Advanced Consumer Information

toremifene (Oral route)

tore-EM-i-feen

Commonly used brand name(s):

In the U.S.

Fareston

Available Dosage Forms:

Tablet

Therapeutic Class: Antiestrogen

Uses For toremifene

Toremifene is a medicine that blocks the effects of the estrogen hormone in the body. It is used to treat breast cancer in women.

The exact way that toremifene works against cancer is not known but it may be related to the way it blocks the effects of estrogen in the body.

Before you begin treatment with toremifene, you and your doctor should talk about the good toremifene will do as well as the risks of using it.

Toremifene is available only with your doctor's prescription.

Before Using toremifene

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For toremifene, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to toremifene or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of toremifene

Dosing

The dose of toremifene will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of toremifene. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For breast cancer:
  - Adults—60 milligrams (mg) once a day.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

toremifene Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor will watch for others by doing certain tests.

Also, because of the way toremifene acts on the body, there is a chance that it might cause other unwanted effects that may not occur until months or years after the medicine is used. Some patients who have used toremifene have developed cancer of the uterus (womb), although it is not known for sure if it was caused by the medicine. Discuss this possible effect with your doctor.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Blurred vision
change in vaginal discharge
changes in vision
confusion
increased urination
loss of appetite
pain or feeling of pressure in pelvis
unusual tiredness
vaginal bleeding

Rare

Chest pain
pain or swelling of feet or legs
shortness of breath

toremifene may also cause the following side effect(s) that your doctor will watch for:

Less common

Liver problems

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Nausea
sudden sweating and feelings of warmth

Less common

Bone pain
dizziness
dry eyes
vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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