Imvexxy 10mcg Vag Inserts 18 Strtpk
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
Category X
FDA Approved
May 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Imvexxy is a small, low-dose vaginal insert containing the hormone estradiol. It's used to treat vaginal dryness, itching, burning, and painful intercourse that can happen after menopause. It works by replacing some of the estrogen that your body no longer makes, helping to restore the health of your vaginal tissues.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
This medication is for vaginal use only and should not be taken by mouth. Avoid getting it in your mouth, nose, or eyes, as it may cause irritation or burning.
To establish a routine, take this medication at the same time every day. Insert it into the vagina as directed by your doctor, making sure you understand the correct dosage and frequency. If you have any questions or concerns, consult your doctor.
Before and after using the medication, wash your hands thoroughly to maintain hygiene.
Storing and Disposing of Your Medication
Store the medication in its original container at room temperature, protecting it from heat sources. Keep all medications in a secure location, out of the reach of children and pets.
Missing a Dose
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at once or take extra doses to make up for a missed one.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
This medication is for vaginal use only and should not be taken by mouth. Avoid getting it in your mouth, nose, or eyes, as it may cause irritation or burning.
To establish a routine, take this medication at the same time every day. Insert it into the vagina as directed by your doctor, making sure you understand the correct dosage and frequency. If you have any questions or concerns, consult your doctor.
Before and after using the medication, wash your hands thoroughly to maintain hygiene.
Storing and Disposing of Your Medication
Store the medication in its original container at room temperature, protecting it from heat sources. Keep all medications in a secure location, out of the reach of children and pets.
Missing a Dose
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at once or take extra doses to make up for a missed one.
Lifestyle & Tips
- Use the insert exactly as prescribed by your doctor.
- Do not use more than the recommended dose.
- Continue regular medical check-ups, including breast exams and mammograms, and pelvic exams.
- Report any unusual vaginal bleeding or spotting to your doctor immediately.
- Discuss any concerns about blood clots, heart disease, or cancer risk with your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mcg vaginal insert once daily for 2 weeks, then 10 mcg vaginal insert twice weekly
Dose Range:
10 - 10 mg
Condition-Specific Dosing:
vulvarAndVaginalAtrophy:
10 mcg vaginal insert once daily for 2 weeks, then 10 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 specific dose adjustment recommended
Moderate:
No specific dose adjustment recommended
Severe:
No specific dose adjustment recommended
Dialysis:
No specific dose adjustment recommended; use with caution
Hepatic Impairment:
Mild:
No specific dose adjustment recommended
Moderate:
Use with caution; monitor for adverse effects
Severe:
Contraindicated in severe hepatic impairment due to impaired estrogen metabolism
Confidence:
Medium
Pharmacology
Mechanism of Action
Estradiol is an estrogen. It binds to estrogen receptors in estrogen-responsive tissues, including the vagina, uterus, breast, hypothalamus, and pituitary gland. This binding leads to the activation of specific genes, resulting in the synthesis of proteins responsible for the physiological effects of estrogen, such as the restoration of vaginal epithelial integrity and lubrication.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic bioavailability (vaginal route), but some systemic absorption occurs. Peak serum concentrations are typically low and within postmenopausal range.
Tmax:
Approximately 5-12 hours after vaginal administration.
FoodEffect:
Not applicable for vaginal administration.
Distribution:
Vd:
Approximately 1.2 L/kg (for estradiol)
ProteinBinding:
Highly protein bound (approximately 98%) to sex hormone-binding globulin (SHBG) and albumin.
CnssPenetration:
Limited systemic penetration; primarily local action for vaginal inserts.
Elimination:
HalfLife:
Approximately 1-2 hours (for estradiol, but effective half-life for vaginal products is longer due to sustained release and local tissue binding)
Clearance:
High hepatic clearance
ExcretionRoute:
Mainly renal (as glucuronide and sulfate conjugates), some biliary/fecal.
Unchanged:
<1% (systemically)
Pharmacodynamics
OnsetOfAction:
Local symptomatic relief may begin within days to weeks.
PeakEffect:
Maximal symptomatic relief typically observed after 8-12 weeks of continuous use.
DurationOfAction:
Effects persist as long as treatment is continued; twice-weekly dosing maintains therapeutic levels for local effects.
Safety & Warnings
BLACK BOX WARNING
Estrogens, including IMVEXXY, increase the risk of endometrial cancer in women with a uterus. Adequate diagnostic measures, including directed endometrial biopsy when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurrent abnormal genital bleeding. Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) study reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50-79 years of age) receiving daily oral conjugated estrogens (CE) alone. The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older receiving daily oral CE alone. Other doses of oral estrogens and other routes of administration of estrogens have not been studied in the WHI and WHIMS and, in the absence of comparable data, these risks should be assumed to be similar. IMVEXXY is indicated only for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
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 immediate medical attention:
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, difficulty 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, changes 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, vomiting, or yellow skin or eyes.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in eyesight.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Weakness on one side of the body, difficulty speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision.
Pelvic pain or pressure, vaginal irritation, vaginal itching or discharge, or abnormal vaginal bleeding.
Breast changes: lump, pain, soreness, or nipple discharge.
Depression or 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 difficulty 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 difficulty speaking or swallowing.
High calcium levels: weakness, confusion, fatigue, headache, upset stomach or vomiting, 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, vomiting, stomach pain or cramps, bloating, or back pain.
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 immediate medical attention:
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, difficulty 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, changes 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, vomiting, or yellow skin or eyes.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in eyesight.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Weakness on one side of the body, difficulty speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision.
Pelvic pain or pressure, vaginal irritation, vaginal itching or discharge, or abnormal vaginal bleeding.
Breast changes: lump, pain, soreness, or nipple discharge.
Depression or 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 difficulty 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 difficulty speaking or swallowing.
High calcium levels: weakness, confusion, fatigue, headache, upset stomach or vomiting, 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, vomiting, stomach pain or cramps, bloating, or back pain.
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 lump in your breast or changes in your breasts
- Pain in your legs or groin, especially calf pain
- Sudden shortness of breath
- Sudden severe headache
- Dizziness or faintness
- Vision changes (e.g., sudden partial or complete loss of vision)
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain
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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are influenced by estrogen
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note that 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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are influenced by estrogen
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note that 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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels. Additionally, have your blood work and other laboratory tests checked as directed by your doctor.
Regular breast exams and gynecology check-ups are vital, and you should also perform breast self-exams as instructed by your doctor.
Be aware that this medication can cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
Elevated triglyceride levels have been associated with this drug. If you have a history of high triglyceride levels, inform your doctor.
This medication may affect the results of certain laboratory tests. Be sure to 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 years 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 closely monitor your blood sugar levels. Additionally, have your blood work and other laboratory tests checked as directed by your doctor.
Regular breast exams and gynecology check-ups are vital, and you should also perform breast self-exams as instructed by your doctor.
Be aware that this medication can cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
Elevated triglyceride levels have been associated with this drug. If you have a history of high triglyceride levels, inform your doctor.
This medication may affect the results of certain laboratory tests. Be sure to 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 years 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 women with a uterus)
What to Do:
Overdose with vaginal inserts is unlikely due to low systemic absorption. If suspected, contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive.
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole, exemestane) - concurrent use may reduce the efficacy of aromatase inhibitors.
Major Interactions
- Tamoxifen - may interfere with the therapeutic effect of tamoxifen.
- Fulvestrant - may interfere with the therapeutic effect of fulvestrant.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenobarbital, St. John's Wort) - may decrease estradiol plasma concentrations, potentially reducing efficacy.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice) - may increase estradiol plasma concentrations, potentially increasing adverse effects.
- Thyroid hormone replacement therapy - estrogens can increase thyroid-binding globulin (TBG), leading to increased circulating total thyroid hormone levels and potentially requiring an increase in thyroid hormone dose.
Minor Interactions
- Corticosteroids - estrogens may decrease the clearance of corticosteroids, leading to increased effects.
- Oral anticoagulants (e.g., warfarin) - estrogens may affect coagulation parameters; monitor INR.
Monitoring
Baseline Monitoring
Complete medical history and physical examination
Rationale: To identify contraindications, risk factors, and establish baseline health status.
Timing: Prior to initiation of therapy
Blood pressure
Rationale: Estrogens can affect blood pressure.
Timing: Prior to initiation of therapy
Breast examination and mammography
Rationale: To screen for breast cancer, as estrogen therapy may increase risk.
Timing: Prior to initiation of therapy, as appropriate for age and risk factors
Pelvic examination and Pap test
Rationale: To screen for gynecological conditions, including endometrial cancer (though risk is lower with local therapy, it's still part of general women's health).
Timing: Prior to initiation of therapy, as appropriate for age and risk factors
Lipid profile
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation of therapy
Routine Monitoring
Annual physical examination, including breast and pelvic exams
Frequency: Annually
Target: Normal findings
Action Threshold: Any abnormal findings (e.g., new breast lump, abnormal bleeding) require immediate investigation.
Mammography
Frequency: As recommended by guidelines (e.g., every 1-2 years)
Target: Normal findings
Action Threshold: Suspicious findings require further diagnostic evaluation.
Blood pressure
Frequency: Annually or as clinically indicated
Target: <130/80 mmHg
Action Threshold: Sustained elevation requires evaluation and management.
Symptom Monitoring
- Unusual vaginal bleeding or spotting
- New breast lump or changes in breasts
- Leg pain, swelling, or tenderness (signs of DVT)
- Sudden chest pain or shortness of breath (signs of PE)
- Sudden severe headache or vision changes (signs of stroke)
- Yellowing of skin or eyes (signs of liver problems)
- Abdominal pain or bloating
- Changes in mood or memory
Special Patient Groups
Pregnancy
IMVEXXY is contraindicated in women who are pregnant. There is no indication for estrogen therapy in pregnancy. Estrogen exposure during pregnancy has been associated with an increased risk of birth defects in the reproductive organs of female fetuses.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, particularly reproductive organs.
Second Trimester:
Not recommended; continued exposure may pose risks.
Third Trimester:
Not recommended; continued exposure may pose risks.
Lactation
IMVEXXY is not recommended for use during lactation. Estrogens are excreted in human milk and may decrease milk production and quality. The effects on the breastfed infant are unknown.
Infant Risk:
L4 (Possibly hazardous) - Potential for adverse effects on milk production and unknown effects on the infant.
Pediatric Use
IMVEXXY is not indicated for use in pediatric patients. Safety and effectiveness have not been established in this population.
Geriatric Use
No overall differences in safety or effectiveness were observed between older (âĨ65 years) and younger patients. However, due to the increased risk of certain conditions (e.g., cardiovascular events, dementia) with systemic estrogen therapy, the lowest effective dose should be used for the shortest duration consistent with treatment goals. Close monitoring is advised.
Clinical Information
Clinical Pearls
- Imvexxy is a low-dose vaginal estrogen product primarily for local treatment of vulvar and vaginal atrophy symptoms, with minimal systemic absorption compared to oral estrogens.
- Despite low systemic absorption, the Black Box Warning for estrogens regarding endometrial cancer, cardiovascular disorders, and probable dementia still applies, and patients should be counseled on these risks.
- Patients should be instructed on proper insertion technique to ensure optimal efficacy and minimize discomfort.
- Regular follow-up, including annual gynecological exams and mammograms, is crucial, similar to systemic hormone therapy, due to the potential for some systemic absorption and general women's health screening recommendations.
- This product is specifically for dyspareunia (painful intercourse) due to vulvar and vaginal atrophy and is not indicated for other menopausal symptoms like hot flashes.
Alternative Therapies
- Other low-dose vaginal estrogen products (e.g., Estradiol vaginal cream, Estradiol vaginal tablets (Vagifem, Yuvafem), Estradiol vaginal ring (Estring))
- Ospemifene (Osphena) - oral selective estrogen receptor modulator (SERM) for dyspareunia
- Prasterone (Intrarosa) - vaginal insert containing DHEA, converted to estrogens and androgens locally
- Non-hormonal lubricants and moisturizers (e.g., Replens, K-Y Jelly) for symptomatic relief of vaginal dryness
- Pelvic floor physical therapy
Cost & Coverage
Average Cost:
$150 - $250 per 18 inserts (approx. 3-month supply for maintenance)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Preferred Brand or Non-Preferred Brand)
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 this medication, don't hesitate to discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.