Imvexxy 4mcg Vaginal Inserts 8s
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 applicable (Contraindicated)
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 burning, and painful intercourse caused by menopause. It works by releasing estrogen directly into the vagina to help restore vaginal tissue, with very little of the medicine getting into your bloodstream.
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 closely.
Important Administration Instructions
Do not take this medication by mouth. It is for vaginal use only.
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 establish a routine.
Insert the medication into your vagina as directed by your doctor. Make sure you understand the correct dosage and frequency of use. If you have any questions, consult your doctor.
Hygiene Precautions
Wash your hands thoroughly before and after using the medication to maintain cleanliness and prevent infection.
Storage and Disposal
Store the medication in its original container at room temperature, away from heat sources.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember.
However, if it is 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 the same time or take extra doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Important Administration Instructions
Do not take this medication by mouth. It is for vaginal use only.
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 establish a routine.
Insert the medication into your vagina as directed by your doctor. Make sure you understand the correct dosage and frequency of use. If you have any questions, consult your doctor.
Hygiene Precautions
Wash your hands thoroughly before and after using the medication to maintain cleanliness and prevent infection.
Storage and Disposal
Store the medication in its original container at room temperature, away from heat sources.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember.
However, if it is 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 the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Maintain regular follow-up appointments with your healthcare provider.
- Report any unusual vaginal bleeding or other new symptoms immediately.
- Discuss any concerns about breast health or cardiovascular risk with your doctor.
- Do not use if pregnant or breastfeeding.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One 4 mcg vaginal insert administered vaginally once daily for 2 weeks, followed by one 4 mcg vaginal insert administered vaginally twice weekly.
Dose Range:
4 - 4 mg
Condition-Specific Dosing:
vulvarAndVaginalAtrophy:
One 4 mcg vaginal insert administered vaginally once daily for 2 weeks, followed by one 4 mcg vaginal insert administered vaginally 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 due to minimal systemic absorption.
Moderate:
No specific dose adjustment recommended due to minimal systemic absorption.
Severe:
No specific dose adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific recommendations; use with caution and monitor for adverse effects if systemic absorption is a concern.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended due to minimal systemic absorption.
Moderate:
No specific dose adjustment recommended due to minimal systemic absorption.
Severe:
Use with caution. Estrogens are metabolized by the liver; although systemic absorption is minimal, severe hepatic impairment may theoretically alter metabolism. Not recommended for use in women with severe liver dysfunction.
Pharmacology
Mechanism of Action
Estradiol is an estrogen that binds to estrogen receptors in the vagina, leading to proliferation of the vaginal epithelium, increased superficial cells, and restoration of vaginal pH. This helps to alleviate symptoms of vulvar and vaginal atrophy (VVA) due to menopause.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (local action primarily)
Tmax:
Approximately 5 hours (for systemic estradiol Cmax)
FoodEffect:
Not applicable for vaginal administration
Distribution:
Vd:
Not specifically quantified for vaginal administration, but systemically, estradiol distributes widely.
ProteinBinding:
Approximately 98% (to sex hormone-binding globulin (SHBG) and albumin) for systemically absorbed estradiol.
CnssPenetration:
Limited (for systemically absorbed estradiol, but not relevant for local vaginal action)
Elimination:
HalfLife:
Systemic estradiol half-life is 1-2 hours; however, the vaginal insert provides sustained local release.
Clearance:
Not specifically quantified for vaginal administration.
ExcretionRoute:
Primarily renal (as glucuronide and sulfate conjugates)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Weeks (for symptomatic relief of VVA)
PeakEffect:
Weeks to months (for full symptomatic relief and epithelial changes)
DurationOfAction:
Sustained local effect with twice-weekly dosing
Safety & Warnings
BLACK BOX WARNING
The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5.2 years of treatment with daily oral conjugated estrogens (CE 0.625 mg) alone or in combination with medroxyprogesterone acetate (CE/MPA 0.625 mg/2.5 mg) relative to placebo. The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily oral CE alone or in combination with MPA relative to placebo. Because IMVEXXY is an estrogen product, the risks associated with systemic estrogen therapy should be considered. However, due to the minimal systemic absorption of IMVEXXY, the relevance of these risks to IMVEXXY is uncertain.
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, 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, 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, passing out, 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, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Pelvic pain or pressure.
Vaginal irritation, itching, or discharge.
Abnormal vaginal bleeding.
Breast lump, breast pain or soreness, or nipple discharge.
Depression or other mood changes.
Memory problems or loss.
Changes in eyesight or loss, bulging eyes, or changes in how contact lenses feel.
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing.
Additional Serious Side Effects
Blood clots: 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 (in people with cancer): weakness, confusion, feeling tired, headache, upset stomach or vomiting, constipation, or bone pain.
Common Side Effects
Not everyone experiences side effects, and many people have only minor side effects. However, if you notice any of the following side effects or if they bother you or do not go away, contact your doctor:
Headache.
Hair loss.
Tender breasts.
Diarrhea, upset stomach, or vomiting.
Stomach pain or cramps.
Bloating.
* Back pain.
Reporting Side Effects
This is not an exhaustive list of 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 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, 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, 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, passing out, 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, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Pelvic pain or pressure.
Vaginal irritation, itching, or discharge.
Abnormal vaginal bleeding.
Breast lump, breast pain or soreness, or nipple discharge.
Depression or other mood changes.
Memory problems or loss.
Changes in eyesight or loss, bulging eyes, or changes in how contact lenses feel.
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing.
Additional Serious Side Effects
Blood clots: 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 (in people with cancer): weakness, confusion, feeling tired, headache, upset stomach or vomiting, constipation, or bone pain.
Common Side Effects
Not everyone experiences side effects, and many people have only minor side effects. However, if you notice any of the following side effects or if they bother you or do not go away, contact your doctor:
Headache.
Hair loss.
Tender breasts.
Diarrhea, upset stomach, or vomiting.
Stomach pain or cramps.
Bloating.
* Back pain.
Reporting Side Effects
This is not an exhaustive list of 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
- Sudden severe headache or migraine
- Sudden vision changes (e.g., blurred vision, loss of vision)
- Chest pain, shortness of breath, or coughing up blood
- Pain, swelling, or tenderness in one leg
- Yellowing of skin or eyes (jaundice)
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
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 sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
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 dose 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 sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
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 dose 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. Follow your doctor's instructions for regular blood pressure checks.
Elevated triglyceride levels have been associated with this drug. If you have a history of high triglyceride levels, inform your doctor.
This medication may interfere with 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 regularly, consult with your doctor to discuss potential interactions.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, talk to 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 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. Follow your doctor's instructions for regular blood pressure checks.
Elevated triglyceride levels have been associated with this drug. If you have a history of high triglyceride levels, inform your doctor.
This medication may interfere with 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 regularly, consult with your doctor to discuss potential interactions.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, talk to 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 potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding (in women)
What to Do:
Overdose with vaginal inserts is unlikely due to minimal systemic absorption. If suspected, discontinue use and treat symptomatically. Contact a poison control center (Call 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Complete medical history and physical examination (including blood pressure, breast, abdomen, and pelvic organs)
Rationale: To assess overall health, identify contraindications, and establish baseline for future comparisons.
Timing: Prior to initiation of therapy
Mammography
Rationale: To screen for breast cancer, as estrogens may increase risk.
Timing: Prior to initiation of therapy, as appropriate for age and risk factors
Pap test
Rationale: To screen for cervical abnormalities.
Timing: Prior to initiation of therapy, as appropriate for age and risk factors
Routine Monitoring
Periodic re-evaluation of therapy
Frequency: At least annually
Target: Not applicable
Action Threshold: Discontinue if benefits no longer outweigh risks or if symptoms resolve.
Annual physical examination (including blood pressure, breast, abdomen, and pelvic organs)
Frequency: Annually
Target: Normal findings
Action Threshold: Investigate any new or concerning findings (e.g., abnormal vaginal bleeding, breast lumps).
Mammography
Frequency: As clinically indicated based on age and risk factors
Target: Normal findings
Action Threshold: Investigate any suspicious findings.
Symptom Monitoring
- Abnormal vaginal bleeding or spotting
- Breast lumps or changes
- Changes in vision (e.g., sudden partial or complete loss of vision, sudden onset of proptosis, diplopia)
- Severe headache or migraine
- Chest pain, shortness of breath, or coughing up blood (signs of pulmonary embolism)
- Pain, swelling, or tenderness in one leg (signs of deep vein thrombosis)
- Yellowing of skin or eyes (jaundice)
- Symptoms of stroke (e.g., sudden numbness or weakness, confusion, trouble speaking, trouble walking, dizziness, loss of balance)
- Symptoms of myocardial infarction (e.g., chest pain, discomfort in other areas of upper body, shortness of breath)
Special Patient Groups
Pregnancy
Contraindicated. There is no indication for estrogen therapy in pregnancy. Estrogen exposure during pregnancy has been associated with adverse fetal outcomes.
Trimester-Specific Risks:
First Trimester:
Contraindicated. Potential for adverse effects on fetal development.
Second Trimester:
Contraindicated. Potential for adverse effects on fetal development.
Third Trimester:
Contraindicated. Potential for adverse effects on fetal development.
Lactation
Contraindicated. Estrogens can decrease the quantity and quality of breast milk. Small amounts of estrogens can be excreted in breast milk and may have undesirable effects on the nursing infant.
Infant Risk:
Risk of decreased milk production and potential adverse effects on infant (e.g., feminization, jaundice).
Pediatric Use
Not indicated for use in pediatric patients. Safety and effectiveness have not been established.
Geriatric Use
No specific dose adjustment is necessary based on age. Use the lowest effective dose for the shortest duration consistent with treatment goals. The risks associated with systemic estrogen therapy should be considered, although the relevance to low-dose vaginal estradiol with minimal systemic absorption is uncertain.
Clinical Information
Clinical Pearls
- Imvexxy is a low-dose, locally acting estrogen therapy designed to treat moderate to severe vulvar and vaginal atrophy symptoms associated with menopause.
- Its unique formulation allows for minimal systemic absorption of estradiol, which may be beneficial for women who are concerned about or cannot use systemic hormone therapy.
- Patients should be instructed on the correct insertion technique for the vaginal insert.
- Regular follow-up is important to assess symptom improvement and monitor for any potential adverse effects, including abnormal vaginal bleeding.
- While systemic risks are considered minimal, the boxed warning for estrogens should be discussed with patients.
Alternative Therapies
- Other low-dose vaginal estrogen products (e.g., Vagifem (estradiol vaginal tablets), Estring (estradiol vaginal ring), Premarin Vaginal Cream (conjugated estrogens vaginal cream), Estrace Vaginal Cream (estradiol vaginal cream))
- Ospemifene (oral selective estrogen receptor modulator for dyspareunia)
- Prasterone (DHEA) vaginal inserts (Intrarosa)
- Non-hormonal lubricants and moisturizers (e.g., Replens, K-Y Jelly) for symptomatic relief.
Cost & Coverage
Average Cost:
$150 - $250 per 8 inserts
Insurance Coverage:
Tier 2 or 3 (Brand-name prescription)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more details. 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 medical attention. When reporting the incident, be prepared to provide information about the medication taken, the amount, and the time it occurred.