Fareston

DRUG DESCRIPTION

FARESTON (toremifene citrate) Tablets for oral administration each contain 88.5 mg of toremifene citrate, which is equivalent to 60 mg toremifene.

FARESTON is an estrogen agonist/antagonist. The chemical name of toremifene is: 2-{p-[(Z)-4-chloro-1,2diphenyl-1-butenyl]phenoxy}-N,N-dimethylethylamine citrate (1:1). The structural formula is:

FARESTON® (toremifene citrate) Structural Formula Illustration

and the molecular formula is C26H28ClNO • C6H8O7. The molecular weight of toremifene citrate is 598.10. The pKa is 8.0. Water solubility at 37°C is 0.63 mg/mL and in 0.02N HCl at 37°C is 0.38 mg/mL.

FARESTON is available only as tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch.

What are the possible side effects of toremifene (Fareston)?

Stop taking toremifene and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • constipation, loss of appetite, nausea, vomiting, and severe stomach pain, which may be caused by hypercalcemia (excess calcium in the blood);
  • pain, redness, or warmth in an arm or leg (may indicate a blood clot);
  • chest...

Read All Potential Side Effects and See Pictures of Fareston »

What are the precautions when taking toremifene (Fareston)?

See also Warning section.

Before taking toremifene, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bone cancer (metastases), blood disorders (e.g., anemia, low platelets), diabetes, history of stroke or other blood clots (e.g., in the legs, lungs), heart disease (e.g., heart attack, irregular heartbeat), high blood pressure, liver disease, long periods of sitting or lying down (e.g., immobility such as being bedridden), uterus problems such as endometrial hyperplasia.

This drug may...

Read All Potential Precautions of Fareston »


Fareston Consumer (continued)

SIDE EFFECTS: See also Warning section.

Hot flashes, sweating, nausea, vomiting, dry eyes, or dizziness may occur. If any of these side effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: bone/joint/muscle pain or swelling, constipation, mental/mood changes (e.g., depression), trouble walking/clumsiness, swelling ankles/feet, unusual tiredness, vision changes (e.g., blurred vision, eye pain).

Toremifene may increase your risk of uterine cancer. Tell your doctor immediately if you develop changes in menstrual period, unusual vaginal bleeding/discharge or pain/pressure below your "belly button" (navel).

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of infection (e.g., fever, chills, persistent sore throat), persistent nausea/vomiting, severe abdominal/stomach pain, dark urine, yellowing eyes/skin.

Toremifene has rarely caused very serious (possibly fatal) blood clots in the lungs/legs, brain (stroke), and heart (heart attack). Seek immediate medical attention if you develop pain/swelling in the groin/calf, pain in the chest/jaw/left arm, confusion, fainting, severe sudden headache, slurred speech, sudden vision changes, shortness of breath, or weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking toremifene, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bone cancer (metastases), blood disorders (e.g., anemia, low platelets), diabetes, history of stroke or other blood clots (e.g., in the legs, lungs), heart disease (e.g., heart attack, irregular heartbeat), high blood pressure, liver disease, long periods of sitting or lying down (e.g., immobility such as being bedridden), uterus problems such as endometrial hyperplasia.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight).

During pregnancy, toremifene should be used only when clearly needed. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Women of childbearing age should use 2 forms of birth control while using this medication. Discuss the use of birth control, the risks and benefits of this medication, and any other concerns about using this medication with your doctor.

It is not known if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Fareston Patient Information Including Side Effects

Brand Names: Fareston

Generic Name: toremifene (Pronunciation: tor EH mih feen)

  • What is toremifene (Fareston)?
  • What are the possible side effects of toremifene (Fareston)?
  • What is the most important information I should know about toremifene (Fareston)?
  • What should I discuss with my healthcare provider before taking toremifene (Fareston)?
  • How should I take toremifene (Fareston)?
  • What happens if I miss a dose (Fareston)?
  • What happens if I overdose (Fareston)?
  • What should I avoid while taking toremifene (Fareston)?
  • What other drugs will affect toremifene (Fareston)?
  • Where can I get more information?

What is toremifene (Fareston)?

Toremifene blocks estrogen from reaching cancer cells. Certain types of breast cancer require estrogen to grow.

Toremifene is used to slow the growth of metastatic breast cancer (cancer that has spread from the original tumor). Unlike chemotherapy, toremifene does not actually destroy cancer cells.

Toremifene may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of toremifene (Fareston)?

Stop taking toremifene and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • constipation, loss of appetite, nausea, vomiting, and severe stomach pain, which may be caused by hypercalcemia (excess calcium in the blood);
  • pain, redness, or warmth in an arm or leg (may indicate a blood clot);
  • chest pain;
  • blurred vision; or
  • vaginal bleeding.

If you experience any of the following less serious side effects, continue taking toremifene and talk to your doctor:

  • hot flashes;
  • sweating; or
  • vaginal discharge.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about toremifene (Fareston)?

Before taking toremifene, tell your doctor if you have ever had blood clots. You may not be able to take this medication.

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