• Duavee is a combination medicine that contains bazedoxifene and conjugated estrogens. Together, these two ingredients bind to and activate estrogen receptors, producing a composite effect that is specific to each target tissue. In bone tissue, the combination helps to increase bone mineral density and reduce bone turnover. In uterine tissue, the bazedoxifene helps to protect the uterine lining from endometrial hyperplasia, which is a condition associated with an increased risk of cancer.
• Bazedoxifene belongs to the class of medicines known as estrogen agonists/antagonists (also called selective estrogen receptor modulators [SERMs]).
• Conjugated estrogens are used as estrogen replacement therapy and help improve estrogen levels that decline when a woman reaches menopause. Estrogen is one of two major classes of female hormones (the other class is progestins).

• Duavee may be used to prevent osteoporosis in postmenopausal women who have a uterus.
• Duavee may also be used to treat moderate-to-severe hot flashes associated with menopause in women who have a uterus.
• Duavee is taken as one tablet daily.
• The bazedoxifene contained in Duavee helps protect the lining of the uterus from endometrial hyperplasia (a condition that is associated with endometrial cancer). It is not known if Duavee affects a woman's risk for breast cancer or ovarian cancer.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Nausea, diarrhea, dyspepsia, abdominal pain, neck pain, and dizziness are the most common side effects reported.
• Taking Duavee increases the risk of blood clots, increasing the risk of stroke, pulmonary embolism, and deep vein thrombosis, as well as other conditions associated with blood clots. People who have high blood pressure, high cholesterol, diabetes, who smoke, who are overweight, or with a family history of blood clots are more at risk.
• Duavee should only be used to prevent osteoporosis in women at significant risk. The benefits versus the risks of using Duavee in comparison to other non-estrogen medications for osteoporosis treatment should be weighed up before using Duavee.
• Not suitable for some people including those with abnormal uterine bleeding, a history of breast cancer, estrogen-dependent cancers, past or present history of blood clots, liver or kidney problems, known deficiency or clotting disorders, or during pregnancy or breastfeeding.
• May increase the risk of gallbladder disease, visual abnormalities, high blood pressure and high triglyceride levels, and cause low calcium levels in hypoparathyroidism. Estrogens may also exacerbate other conditions such as asthma and diabetes.
• Estrogens should not be used to prevent cardiovascular disease or dementia. Unopposed estrogens have been shown to increase the risk of endometrial cancer; however, the bazedoxifene in Duavee mitigates this risk. Estrogens should be prescribed at the lowest dosages and for the shortest duration consistent with treatment goals.
• Should not be taken with other hormone therapies such as other estrogens, progestins, or estrogen agonists/antagonists.
• Duavee may cause interactions with some laboratory tests or elevations in some laboratory tests. It may interact with several other medications, such as some anticonvulsants and inducers of CYP3A4 hepatic enzymes such as itraconazole and St John's Wort.
• Duavee has not been studied in women older than 75 years of age.
• Duavee is not available as a generic.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• May be taken with or without food. Swallow the tablets whole.
• Keep Duavee in its original container to protect it from moisture; do not transfer it to pill boxes or pill organizers. Only open one foil pouch at a time.
• If more than one blister package is dispensed to the patient, instruct them to open one foil pouch at a time. Do not use it if the blister package has been open for more than 60 days. Only remove one tablet from the blister package at a time.
• Report to your doctor any abnormal bleeding or any signs of blood clots or excessive bleeding such as calf or leg pain, shortness of breath, or blood in your vomit or feces.
• Your doctor may advise you to take supplements such as calcium or vitamin D while you are taking Duavee. Take them as directed.
• Always keep your appointments with your doctor and tell him/her how you are tolerating Duavee and if you have any symptoms of concern.
• Do not take additional estrogens while taking Duavee. Talk to your doctor or pharmacist before taking any other medication including that brought over the counter.

• 24 months of Duavee therapy increased bone mineral density by 1.72% (3.62% from placebo) in women 1-5 years postmenopausal, and by 1.64% (3.1% from placebo) in women more than 5 years postmenopausal.
• The incidence of endometrial hyperplasia or malignancy for Duavee has been reported as being below 1%.

Medicines that interact with Duavee may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Duavee. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Duavee include:

• anticonvulsants, such as carbamazepine, phenytoin
• carfilzomib
• dantrolene
• estrogen preparations
• lenalidomide
• medications that inhibit or induce CYP3A4 enzymes, such as itraconazole, erythromycin, ritonavir
• St John's Wort
• tranexamic acid.

Note that this list is not all-inclusive and includes only common medications that may interact with Duavee. You should refer to the prescribing information for Duavee for a complete list of interactions.