It contains 2 medications:
- Conjugated estrogens which belong to the drug class, estrogen derivatives.
- Bazedoxifene which belongs to the drug class, selective estrogen receptor modulators (SERM).
These medications work by regulating the amount of estrogen in the body, which relieves menopausal symptoms, prevents osteoporosis, and reduces the risk of uterine cancer.
Duavee is not recommended:
- If you are allergic or have had an allergic reaction to Duavee or any of its ingredients.
- If you’ve had your uterus removed (hysterectomy).
- For women older than 75 years old.
- If you had or have breast cancer.
- If you have undiagnosed uterine bleeding.
What are the Indications for Duavee?
Duavee is approved to reduce the symptoms of moderate to severe hot flashes and night sweats during menopause and prevent osteoporosis.
How is Duavee used?
This medication should be stored in its original packaging at between 68-77°F (20-25°C) with excursions permitted between 59-86°F (15-30°C).
Only remove the tablet from the blister immediately before use. Use the product within 60 days of opening the foil pouch.
Store in a dry place away from moisture.
Take Duavee orally as directed by your physician with or without food. Swallow the capsule whole and do not chew or crush it.
Do not change your dosage and take more than what is prescribed or stop using Duavee without consulting with a doctor. If you took more than prescribed, contact your doctor immediately or seek emergency medical care.
If you miss a dose, take it as soon as you remember, unless it’s almost time for your next dose. Do not catch up by taking two doses at once. If you took more than prescribed, contact your doctor immediately or seek emergency medical care.
Duavee is available in 0.45 mg of conjugated estrogens/20 mg of bazedoxifene tablet form.
The recommended dose is one tablet once a day.
Duavee should be taken for the shortest time possible.
It’s important to understand that although Duavee is FDA-approved, it comes with side effects that may or may not affect you.
Before using Duavee, you should discuss possible side effects with your doctor or pharmacist.
Common Side Effects
Not all side effects require medical attention. As your body adjusts, side effects may go away. Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:
- Stomach issues: diarrhea, upper abdominal pain, indigestion
- Water retention, usually in the legs, feet, or hands
- Sore throat
- Neck pain
- Muscle spasms
Serious Side Effects
Severe adverse reactions while using Duavee may occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:
- Severe allergic reaction: a rash over your whole body, sweating, extreme drowsiness, swelling of your face, tongue, or throat, difficulty breathing or swallowing, feeling faint, dizziness, rapid heartbeat, shortness of breath, or becoming confused.
- Eye problems: vision loss, blurred/tunnel vision, eye pain/swelling, seeing halos around lights.
- Heart symptoms: fast/irregular/pounding heartbeat, fluttering in the chest, shortness of breath, sudden dizziness/lightheadedness, passing out.
- Blood clots: leg pain/swelling, warm skin, trouble breathing, stabbing chest pain, coughing up blood.
- Stroke: sudden weakness on one side of the body, headache, slurred speech, confusion.
- Unusual vaginal bleeding, pelvic pain.
- Breast lumps
- Other:slurred speech, arm/leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.
WARNINGS & PRECAUTIONS
Before taking Duavee, tell your doctor or pharmacist if you:
- Have or ever had breast, endometrial, or ovarian cancer.
- Are taking any progestins, additional estrogens, or estrogen agonists.
- Are going through other hormone therapy.
- Have ever had any blood clots or deep vein thrombosis.
- Have any cardiovascular disorders.
- Have diabetes, asthma, epilepsy, high triglyceride levels, migraine, lupus, hereditary angioedema (swelling), thyroid or kidney problems, gallbladder disease, or high levels of calcium porphyria.
- Have live tumors.
- Have a history of jaundice.
- Are having surgery or be on bed rest.
- Are pregnant or planning to become pregnant.
- Are breastfeeding or planning to breastfeed.
Cancer of the uterus
It can increase your chance of developing cancer of the uterus. Let your doctor know if you have any unusual vaginal bleeding, especially after menopause.
Avoid drinking grapefruit juice or eating grapefruit when taking Duavee as it may increase the amount of Duavee in your body and increase the risk of side effects.
Taking CYP3A inhibitors with Duavee can cause your body to break Duavee down too quickly. This can increase the levels of Duavee in your blood and the risk of side effects. You should avoid taking these medications together unless directed otherwise by your doctor.
Pregnant or planning to become pregnant
Duavee must not be used if pregnant or planning to become pregnant.
Breastfeeding or planning to breastfeed
Speak to a doctor if you are breastfeeding or planning to breastfeed. It is not known if Duavee passes through breast milk and is not recommended that you breastfeed while using it. Estrogens can decrease the amount and quality of breast milk you produce.
Before using Duavee, inform your doctor or pharmacist if you take any medications, herbal supplements, or vitamins, as these may interact with Duavee.
Do not use if you take progestins, additional estrogens, or estrogen antagonists as it can cause very serious side effects, and increase your risk of breast/ovarian cancer, stroke, dementia, and blood clots.
Duavee should be used for the shortest duration possible and only as long as needed.
Do not use to prevent heart disease/attacks, strokes, or dementia