Duavee contains conjugated estrogens and bazedoxifene, so it has important precautions related to blood clots, certain cancers, liver and gallbladder problems, and other estrogen-related effects. It should be used only as prescribed and for the shortest duration that meets your treatment goals.
Blood Clots, Stroke, and Heart Problems
Duavee may increase the risk of deep vein thrombosis, pulmonary embolism, and stroke. It should not be used if you currently have, or have previously had, certain blood clots, a stroke, or a heart attack.
Seek immediate medical attention if you develop sudden chest pain, shortness of breath, coughing up blood, pain or swelling in one leg, sudden weakness or numbness, difficulty speaking, or sudden vision changes.
Abnormal Vaginal Bleeding
Tell your healthcare provider if you experience unexpected or unexplained vaginal bleeding, especially after menopause.
Although bazedoxifene helps reduce estrogen’s effects on the uterine lining, unusual bleeding still needs to be evaluated because it may be a sign of a problem involving the uterus.
Breast and Other Estrogen-Sensitive Cancers
Duavee should not be used if you have known, suspected, or a past history of breast cancer or another estrogen-dependent cancer.
Tell your healthcare provider about any history of hormone-sensitive cancers before starting treatment.
Do Not Take Extra Estrogen or Similar Hormone Medicines
While taking Duavee, do not take additional estrogen, progestins, or other estrogen agonist/antagonist medicines unless specifically directed by your healthcare provider.
Duavee already contains both estrogen and bazedoxifene, so adding similar medicines may increase the risk of side effects.
Liver Problems
Duavee should not be used in women with known liver disease or liver impairment.
Contact your healthcare provider if you develop yellowing of the skin or eyes, dark urine, severe abdominal discomfort, or other possible signs of liver problems.
Gallbladder Problems
Estrogen therapy can increase the risk of gallbladder disease.
Tell your healthcare provider if you develop persistent or severe pain in the upper abdomen, especially if it occurs with nausea, vomiting, or fever.
Vision Changes
Rarely, estrogen therapy may be associated with blood clots affecting the blood vessels of the eye.
Stop taking Duavee and seek prompt medical attention if you develop sudden partial or complete vision loss, double vision, or other sudden major changes in eyesight.
High Triglyceride Levels
Estrogen can sometimes cause a significant rise in triglyceride levels, particularly in people who already have high triglycerides.
Tell your healthcare provider if you have a history of high triglycerides. Severe increases can contribute to inflammation of the pancreas.
Thyroid Conditions
If you take thyroid replacement medicine, estrogen may change the amount of thyroid hormone your body needs.
Your healthcare provider may monitor your thyroid levels and adjust your thyroid medication if necessary.
Blood-Clotting Disorders
Duavee should not be used if you have certain inherited conditions that make your blood more likely to clot, including protein C deficiency, protein S deficiency, antithrombin deficiency, or other known thrombophilic disorders.
Pregnancy
Duavee is intended for postmenopausal women and should not be used during pregnancy. The prescribing information lists pregnancy as a contraindication because the medication may harm an unborn baby.
Kidney Problems and Older Adults
Duavee is not recommended in women with kidney impairment because it has not been adequately studied in this group. It is also not recommended for women older than 75 years because there is not enough safety and effectiveness information for this age group.
Allergic Reactions
Do not take Duavee if you have had a serious allergic reaction to conjugated estrogens, bazedoxifene, or any ingredient in the tablets.
Seek emergency medical care if you develop swelling of the face, lips, tongue, or throat, difficulty breathing, or another severe allergic reaction.
Important Reminder
Before starting Duavee, tell your healthcare provider about all medical conditions and medications you take, especially a history of blood clots, stroke, heart attack, cancer, liver disease, gallbladder problems, high triglycerides, or thyroid disease.
Your healthcare provider should periodically review whether Duavee is still needed and whether its benefits continue to outweigh its risks.
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