Generic Name: conjugated estrogens/bazedoxifene (KON-joo-GAY-ted ES-troe-jenz/BA-ze-DOX-i-feen)
Brand Name: Duavee
Do not take other medicines that contain estrogens, progestins, or other medicines like bazedoxifene while you are taking Duavee.
Duavee should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens may increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Duavee. Talk with your doctor if you have questions about the benefits and risks of using Duavee.
Duavee should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Duavee.
Duavee is used for:
Treating moderate to severe hot flashes associated with menopause. It is used to prevent osteoporosis (weak bones) after menopause in certain patients. It may also be used for other conditions as determined by your doctor.
Duavee is a combination of estrogen hormones and an estrogen agonist/antagonist. It works by replacing natural estrogens in women who no longer produce enough estrogen.
Do NOT use Duavee if:
- you are allergic to any ingredient in Duavee
- you have had a severe reaction (eg, swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness) after taking Duavee
- you are pregnant, think you may be pregnant, or are breast-feeding
- you have kidney problems, liver problems, undiagnosed abnormal vaginal bleeding, estrogen-dependent growths, or a condition that may increase your risk of blood clots
- you have had blood clots (eg, in the lungs, legs, or eyes) or breast cancer
- you have ever had bleeding in the brain, stroke, heart attack, or other serious blood vessel problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using Duavee:
Some medical conditions may interact with Duavee. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had your uterus removed (hysterectomy) or you have a history of endometrial, cervical, or vaginal cancer; growths in the uterus; uterine fibroids; abnormal mammograms; or lumps in the breast
- if you have a history of asthma, kidney problems, heart problems (eg, heart failure), high blood pressure, blood vessel problems, heart attack, stroke, high cholesterol or lipid levels, diabetes, depression, dementia, gallbladder problems, or pancreas problems
- if you have high or low blood calcium levels or a history of cancer, growths in the liver, lupus, blood problems (eg, porphyria), migraine headaches, seizures, thyroid problems, or vision loss
- if you have a history of fluid retention (swelling) or tobacco use or if you are very overweight
- if a member of your family has ever had a blood clot (eg, in the lung or leg) or breast cancer
- if you have a history of jaundice (yellowing of the eyes or skin) caused by pregnancy or estrogen use
- if you will be confined to a bed or chair for an extended period of time (eg, because of surgery or a long airplane ride
- if you have a condition called hereditary angioedema
Some MEDICINES MAY INTERACT with Duavee. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, erythromycin), or protease inhibitors (eg, ritonavir) because they may increase the risk of Duavee's side effects
- Carbamazepine, hydantoins (eg, phenytoin), phenobarbital, rifamycins (eg, rifampin), or St. John's wort because they may decrease Duavee's effectiveness
- Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Duavee
This may not be a complete list of all interactions that may occur. Ask your health care provider if Duavee may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Duavee:
Use Duavee as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Duavee. Talk to your pharmacist if you have questions about this information.
- Take Duavee by mouth with or without food.
- Swallow Duavee whole. Do not break, crush, or chew before swallowing.
- Duavee comes in a blister pack. Do not remove the blister from the outer foil pouch until you are ready to take Duavee. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack and take Duavee immediately. Do not store the removed tablet for future use. Record the date you open the foil pouch in the space provided on the package label. Do not use Duavee if the blister package has been open for more than 60 days.
- Eating grapefruit or drinking grapefruit juice may increase the risk of Duavee's side effects. Check with your doctor before including grapefruit or grapefruit juice in your diet.
- Taking Duavee at the same time each day will help you remember to take it.
- If you miss a dose of Duavee, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once unless directed by your doctor.
Ask your health care provider any questions you may have about how to use Duavee.
Important safety information:
- Duavee may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
- Ask your doctor about taking a calcium and vitamin D supplement while you are using Duavee.
- Diabetes patients - Duavee may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Duavee may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
- If you wear contact lenses and you develop problems with them or with your vision, contact your doctor as soon as possible.
- Tell your doctor or dentist that you take Duavee before you receive any medical or dental care, emergency care, or surgery. Duavee should be discontinued at least 4 to 6 weeks before surgery or any time you will be confined to a chair or bed for a long period of time (eg, a long plane flight). Talk to your doctor about the safe use of Duavee if any of these conditions apply to you.
- Duavee may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Duavee.
- Lab tests, including physical exams, cholesterol levels, and blood pressure, may be performed while you use Duavee. You should have breast and pelvic exams and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Follow your doctor's instructions for examining your own breasts. Report any lumps immediately.
- Talk with your doctor regularly about whether you need to continue taking Duavee.
- Use Duavee with caution in ELDERLY women; they may be more sensitive to its effects.
- Duavee should not be used in women 75 years old and older.
- Duavee should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Duavee may cause harm to the fetus. Do not use Duavee if you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Duavee.
Possible side effects of Duavee:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; dizziness; mild stomach pain or upset; muscle spasms; nausea; neck pain; sore throat.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal vaginal bleeding; breast lumps or pain; bulging eyes; calf or leg pain, swelling, redness, or tenderness; chest pain; coughing up blood; discharge from the nipples; fainting; mental or mood changes (eg, depression); migraine headache; new or worsening memory problems; pelvic pain; severe or persistent dizziness or headache; severe or persistent stomach or back pain (with or without nausea or vomiting); shortness of breath; sudden, unusual weight gain; swelling of the hands or feet; symptoms of liver problems (eg, dark urine, pale stools, loss of appetite, severe or persistent nausea or stomach pain, unusual tiredness, yellowing of the skin or eyes); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); unusual vaginal discharge/itching/odor; vision changes (eg, double vision, sudden vision loss).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Duavee:
Store Duavee at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Duavee in the blister pack until you are ready to take it. Do not place the tablet in pill boxes or organizers. Throw away any medicine remaining in the foil pouch 60 days after opening it. Keep Duavee out of the reach of children and away from pets.
- If you have any questions about Duavee, please talk with your doctor, pharmacist, or other health care provider.
- Duavee is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Duavee or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Duavee. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Duavee. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Duavee.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.