toremifene

What is the most important information I should know about toremifene?

Do not use toremifene if you are pregnant. It could harm the unborn baby.

You should not use toremifene if you are allergic to it, or if you have a history of Long QT syndrome, or an uncontrolled electrolyte imbalance (low levels of potassium or magnesium in your blood).

Before you take toremifene, tell your doctor if you have endometrial hyperplasia (overgrowth of cells lining the uterus), bone cancer, or if you have ever had a blood clot.

Taking toremifene may increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Talk to your doctor about your individual risk.

Stop using toremifene and call your doctor at once if you have symptoms of a serious heart rhythm disorder (severe dizziness, fainting, fast or pounding heartbeats) or signs of high levels of calcium in your blood (nausea, vomiting, stomach pain, loss of appetite, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless).

What is toremifene?

Toremifene blocks estrogen from reaching cancer cells. Certain types of breast cancer require estrogen to grow.

Toremifene is used to slow the growth of metastatic breast cancer (cancer that has spread from the original tumor). Unlike chemotherapy, toremifene does not actually destroy cancer cells.

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

What should I discuss with my healthcare provider before taking toremifene?

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

• a history of Long QT syndrome; or
• an uncontrolled electrolyte imbalance (low levels of potassium or magnesium in your blood).

To make sure you can safely take toremifene, tell your doctor if you have any of these other conditions:

• endometrial hyperplasia (overgrowth of cells lining the uterus);
• bone cancer; or
• if you have ever had a blood clot.

FDA pregnancy category D. Do not use toremifene if you are pregnant. It could harm the unborn baby. Use effective birth control if you are not past menopause, and tell your doctor if you become pregnant during treatment.

It is not known whether toremifene passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using toremifene.

Taking toremifene may increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Talk to your doctor about your individual risk.

How should I take toremifene?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Toremifene is usually taken once a day. Follow your doctor's instructions.

You may take toremifene with or without food. Take the medicine at the same time each day.

To be sure this medicine is not causing harmful effects, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking toremifene?

Grapefruit and grapefruit juice may interact with toremifene and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

What are the possible side effects of toremifene?

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

Stop using toremifene and call your doctor at once if you have a serious side effect such as:

• severe dizziness, fainting, fast or pounding heartbeats, seizure (convulsions);
• nausea, vomiting, stomach pain, loss of appetite, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless;
• easy bruising, unusual bleeding, purple or red pinpoint spots under your skin;
• vaginal bleeding or discharge;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• sudden numbness or weakness, especially on one side of the body;
• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• pain, swelling, warmth, or redness in one or both legs;
• blurred vision, eye pain, or seeing halos around lights;
• jaundice (yellowing of the skin or eyes);
• tremor; or
• loss of movement in any part of your body.

Less serious side effects may include:

• sweating, hot flashes;
• mild nausea, constipation;
• dizziness, spinning sensation;
• depressed mood;
• swelling in your hands or feet;
• itching, skin discoloration; or
• hair loss.

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.

What other drugs will affect toremifene?

Tell your doctor about all other medicines you use, especially:

• arsenic trioxide (Trisenox);
• isoniazid (for treating tuberculosis);
• lithium (Eskalith, Lithobid);
• St. John's wort;
• tacrolimus (Prograf);
• vitamin or mineral supplements that contain calcium or vitamin D;
• warfarin (Coumadin, Jantoven);
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), ofloxacin (Floxin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), telithromycin (Ketek), and others;
• an antidepressant such as amitriptylline (Elavil, Vanatrip, Limbitrol), venlafaxine (Effexor), nefazodone, and others;
• antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), voriconazole (Vfend), and others;
• seizure medicine such as carbamazepine (Carbatrol, Tegretol), clonazepam (Klonopin), phenobarbital (Solfoton), or phenytoin (Dilantin);
• a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor HCT, Vasoretic, Zestoretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others;
• heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nicardipine (Cardene), verapamil (Calan, Covera, Isoptin, Verelan), and others;
• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), quinidine (Quin-G), sotalol (Betapace), and others;
• HIV/AIDS medicine such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), ritonavir (Norvir, Kaletra), and others;
• medicine to prevent or treat nausea and vomiting such as granisetron (Kytril) or ondansetron (Zofran);
• medicines to treat psychiatric disorders, such as haloperidol (Haldol), thioridazine (Mellaril), and others;
• migraine headache medicine such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig); or
• narcotic medication such as methadone (Methadose, Diskets, Dolophine).

This list is not complete and there are many other drugs that can interact with toremifene. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about toremifene.