SUMMARY CMI

FARESTON^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using FARESTON?

FARESTON contains the active ingredient toremifene citrate. FARESTON is used to treat hormone-sensitive breast cancer in women who have had their menopause

For more information, see Section 1. Why am I using FARESTON? in the full CMI.

2. What should I know before I use FARESTON?

Do not use if you have ever had an allergic reaction to toremifene citrate, other anti-oestrogens (e.g. tamoxifen), or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use FARESTON? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FARESTON and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use FARESTON?

• The usual dose is one tablet once a day.
• More instructions can be found in Section 4. How do I use FARESTON? in the full CMI.

5. What should I know while using FARESTON?

For more information, see Section 5. What should I know while using FARESTON? in the full CMI.

6. Are there any side effects?

Less serious side effects include: sweating, itching, rash, nausea or vomiting, dizziness, depression, mood changes or shortness of breath, swelling of the hands, feet and/or ankles, pain, tiredness or hot flushes. Serious side effects include: a white vaginal discharge, heavy menstrual periods, blood clot in blood vessel, liver problems or high levels of calcium in your blood.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

FARESTON^®

Active ingredient(s): toremifene citrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using FARESTON. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using FARESTON.

Where to find information in this leaflet:

1. Why am I using FARESTON?
2. What should I know before I use FARESTON?
3. What if I am taking other medicines?
4. How do I use FARESTON?
5. What should I know while using FARESTON?
6. Are there any side effects?
7. Product details

1. Why am I using FARESTON?

FARESTON contains the active ingredient toremifene citrate. FARESTON belongs to the group of medicines known as anti-oestrogens. It helps to stop the tumour cells from growing and multiplying.

FARESTON is used to treat hormone-sensitive breast cancer in women who have had their menopause.

2. What should I know before I use FARESTON?

Warnings

Do not use FARESTON if:

• you are allergic to toremifene citrate, other anti-oestrogens (e.g. tamoxifen), or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
• you have endometrial hyperplasia (an overgrowth in the lining of the uterus)
• you have severe liver failure
• you are pregnant
• you have a heart condition called QT prolongation, where the heart muscle takes longer to contract and then recover due to a disorder involving electrical impulses.
• you have other heart conditions including bradycardia (slow heart rhythm), symptomatic arrhythmias (irregular heart rhythm) or heart failure.
• you have electrolyte disturbances including uncorrected hypokalaemia (low blood potassium levels).

Check with your doctor if you:

• have any other medical conditions, particularly:
  - angina or a heart condition, including an irregular heart beat
  - feel pain in your bones
  - have had problems with blood clots in the past. In severe cases, FARESTON is not recommended.
  - liver problems
  - have any other medical conditions or health problems
• are lactose intolerant. FARESTON tablets contain lactose.
• take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

FARESTON is for use by women who have had their menopause and should not be used by pregnant or breastfeeding women.

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with FARESTON and affect how it works.

In particular, tell your doctor or pharmacist if you are taking any of the following:

• medicines used to treat irregular heartbeat such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, doretilide and ibutilide.
• prochlorperazine, a medicine used to treat nausea and dizziness
• medicines used to treat mental illness such as phenothiazides, pimozide, sertindole, haloperidol, sultopride, chlorpromazine.
• certain antibiotics such as erythromycin and related medicines (including, clarithromycin, moxifloxacin and pentamidine, telithromycine, troleandomycin).
• certain antimalarials, particularly halofantrine.
• some antihistamines, such as terfenadine, astemizole and mizolastine
• some diuretics, also called water or fluid tablets
• phenytoin, carbamazepine and phenobarbitone, medicines used to treat epilepsy.
• warfarin, a medicine used to stop blood clots, and related medicines
• certain medicines used to treat fungal infections, such as ketoconazole, itraconazole, voriconazole and posaconazole.
• medicines used to treat HIV infection such as ritonavir and nelfinavir
• cisapride
• bepridil
• diphemanil.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect FARESTON.

4. How do I use FARESTON?

How much to take

• The usual dose is one tablet once a day.
• Follow the instructions provided and use FARESTON until your doctor tells you to stop.

When to take FARESTON

• FARESTON can be taken with or without food.
• It is good practice to take FARESTON at about the same time each day.

How to take FARESTON

• Swallow FARESTON tablets with a glass of water.

How long to take FARESTON

• Take FARESTON for as long as your doctor tells you.

If you forget to use FARESTON

FARESTON should be used regularly at the same time each day.

If you miss your dose at the usual time, and it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose you missed.

If you use too much FARESTON

If you think that you have used too much FARESTON, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using FARESTON?

Things you should do

Keep all of your doctor's appointments so that your progress can be checked.

• You will need to have regular gynaecological check-ups while you are taking FARESTON.
• FARESTON can cause problems with your blood and liver. Your doctor may organise blood tests to check for these problems.

Remind any doctor, dentist or pharmacist you visit that you are using FARESTON.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how FARESTON affects you.

FARESTON may cause dizziness or light-headedness in some people and may affect your ability to drive.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Store FARESTON below 25°C.

Follow the instructions on the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Some of side effects can only be found when your doctor does blood or other tests from time to time to check your progress.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What FARESTON contains

Do not take this medicine if you are allergic to any of these ingredients.

What FARESTON looks like

FARESTON tablets are white or almost white, flat, round, uncoated tablets marked with TO60 on one side of the tablet. It is available in blister packs of 30 tablets (AUST R 59743).

Who distributes FARESTON

Orion Pharma (Aus) Pty Limited
Level 24, Tower 3
300 Barangaroo Avenue, Sydney, NSW 2000, Australia
Telephone: 1800 861 913

This leaflet was prepared in November 2024.

Published by MIMS February 2025

1 Name of Medicine

Toremifene citrate.

2 Qualitative and Quantitative Composition

Each Fareston Tablet contains toremifene citrate equivalent to toremifene 60 mg.

Excipients with known effects.

3 Pharmaceutical Form

Tablet.
Fareston Tablets are white or almost white, round, flat, uncoated tablets with bevelled edges, embossed with "TO60" on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Fareston is indicated for first line treatment of hormone dependent metastatic breast cancer in postmenopausal patients. Fareston is not recommended for patients with oestrogen receptor negative tumours.

4.2 Dose and Method of Administration

The recommended dose is one tablet (60 mg) daily.
No dose adjustment is needed in renal insufficiency. Fareston should be used cautiously in patients with hepatic impairment (see Section 5.2 Pharmacokinetic Properties, Characteristics in patients).
Toremifene is administered orally. Toremifene can be taken with or without food.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed, see Section 6.1 List of Excipients.
Pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).
Pre-existing endometrial hyperplasia and severe hepatic failure are contraindications for long-term use of toremifene.
Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to toremifene, in the form of QT prolongation. For reasons of drug safety, toremifene is therefore contraindicated in patients with:
congenital or documented acquired QT prolongation;
electrolyte disturbances, particularly in uncorrected hypokalaemia;
clinically relevant bradycardia;
clinically relevant heart failure with reduced left-ventricular ejection fraction;
previous history of symptomatic arrhythmias.
Toremifene should not be used concurrently with other drugs that prolong the QT interval.

4.4 Special Warnings and Precautions for Use

Gynaecological examination should be performed before treatment administration, closely looking at pre-existing endometrial abnormality. Afterwards gynaecological examination should be repeated at least once a year. Patients with additional risk of endometrial cancer, e.g. patients suffering from hypertension or diabetes, having high BMI (> 30) or history of hormone replacement therapy should be closely monitored.
Anemia, leukopenia and thrombocytopenia have been reported. Red blood cell, leukocyte or platelet counts should be monitored when using Fareston.
Cases of liver injury, including elevation of liver enzymes (> 10 times upper limit of normal), hepatitis and jaundice have been reported with toremifene. Most of them occurred during the first months of treatment. The pattern of the liver damage was predominantly hepatocellular.
In clinical trials, Fareston has been shown to prolong the QT/QTc interval on the electrocardiogram in a dose-related manner. The following information regarding the effects of toremifene on QT/QTc-prolongation is of special importance (also see Section 4.3 Contraindications).
A thorough QT/QTc study was conducted in 250 healthy men to characterize the effects of toremifene on the QT/QTc interval duration. In a randomized, multiple-dose 5-arm parallel group study subjects (n = 50 per treatment group) received either placebo, moxifloxacin 400 mg or toremifene 20 mg, 80 mg, or 300 mg per day. The results of this study show that toremifene causes dose related increases in QT/QTc with a mean change from baseline in QTc of 6, 24 and 57 msec the 20 mg, 80 mg and 300 mg groups, respectively. As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QT-prolonging medications. Elderly patients may also be more susceptible to drug-associated effects on the QT interval.
Fareston should be used with caution in patients with ongoing proarrhythmic conditions (especially elderly patients) such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (including Torsade de pointes) and cardiac arrest. If signs or symptoms that may be associated with cardiac arrhythmia occur during treatment with Fareston, treatment should be stopped and an ECG should be performed.
If the QTc interval is > 500 msec, Fareston should not be used.
Patients with non-compensated cardiac insufficiency or severe angina pectoris should be monitored closely.
Hypercalcaemia may rarely occur during the first week of treatment, especially in patients with bone metastases. They should be informed about the clinical symptoms of hypercalcaemia and closely monitored.
Patients with a history of severe thromboembolic disease should generally not be treated.
There are no clinical data available in patients with labile or poorly controlled diabetes, in patients with severely altered performance status or in patients with non-compensated cardiac insufficiency or serious angina pectoris.
Experience of the long-term use of toremifene is limited.
Patients who have known hypersensitivity to anti-oestrogens or ingredients in Fareston tablets should not take Fareston.
Fareston tablets contain lactose (30 mg/tablet). Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No specific interaction studies have been performed.
An additive effect on QT interval prolongation between Fareston and the following drugs and other medicinal products that may prolong the QT interval cannot be excluded. This might lead to an increased risk of ventricular arrhythmias, including Torsade de pointes. Therefore, co-administration of Fareston with any of the following medicinal products is contraindicated (also see Section 4.3 Contraindications):
Antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide); or
Antiarrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide);
Neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride);
Certain antimicrobial agents (moxifloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine);
Certain antihistamines (terfenadine, astemizole, mizolastine);
Others (cisapride, vincamine IV, bepridil, diphemanil).
Drugs which decrease renal calcium excretion, e.g. thiazide diuretics, may increase the risk of hypercalcaemia. Enzyme inducers, like phenobarbitone, phenytoin and carbamazepine, may increase the rate of toremifene metabolism thus lowering the steady-state concentration in serum. In such cases doubling of the daily dose may be necessary.
There is a known interaction between anti-oestrogens and warfarin-type anticoagulants leading to a seriously increased bleeding time. Therefore, the concomitant use of toremifene with such medicaments should be avoided.
Theoretically there is a metabolic interaction of toremifene with drugs known to inhibit the CYP3A4-6 enzyme system. Examples of such drugs are antifungal imidazoles (ketoconazole); other antifungal agents (itraconazole, voriconazole, posaconazole); protease inhibitors (ritonavir, nelfinavir), and similar macrolide antibiotics (clarithromycin, erythromycin, telithromycin, troleandomycin). Concomitant use of those drugs with toremifene should be carefully considered.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adverse drug reactions are usually mild. They are mostly due to the hormonal action of toremifene.
The frequency of adverse drug reactions reported in clinical trials or spontaneously is listed below and classified according to body system.

Very common (> 10%).

Vascular disorders.

Skin and appendages disorders.

Common (> 1%, < 10%).

Psychic disorders.

Nervous system disorders.

Gastrointestinal disorders.

Reproductive disorders.

Skin and subcutaneous tissue disorders.

General disorders.

Uncommon (> 0.1%, < 1%).

Skin and appendages disorders.

Central and peripheral nervous system disorders.

Vision disorders.

Psychic disorders.

Gastrointestinal disorders.

Respiratory system disorders.

Reproductive disorders.

General disorders.

Vascular disorders.

Rare (> 0.01%, < 0.1%).

Skin and appendages disorders.

Psychic disorders.

Central and peripheral nervous system disorders.

Hepatic disorders.

Metabolic disorders.

Reproductive system and breast disorders.

Very rare (< 1/10,000), not known (cannot be estimated from the available data).

Neoplasms benign, malignant and unspecified (including cysts and polyps).

Blood and lymphatic system disorders.

Hepatobiliary disorders.

Metabolism and nutrition disorders.

Reproductive system and breast disorders.

Reporting suspected adverse effects.

4.9 Overdose

No overdose cases are known. Vertigo, headache and dizziness were observed in healthy volunteer studies at a daily dose of 680 mg. The dose-related QTc interval prolongation potential of Fareston should also be taken into account in cases of overdose. There is no specific antidote and the treatment is symptomatic.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Elimination.

Characteristics in patients.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, lactose monohydrate, maize starch, sodium starch glycollate, povidone, magnesium stearate and colloidal anhydrous silica.

6.2 Incompatibilities

Incompatibilities were either not assessed or identified as part of the registration of this medicine.

6.3 Shelf Life

3 years.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Blister (PVC/Al) pack containing 30 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4: Prescription Only Medicine.

Summary Table of Changes