Toremifene is used in postmenopausal women to treat metastatic breast cancer (cancer that has spread to other parts of the body). Your doctor may test your tumor before prescribing toremifene.

Toremifene may also be used for purposes not listed in this medication guide.

You should not use toremifene if you have a history of long QT syndrome, or low levels of potassium or magnesium in your blood.

Toremifene can cause a life-threatening heart rhythm disorder. Stop using toremifene and call your doctor at once if you have: fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness.

Your doctor may perform a pelvic exam to make sure you do not have conditions that would prevent you from safely using toremifene.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

You will need frequent medical tests.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Breast Cancer:

60 mg orally once daily
Duration of therapy: Treatment is generally continued until disease progression is observed.

Use: Treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.

You should not use toremifene if you are allergic to it, or if you have:

• long QT syndrome; or

• an uncontrolled electrolyte imbalance (low levels of potassium or magnesium in your blood).

Tell your doctor if you have ever had:

• high levels of calcium in your blood (hypercalcemia);

• endometrial hyperplasia (overgrowth of cells lining the uterus);

• long QT syndrome (in you or a family member);

• liver disease;

• bone cancer; or

• a blood clot.

Toremifene may increase your risk of developing a condition that can lead to uterine cancer. Talk to your doctor about your individual risk. Report any unusual vaginal bleeding right away.

toremifene is for use only in women who can no longer get pregnant. Toremifene can harm an unborn baby. Do not use if you are pregnant. Use effective birth control if you are not past menopause. Tell your doctor if you think you may be pregnant.

Toremifene can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using toremifene, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

You should not breastfeed while using toremifene.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, dizziness and nausea.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom).

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

Do not eat grapefruit or drink grapefruit juice while you are taking this medicine.

Grapefruit and grapefruit juice may interact with toremifene and lead to unwanted side effects. Avoid the use of grapefruit products while taking toremifene.

Ask your doctor or pharmacist before taking any over-the-counter medicines, vitamins, or herbal products. Avoid taking an herbal supplement containing St. John's wort.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Toremifene can cause a life-threatening heart rhythm disorder. Stop using toremifene and call your doctor at once if you have:

• fast or pounding heartbeats;

• fluttering in your chest;

• sudden dizziness (like you might pass out);

• shortness of breath; or

• a seizure.

Also call your doctor at once if you have:

• pelvic pain, abnormal vaginal bleeding;

• a slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• high calcium levels--confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss;

• liver problems--loss of appetite, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• signs of a blood clot--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance, chest pain, wheezing, coughing up blood.

Common side effects of toremifene may include:

• sweating, hot flashes;

• nausea; or

• vaginal discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Toremifene can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect toremifene. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.