Duavee contains a combination of bazedoxifene and conjugated estrogens. Bazedoxifene blocks estrogen from reaching certain cells in the uterine lining, to protect against overgrowth of uterine tissue.

Estrogen is a female sex hormone produced by the ovaries. Conjugated estrogens are a mixture of estrogen hormones.

Duavee is used short-term in women after menopause to treat moderate to severe hot flashes, and to prevent osteoporosis.

Duavee is used in women who have NOT had a hysterectomy (uterus removed).

You should not use Duavee if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Using Duavee can increase your risk of blood clots, stroke, or heart attack, or cancer of the breast, uterus, or ovaries. Estrogens should not be used to prevent heart disease, stroke, or dementia.

Estrogens may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Duavee is for short-term use at the lowest dose needed to treat your condition.

Do not take any other estrogens while you are taking this medicine.

Take Duavee exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Duavee is for short-term use at the lowest dose needed to treat your condition.

You may take this medicine with or without food, at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

If you need major surgery on will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.

Your doctor may have you take extra calcium or vitamin D while you are taking Duavee. Take only the amount that your doctor has prescribed.

Store at room temperature away from moisture and heat. Keep each tablet in its blister pack until you are ready to take it. Do not use a pill box for this medicine.

Write down the date you open a Duavee foil pouch. Use the medicine within 60 days after opening the pouch.

Usual Adult Dose for Osteoporosis:

Initial dose: Bazedoxifene-conjugated estrogens 20 mg-0.45 mg tablet orally daily
Duration of therapy: Bazedoxifene-conjugated estrogens should be for the shortest duration consistent with treatment goals and risks for the patient.

Approved indication: Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause and
Prevention of Postmenopausal Osteoporosis.

Usual Adult Dose for Postmenopausal Symptoms:

Initial dose: Bazedoxifene-conjugated estrogens 20 mg-0.45 mg tablet orally daily
Duration of therapy: Bazedoxifene-conjugated estrogens should be for the shortest duration consistent with treatment goals and risks for the patient.

Approved indication: Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause and
Prevention of Postmenopausal Osteoporosis.

You should not use Duavee if you are allergic to bazedoxifene or conjugated estrogens, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease;

• a history of heart attack, stroke, or blood clot;

• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder; or

• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Do not use other estrogen products while you are taking Duavee.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Duavee should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

Women who are 75 or older should not take Duavee.

Tell your doctor if you have ever had:

• a hysterectomy;

• heart disease;

• liver problems, or jaundice caused by pregnancy or taking hormones;

• kidney disease;

• gallbladder disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• endometriosis or uterine fibroid tumors;

• hereditary angioedema;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• a thyroid disorder; or

• high levels of calcium in your blood.

Use of Duavee may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

This medicine is for use only in women who can no longer get pregnant. Bazedoxifene and conjugated estrogens can harm an unborn baby. Do not use if you are pregnant. Use effective birth control if you are not past menopause. Tell your doctor if you think you may be pregnant.

You should not breast-feed while using this medicine.

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 two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not take progestins or any other estrogen while you are taking Duavee.

Get emergency medical help if you have signs of an allergic reaction to Duavee: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot - sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

• sudden vision loss;

• swelling, rapid weight gain;

• jaundice (yellowing of the skin or eyes);

• memory problems, confusion, unusual behavior;

• unusual vaginal bleeding, pelvic pain;

• a lump in your breast; or

• low calcium level - muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common Duavee side effects may include:

• dizziness;

• nausea, stomach pain or discomfort, diarrhea;

• muscle spasm; or

• throat pain, neck pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with bazedoxifene and conjugated estrogens. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.