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This document provides essential safety information regarding the use of this medication, highlighting potential risks, precautions, and important instructions. Please read carefully and consult your healthcare provider with any concerns.

• Blood Clots and Related Complications: The active components in this medication may increase the risk of developing blood clots, which can obstruct blood flow to critical areas such as the legs, lungs, heart, or brain, potentially leading to severe complications like heart attacks or strokes. Individuals with a personal or family history of blood clots, high blood pressure, diabetes, obesity, high cholesterol, lupus, or those who smoke or are using additional estrogen medications should exercise caution.

• Uterine Cancer Risk: Estrogens in the medication can alter the uterine lining, increasing the risk of endometrial cancer. Bazedoxifene helps mitigate this risk. Women with a healthy uterus, those on estrogen therapy without progestin, or those using estrogen for over a year should take note. Watch for unusual vaginal bleeding and report it to your doctor.

• Breast and Ovarian Cancer: It remains unclear if this medication affects the risk of breast or ovarian cancer. Regular screenings are advised while using this treatment.

• Dementia Risk: Postmenopausal individuals aged 65 and above taking estrogen-only therapy may face an increased risk of dementia. Look out for early signs such as memory loss and disorientation. This medication should not be used for dementia prevention.

• Gallbladder and Liver Concerns: Estrogen medications can elevate the risk of gallbladder issues, particularly in postmenopausal individuals. Report any persistent jaundice or stomach pain to your healthcare provider. Avoid use if you have liver problems.

• Vision Changes: Rarely, estrogens may cause vision changes due to clots affecting eye blood vessels. Discontinue use and consult your provider if you experience sudden vision loss or migraines.

• Triglyceride Levels: Estrogen therapy may increase blood triglyceride levels, leading to pancreatitis. Those with a history of high triglycerides should monitor for symptoms like abdominal pain radiating to the back.

• Thyroid Hormone Levels: Estrogens can alter thyroid hormone levels, particularly affecting individuals with hypothyroidism.

• Fluid Retention: This medication may cause fluid retention, leading to swelling in extremities. Those with heart failure or kidney issues should be cautious.

• Worsening of Existing Conditions: Disclose your full medical history, as this medication might exacerbate conditions such as asthma, diabetes, epilepsy, migraines, lupus, hypoparathyroidism, and hereditary angioedema.

Contraindications: Do not use this medication if you have abnormal vaginal bleeding, current or past breast cancer, estrogen-dependent tumors, blood clotting disorders, a history of stroke or heart attack, liver problems, or if you are pregnant. Always consult your healthcare provider if any of these apply to you.

When taking this medication, you might experience some common side effects. These include stomach upset, nausea, vomiting, bloating, breast tenderness, headache, and weight changes. Some people also report muscle spasms, diarrhea, indigestion, upper stomach pain, throat pain, dizziness, and neck pain. These effects are generally mild and should ease over time. However, if they persist or worsen, it's important to consult your healthcare provider for advice.

In some cases, more serious side effects may occur. These include persistent nausea or vomiting, lumps in the breast, mental or mood changes like depression or memory loss, severe abdominal pain, yellowing of the eyes or skin, dark urine, swelling in the hands, ankles, or feet, increased thirst or urination, and unusual vaginal bleeding. Additionally, this medication can cause a rise in blood pressure, so regular monitoring is advised. Contact your healthcare provider immediately if you experience any of these symptoms.

Rarely, this medication can lead to serious complications such as blood clots. Signs of blood clots may include pain or swelling in the leg, chest pain, trouble breathing, sudden dizziness, severe headaches, sudden vision changes, or weakness on one side of the body. These require urgent medical attention. Although a serious allergic reaction is rare, seek immediate help if you notice symptoms like a rash, itching, swelling, severe dizziness, or trouble breathing.

It's crucial to remain vigilant for any new or worsening symptoms and seek medical advice when needed. While this overview includes many potential side effects, it's not exhaustive. Always communicate openly with your healthcare provider about any concerns regarding your medication.

Duavee (conjugated estrogens / bazedoxifene) can interact with various other drugs and supplements. It is important to inform your doctor and pharmacist about all the medications, vitamins, and supplements you are taking, whether they are prescription or over-the-counter.

Drug Interactions:

• Potentially Avoidable Combinations: Avoid using Duavee with aromatase inhibitors like Anastrozole, Exemestane, and Letrozole, as well as other estrogen agonist/antagonists such as ospemifene and Raloxifene. Medications like fezolinetant, Fulvestrant, Tamoxifen, and Tranexamic Acid also fall into this category due to potential interactions. Additionally, using Duavee with amifampridine, bupropion, or Donepezil is generally not advised unless necessary.

• Increased Side Effect Risk: Some drugs, when used with Duavee, may elevate the risk of side effects. These include etoricoxib, Ginseng, Levothyroxine, licorice, and tipranavir. If these combinations are deemed essential, your doctor might adjust the dosage or frequency of administration.

Lab Test Interference: Duavee might affect certain laboratory tests, such as those for metyrapone, blood clotting, and thyroid function, potentially leading to inaccurate results. It is essential to inform lab personnel and all your healthcare providers that you are using Duavee to prevent misinterpretation of test outcomes.