Duavee

Generic Name: bazedoxifene and conjugated estrogens (BA ze DOX i feen and KON joo GAY ted ES troe jens)
Brand Names: Duavee

What is Duavee?

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

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

Duavee may also be used for purposes not listed in this medication guide.

Important information

Do not take any other estrogens while you are taking Duavee.

You should not use this medicine if you have any of the following conditions: a history of heart attack, stroke, or blood clot; liver disease; abnormal vaginal bleeding; a hormone-related cancer such as breast or uterine cancer.

Slideshow: Flashback: FDA Drug Approvals 2013

Duavee may increase your risk of developing cancer of the breast or uterus, and may also increase your risk of dementia, heart attack, stroke, or blood clot. Ask your doctor about your individual risk.

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

Before taking this medicine

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

  • a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

  • abnormal vaginal bleeding that a doctor has not checked;

  • a bleeding or blood-clotting disorder;

  • liver disease; or

  • any type of breast, uterine, or hormone-dependent cancer.

Women who are 75 or older should not take Duavee.

To make sure Duavee is safe for you, tell your doctor if you have:

  • high blood pressure, heart disease, or circulation problems;

  • vision problems, or circulation problems in the blood vessels of your eyes;

  • endometriosis;

  • a problem with your thyroid or gallbladder;

  • kidney disease;

  • asthma or other breathing problems;

  • epilepsy or other seizure disorder;

  • migraine headaches;

  • systemic lupus erythematosus (SLE);

  • high levels of calcium in your blood;

  • risk factors for coronary artery disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol); or

  • if you use hormone medications to treat cancer of the breast, ovary, or uterus.

This medicine may increase your risk of developing cancer of the breast or uterus. Your risk of uterine cancer may be greater if you are overweight. This medicine may also increase your risk of dementia, heart attack, stroke, or blood clot. Ask your doctor about your individual risk.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use Duavee if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether bazedoxifene and conjugated estrogens passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take Duavee?

Take Duavee exactly as prescribed by your doctor. This medicine is usually taken once daily. Follow all directions on your prescription label. Duavee is for short-term use at the lowest dose needed to treat your condition. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Duavee with or without food. Take the medicine at the same time each day.

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

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using this medicine.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are taking Duavee.

Your doctor may have you take extra calcium and 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. After opening the pouch, you should use the medicine within 60 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

dosing information

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.

What should I avoid?

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

Duavee side effects

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

Stop using Duavee and call your doctor at once if you have:

  • sudden vision loss;

  • a lump in your breast;

  • signs that you may need a lower dose--abnormal vaginal bleeding, dizziness, tiredness, stomach pain, vomiting, breast tenderness

  • 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 in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

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

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Duavee side effects may include:

  • mild dizziness;

  • nausea, stomach pain or discomfort, diarrhea;

  • neck pain, muscle spasm; or

  • throat or sinus 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.

See also: Side effects (in more detail)

What other drugs will affect Duavee?

Other drugs may interact with bazedoxifene and conjugated estrogens, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Duavee.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2014-01-09, 9:00:44 AM.

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