Toremifene Citrate, Oral

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KEY POINTS

• This medicine is taken by mouth to treat breast cancer. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may increase your risk for blood clots. This medicine may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); antiestrogen; selective estrogen receptor modulator (SERM)

Generic and brand names: toremifene citrate, oral; Fareston

What is this medicine used for?

This medicine is taken by mouth to treat breast cancer in women who have permanently stopped having monthly periods (menopause).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blood clot
• A heart attack
• A stroke or transient ischemic attack (TIA)
• Bleeding problems or blood disorders
• Endometrial hyperplasia (overgrowth of the lining of the uterus) or any abnormal vaginal bleeding
• Imbalances of calcium, potassium, or magnesium in your blood
• Liver disease
• Long QT syndrome (problems with electrical activity in the heart muscle)

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. Talk to your healthcare provider if you need birth control. Birth control pills may not prevent pregnancy while you are taking this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

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

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take a double dose the next day. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: hot flashes, sweating, nausea, vomiting, vaginal bleeding or discharge, dizziness, loss of balance.

What should I watch out for?

This medicine may increase your risk for blood clots. You will need to have blood tests regularly to find out how this medicine affects you. Keep all your appointments.

If this medicine causes vaginal bleeding or if your vision changes, contact your healthcare provider.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

You may have increased bone pain and hot flashes when you first start taking this medicine. These should get better as your body adjusts to the medicine.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Depression; tiredness; confusion; muscle weakness; severe stomach pain; loss of appetite; nausea; vomiting; constipation; increased urination; irregular or rapid heartbeat; vaginal bleeding; chest pain; shortness of breath; vision changes; dark yellow or brown urine; unusual bruising or bleeding; yellowing of the eyes or skin; pain, redness, or warmth in your lower leg.

Other: Hot flashes, sweating, vaginal discharge, dizziness, swelling in your ankles or feet, bone pain, dry eyes.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as azithromycin (Zithromax, Zmax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), desvenlafaxine (Pristiq), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and miconazole (Monistat, Oravig), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, and phenytoin (Dilantin, Phenytek)
• Artemether/lumefantrine (Coartem)
• Cancer medicines such as arsenic trioxide (Trisenox), crizotinib (Xalkori), daunorubicin (Cerubidine), doxorubicin (Doxil), idarubicin (Idamycin), lapatinib (Tykerb), nilotinib (Tasigna), sorafenib (Nexavar), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Dexamethasone
• Dextromethorphan/quinidine (Nuedexta)
• Diuretics (water pills) such as chlorothiazide (Diuril), chlorthalidone, hydrochlorothiazide (Microzide), and triamterene/hydrochlorothiazide (Dyazide, Maxzide)
• Doxepin (Silenor)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, nicardipine (Cardene), procainamide, propafenone (Rythmol), quinidine, and sotalol (Betapace, Sorine)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, estradiol (Climara, Estrace, Estraderm, Vivelle), and estrogen hormones such as Cenestin, Estinyl, Estratab, FemPatch, and Premarin
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as granisetron (Sancuso) and ondansetron (Zofran)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Quinine
• St. John’s wort
• Warfarin (Coumadin)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.