Divigel 1.25mg/day Top Gel Pk
WARNING: All products: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.Skin gel and spray:Do not let another person or a pet touch this drug or the treated part of your skin. If they do, wash their skin with soap and water. If you notice any signs that others may have been in contact with the treated area by accident, call the doctor. This may include signs of unusual sexual development like breast changes in children. @ COMMON USES: It is used to prevent or lower the signs of the change of life (menopause).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Estrogen
Pharmacologic Class
Estrogen receptor agonist
Pregnancy Category
Category X
FDA Approved
Jun 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Divigel is a gel containing estradiol, a type of estrogen, that you apply to your skin. It's used to help relieve symptoms of menopause, such as hot flashes and vaginal dryness, by replacing the estrogen your body no longer makes after menopause.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed and follow all instructions carefully.
Application Instructions
Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Apply the medication at the same time every day to maintain a consistent routine.
Before and after applying the medication, wash your hands thoroughly.
Apply the medication to clean, dry, and healthy skin on your thigh.
Certain products are designed for specific areas of the body. Be sure to read the package insert to understand where to apply this medication.
Do not apply the medication to skin with any problems or irritations.
Avoid applying the medication to your face, breast, or vagina.
Special Instructions for Pump or Packet Products
If you are using a pump product, you will need to prime it before the first use. Follow the instructions in the package insert for priming the pump.
If you are using a packet product, follow the instructions provided.
Safety Precautions
Do not have someone else apply the medication to your skin. If someone else must apply it, they should wear gloves and avoid touching the medication.
Avoid exposure to fire, flames, or smoking until the medication is dry.
Allow the medication to dry completely before covering the treated area with clothing.
Do not wash the treated area for at least 1 hour after applying the medication.
Rotate the application site with each dose to minimize skin irritation.
Storage and Disposal
Store the medication at room temperature in a dry place, away from bathrooms and heat sources.
Protect the medication from heat or open flames.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is less than 12 hours until your next scheduled dose, skip the missed dose and continue with your regular schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed and follow all instructions carefully.
Application Instructions
Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Apply the medication at the same time every day to maintain a consistent routine.
Before and after applying the medication, wash your hands thoroughly.
Apply the medication to clean, dry, and healthy skin on your thigh.
Certain products are designed for specific areas of the body. Be sure to read the package insert to understand where to apply this medication.
Do not apply the medication to skin with any problems or irritations.
Avoid applying the medication to your face, breast, or vagina.
Special Instructions for Pump or Packet Products
If you are using a pump product, you will need to prime it before the first use. Follow the instructions in the package insert for priming the pump.
If you are using a packet product, follow the instructions provided.
Safety Precautions
Do not have someone else apply the medication to your skin. If someone else must apply it, they should wear gloves and avoid touching the medication.
Avoid exposure to fire, flames, or smoking until the medication is dry.
Allow the medication to dry completely before covering the treated area with clothing.
Do not wash the treated area for at least 1 hour after applying the medication.
Rotate the application site with each dose to minimize skin irritation.
Storage and Disposal
Store the medication at room temperature in a dry place, away from bathrooms and heat sources.
Protect the medication from heat or open flames.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is less than 12 hours until your next scheduled dose, skip the missed dose and continue with your regular schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply the gel to clean, dry skin on one thigh, alternating thighs daily. Do not apply to breasts or face.
- Wash hands thoroughly after application.
- Allow the gel to dry for at least 5 minutes before dressing.
- Avoid contact with the application site by others for at least one hour after application.
- Avoid swimming or showering for at least 2 hours after application.
- Do not use sunscreen or other skin products on the application site at the same time as Divigel, as this may affect absorption.
- Maintain a healthy lifestyle, including regular exercise and a balanced diet.
- Quit smoking, as smoking increases the risk of serious cardiovascular events with estrogen use.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Divigel 1.25 mg applied once daily to the skin of one thigh or alternating thighs on a rotating basis. The dose may be adjusted based on individual patient response and clinical judgment, typically starting at 0.25 mg/day and titrating up.
Dose Range:
0.25 - 1.25 mg
Condition-Specific Dosing:
vasomotor_symptoms:
Initial dose typically 0.25 mg/day, titrated up to 1.25 mg/day as needed for symptom control.
vulvar_vaginal_atrophy:
Initial dose typically 0.25 mg/day, titrated up to 1.25 mg/day as needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (not indicated for pediatric use)
Note:
Estradiol is not indicated for use in pediatric patients.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution.
Dialysis:
Not available; use with caution.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Use with caution; monitor for adverse effects. Estrogens are extensively metabolized by the liver.
Severe:
Contraindicated in patients with severe liver dysfunction or disease.
Note:
Estrogens are extensively metabolized by the liver. Impaired liver function may reduce metabolism and increase systemic exposure.
Pharmacology
Mechanism of Action
Estradiol is the primary estrogen secreted by the human ovary. It binds to and activates nuclear estrogen receptors (ERΞ± and ERΞ²) in target tissues, forming a complex that interacts with DNA to regulate gene expression. This leads to the physiological effects of estrogens, including the development and maintenance of the female reproductive system and secondary sex characteristics. In postmenopausal women, it replaces the declining endogenous estrogen levels to alleviate menopausal symptoms.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 82% (transdermal, relative to oral)
Tmax:
2-8 hours (for transdermal gel)
FoodEffect:
Not applicable for transdermal administration.
Distribution:
Vd:
Not readily available for transdermal, but generally high due to lipophilicity.
ProteinBinding:
Approximately 98% (primarily to sex hormone-binding globulin (SHBG) and albumin)
CnssPenetration:
Limited, but some effects on CNS are known (e.g., mood, thermoregulation).
Elimination:
HalfLife:
Approximately 24-36 hours (for transdermal estradiol)
Clearance:
Not readily available for transdermal, but rapid hepatic clearance.
ExcretionRoute:
Primarily renal (as glucuronide and sulfate conjugates), some fecal.
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within days to weeks for symptom relief.
PeakEffect:
Weeks to months for full therapeutic effect.
DurationOfAction:
Approximately 24 hours (due to daily application).
Safety & Warnings
BLACK BOX WARNING
Estrogens and 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 (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. The WHI study also reported an increased risk of stroke and deep vein thrombosis in postmenopausal women (50-79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (0.625 mg) alone relative to placebo. The WHI Memory Study (WHIMS), an ancillary study of WHI, reported an increased risk of probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily oral conjugated estrogens plus medroxyprogesterone acetate and in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily oral conjugated estrogens alone relative to placebo. These risks apply to all estrogen-containing 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 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 liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Breast-related symptoms: lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal symptoms: itching or discharge, or abnormal vaginal bleeding.
Depression or other mood changes, memory problems or loss, or fever.
Urinary problems: inability to pass urine or changes in urine output, or pain while passing urine.
Fluid retention: swelling, 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 (more common in people with cancer): weakness, confusion, feeling tired, headache, upset stomach or vomiting, constipation, or bone pain.
Common Side Effects
Most people experience no side effects or only mild side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness or headache
Hair loss
Upset stomach or vomiting
Constipation
Stomach pain or cramps
Bloating
Enlarged or tender breasts
Vaginal bleeding or spotting
Painful periods
Signs of a common cold
Nose or throat irritation
Weight gain or loss
Joint pain
Leg cramps
* Changes in sex interest
Reporting Side Effects
This is not an exhaustive list of potential 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 liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Breast-related symptoms: lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal symptoms: itching or discharge, or abnormal vaginal bleeding.
Depression or other mood changes, memory problems or loss, or fever.
Urinary problems: inability to pass urine or changes in urine output, or pain while passing urine.
Fluid retention: swelling, 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 (more common in people with cancer): weakness, confusion, feeling tired, headache, upset stomach or vomiting, constipation, or bone pain.
Common Side Effects
Most people experience no side effects or only mild side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness or headache
Hair loss
Upset stomach or vomiting
Constipation
Stomach pain or cramps
Bloating
Enlarged or tender breasts
Vaginal bleeding or spotting
Painful periods
Signs of a common cold
Nose or throat irritation
Weight gain or loss
Joint pain
Leg cramps
* Changes in sex interest
Reporting Side Effects
This is not an exhaustive list of potential 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:
- Sudden chest pain, shortness of breath, or coughing up blood (signs of blood clot in lungs)
- Sudden severe headache, dizziness, vision changes, slurred speech, weakness or numbness in an arm or leg (signs of stroke)
- Pain, swelling, or tenderness in one leg (signs of deep vein thrombosis)
- New breast lump or changes in breast tissue
- Unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged bleeding)
- Yellowing of skin or eyes (jaundice), dark urine, severe abdominal pain (signs of liver problems)
- Severe mood changes or depression
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. Be sure to describe the allergic reaction and its symptoms.
A history of certain health conditions, such as:
+ 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 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 the safety of taking this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of certain health conditions, such as:
+ 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 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 the safety of taking this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor first.
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 will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged immobility may increase your risk of developing blood clots. If you have diabetes, it is crucial to closely monitor your blood sugar levels.
Be aware that medications like this one can cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks. Additionally, have your blood work and bone density checked as recommended 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. The risk of certain side effects, such as heart attack, stroke, breast cancer, and ovarian cancer, may vary depending on factors like the duration of estrogen use, whether it is taken with or without a progestin, and other individual factors. Discuss the benefits and risks of using this medication with your doctor.
High triglyceride levels have been associated with this drug. If you have a history of high triglyceride levels, inform your doctor. This medication may cause dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and use protective measures like sunscreen, clothing, and eyewear.
This drug may interfere with certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this medication. Avoid smoking, as it increases the risk of heart disease, and limit your alcohol consumption. If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor.
In some cases, this medication may affect growth in children and teenagers, and they may require regular growth checks. Consult with your doctor before using other medications or skin products, including soaps. When using the gel form of this medication, avoid applying sunscreen before or soon after application, and do not use sunscreen on the treated area for 7 consecutive days.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged immobility may increase your risk of developing blood clots. If you have diabetes, it is crucial to closely monitor your blood sugar levels.
Be aware that medications like this one can cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks. Additionally, have your blood work and bone density checked as recommended 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. The risk of certain side effects, such as heart attack, stroke, breast cancer, and ovarian cancer, may vary depending on factors like the duration of estrogen use, whether it is taken with or without a progestin, and other individual factors. Discuss the benefits and risks of using this medication with your doctor.
High triglyceride levels have been associated with this drug. If you have a history of high triglyceride levels, inform your doctor. This medication may cause dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and use protective measures like sunscreen, clothing, and eyewear.
This drug may interfere with certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this medication. Avoid smoking, as it increases the risk of heart disease, and limit your alcohol consumption. If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor.
In some cases, this medication may affect growth in children and teenagers, and they may require regular growth checks. Consult with your doctor before using other medications or skin products, including soaps. When using the gel form of this medication, avoid applying sunscreen before or soon after application, and do not use sunscreen on the treated area for 7 consecutive days.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, consult with your doctor to discuss any 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. There is no specific antidote. Treatment is symptomatic and supportive. Remove the gel from the skin if possible. Call 911 or Poison Control at 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole) - concurrent use would counteract their mechanism.
- Tamoxifen (concurrent use may reduce tamoxifen efficacy and increase risk of VTE).
Major Interactions
- CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) - may decrease estradiol levels.
- CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir, grapefruit juice) - may increase estradiol levels.
- Thyroid hormone replacement therapy (estrogens may increase thyroid-binding globulin, requiring increased thyroid hormone dose).
Moderate Interactions
- Corticosteroids (estrogens may decrease corticosteroid clearance, leading to increased effects).
- Anticoagulants (estrogens may alter coagulation parameters, requiring monitoring of INR/PTT).
- Fluvoxamine (may increase estradiol levels).
Minor Interactions
- Not readily available for minor interactions specific to transdermal estradiol.
Monitoring
Baseline Monitoring
Complete medical history and physical examination (including blood pressure, breast and pelvic exam)
Rationale: To identify contraindications, risk factors, and establish baseline health status.
Timing: Prior to initiation of therapy.
Mammography
Rationale: To screen for breast cancer before initiating estrogen therapy.
Timing: Prior to initiation of therapy, and periodically thereafter as per guidelines.
Lipid profile (total cholesterol, HDL, LDL, triglycerides)
Rationale: Estrogens can affect lipid metabolism; establish baseline.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess hepatic function, as estrogens are metabolized by the liver.
Timing: Prior to initiation of therapy, especially if history of liver disease.
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if clinically indicated.
Target: <130/80 mmHg
Action Threshold: Sustained elevation requiring intervention.
Breast examination
Frequency: Annually by a healthcare provider; monthly self-exam.
Target: No new lumps or changes.
Action Threshold: Any new or suspicious findings require immediate investigation.
Mammography
Frequency: Periodically, as per national screening guidelines (e.g., every 1-2 years).
Target: No suspicious findings.
Action Threshold: Suspicious findings require further diagnostic evaluation.
Pelvic examination (including Pap test if indicated)
Frequency: Annually, or as per clinical guidelines.
Target: Normal findings.
Action Threshold: Abnormal findings require further investigation.
Endometrial monitoring (if uterus intact)
Frequency: Annually, or if abnormal uterine bleeding occurs.
Target: No endometrial hyperplasia or cancer.
Action Threshold: Abnormal bleeding or endometrial thickening requires biopsy.
Symptom Monitoring
- Signs/symptoms of thromboembolic events (e.g., sudden chest pain, shortness of breath, leg pain/swelling, sudden severe headache, vision changes, slurred speech, weakness/numbness in an arm or leg)
- Signs/symptoms of breast cancer (e.g., new lump, skin changes, nipple discharge)
- Abnormal vaginal bleeding (spotting, breakthrough bleeding, prolonged bleeding)
- Signs/symptoms of liver dysfunction (e.g., jaundice, severe abdominal pain)
- Severe headache or migraine exacerbation
- Mood changes, depression
Special Patient Groups
Pregnancy
Contraindicated. Estrogen therapy during pregnancy is associated with an increased risk of birth defects and should not be used.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, including cardiovascular and limb defects.
Second Trimester:
Not indicated; continued exposure may lead to adverse effects.
Third Trimester:
Not indicated; continued exposure may lead to adverse effects.
Lactation
Not recommended. Estrogens are excreted in breast milk and may decrease the quantity and quality of breast milk. Potential adverse effects on the nursing infant are unknown but possible.
Infant Risk:
Low to moderate risk. May cause adverse effects in the infant (e.g., feminization, jaundice) and reduce milk supply.
Pediatric Use
Not indicated for use in pediatric patients. Safety and efficacy have not been established.
Geriatric Use
Use with caution. Women 65 years of age or older may have an increased risk of probable dementia with estrogen therapy. Consider the lowest effective dose for the shortest duration consistent with treatment goals. Monitor closely for adverse cardiovascular and cognitive events.
Clinical Information
Clinical Pearls
- Divigel is a transdermal gel, which bypasses first-pass hepatic metabolism, potentially leading to a more favorable lipid profile and less impact on clotting factors compared to oral estrogens.
- Ensure patients understand proper application technique to maximize absorption and minimize transfer to others.
- For women with an intact uterus, a progestin must be co-administered to reduce the risk of endometrial hyperplasia and cancer.
- Regular monitoring, including breast exams and mammograms, is crucial due to the increased risk of breast cancer with long-term estrogen use.
- Patients should be advised to report any signs of blood clots (e.g., sudden chest pain, leg swelling) immediately.
- The lowest effective dose for the shortest duration consistent with treatment goals should always be used.
Alternative Therapies
- Selective Estrogen Receptor Modulators (SERMs) like ospemifene (for dyspareunia) or bazedoxifene/conjugated estrogens (Duavee, for vasomotor symptoms and osteoporosis prevention)
- Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
- Lifestyle modifications (e.g., diet, exercise, stress reduction, layered clothing for hot flashes)
Cost & Coverage
Average Cost:
Varies, typically $150-$300 per 30-day supply (1.25mg/day)
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 is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.