Duavee is a prescription medication containing a combination of bazedoxifene and conjugated estrogens. Estrogen, a female sex hormone produced by the ovaries, plays a crucial role in various bodily functions. Duavee is primarily prescribed for women after menopause to manage moderate to severe vasomotor symptoms, such as hot flashes and night sweats, and to prevent osteoporosis.
What is Duavee?
Duavee contains two active drugs, conjugated estrogens and bazedoxifene, working together to regulate estrogen levels in the body. Conjugated estrogens are a form of hormone replacement therapy (HRT) used to balance hormone levels, while bazedoxifene belongs to a group of medications called selective estrogen receptor modulators (SERMs).
It is available as an oral tablet in one strength: 0.45 milligrams (mg) of conjugated estrogens/20 mg of bazedoxifene.
Uses of Duavee
Duavee is FDA-approved for specific uses in women with a uterus:
- Treatment of moderate to severe vasomotor symptoms related to menopause (hot flashes, night sweats, etc.).
- Prevention of osteoporosis after menopause.
Important Considerations
Duavee is intended for women who can no longer get pregnant and should not be used during pregnancy as it can harm an unborn baby. Effective birth control is necessary for women who are not past menopause while taking Duavee.
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How to Use Duavee
- Take Duavee exactly as prescribed by your doctor.
- Follow all directions on your prescription label and read all medication guides or instruction sheets.
- Take it by mouth with a glass of water at the same time every day.
- Do not take other estrogen or progestin hormones while taking this medication.
- Keep each tablet in its blister pack until you are ready to take it. Write down the date you open a Duavee foil pouch.
- If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time.
- Your doctor may have you take extra calcium or vitamin D while you are taking Duavee.
- Store at room temperature away from moisture and heat.
- Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take double or extra doses.
Regular check-ups with your doctor are essential to monitor your progress and determine if you should continue treatment.
Potential Side Effects of Duavee
Like all medications, Duavee can cause side effects. It's crucial to be aware of these potential effects and discuss any concerns with your doctor.
Common Side Effects
Some of the more common side effects reported by people who took Duavee in clinical trials include:
- Diarrhea
- Dizziness
- Indigestion (upset stomach)
- Muscle spasms (muscle cramps or twitches)
- Nausea
- Sore throat
- Upper abdominal (belly) pain
- Swelling of the ankles, hands, or feet
These side effects are usually mild and may go away within a few days or weeks. If they become severe or don't disappear, consult your doctor.
Serious Side Effects
Although less common, Duavee can cause serious side effects that require immediate medical attention. Call your doctor right away if you experience any of the following:
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- Retinal vascular thrombosis: A blood clot in a blood vessel in your retina, causing blurry vision, bulging eyes, double vision, migraines, or sudden vision loss.
- Hypertension: High blood pressure, which often doesn't cause noticeable symptoms.
- Unusual vaginal bleeding: Any vaginal bleeding after menopause should be reported to your doctor immediately as it could be a sign of uterine cancer.
- Allergic reaction: Symptoms include skin rash, itching, hives, swelling of the face, lips, tongue, or throat, and trouble breathing.
- Gallbladder disease: Severe stomach pain, nausea, vomiting, fever.
- Cancer: Increased risk of endometrial, ovarian, and breast cancer.
- Cardiovascular disease: Stroke or certain blood clots called venous thromboembolism (VTE).
- Dementia: Trouble with memory, thinking, and communication.
Boxed Warnings
Duavee has boxed warnings, the most serious warnings from the FDA, for the following risks:
- Endometrial cancer: Estrogens may increase the risk of developing a condition that may lead to uterine cancer.
- Cardiovascular disorders: Increased risk of blood clots, stroke, or heart attack.
- Dementia: Increased risk of probable dementia.
Side Effect Details
- Allergic Reaction: As with most drugs, some people can have an allergic reaction after taking Duavee.
- Cancer: Duavee may increase your risk for certain types of cancer, including endometrial, ovarian, and breast cancer.
- Neck Pain: Neck pain is a possible side effect of Duavee.
- Gallbladder Disease: Some people who take Duavee may develop gallbladder disease.
- Cardiovascular Disease: Your risk for cardiovascular disease may increase after taking Duavee.
- Stroke: Using Duavee may increase your risk for stroke.
- Blood Clots: Taking Duavee can increase your risk for blood clots.
- Dementia: Your risk for dementia may be increased while you’re taking Duavee.
Duavee and Weight Gain: Addressing the Concerns
Weight changes are a common concern for women during menopause, and it's natural to wonder if Duavee might contribute to weight gain.
Does Duavee Cause Weight Gain?
Weight gain and weight loss are not considered direct side effects of Duavee. These weight changes weren’t seen in clinical studies of the drug.
Weight Gain During Menopause
It's common for women to gain weight during menopause, typically around 1.5 pounds per year during their 50s and 60s. This weight gain may be related to:
- Hormonal changes: Fluctuations in estrogen levels can affect metabolism and fat distribution.
- Age: Metabolism naturally slows down with age.
- Lifestyle factors: Changes in activity levels and dietary habits can contribute to weight gain.
- Genetics: Predisposition to weight gain can be inherited.
FSH and Weight Gain
Emerging research suggests that follicle-stimulating hormone (FSH), which rises during menopause, may also play a role in weight gain, particularly around the abdomen. However, more research is needed to fully understand this connection.
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Important Note
Unexplained weight loss can be a symptom of cancer. As Duavee may increase the risk for certain types of cancer, including endometrial, ovarian, and breast cancer, tell your doctor right away if you have unexplained weight loss while taking Duavee.
Precautions and Warnings
Before taking Duavee, it's crucial to discuss your medical history with your doctor, including any existing conditions such as:
- Abnormal vaginal bleeding
- Blood vessel disease or blood clots
- Breast, cervical, endometrial, ovarian, liver, or uterine cancer
- Dementia
- Diabetes
- Endometriosis
- Fibroids
- Gallbladder disease
- Heart disease or recent heart attack
- Hereditary angioedema
- High blood pressure
- High cholesterol
- High level of calcium in the blood
- Kidney disease
- Liver disease
- Mental health condition
- Migraine headaches
- Porphyria
- Protein C deficiency
- Protein S deficiency
- Seizure disorder
- Stroke
- Systemic lupus erythematosus
- Thyroid disorder
- Tobacco use
Also, inform your doctor about all medications, supplements, and herbal products you are taking, as some may interact with Duavee.
Duavee has boxed warnings for the increased risk of endometrial cancer, cardiovascular disorders, and dementia. These warnings highlight the potential for serious side effects and the importance of careful consideration before starting treatment.
Managing Side Effects
If you experience side effects while taking Duavee, talk to your doctor. They may recommend strategies to manage these effects, such as:
- For muscle spasms: Hot or cold therapy, over-the-counter pain relievers, or prescription medications.
- For nausea: Taking Duavee with food, eating smaller meals more frequently, or using anti-nausea medications.
- For diarrhea: Staying hydrated, avoiding fatty foods, and using anti-diarrheal medications.