but they're FDA approved for different uses. Imvexxy is approved to treat pain during sex due to menopause, while Vagifem is for vaginal dryness and thinning from menopause. Imvexxy comes in two strengths (4 mcg and 10 mcg) and is inserted with your finger. On the other hand, Vagifem only comes in one strength (10 mcg) and is inserted using an applicator. Talk to your prescriber if you have questions comparing the two medications.
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Risks and warnings for Imvexxy
Imvexxy can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk for blood clots and related complications
- Risk factors: Personal or family history of blood clots | High blood pressure | Diabetes | High cholesterol | Smoking | People who identify as obese | Systemic lupus erythematosus (SLE)
Estrogen therapy, like Imvexxy, can raise your risk of blood clots. Sometimes, these blood clots can be very dangerous and lead to a heart attack, stroke, or a blood clot in your lungs (called a pulmonary embolism). Because of this risk, Imvexxy shouldn't be used to prevent heart disease.
Tell your prescriber about your full medical history, especially if you've ever had a blood clot. Also let them know if you have a planned surgery or expect to be on bedrest for a long time. Your prescriber will let you know when to stop Imvexxy before your procedure and when to restart it after you're moving around again to lower your risk of blood clots. In general, you should use the lowest dose for the shortest amount of time to stay safe.
Know the signs of a blood clot or related problem:
- Blood clot in arm or leg: swelling or pain in the arm or leg
- Blood clot in the lung: chest pain, trouble breathing
- Blood clot in the eye: sudden partial or complete vision loss, bulging eyes, double vision
- Heart attack: chest pain, arm pain, shortness of breath, a cold sweat, lightheadedness
- Stroke: sudden weakness on one side of the body, drooping face, trouble breathing, bad headache, changes in speech or vision
Remove Imvexxy and get medical help right away if you have any signs or symptoms of a blood clot.
Risk for uterine cancer (also called endometrial cancer)
- Risk factors: Taking Imvexxy by itself without additional progestin if you have a uterus | Taking estrogen therapy for more than one year | High estrogen dose
Estrogens like estradiol, found in Imvexxy, can thicken and change the lining of your uterus (called the endometrium). This can lead to uncontrolled growth of the uterine lining and put people who have a uterus at risk for uterine cancer (or endometrial cancer). Watch for warning signs like vaginal bleeding after menopause or pelvic pain, and let your prescriber know if you notice anything unusual.
Because of this cancer risk, if you haven't had your uterus removed (through a hysterectomy), your prescriber will usually have you take a progestin along with Imvexxy. Progestins help balance estrogen's effect and protect the uterus. Speak with your prescriber if you have questions about uterine cancer risk and how to lower it.
Risk for breast cancer
- Risk factors: Personal or family history of breast cancer | Taking estrogen and progestin together | Taking estrogen for many years
Studies suggest that taking estrogens like Imvexxy for several years might raise the risk for breast cancer. This risk is even higher if you take estrogen with a progestin. Don't take Imvexxy if you currently have or have ever had breast cancer.
To lower your risk for breast cancer, take the lowest dose of Imvexxy for the shortest time needed. Regularly check your breasts for any changes and get recommended breast scans (mammograms). Let your prescriber know if you notice any lumps, pain, or swelling in your breasts.
Risk for ovarian cancer
- Risk factors: Taking estrogen and progestin together
Some studies suggest that people who take estrogens like Imvexxy for menopause symptoms might have a higher risk for ovarian cancer. Speak with your prescriber if you're concerned about this risk. Let your care team know if you have any unusual bloating, pelvic pain, trouble eating, or feeling full quickly. These can be signs of ovarian cancer.
Risk for dementia
- Risk factors: Older adults
People ages 65 and older who take estrogen medications like Imvexxy might have a higher risk of developing dementia. Because of this, estrogen therapy shouldn’t be used to prevent dementia.
Be aware of the early signs of dementia, such confusion, memory loss, getting lost, or struggling to do everyday tasks. If you’re worried about the risk for dementia, talk to your prescriber.
Gallbladder or liver problems in certain people
- Risk factors: History of liver disease or jaundice
The risk for gallbladder problems is higher for people who have gone through menopause and are taking estrogen therapy, like Imvexxy. In some cases, these problems have required surgery. Let your prescriber know if you've ever had jaundice (yellowing of your skin or whites of your eyes). Also tell your care team right away if you notice jaundice, stomach pain that doesn't go away, nausea, or vomiting while you're taking this medication — these could be signs of liver damage or gallbladder problems.
High triglyceride (fat) levels
- Risk factors: History of high triglyceride levels in the blood
Let your prescriber know if you've ever had high triglyceride levels. Estrogens like estradiol (found in Imvexxy) can sometimes raise the amount of triglycerides (fat) in your blood. Having too much can lead to swelling of the pancreas (pancreatitis). Tell your care team right away if you have symptoms like sudden stomach or back pain, nausea, vomiting, fever, or weakness.
Changes in calcium levels in certain people
Estrogen therapy like Imvexxy can affect the calcium levels in your blood. People with breast cancer or cancer that's spread to the bones are at higher risk of dangerously high calcium levels while they're taking estrogens. Tell your care team if you have any symptoms of high calcium levels like tiredness, muscle weakness, bone pain, nausea, constipation, and thirst.
On the other hand, if you have low parathyroid hormone levels, estrogen can cause your calcium to drop too low. Call your care team if you have signs of low calcium, like muscle cramps, brittle nails, or tingling in your fingers, toes, or lips.
Low thyroid hormone levels
- Risk factors: Conditions that cause low thyroid hormone levels
Estrogen therapy like Imvexxy can change thyroid hormone levels. If you have low thyroid hormone levels (hypothyroidism), it might be harder for your body to adjust. If you're taking thyroid replacement medication, you might need a higher dose while using estrogen therapy. Talk to your prescriber so they can help adjust your medication if needed.
Buildup of fluids in your body (fluid retention)
- Risk factors: Certain heart conditions | Kidney damage
Estrogen therapy like Imvexxy can make your body hold onto extra fluids. This can sometimes cause swelling of your hands and feet. Fluid retention can worsen symptoms of certain heart conditions like heart failure, or kidney damage. If you have heart or kidney problems, tell your healthcare team right away if you notice swelling, sudden weight gain, or other signs of fluid retention while taking Imvexxy.
Worsening of certain other health conditions
Before you start Imvexxy, talk to your care team about your medical history. Estrogen-containing medications can make certain health conditions worse, and you might need closer monitoring. These conditions include diabetes, asthma, migraine, lupus, seizures, and hereditary angioedema.
Imvexxy dosage
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 8 inserts of 4mcg | 1 carton | $85.00 | $85.00 |
| 8 inserts of 10mcg | 1 carton | $85.00 | $85.00 |
| 18 inserts of 10mcg | 1 carton | $85.00 | $85.00 |
| 18 inserts of 4mcg | 1 carton | $85.00 | $85.00 |
Typical dosage for Imvexxy
Each Imvexxy vaginal softgel contains 4 mcg or 10 mcg of estradiol. You'll generally start with the 4 mcg dose, and your prescriber might raise your dose if needed.
Place 1 softgel into the vagina once a day for the first 2 weeks. After that, place 1 softgel into the vagina twice a week, every 3 to 4 days (for example, on Monday and Thursday).
How much does Imvexxy cost?
$85.00
Imvexxy contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Imvexxy will not be safe for you to take.
- Abnormal vaginal bleeding
- History of breast cancer
- Tumor that depends on estrogen for growth
- History of blood clot or blood clotting conditions
- History of heart attack or stroke
- Liver problems
What are alternatives to Imvexxy?
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