Conjugated Estrogens; Bazedoxifene Tablets

What is this medication?

CONJUGATED ESTROGENS; BAZEDOXIFENE (CON ju gate ed ESS troe jenz; BAY ze DOX i feen) reduces the number and severity of hot flashes due to menopause. It works by increasing levels of the hormone estrogen in the body, which decreases the symptoms of menopause. It may also be used to prevent osteoporosis. It is an estrogen hormone.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): DUAVEE

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Abnormal vaginal bleeding
• Blood vessel disease or blood clots
• Breast, cervical, endometrial, ovarian, liver, or uterine cancer
• Dementia
• Diabetes
• Endometriosis
• Fibroids
• Gallbladder disease
• Heart disease or recent heart attack
• Hereditary angioedema
• High blood pressure
• High cholesterol
• High level of calcium in the blood
• Kidney disease
• Liver disease
• Mental health condition
• Migraine headaches
• Porphyria
• Protein C deficiency
• Protein S deficiency
• Seizure disorder
• Stroke
• Systemic lupus erythematosus
• Thyroid disorder
• Tobacco use
• An unusual or allergic reaction to estrogens, bazedoxifene, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label at the same time every day. Keep taking it unless your care team tells you to stop.

A patient package insert for the product will be given with each prescription and refill. Be sure to read this information carefully each time. The sheet may change often.

Talk to your care team about the use of this medication in children. It is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Aromatase inhibitors, such as aminoglutethimide, anastrozole, exemestane, letrozole, testolactone
• Metyrapone

This medication may also interact with the following:

• Barbiturates, such as phenobarbital
• Carbamazepine
• Clarithromycin
• Erythromycin
• Grapefruit juice
• Medications for fungal infections, such as ketoconazole and itraconazole
• Phenytoin
• Rifampin
• Ritonavir
• St. John's wort
• Thyroid hormones

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need a regular pelvic exam, breast exam, and mammogram while on this medication.

Do not take other estrogen or progestin hormones while taking this medication.

Talk to your care team about your risk of cancer. Estrogens may increase the risk of certain types of cancer, such as cancer of the breast or uterus. Report any unusual vaginal bleeding to your care team right away. This may be a warning sign of uterine cancer.

Estrogen alone therapy may increase the risk of blood clots or stroke. This risk is increased in people with high blood pressure, diabetes, or high cholesterol. Excess weight, limited movement, and tobacco use may also increase risk. Talk to your care team about the benefits and risks of taking this medication.

If you are going to have surgery or be on prolonged bed rest, tell your care team that you are using this medication. You may need to stop taking this medication before the procedure. After surgery, it should be restarted only after you are walking again.

Make sure you get enough calcium and vitamin D while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Vaginal bleeding after menopause, pelvic pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Muscle spasms
• Nausea
• Sore throat
• Swelling of the ankles, hands, or feet
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Get rid of any unused medication after it expires or 60 days after opening the foil pouch, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.