Imvexxy 10mcg 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
Hormone Replacement Therapy
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, soft 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 the 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 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 before and after handling the medication to maintain cleanliness and prevent infection.
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 Instructions
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 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 before and after handling the medication to maintain cleanliness and prevent infection.
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 Instructions
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 make up for a missed dose.
Lifestyle & Tips
- Use exactly as prescribed by your doctor.
- Do not use more than the recommended dose.
- Report any unusual vaginal bleeding, breast lumps, or other new symptoms to your doctor immediately.
- Maintain regular follow-up appointments and screenings (e.g., mammograms, pelvic exams) as advised by your doctor.
- Discuss any concerns about long-term use with your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mcg (one insert) vaginally once daily for 2 weeks, then 10 mcg (one insert) twice weekly
Dose Range:
10 - 10 mg
Condition-Specific Dosing:
vulvarAndVaginalAtrophy:
10 mcg (one insert) vaginally once daily for 2 weeks, then 10 mcg (one insert) twice weekly
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
No specific adjustment recommended due to minimal systemic absorption.
Severe:
No specific adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific adjustment recommended due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
No specific adjustment recommended due to minimal systemic absorption.
Severe:
No specific adjustment recommended due to minimal systemic absorption. Use with caution, as estrogens are metabolized in the liver.
Pharmacology
Mechanism of Action
Estradiol is an estrogen, a hormone that binds to and activates estrogen receptors (ERs) in target tissues, including the vagina, uterus, and breast. In the vagina, it helps restore the vaginal epithelium, increasing maturation index, reducing vaginal pH, and alleviating symptoms of vulvar and vaginal atrophy (VVA) associated with menopause.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; primarily local action.
Tmax:
Systemic absorption is low and variable. Peak serum concentrations of estradiol are typically reached within 5-12 hours after vaginal administration.
FoodEffect:
Not applicable for vaginal administration.
Distribution:
Vd:
Not well-quantified for vaginal administration due to minimal systemic absorption.
ProteinBinding:
Estradiol is highly bound to sex hormone-binding globulin (SHBG) and albumin in systemic circulation (approximately 98%).
CnssPenetration:
Limited systemic penetration, therefore limited CNS penetration.
Elimination:
HalfLife:
Systemic half-life of estradiol is approximately 1-2 hours, but the local effect persists longer.
Clearance:
Not well-quantified for vaginal administration due to minimal systemic absorption.
ExcretionRoute:
Metabolites are primarily excreted in the urine, with some fecal excretion.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Symptom relief may begin within a few weeks.
PeakEffect:
Optimal effects on vaginal atrophy symptoms typically observed after 8-12 weeks of consistent use.
DurationOfAction:
Effects persist as long as treatment is continued; twice-weekly dosing maintains therapeutic levels.
Safety & Warnings
BLACK BOX WARNING
Estrogens, including Imvexxy, increase the risk of endometrial cancer, cardiovascular disorders (e.g., stroke, deep vein thrombosis, pulmonary embolism), and probable dementia. The Women's Health Initiative (WHI) study found increased risks of stroke and DVT in postmenopausal women (50-79 years of age) receiving daily oral conjugated estrogens (CE) alone or in combination with medroxyprogesterone acetate (MPA). The WHI Memory Study (WHIMS) found an increased risk of probable dementia in postmenopausal women 65 years of age or older. These risks may not apply to low-dose vaginal estrogen products with minimal systemic absorption, but the warning is generally included for all estrogen products.
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 experience 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.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Hair loss
Tender breasts
Diarrhea, upset stomach, or throwing up
Stomach pain or cramps
Bloating
* Back pain
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 experience 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.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Hair loss
Tender breasts
Diarrhea, upset stomach, or throwing up
Stomach pain or cramps
Bloating
* Back pain
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
- Sudden vision changes
- Slurred speech or weakness on one side of the body
- Chest pain or shortness of breath
- Pain, swelling, or redness in your leg (especially calf or thigh)
- Yellowing of your 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 sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or potential 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 issues 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 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 sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or potential 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 issues 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 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 undergoing certain types of surgery. 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 closely monitor your blood sugar levels. 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 directed by your doctor.
Be aware that this medication can cause high blood pressure. Follow your doctor's recommendations for regular blood pressure checks.
Elevated triglyceride levels have been associated with this drug. 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 regularly, consult with your doctor to discuss potential interactions.
If you anticipate being 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 to discuss potential risks to your baby.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels. 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 directed by your doctor.
Be aware that this medication can cause high blood pressure. Follow your doctor's recommendations for regular blood pressure checks.
Elevated triglyceride levels have been associated with this drug. 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 regularly, consult with your doctor to discuss potential interactions.
If you anticipate being 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 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 low systemic absorption. If suspected, contact a poison control center or seek immediate medical attention. Call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenobarbital, St. John's Wort) - may decrease estrogen levels, though less relevant for low-dose vaginal products.
- CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - may increase estrogen levels, though less relevant for low-dose vaginal products.
Monitoring
Baseline Monitoring
Complete medical history and physical examination (including blood pressure, breast, abdomen, and pelvic organs)
Rationale: To identify pre-existing conditions, risk factors, and establish baseline health status before initiating estrogen therapy.
Timing: Prior to initiation of therapy
Pap test
Rationale: To screen for cervical abnormalities.
Timing: Prior to initiation of therapy
Mammogram
Rationale: To screen for breast cancer.
Timing: Prior to initiation of therapy, as appropriate for age and risk factors
Routine Monitoring
Annual physical examination (including blood pressure, breast, abdomen, and pelvic organs)
Frequency: Annually
Target: Normal for age and individual
Action Threshold: Any significant changes or abnormalities require further investigation.
Mammogram
Frequency: Periodically, as recommended by healthcare provider based on age and risk factors
Target: Normal
Action Threshold: Abnormal findings require further diagnostic evaluation.
Evaluation of symptoms
Frequency: Regularly (e.g., at follow-up visits)
Target: Improvement of VVA symptoms, absence of new or worsening adverse effects.
Action Threshold: Persistent or worsening symptoms, or new adverse effects, may require dose adjustment or discontinuation.
Symptom Monitoring
- Unusual vaginal bleeding or spotting
- Breast lumps or changes
- Changes in vision or speech
- Sudden severe headache
- Chest pain or shortness of breath
- Pain, swelling, or redness in leg
- Yellowing of skin or eyes (jaundice)
- Severe abdominal pain
Special Patient Groups
Pregnancy
Contraindicated. Estrogen use during pregnancy is associated with an increased risk of birth defects and should not be used.
Trimester-Specific Risks:
First Trimester:
Potential for feminization of male fetuses and other birth defects.
Second Trimester:
Not applicable, contraindicated.
Third Trimester:
Not applicable, contraindicated.
Lactation
Contraindicated/Not recommended. Estrogens can decrease the quantity and quality of breast milk and are excreted in breast milk, potentially affecting the nursing infant.
Infant Risk:
L4 (Possibly hazardous) - Potential for adverse effects on infant (e.g., feminization, jaundice) and reduction in milk supply.
Pediatric Use
Not indicated for use in pediatric patients. Safety and efficacy have not been established.
Geriatric Use
No specific dose adjustment is required for elderly patients. However, use the lowest effective dose for the shortest duration consistent with treatment goals. The risks associated with systemic estrogen therapy (e.g., cardiovascular events, dementia) should be considered, although the systemic absorption from Imvexxy is minimal.
Clinical Information
Clinical Pearls
- Imvexxy is a low-dose, locally acting vaginal estrogen designed to treat moderate to severe vulvar and vaginal atrophy symptoms with minimal systemic absorption.
- Patients should be instructed on the correct insertion technique for the vaginal insert.
- Due to the Black Box Warning for systemic estrogens, it's crucial to emphasize that while the systemic risks are considered low with Imvexxy due to minimal absorption, regular monitoring and discussion of risks/benefits are still important.
- Consider a trial period of 3-6 months to assess efficacy and tolerability, then re-evaluate the need for continued therapy.
- This product is specifically for vaginal symptoms and is not intended for systemic hormone replacement therapy for other menopausal symptoms like hot flashes.
Alternative Therapies
- Other low-dose vaginal estrogens (e.g., Estradiol vaginal cream, Estradiol vaginal ring (Estring), Estradiol vaginal tablets (Vagifem), Estradiol vaginal inserts (Vaginal Estradiol)
- Ospemifene (oral SERM for dyspareunia)
- Prasterone (DHEA) vaginal inserts (Intrarosa)
- Non-hormonal vaginal moisturizers and lubricants
- Pelvic floor physical therapy
Cost & Coverage
Average Cost:
Approximately $200 - $300 per 8 inserts
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand) for many insurance plans, may require prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.