Divigel is a transdermal estradiol gel, a type of estrogen replacement therapy (ERT). It is a clear, colorless gel that becomes odorless once dry. Estradiol, the active ingredient in Divigel, is a naturally occurring estrogen hormone. This article provides a detailed overview of Divigel, including its uses, how it works, application instructions, potential side effects, and essential safety precautions.
What is Divigel and What Is It Used For?
Divigel is primarily prescribed for hormone replacement therapy (HRT) to manage symptoms associated with menopause. Menopause is a natural biological process that typically occurs in women in their late 40s or early 50s, marking the end of their reproductive years. During menopause, the ovaries gradually produce less estrogen and progesterone, leading to various symptoms.
Divigel is also used in hormone replacement therapy (HRT) for transgender women (individuals assigned male at birth) and non-binary people seeking feminization, as well as for cisgender women requiring estrogen supplementation. This topical gel helps promote feminizing physical changes and improve overall quality of life.
Specifically, Divigel is used to:
- Reduce Hot Flashes: Estradiol reduces the number and severity of hot flashes due to menopause.
- Relieve Menopausal Symptoms: It may also help relieve other symptoms of menopause, such as vaginal irritation, dryness, or pain during sex.
- Prevent Osteoporosis: Transdermal estradiol can help prevent osteoporosis (bone loss) after menopause.
- Increase Estrogen Levels: It is used to increase estrogen levels in people when their bodies are not producing enough estrogen naturally.
How Divigel Works
Divigel works by delivering estradiol directly into the bloodstream through the skin. This helps to increase estrogen levels in the body, alleviating symptoms caused by estrogen deficiency. Estrogen is crucial for maintaining the health of the vagina and bones, and it also plays a role in regulating body temperature. When estrogen levels decline, the vagina can become dry and irritated, bones can weaken, and hot flashes or night sweats may occur.
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Dosage and Administration
It is essential to use Divigel exactly as prescribed by your doctor. Follow all directions on your prescription label and read all patient information, medication guides, and instruction sheets provided to you.
Application Instructions
- Apply to Clean, Dry Skin: Divigel should be applied once daily to clean, dry, unbroken skin.
- Application Site: The gel should be applied to the skin of either the right or left upper thigh. To avoid potential skin irritation, alternate thighs each day. Some sources also suggest applying it to clean, dry skin on arms, shoulders, or the abdomen, but avoiding the breasts and broken skin.
- Application Area: The application surface area should be about 5 by 7 inches, roughly the size of two palm prints.
- Unit Dose: The entire contents of a unit dose packet should be applied each day.
- Avoid Specific Areas: Divigel should not be applied to the face, breasts, irritated skin, or in or around the vagina.
- Drying Time: After application, allow the gel to dry completely before dressing. Avoid fire, flame, or smoking until the gel has dried, as Divigel contains alcohol and is flammable.
- Washing Hands: Wash your hands thoroughly with soap and water after applying the gel.
- Avoid Contact with Others: Avoid allowing other people, especially children, to get Divigel on their skin. Topical estradiol can be absorbed through the skin and cause premature puberty in a child who comes into contact with the medicine or the application area.
- Do not wash the application site: Do not wash the application site within 1 hour after applying Divigel. Avoid contact of the gel with eyes.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if you are more than 12 hours late, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one.
Storage
Store Divigel at room temperature, between 68°F to 77°F (20°C to 25°C). Short-term exposure to temperatures between 59°F to 86°F (15°C to 30°C) is permitted, such as during transportation. Only open the foil pouch when you are ready to apply the gel.
Potential Side Effects
Like all medications, Divigel can cause side effects. It is essential to be aware of these potential effects and to discuss any concerns with your doctor.
Common Side Effects
The most common side effects of Divigel include:
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- Breast pain or tenderness
- Headache
- Pain in the arms, legs, or back
- Stomach pain, discomfort, cramps, bloating, nausea, or vomiting
- Fluid retention (edema)
- Flu-like symptoms
- Irregular vaginal bleeding or spotting
- Vaginal yeast infection
- Hair loss
- Skin redness and irritation at the application site
These side effects are usually mild and may subside with continued treatment as your body adjusts to the medicine. However, if these side effects persist or become bothersome, consult your doctor.
Serious Side Effects
Although less common, Divigel can cause serious side effects that require immediate medical attention. These include:
- Blood Clots: Estradiol may increase the risk of blood clots in your arteries or veins, leading to stroke, heart attack, or venous thromboembolism (VTE). Symptoms of a blood clot include chest pain or pressure, fast or abnormal heartbeat, trouble breathing, pain in your back, jaw, throat, or arm, sweating, upset stomach, vomiting, dizziness, sudden weakness on one side of your body, sudden and severe headache, slurred speech, vision loss, bulging eyes, or double vision.
- Endometrial Cancer: Women with a uterus may be at a higher risk for cancer in the lining of the uterus (endometrial cancer) when using estradiol. Report any abnormal vaginal bleeding to your doctor immediately.
- Breast Cancer: Estradiol use may increase the risk of breast cancer. Be vigilant about breast self-exams and report any new lumps or changes in the breast to your doctor.
- Ovarian Cancer: There may be a higher risk for cancer in your ovaries (ovarian cancer) if you use transdermal estradiol. Symptoms include unusual vaginal discharge, belly or back pain, and the need to urinate more often or urgently.
- Gallbladder Problems: Estradiol may cause gallbladder problems, including cholecystitis and cholelithiasis (gallstones). Symptoms include yellowing of the skin or eyes (jaundice), fever, pain in the upper stomach area, and clay-colored stools.
- Memory Problems: Using estradiol may increase the risk of memory problems (dementia), especially in women 65 years or older.
- Increased Blood Pressure (Hypertension): Estradiol may increase blood pressure or worsen pre-existing hypertension. Monitor your blood pressure regularly and contact your doctor if it increases.
- Severe Allergic Reactions: In rare cases, estradiol can cause severe allergic reactions. Seek immediate medical help if you experience breathing problems, wheezing, racing heart, fever, swollen lymph nodes, swelling of the face, lips, tongue, or throat, trouble swallowing, itching, skin rash, hives, nausea, vomiting, dizziness, stomach cramps, or joint pain.
Warnings and Precautions
Before using Divigel, it is crucial to inform your doctor about any existing health conditions, allergies, and medications you are taking. Certain conditions may make Divigel unsafe for you.
Contraindications
You should not use Divigel if you have any of the following conditions:
- Allergy to estradiol or any of the ingredients in Divigel
- History of blood clots in your veins, such as deep venous thrombosis (DVT) or pulmonary embolism (PE)
- Current, suspected, or past breast cancer
- Cancer that needs estrogen to grow, such as ovarian cancer or endometrial/uterine cancer
- History of stroke or heart attack
- Undiagnosed abnormal vaginal bleeding
- Low blood levels of protein C, protein S, or antithrombin, or any condition that increases your risk of developing blood clots
- Liver problems
Precautions
Use Divigel with caution and discuss the risks with your doctor if you have:
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- A uterus: Your doctor may prescribe a progestin to take with estradiol to reduce the risk of endometrial cancer.
- Surgery or bed rest: You may need to stop using Divigel temporarily before surgery or if you will be on bed rest.
- Heart problems
- High blood pressure
- High cholesterol or triglycerides
- Diabetes
- Kidney problems
- Liver problems, including hepatic hemangiomas
- Systemic lupus erythematosus
- Asthma
- Migraines
- Porphyria
- Seizures
- Thyroid or parathyroid problems
- Vision problems
- Hereditary angioedema
- Smoking
- High blood calcium levels
- Gallbladder problems with estrogen use or during pregnancy
Other Important Considerations
- Regular Check-ups: Your doctor should check your progress on a regular basis, typically every 3 to 6 months, to determine if you should continue this treatment. These visits may include pelvic exams, breast exams, and mammograms.
- Pregnancy and Breastfeeding: Do not use Divigel if you are pregnant, as estradiol can harm an unborn baby. Estradiol can also pass into breast milk and may harm a nursing baby or slow breast milk production.
- Children: Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine.
- Grapefruit Juice: Avoid drinking grapefruit juice while using Divigel, as it may increase estradiol levels in your blood and cause serious side effects.
- Alcohol: Limit alcohol consumption while using Divigel, as it may increase the risk of liver damage.
- Sunscreen: Sunscreen may affect how your body absorbs transdermal estradiol. Follow any specific instructions about using sunscreen that come with your medication.
- Age: People aged 65 or older may be at greater risk for certain side effects from transdermal estradiol.
Drug Interactions
Divigel can interact with other medications, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all the medications and supplements you are taking to avoid potential interactions.
Medications That May Interact with Estradiol
Some of the medications that may interact with estradiol include:
- Aromatase inhibitors, such as aminoglutethimide, anastrozole, exemestane, and letrozole
- Antibiotics used to treat tuberculosis, such as rifabutin, rifampin, and rifapentine
- Raloxifene or tamoxifen
- Warfarin
- St. John’s wort
- Phenobarbital and carbamazepine
This list is not exhaustive, and other medications may also interact with Divigel. Always provide a complete list of your medications to your healthcare provider.
Additional Information
- Avoid Fire: Divigel is flammable until dry due to its alcohol content. Avoid smoking or being near open flames while applying the medication and until it has dried.
- Limit Exposure to Others: To limit exposing others to estradiol, allow the application area to dry completely after applying the gel and cover it with clothing when possible. If someone comes into contact with the application area before it dries, wash the affected area with soap and water as soon as possible.
- Disposal: Safely dispose of used Divigel packets in a garbage container that is inaccessible to children and pets.
Divigel for Transgender and Non-Binary Individuals
Divigel is also used in hormone replacement therapy (HRT) for transgender women (individuals assigned male at birth) and non-binary people seeking feminization. In these cases, Divigel helps to:
- Develop feminine secondary sex characteristics, such as breast growth and fat redistribution.
- Reduce masculine features, such as muscle mass and facial hair growth.
- Improve overall psychological well-being and reduce gender dysphoria.
The dosage and administration for transgender individuals are generally the same as for cisgender women, but it is essential to work closely with an endocrinologist or other healthcare professional experienced in transgender HRT to determine the most appropriate regimen.