Toremifene citrate (By mouth)

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

Introduction

Toremifene Citrate (tore-EM-i-feen SIT-rate)

Treats metastatic (spreading) breast cancer in postmenopausal (no longer have menstrual periods) women with certain types of tumors.

Brand Name(s)

Fareston

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using a diuretic or "water pill" (such as hydrochlorothiazide [HCTZ]), carbamazepine (Carbatol®, Tegretol®), midazolam (Versed®), phenobarbital (Luminal®, Solfoton®), phenytoin (Dilantin®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®), tolbutamide (Orinase®), medicine to treat fungal infection (such as itraconazole, ketoconazole, voriconazole, Nizoral®, Sporanox®, or Vfend®), medicine to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, or Viracept®), steroid medicine (such as dexamethasone, Decadron®), a blood thinner (such as warfarin, Coumadin®), or St. John's wort.
• Make sure your doctor knows if you are also using medicine for heart rhythm problems (such as amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol, Betapace®, Cardioquin®, Cordarone®, Norpace®, Procanbid®, Quinaglute®, or Tikosyn®), medicine for depression (such as amitriptyline, nefazodone, venlafaxine, Effexor®, Elavil®, or Serzone®), certain antibiotics (such as clarithromycin, erythromycin, levofloxacin, ofloxacin, telithromycin, Biaxin®, E-Mycin®, Eryc®, Ery-Tab®, Floxin®, Ketek®, or Levaquin®), medicine for nausea and vomiting (such as granisetron, ondansetron, Kytril®, or Zofran®), or medicine to treat mental illness (such as haloperidol, thioridazine, Haldol®, or Mellaril®).
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine

• It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away..
• Make sure your doctor knows if you are breastfeeding, or if you have had a blood clot or have other medical conditions that might make you more likely to get one. Tell your doctor if you have liver problems (including cirrhosis), bone problems, congestive heart failure, heart rhythm problems (such as QT prolongation), or problems with your uterus (womb).
• This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.
• Hypercalcemia (high calcium in the blood) and tumor flare (increased size of a tumor) are more likely to occur in patients with bone problems who are taking this medicine. Stop using this medicine and check with your doctor right away if you have abdominal or stomach pain, confusion, constipation, depression, dry mouth, increased urination, loss of appetite, metallic taste, muscle weakness, pain and swelling in the bones and muscles surrounding a tumor, thirst, unusual tiredness, or weight loss.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• This medicine may cause you to have bleeding from the vagina, especially when you first start using it. If the bleeding continues or is bothersome, check with your doctor right away.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects. It is important for women to have regular gynecologic check-ups while taking this medicine.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Clouding of the eyes.
• Confusion, constipation, dry mouth, thirst, or unusual tiredness.
• Fast, pounding, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Swelling in your hands, ankles, or feet.
• Vaginal bleeding.

If you notice these less serious side effects, talk with your doctor:

• Dizziness or headache.
• Dry or painful eyes, trouble seeing, or double vision.
• Feeling unusually tired, weak, or sad.
• Hot flashes and sweating.
• Loss of appetite, or nausea or vomiting.
• Loss of coordination.
• Pain, tenderness, or redness in your joints, bones, muscles, trunk, or back.
• Swelling or bloating.
• Vaginal bleeding.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088