Vagifem 10mcg Vaginal Tabs 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 irritation and dryness caused by 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
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vagifem is a small vaginal tablet containing a low dose of estrogen (estradiol). It's used to treat vaginal dryness, itching, and burning, and painful intercourse that can happen after menopause. It works by releasing estrogen directly into the vagina to help restore the natural health of the vaginal tissues, with very little of the medicine getting into the rest of your body.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all the information provided. Before each use, wash your hands thoroughly. Insert the medication into your vagina using the applicator that comes with it, and be sure to wash the applicator after each use. Establish a routine by taking this medication at the same time every day. Note that there may be days when you are not scheduled to take this medication.
Storing and Disposing of Your Medication
Keep your medication in its original container at room temperature, away from heat sources. It is essential to store all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you forget to take 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 take two doses at the same time or take extra doses to make up for a missed one.
To use this medication effectively, follow your doctor's instructions and read all the information provided. Before each use, wash your hands thoroughly. Insert the medication into your vagina using the applicator that comes with it, and be sure to wash the applicator after each use. Establish a routine by taking this medication at the same time every day. Note that there may be days when you are not scheduled to take this medication.
Storing and Disposing of Your Medication
Keep your medication in its original container at room temperature, away from heat sources. It is essential to store all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you forget to take 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 take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Continue regular gynecological exams, including Pap tests and mammograms, as recommended by your doctor.
- Report any unusual vaginal bleeding, breast lumps, or severe pain immediately to your doctor.
- Maintain good vaginal hygiene.
- Discuss any concerns about sexual health or discomfort with your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One 10 mcg vaginal tablet administered vaginally once daily for 2 weeks, followed by one tablet twice weekly.
Dose Range:
10 - 10 mg
Condition-Specific Dosing:
vulvovaginal_atrophy:
One 10 mcg vaginal tablet administered vaginally once daily for 2 weeks, followed by one tablet twice weekly.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Use with caution; however, due to minimal systemic absorption, significant adjustment is unlikely to be required for local vaginal use.
Confidence:
Medium
Pharmacology
Mechanism of Action
Estradiol is an estrogen, a hormone that binds to estrogen receptors (ERs) in target tissues, including the vagina, uterus, breast, and hypothalamus. In the vagina, it helps restore the vaginal epithelium, increasing superficial cells and decreasing parabasal cells, and restoring vaginal pH, thereby alleviating symptoms of vulvovaginal atrophy.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; primarily local effect.
Tmax:
Systemic absorption is low and variable. Peak serum concentrations of estradiol are typically reached within 1-2 hours after vaginal administration, but levels remain close to baseline.
FoodEffect:
Not applicable for vaginal administration.
Distribution:
Vd:
Not precisely quantified for vaginal administration due to minimal systemic absorption; for systemic estradiol, Vd is approximately 0.9-1.1 L/kg.
ProteinBinding:
Approximately 98% bound to sex hormone-binding globulin (SHBG) and albumin in systemic circulation.
CnssPenetration:
Limited for vaginally administered estradiol at therapeutic doses.
Elimination:
HalfLife:
Systemic half-life of estradiol is approximately 1-2 hours; however, the local effect in the vagina persists longer.
Clearance:
Not precisely quantified for vaginal administration due to minimal systemic absorption.
ExcretionRoute:
Metabolites are primarily excreted in the urine, with some fecal excretion.
Unchanged:
Less than 1% of estradiol is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Symptomatic relief may begin within a few weeks.
PeakEffect:
Optimal symptomatic relief typically observed after 8-12 weeks of continuous use.
DurationOfAction:
Local effects persist as long as treatment is maintained; twice-weekly dosing maintains therapeutic effect.
Safety & Warnings
BLACK BOX WARNING
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. 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 5.6 years of treatment with daily oral conjugated estrogens (CE 0.625 mg) alone, or in combination with medroxyprogesterone acetate (CE 0.625 mg/MPA 2.5 mg). The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older. Vaginal estrogen products, including Vagifem, have minimal systemic absorption; however, the risks associated with systemic estrogen therapy should be considered.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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.
Other 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 any other unusual symptoms, contact your doctor or seek medical attention:
Headache.
Hair loss.
Tender breasts.
Diarrhea, upset stomach, or vomiting.
Stomach pain or cramps.
Bloating.
* 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 medical attention right away:
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.
Other 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 any other unusual symptoms, contact your doctor or seek medical attention:
Headache.
Hair loss.
Tender breasts.
Diarrhea, upset stomach, or vomiting.
Stomach pain or cramps.
Bloating.
* 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 breast lump or changes in breasts
- Severe headache, dizziness, or vision changes
- Sudden chest pain or shortness of breath
- Pain, swelling, or redness in one leg
- Yellowing of 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 and its symptoms.
A history of certain health conditions, including:
+ Bleeding disorders or blood clots
+ A higher risk of developing blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack or stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note: This medication is contraindicated during pregnancy and should not be taken 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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Do not initiate, 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 and its symptoms.
A history of certain health conditions, including:
+ Bleeding disorders or blood clots
+ A higher risk of developing blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack or stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note: This medication is contraindicated during pregnancy and should not be taken 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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Do not initiate, 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. Ensure that your blood pressure is 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. Notify all your healthcare providers and laboratory personnel that you are taking this drug.
Smoking can increase the risk of heart disease. It is recommended that you do not smoke, and discuss this with your doctor if you need help quitting.
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 the 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. Ensure that your blood pressure is 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. Notify all your healthcare providers and laboratory personnel that you are taking this drug.
Smoking can increase the risk of heart disease. It is recommended that you do not smoke, and discuss this with your doctor if you need help quitting.
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 the potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding (in women)
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. Due to the vaginal route and low dose, overdose is unlikely to be life-threatening. Contact a poison control center or seek immediate medical attention. Call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Complete medical history and physical examination (including blood pressure, breast, abdomen, and pelvic organs)
Rationale: To identify contraindications, risk factors, and establish baseline health status.
Timing: Prior to initiation of therapy.
Pap test
Rationale: Screen for cervical abnormalities.
Timing: Prior to initiation of therapy, if due.
Mammogram
Rationale: Screen for breast cancer.
Timing: Prior to initiation of therapy, if due.
Routine Monitoring
Annual physical examination (including blood pressure, breast, abdomen, and pelvic organs)
Frequency: Annually or as clinically indicated.
Target: Normal findings
Action Threshold: Any abnormal findings require further investigation.
Mammogram
Frequency: As recommended by age and risk factors.
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Pap test
Frequency: As recommended by current guidelines.
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Symptom Monitoring
- Vaginal bleeding or spotting (especially if new or persistent)
- Breast lumps or changes
- Leg pain, swelling, or tenderness (signs of blood clot)
- Chest pain or shortness of breath
- Sudden severe headache or vision changes
- Yellowing of skin or eyes (jaundice)
- Changes in mood or memory
Special Patient Groups
Pregnancy
Vagifem is not indicated for use in pregnant women. Estrogen therapy is contraindicated during pregnancy. If pregnancy occurs during treatment, Vagifem should be discontinued immediately.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, though data for vaginal estradiol are limited due to minimal systemic absorption.
Second Trimester:
Not applicable, contraindicated.
Third Trimester:
Not applicable, contraindicated.
Lactation
Estradiol is excreted in human milk and may reduce the quantity and quality of breast milk. Vagifem is not recommended for use in nursing mothers.
Infant Risk:
Potential for adverse effects on the infant (e.g., feminization) and reduction in milk supply. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Vagifem and any potential adverse effects on the breastfed child from Vagifem or from the underlying maternal condition.
Pediatric Use
Vagifem is not indicated for use in pediatric patients. Safety and effectiveness have not been established.
Geriatric Use
No dosage adjustment is generally necessary for elderly patients. The WHI study showed an increased risk of probable dementia in women 65 years of age or older receiving oral estrogen therapy; however, the systemic absorption of Vagifem is minimal, and this risk is considered less relevant for local vaginal therapy. Use the lowest effective dose for the shortest duration consistent with treatment goals.
Clinical Information
Clinical Pearls
- Vagifem is a local estrogen therapy, meaning it primarily acts on vaginal tissues with minimal systemic absorption, reducing the risks associated with systemic estrogen.
- It is specifically designed for vulvovaginal atrophy symptoms (dryness, itching, burning, painful intercourse) and is not for hot flashes or osteoporosis prevention.
- The initial dosing is daily for two weeks, then maintenance is twice weekly. Consistency is key for optimal results.
- Patients should be advised that while systemic risks are low, regular gynecological exams, including mammograms, are still important.
- Unlike higher-dose systemic estrogens, Vagifem 10 mcg generally does not require concomitant progestin therapy in women with an intact uterus due to its minimal endometrial stimulation.
Alternative Therapies
- Non-hormonal vaginal moisturizers and lubricants (e.g., Replens, K-Y Jelly)
- Ospemifene (oral SERM for dyspareunia)
- Dehydroepiandrosterone (DHEA) vaginal inserts (e.g., Intrarosa)
Cost & Coverage
Average Cost:
$200 - $300 per 8 tablets (1 month supply)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 be sure 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.