Estrogen and Bazedoxifene

IMPORTANT WARNING:

Taking estrogen increases the risk that you will develop endometrial cancer (cancer of the lining of the uterus [womb]) during your treatment or up to 15 years after your treatment, if you have not had a hysterectomy (surgery to remove the uterus [womb]). The longer you take estrogen, the greater the risk that you will develop endometrial cancer. Taking bazedoxifene along with estrogen may decrease the risk that you will develop endometrial cancer. Do not take any other medications that contain estrogen during your treatment because this may increase the risk that you will develop endometrial cancer. Before you begin taking estrogen, tell your doctor if you have or have ever had cancer and if you have unusual vaginal bleeding. Your doctor may tell you not to take estrogen and bazedoxifene if you have abnormal vaginal bleeding. Your doctor will monitor you closely because of the risk that you will develop endometrial cancer during or after your treatment. Call your doctor immediately if you have any abnormal or unusual vaginal bleeding during your treatment with estrogen.

In a large study, women who take estrogen had a higher risk of heart attacks, strokes, blood clots in the lungs or legs, breast cancer, and dementia (loss of ability to think, learn, and understand) than women who do not take estrogen. Tell your doctor if you or anyone in your family has or has ever had blood clots or breast cancer, if you have had a heart attack or a stroke, or if you have any condition that increases the risk that you will develop blood clots. Your doctor may tell you not to take estrogen and bazedoxifene. Also tell your doctor if you smoke or use tobacco, and if you have or have ever had high blood pressure, high blood levels of cholesterol or fats, diabetes, heart disease, lupus (a condition in which the body attacks its own tissues causing damage and swelling), breast lumps, or an abnormal mammogram (x-ray of the breast used to find breast cancer).

The following symptoms can be signs of the serious health conditions listed above. Call your doctor immediately if you experience any of the following symptoms while you are taking estrogen and bazedoxifene: sudden, severe headache; sudden, severe vomiting; speech problems; dizziness or faintness; sudden complete or partial loss of vision; double vision; weakness or numbness of an arm or a leg; crushing chest pain or chest heaviness; coughing up blood; sudden shortness of breath; difficulty thinking clearly, remembering, or learning new things; breast lumps or other breast changes; discharge from nipples; or pain, tenderness, or redness in one leg.

You should examine your breasts every month and have a mammogram and a breast exam performed by a doctor every year to help detect breast cancer as early as possible. Your doctor will tell you how to properly examine your breasts and whether you should have these exams more often than once a year because of your personal or family medical history.

Tell your doctor if you are having surgery or will be on bed rest. Your doctor may tell you to stop taking estrogen and bazedoxifene 4 to 6 weeks before the surgery or bed rest to decrease the risk that you will develop blood clots. If you will be traveling, be sure to get up and move around from time to time because sitting still for too long may increase the risk that you will develop blood clots.

You can take steps to decrease the risk that you will develop a serious health problem while you are taking estrogen. Estrogen and bazedoxifene should not be used to prevent heart disease, heart attacks, strokes, or dementia. Taking the lowest dose of estrogen that controls your symptoms and only taking estrogen as long as needed can help reduce these risks. Talk to your doctor from time to time to decide if you should take a lower dose of estrogen or should stop taking the medication.

Talk to your doctor regularly about the risks of taking estrogen and bazedoxifene.

WHY is this medicine prescribed?

Estrogen and bazedoxifene tablets are used to treat hot flashes (sudden feelings of warmth, especially in the face, neck, and chest) in women who are experiencing menopause (stage of life when menstrual periods become less frequent and stop and women may experience other symptoms and body changes). Estrogen and bazedoxifene tablets are also used to prevent osteoporosis (condition in which the bones become thin and weak and break easily) in women who have undergone menopause. Estrogen is in a class of medications called hormones and bazedoxifene is in a class of medications called estrogen agonist–antagonists. Estrogen works by replacing estrogen that is normally produced by the body. Bazedoxifene is used to block the action of estrogen on the lining of the uterus, decreasing the risk of overgrowth that may lead to cancer.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Estrogen and bazedoxifene combination comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take estrogen and bazedoxifene at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take estrogen and bazedoxifene exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablet whole; do not split, chew, or crush them.

Estrogen and bazedoxifene may help to control your symptoms only as long as you continue to take the medication. Do not stop taking estrogen and bazedoxifene without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking estrogen and bazedoxifene,

• tell your doctor and pharmacist if you are allergic to estrogen (in many hormone replacement and birth control medications), bazedoxifene, any other medications, or any of the ingredients in estrogen and bazedoxifene tablets. Ask your pharmacist or check the manufacturer's information for the patient for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• the following nonprescription or herbal products may interact with estrogen and bazedoxifene: St John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking estrogen and bazedoxifene. Do not start this medication while taking estrogen and bazedoxifene without discussing with your healthcare provider.

• tell your doctor if you have or have ever had liver disease. Your doctor may tell you not to take estrogen and bazedoxifene.

• tell your doctor if you have ever had jaundice (a condition that causes yellowing of the skin or eyes) during pregnancy or during your treatment with an estrogen product. Also tell your doctor if you have or have ever had endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body), asthma, diabetes, epilepsy, migraine headaches porphyria (condition in which abnormal substances build up in the blood and cause problems with the skin or nervous system), hereditary angioedema (inherited condition that causes episodes of swelling in the hands, feet, face, airway, or intestines), very high or very low levels of calcium in your blood, hypoparathyroidism (condition in which the body does not produce enough parathyroid hormone), or thyroid or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking estrogen and bazedoxifene, call your doctor immediately. Estrogen and bazedoxifene may harm the fetus.

• if you are taking estrogen to prevent osteoporosis, talk to your doctor about other ways to prevent the disease such as exercising and taking vitamin D and/or calcium supplements.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Talk to your doctor about ways to increase the amount of calcium and vitamin D in your diet, especially if you are taking estrogen to prevent osteoporosis.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Estrogen and bazedoxifene may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• heartburn
• stomach pain
• diarrhea
• muscle spasms
• neck pain
• sore throat
• dizziness

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• bulging eyes
• swelling of the eyes, face, mouth, tongue, or throat
• hoarseness
• difficulty breathing or swallowing

Taking estrogen and bazedoxifene may increase the risk that you will develop cancer of the ovaries or gallbladder disease the must be treated with surgery. Talk to your doctor about the risks of taking this medication.

Estrogen and bazedoxifene may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the foil pouch and blister pack it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). If you receive more than one foil pouch of medication, do not open the second pouch until you use all of the medication in the first pouch. Mark down the date that you open a foil pouch and dispose of any unused medication in the pouch 60 days after you open it. Do not remove tablets from the blister pack until you are ready to take them. Do not store tablets in a pillbox or pill-organizer.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• nausea
• vomiting
• breast tenderness
• dizziness
• stomach pain
• tiredness
• vaginal bleeding

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking estrogen and bazedoxifene.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.