Conjugated estrogens and bazedoxifene (Oral)

Bazedoxifene and conjugated estrogens combination is used to treat moderate to severe hot flashes and other symptoms of menopause in women who have a uterus (womb). This medicine is also used to prevent osteoporosis (thinning of the bones) after menopause.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working correctly and does not cause unwanted effects. You may need a pelvic exam, breast exam, and mammogram (breast x-ray) to check for unwanted effects, unless your doctor advises otherwise. Be sure to keep all appointments.

Do not take other medicines that contain estrogen or progestin while you are being treated with this medicine.

It is unlikely that a postmenopausal woman may become pregnant. However, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor immediately.

Using this medicine may increase your risk for blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even higher if you have high blood pressure, high cholesterol, diabetes, are overweight, or smoke cigarettes. Contact your doctor right away if you experience chest pain, confusion, difficulty speaking, double vision, headaches, inability to move your arms, legs, or facial muscles, or inability to speak.

Using this medicine may increase your risk of endometrial cancer, breast cancer, or uterine cancer. Discuss this risk with your doctor. Check with your doctor immediately if you experience abnormal vaginal bleeding.

Using this medicine may increase your risk of dementia, especially in women aged 65 years and older.

Contact your doctor immediately if you experience severe headache, sudden loss of vision, or any other change in vision while using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before having surgery or if you need to stay in bed for a long time. This medicine may affect the results of certain medical tests.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This decision is made between you and your doctor. For this medicine, you should consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your health care professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Duavee® is not for use in children.

Geriatric

Studies have not shown any specific problems in older adults that would limit the usefulness of Duavee® in this age group. However, older patients may be more likely to experience certain unwanted effects (e.g., dementia), which may require caution when using this medicine. Use of Duavee® is not recommended in women older than 75 years of age.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. You should be prescribed an alternative to this medication or stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could occur. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. When taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are highlighted for their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Amifampridine
• Bupropion
• Donepezil

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Etoricoxib
• Ginseng
• Levothyroxine
• Licorice
• Tipranavir

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may happen. Drinking alcohol or using tobacco with some medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), either active or in your history, or
• Breast cancer, known or suspected, or a history of, or
• Heart attack, history of, or
• Liver disease or
• Protein C, protein S, or other known blood clotting disorders or
• Stroke, history of, or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Asthma or
• Diabetes or
• Edema (fluid retention or body swelling) or
• Endometriosis or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hereditary angioedema (swelling of the face, lips, tongue, or throat) or
• Hypercalcemia (high calcium in the blood) or
• Hypocalcemia (low calcium in the blood) or
• Hypothyroidism (an underactive thyroid) or
• Jaundice during pregnancy or from past hormonal therapy or
• Liver tumors or
• Migraine headache or
• Porphyria (an enzyme problem) or
• Systemic lupus erythematosus (SLE)—Use with caution. May worsen these conditions.

• Heart disease or
• Hypercholesterolemia (high cholesterol or fats in the blood) or
• Hypertension (high blood pressure) or
• Hypertriglyceridemia (high triglycerides or fats in the blood) or
• Obesity, or history of, or
• Prolonged periods of immobilization—Use with caution. These conditions may increase the risk of more serious side effects.

• Kidney disease—Use is not recommended. This medicine has not been studied in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects occur:

Incidence not known

• Acid or sour stomach
• anxiety
• backache
• belching
• bloating
• change in vaginal discharge
• chest pain
• chills
• clear or bloody discharge from the nipple
• confusion
• constipation
• cough
• darkened urine
• difficulty with speaking
• dimpling of the breast skin
• dizziness or lightheadedness
• double vision
• fainting
• fast heartbeat
• fever
• full or bloated feeling or pressure in the stomach
• headache
• heartburn
• inability to move the arms, legs, or facial muscles
• inability to speak
• indigestion
• inverted nipple
• loss of appetite
• lump in the breast or under the arm
• nausea
• pain or feeling of pressure in the pelvis
• pain, redness, or swelling in the arm or leg
• pains in the stomach, side, or abdomen, possibly radiating to the back
• persistent crusting or scaling of the nipple
• redness or swelling of the breast
• slow speech
• sore on the skin of the breast that does not heal
• stomach discomfort, upset, or pain
• sudden shortness of breath or troubled breathing
• swelling of the abdominal or stomach area
• vaginal bleeding
• vomiting
• yellow eyes or skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Diarrhea
• muscle spasm
• throat pain
• upper abdominal or stomach pain

Less common

• Neck pain

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Duavee

Available Dosage Forms:

• Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Bazedoxifene

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.

Your doctor may also want you to take vitamin D and calcium supplements while taking this medicine.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For treatment of menopause symptoms and prevention of osteoporosis: Adults—One tablet once a day. Each tablet contains 20 milligrams (mg) of bazedoxifene and 0.45 mg of conjugated estrogens. Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep your medicine in the original package until you are ready to use it. Do not place the tablets in pill boxes or pill organizers. After opening the foil pouch, use the medicine within 60 days.