Pronunciation:

tore-EM-i-feen

Brand Names:

• Fareston

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antiestrogen

Uses of This Medicine:

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 this medicine will do as well as the risks of using it.

Toremifene is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Other 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.

Other interactions—

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots (history of)—Use of toremifene is usually not recommended

• Unusual growth of the lining of the uterus (womb)—Long-term use of toremifene is usually not recommended

Proper Use of This Medicine:

Dosing—

The dose of this medicine 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 this medicine. 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.

Side Effects of This Medicine:

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 this medicine 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

This medicine 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.

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