Imvexxy 4mcg Vaginal Inserts 18
WARNING: Do not use this drug to prevent heart disease or dementia. A study of women taking an estrogen with a progestin showed a raised chance of heart attack, stroke, blood clot, breast cancer, and dementia. The chance of stroke, blood clot, and dementia was also raised when the estrogen was taken alone. Not all products and doses were studied. It is not known if the same effects may happen with this drug.The chance of endometrial cancer may be raised with the use of estrogen alone in patients with a uterus. Use of a progestin along with estrogen may lower the risk. Call your doctor right away if you have unexplained or long-lasting vaginal bleeding.Use this drug for the shortest time needed at the lowest useful dose. Your doctor will talk with you on a regular basis to see if you need to keep taking this drug. @ COMMON USES: It is used to treat vaginal pain during sex caused by changes that happen with menopause.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Estrogen
Pharmacologic Class
Estrogen receptor agonist
Pregnancy Category
Not available
FDA Approved
May 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Imvexxy is a small vaginal insert containing a low dose of estrogen (estradiol). It's used to treat vaginal dryness, itching, and painful intercourse that can happen after menopause. It works by restoring the natural balance and health of the vaginal tissues.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
This medication is for vaginal use only and should not be taken by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Use the medication at the same time every day to maintain a consistent routine.
Insert the medication into the vagina as instructed by your doctor, making sure to follow the recommended dosage and frequency.
* If you have any questions or concerns, consult with your doctor.
Hygiene and Handling
Before and after using the medication, wash your hands thoroughly to maintain cleanliness.
Storage and Disposal
Store the medication in its original container at room temperature, protected from heat. Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
This medication is for vaginal use only and should not be taken by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Use the medication at the same time every day to maintain a consistent routine.
Insert the medication into the vagina as instructed by your doctor, making sure to follow the recommended dosage and frequency.
* If you have any questions or concerns, consult with your doctor.
Hygiene and Handling
Before and after using the medication, wash your hands thoroughly to maintain cleanliness.
Storage and Disposal
Store the medication in its original container at room temperature, protected from heat. Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Use exactly as prescribed by your doctor.
- Do not use more than the recommended dose.
- Continue regular gynecological exams, including breast exams and Pap tests, as advised by your doctor.
- Report any unusual vaginal bleeding, breast lumps, or severe pain immediately to your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One 4 mcg vaginal insert once daily for two weeks, then one 4 mcg vaginal insert twice weekly.
Dose Range:
4 - 4 mg
Condition-Specific Dosing:
vaginal_atrophy:
One 4 mcg vaginal insert once daily for two weeks, then one 4 mcg vaginal insert twice weekly.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Estradiol is an estrogen that binds to estrogen receptors in the vaginal mucosa, leading to proliferation and maturation of vaginal epithelial cells, increased superficial cells, and a decrease in parabasal cells. This helps restore vaginal pH and alleviate symptoms of vulvar and vaginal atrophy.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly quantifiable for local vaginal application; minimal systemic absorption.
Tmax:
Not applicable for local effect; systemic absorption is minimal and variable.
FoodEffect:
Not applicable for vaginal insert.
Distribution:
Vd:
Not applicable for local vaginal application; systemically absorbed estradiol is highly protein bound.
ProteinBinding:
Approximately 98% (for systemically absorbed estradiol, primarily to sex hormone-binding globulin and albumin).
CnssPenetration:
Limited (for systemically absorbed estradiol).
Elimination:
HalfLife:
Not applicable for local effect; systemic half-life of estradiol is approximately 1-2 hours.
Clearance:
Not applicable for local effect; systemic clearance is rapid.
ExcretionRoute:
Urine (for systemically absorbed metabolites)
Unchanged:
Minimal (for systemically absorbed estradiol)
Pharmacodynamics
OnsetOfAction:
Symptomatic relief typically observed within 2-4 weeks.
PeakEffect:
Maximal symptomatic relief may take 8-12 weeks.
DurationOfAction:
Maintained with twice-weekly dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, change in stools, dark urine, yellow skin or eyes, or fever with chills.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or throwing up.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Pelvic pain or pressure, vaginal irritation, vaginal itching or discharge, or abnormal vaginal bleeding.
Breast changes: lump, pain, soreness, or nipple discharge.
Depression or other mood changes, memory problems or loss, eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Fluid retention: swelling, weight gain, or trouble breathing.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm, or trouble speaking or swallowing.
High calcium levels: weakness, confusion, feeling tired, headache, upset stomach or throwing up, constipation, or bone pain (especially in people with cancer).
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Headache
Hair loss
Tender breasts
Diarrhea, upset stomach, or throwing up
Stomach pain or cramps
Bloating
* Back pain
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, change in stools, dark urine, yellow skin or eyes, or fever with chills.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or throwing up.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Pelvic pain or pressure, vaginal irritation, vaginal itching or discharge, or abnormal vaginal bleeding.
Breast changes: lump, pain, soreness, or nipple discharge.
Depression or other mood changes, memory problems or loss, eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Fluid retention: swelling, weight gain, or trouble breathing.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm, or trouble speaking or swallowing.
High calcium levels: weakness, confusion, feeling tired, headache, upset stomach or throwing up, constipation, or bone pain (especially in people with cancer).
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Headache
Hair loss
Tender breasts
Diarrhea, upset stomach, or throwing up
Stomach pain or cramps
Bloating
* Back pain
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unusual vaginal bleeding or spotting
- New breast lump or changes in breasts
- Severe pain in your legs or chest
- Sudden shortness of breath
- Sudden severe headache or problems with vision or speech
- Yellowing of the skin or eyes
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of certain health conditions, such as:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or suspected pregnancy. Note: This medication should not be taken during pregnancy.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of certain health conditions, such as:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or suspected pregnancy. Note: This medication should not be taken during pregnancy.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before undergoing certain surgical procedures. If you need to stop taking this medication, your doctor will provide guidance on when to resume taking it after your surgery or procedure.
If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely. Follow your doctor's instructions for regular blood work and other laboratory tests.
Regular breast exams and gynecology check-ups are vital. Additionally, perform breast self-exams as instructed by your doctor.
Be aware that medications like this one can cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
Elevated triglyceride levels have been associated with this medication. Inform your doctor if you have a history of high triglyceride levels.
This medication may affect the results of certain laboratory tests. Notify all your healthcare providers and laboratory personnel that you are taking this drug.
Smoking can increase the risk of heart disease. Avoid smoking and discuss any concerns with your doctor.
If you consume grapefruit juice or eat grapefruit frequently, consult with your doctor.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor. Prolonged immobility may increase the risk of blood clots.
The risk of certain side effects, including heart attack, stroke, breast cancer, ovarian cancer, and others, may vary depending on individual factors, such as the duration of estrogen use, whether it is taken with or without a progestin, and other factors. Discuss the benefits and risks of using this medication with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.
If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely. Follow your doctor's instructions for regular blood work and other laboratory tests.
Regular breast exams and gynecology check-ups are vital. Additionally, perform breast self-exams as instructed by your doctor.
Be aware that medications like this one can cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
Elevated triglyceride levels have been associated with this medication. Inform your doctor if you have a history of high triglyceride levels.
This medication may affect the results of certain laboratory tests. Notify all your healthcare providers and laboratory personnel that you are taking this drug.
Smoking can increase the risk of heart disease. Avoid smoking and discuss any concerns with your doctor.
If you consume grapefruit juice or eat grapefruit frequently, consult with your doctor.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor. Prolonged immobility may increase the risk of blood clots.
The risk of certain side effects, including heart attack, stroke, breast cancer, ovarian cancer, and others, may vary depending on individual factors, such as the duration of estrogen use, whether it is taken with or without a progestin, and other factors. Discuss the benefits and risks of using this medication with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding (in females)
What to Do:
Overdose with vaginal inserts is unlikely due to minimal systemic absorption. If suspected, contact a poison control center (Call 1-800-222-1222) or seek emergency medical attention. Treatment is symptomatic and supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Complete medical history and physical examination (including pelvic and breast exam)
Rationale: To assess overall health, identify contraindications, and establish baseline for future comparisons.
Timing: Prior to initiation of therapy.
Blood pressure
Rationale: To establish baseline and monitor for potential cardiovascular effects (though minimal with vaginal estradiol).
Timing: Prior to initiation.
Routine Monitoring
Annual physical examination (including pelvic and breast exam)
Frequency: Annually
Target: Normal findings
Action Threshold: Any abnormal findings (e.g., new breast lump, abnormal vaginal bleeding) require immediate investigation.
Symptom assessment (e.g., vaginal dryness, dyspareunia)
Frequency: Regularly, as needed
Target: Improvement or resolution of symptoms
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of therapy.
Symptom Monitoring
- Unusual vaginal bleeding or spotting
- Breast lumps or changes
- Leg pain, swelling, or tenderness (signs of DVT)
- Sudden severe headache or visual disturbances (signs of stroke)
- Chest pain or shortness of breath (signs of MI or PE)
- Yellowing of skin or eyes (signs of liver problems)
Special Patient Groups
Pregnancy
Contraindicated. There is no indication for Imvexxy in pregnancy. Estrogen use during pregnancy is associated with potential harm to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development.
Second Trimester:
Potential for adverse effects on fetal development.
Third Trimester:
Potential for adverse effects on fetal development.
Lactation
Contraindicated/Not recommended. Estrogens can decrease the quantity and quality of breast milk. Small amounts of estrogens may be excreted in breast milk.
Infant Risk:
Potential for adverse effects on the nursing infant (e.g., feminization, decreased milk supply).
Pediatric Use
Not indicated for use in pediatric patients. Safety and effectiveness have not been established.
Geriatric Use
No specific dose adjustment is required for geriatric patients. Clinical studies included women up to 89 years of age. The safety and efficacy profile is similar to younger postmenopausal women. However, consider overall health status and comorbidities.
Clinical Information
Clinical Pearls
- Imvexxy is an ultra-low dose vaginal estradiol product specifically designed for local treatment of vulvar and vaginal atrophy (VVA) symptoms.
- Due to its minimal systemic absorption, it is generally considered safer than systemic estrogen therapy for women who only need local symptom relief and for whom systemic estrogen may be contraindicated or undesirable.
- The FDA has stated that the Black Box Warnings for systemic estrogen therapy do not apply to ultra-low dose vaginal estradiol products like Imvexxy.
- Patients should be instructed on proper insertion technique for optimal efficacy.
- It is not intended for systemic hormone replacement therapy (HRT) or for the prevention of osteoporosis.
Alternative Therapies
- Other low-dose vaginal estrogen products (e.g., Estradiol vaginal cream, Estradiol vaginal tablets (Vagifem, Yuvafem), Estradiol vaginal ring (Estring))
- Ospemifene (oral SERM for dyspareunia)
- Dehydroepiandrosterone (DHEA) vaginal insert (Intrarosa)
- Non-hormonal vaginal moisturizers and lubricants (e.g., Replens, K-Y Jelly, Astroglide)
Cost & Coverage
Average Cost:
$150 - $250 per 18 inserts
Insurance Coverage:
Tier 2 or Tier 3 (Specialty)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.