Fareston

Name: Fareston

Toremifene Interactions

Grapefruit and grapefruit juice may interact with toremifene and lead to unwanted side effects. Avoid the use of grapefruit products while taking toremifene.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Many drugs can interact with toremifene. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • anagrelide, imatinib, methadone, nefazodone, ondansetron, St. John's wort, warfarin (Coumadin, Jantoven);
  • an antibiotic--azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine, telithromycin;
  • an antidepressant--citalopram, escitalopram;
  • antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole;
  • anti-malaria medication--chloroquine, halofantrine;
  • antiviral medicine to treat hepatitis C or HIV/AIDS--atazanavir, boceprevir, cobicistat (Evotaz, Prezcobix, Stribild, Tybost), delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir;
  • cancer medicine--arsenic trioxide, vandetanib, vemurafenib;
  • heart medicine--amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol;
  • medicine to treat a psychiatric disorder--chlorpromazine, haloperidol, pimozide, thioridazine;
  • seizure medicine--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; or
  • tuberculosis medicine--isoniazid, rifabutin, rifampin, rifapentine.

This list is not complete and there are many other drugs that can interact with toremifene. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Patient information

Vaginal bleeding has been reported in patients using FARESTON. Patients should be informed about this and instructed to contact their physician if such bleeding occurs.

FARESTON may harm the fetus and increase the risk for pregnancy loss [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

Premenopausal women using FARESTON should use nonhormonal contraception during treatment and should be apprised of the potential hazard to the fetus should pregnancy occur [see WARNINGS AND PRECAUTIONS].

Patients with bone metastases should be informed about the typical signs and symptoms of hypercalcemia and instructed to contact their physician for further assessment if such signs or symptoms occur.

Patients who must take medications known to prolong the QT interval, or potent CYP3A4 inhibitors, should be informed of the effect of toremifene on QT interval. Toremifene has been shown to prolong the QTc interval in a dose-related manner [see BOXED WARNING, WARNINGS AND PRECAUTIONS, and CLINICAL PHARMACOLOGY].

Specific interactions with foods that inhibit CYP3A4, including grapefruit juice, have not been studied but may increase toremifene concentrations. Patients should avoid grapefruit products and other foods that are known to inhibit CYP3A4 during FARESTON treatment.

Certain other medicines, including over-the-counter medications or herbal supplements (such as St. John's Wort) and toremifene, can reduce concentrations of coadministered drugs [see DRUG INTERACTIONS].

Fareston Drug Class

Fareston is part of the drug class:

  • Anti estrogens

Fareston Dosage

Take Fareston exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended daily dosage of Fareston is 60 mg.

What should I discuss with my healthcare provider before taking Fareston (toremifene)?

You should not use toremifene if you are allergic to it, or if you have:

  • long QT syndrome; or

  • an uncontrolled electrolyte imbalance (low levels of potassium or magnesium in your blood).

To make sure toremifene is safe for you, tell your doctor if you have ever had:

  • high levels of calcium in your blood (hypercalcemia);

  • endometrial hyperplasia (overgrowth of cells lining the uterus);

  • a family history of long QT syndrome;

  • bone cancer; or

  • if you have ever had a blood clot.

Taking toremifene may increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Talk to your doctor about your individual risk.

This medicine is for use only in women who can no longer get pregnant. Toremifene can harm an unborn baby. Do not use if you are pregnant. Use effective birth control if you are not past menopause. Tell your doctor if you think you may be pregnant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether toremifene passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

What should I avoid while taking Fareston (toremifene)?

Grapefruit and grapefruit juice may interact with toremifene and lead to unwanted side effects. Avoid the use of grapefruit products while taking toremifene.

Avoid taking an herbal supplement containing St. John's wort at the same time you are taking toremifene.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Introduction

Antineoplastic agent; a nonsteroidal estrogen agonist-antagonist that is structurally and pharmacologically related to tamoxifen.1 3 19 20

Proper Use of Fareston

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Do not eat grapefruit or drink grapefruit juice while you are using 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.
      • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Uses of Fareston

  • It is used to treat breast cancer in women after change of life.
  • It may be given to you for other reasons. Talk with the doctor.

How is this medicine (Fareston) best taken?

Use Fareston as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • To gain the most benefit, do not miss doses.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some other side effects of Fareston?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Hot flashes.
  • Not hungry.
  • Upset stomach or throwing up.
  • Sweating a lot.
  • Vaginal discharge.
  • Dry eyes.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Fareston Dosage and Administration

The dosage of Fareston is 60 mg, once daily, orally. Treatment is generally continued until disease progression is observed.

Dosage Forms and Strengths

Tablet is 60 mg, round, convex, unscored, uncoated, and white, or almost white, identified with TO 60 embossed on one side.

Contraindications

Hypersensitivity to the Drug

Fareston is contraindicated in patients with known hypersensitivity to the drug.

QT Prolongation, Hypokalemia, Hypomagnesemia

Toremifene should not be prescribed to patients with congenital/acquired QT prolongation (long QT syndrome), uncorrected hypokalemia, or uncorrected hypomagnesemia.

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