Toremifene

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.

Your doctor may do a pelvic exam to ensure you do not have any conditions that would stop you from safely using toremifene.

Follow all instructions 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.

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 serious heart rhythm problem. Stop using toremifene and call your doctor immediately if you experience: fast or pounding heartbeats, fluttering in your chest, shortness of breath, or sudden dizziness.

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.

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

Toremifene can cause a serious heart rhythm problem. Stop using toremifene and call your doctor right away if you have:

• fast or pounding heartbeats;
• fluttering in your chest;
• sudden dizziness (like you might faint);
• shortness of breath; or
• a seizure.

Also call your doctor right away if you have:

• pelvic pain, unusual 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;
• signs of a heart attack--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.

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.

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

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

Overdose symptoms may include headache, dizziness, and nausea.

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.

Sometimes, it is not safe to take certain medications together. Some drugs can change the levels of other drugs in your blood, 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 take 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.