Vagifem 10mcg Vaginal Tabs 18s
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
X
FDA Approved
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vagifem is a small tablet containing a female hormone called estradiol. It's inserted into the vagina to help relieve symptoms like vaginal dryness, itching, and burning that can happen after menopause. It works by replacing the estrogen that your body no longer makes, helping to restore the health of the vaginal tissues.
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 applying the medication, 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 the medication at the same time every day. Note that there may be days when you are not scheduled to take the medication.
Storing and Disposing of Your Medication
Store the medication in its original container at room temperature, away from heat sources. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure.
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's 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 the missed one.
To use this medication effectively, follow your doctor's instructions and read all the information provided. Before applying the medication, 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 the medication at the same time every day. Note that there may be days when you are not scheduled to take the medication.
Storing and Disposing of Your Medication
Store the medication in its original container at room temperature, away from heat sources. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure.
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's 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 the missed one.
Lifestyle & Tips
- Use exactly as prescribed by your doctor.
- Insert the tablet high into the vagina using the applicator provided.
- Do not take by mouth.
- Continue regular gynecological exams, including breast exams and Pap tests, as recommended by your doctor.
- Report any unusual vaginal bleeding, breast lumps, or severe side effects to your doctor immediately.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One 10 mcg tablet vaginally once daily for 2 weeks, then one 10 mcg tablet vaginally twice weekly.
Dose Range:
10 - 10 mg
Condition-Specific Dosing:
atrophic_vaginitis:
One 10 mcg tablet vaginally once daily for 2 weeks, then one 10 mcg tablet vaginally 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.
Pharmacology
Mechanism of Action
Estradiol is an estrogen, a female sex hormone. It binds to estrogen receptors in the vagina, leading to proliferation of the vaginal epithelium, increased superficial cells, and a decrease in parabasal cells. This helps to restore the vaginal mucosa, increase vaginal secretions, and normalize vaginal pH, thereby alleviating symptoms of vulvar and vaginal atrophy.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; primarily local action.
Tmax:
Not directly applicable for local action; systemic estradiol levels peak within hours but are generally low.
FoodEffect:
Not applicable for vaginal administration.
Distribution:
Vd:
Not well-defined for local vaginal application; systemic distribution is extensive if absorbed.
ProteinBinding:
Approximately 98% (to sex hormone-binding globulin and albumin) if systemically absorbed.
CnssPenetration:
Limited (for local vaginal application).
Elimination:
HalfLife:
Systemic half-life of estradiol is approximately 1-2 hours; however, the duration of local effect is longer.
Clearance:
Not well-defined for local vaginal application.
ExcretionRoute:
Renal (as conjugated metabolites) if systemically absorbed.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Symptomatic relief may begin within a few weeks.
PeakEffect:
Optimal effects on vaginal atrophy typically seen after 8-12 weeks of treatment.
DurationOfAction:
Effects persist as long as treatment is continued; twice-weekly dosing maintains therapeutic levels.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, change in stools, dark urine, yellow skin or eyes, or fever with chills
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or throwing up
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight
Pelvic pain or pressure
Vaginal irritation, 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 (tell your doctor if you experience swelling, weight gain, or trouble breathing)
Blood Clots and High Calcium Levels
If you experience any of the following symptoms, seek medical help right away:
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
Signs of high calcium levels: weakness, confusion, feeling tired, headache, upset stomach or throwing up, constipation, or bone pain (this is more common in people with cancer)
Other Side Effects
Most people do not experience serious side effects, but some may occur. 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 throwing up
Stomach pain or cramps
Bloating
* Back pain
Reporting Side Effects
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, change in stools, dark urine, yellow skin or eyes, or fever with chills
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or throwing up
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight
Pelvic pain or pressure
Vaginal irritation, 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 (tell your doctor if you experience swelling, weight gain, or trouble breathing)
Blood Clots and High Calcium Levels
If you experience any of the following symptoms, seek medical help right away:
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
Signs of high calcium levels: weakness, confusion, feeling tired, headache, upset stomach or throwing up, constipation, or bone pain (this is more common in people with cancer)
Other Side Effects
Most people do not experience serious side effects, but some may occur. 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 throwing up
Stomach pain or cramps
Bloating
* Back pain
Reporting Side Effects
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unusual vaginal bleeding or spotting
- New breast lump or changes in breasts
- Pain, swelling, or redness in your legs
- Sudden chest pain or shortness of breath
- Sudden severe headache or problems with vision or speech
- Yellowing of the skin or eyes (jaundice)
- Severe allergic reaction (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. 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 suspected pregnancy. Note: This medication should not be taken during pregnancy.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health 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 certain surgical procedures, and if so, they will instruct you 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. 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.
If you anticipate being 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 they 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. 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. 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.
If you anticipate being 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 they 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:
Seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is generally supportive; no specific antidote.
Drug Interactions
Moderate Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole, exemestane) - may reduce efficacy of aromatase inhibitors.
- Tamoxifen - may interfere with tamoxifen's anti-estrogenic effects.
- CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) - theoretically could decrease systemic estradiol levels, though minimal systemic absorption limits clinical significance.
- CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir) - theoretically could increase systemic estradiol levels, though minimal systemic absorption limits clinical significance.
Monitoring
Baseline Monitoring
Complete medical history and physical examination (including pelvic and breast exam)
Rationale: To assess overall health, identify contraindications, and establish baseline for future comparisons.
Timing: Prior to initiation of therapy.
Blood pressure
Rationale: Estrogens can affect blood pressure.
Timing: Prior to initiation of therapy.
Routine Monitoring
Annual physical examination (including pelvic and breast exam)
Frequency: Annually or as clinically indicated.
Target: Normal findings
Action Threshold: Any abnormal findings (e.g., new breast lump, abnormal vaginal bleeding) require further investigation.
Blood pressure
Frequency: Periodically, as clinically indicated.
Target: Normal for patient
Action Threshold: Significant or sustained elevation.
Assessment of symptoms of vulvar and vaginal atrophy
Frequency: Periodically, to assess efficacy and need for continued therapy.
Target: Symptom improvement/resolution
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of treatment.
Symptom Monitoring
- Vaginal bleeding (any new or unusual bleeding)
- Breast lumps or pain
- Leg pain, swelling, or redness (signs of blood clot)
- Chest pain or shortness of breath (signs of blood clot or cardiac event)
- Severe headache or vision changes (signs of stroke)
- Abdominal pain or jaundice (signs of liver issues)
- Symptoms of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for Vagifem in pregnancy. Estrogen exposure during pregnancy may cause fetal harm.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, including genital abnormalities.
Second Trimester:
Potential for adverse effects on fetal development.
Third Trimester:
Potential for adverse effects on fetal development.
Lactation
Not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the nursing infant.
Infant Risk:
Potential for adverse effects on infant (e.g., feminization, decreased milk supply).
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not indicated for use in children.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. However, caution should be exercised in elderly patients with co-morbidities, and the lowest effective dose should be used for the shortest duration consistent with treatment goals.
Clinical Information
Clinical Pearls
- Vagifem is a local estrogen therapy, meaning it primarily acts in the vagina with minimal systemic absorption, which generally leads to a lower risk profile compared to systemic estrogen therapies.
- It is specifically designed for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
- Patients should be instructed on the correct use of the applicator to ensure proper placement of the tablet high in the vagina.
- Regular re-evaluation (e.g., annually) is important to determine if continued therapy is needed and to use the lowest effective dose for the shortest duration.
- While systemic risks are minimal, patients should still be monitored for any unusual symptoms, especially vaginal bleeding, breast changes, or signs of thromboembolic events.
Alternative Therapies
- Other low-dose vaginal estrogens (e.g., estradiol vaginal cream, estradiol vaginal ring, conjugated estrogens vaginal cream)
- Ospemifene (oral selective estrogen receptor modulator for dyspareunia)
- Dehydroepiandrosterone (DHEA) vaginal insert (prasterone)
- Non-hormonal lubricants and moisturizers (for mild symptoms or as adjuncts)
Cost & Coverage
Average Cost:
$200 - $300 per 18 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 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 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 information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.