Toremifene Tablets

What is this medication?

TOREMIFENE (tore EM i feen) treats breast cancer. It works by blocking the hormone estrogen in breast tissue, which prevents breast cancer cells from spreading or growing.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Fareston

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Alcohol use
• Cancer in your bones
• Have had blood clots
• Heart disease
• Heart failure
• High or low levels of electrolytes, such as calcium, magnesium, potassium, in your blood
• Irregular heartbeat or rhythm
• Liver disease
• Low blood cell levels (white cells, red cells, and platelets)
• Slow heartbeat
• An unusual or allergic reaction to toremifene, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Certain medications for fungal infections, such as fluconazole, ketoconazole, posaconazole
• Cisapride
• Dronedarone
• Levoketoconazole
• Pimozide
• Saquinavir
• Thioridazine
• Ziprasidone

This medication may also interact with the following:

• Estrogen hormones
• Grapefruit
• Other medications that cause heart rhythm changes
• St. John's wort

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Report any side effects. Continue your course of treatment even if you have side effects unless your care team tells you to stop.

You may need blood work done before or while taking this medication. Your care team may also give you a test called an electrocardiogram (ECG) to check your heart before and during treatment.

You may need pelvic exams while taking this medication. Talk to your care team right away if you have vaginal bleeding, pelvic pain, or unusual vaginal discharge.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy. Estrogen and progestin hormones may not work as well while you are taking this medication. Contraception is recommended while taking this medication. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High calcium level—increased thirst or amount of urine, nausea, vomiting, confusion, unusual weakness or fatigue, bone pain
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Swelling and pain of the tumor site or lymph nodes

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Dizziness
• Hot flashes
• Nausea
• Sweating
• Vaginal discharge

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from heat and light. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.