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STIVARGA® 40 mg tablets
(Sti-VAR-gah)

regorafenib


Consumer Medicine Information

WARNING: Liver problems
Stivarga can cause liver problems which can be serious and in rare cases lead to death. Your doctor will check your liver function before you start taking Stivarga and monitor your liver function during treatment. Your doctor may need to change your dose or advise you to stop taking Stivarga. Please see under section SIDE EFFECTS the possible signs of severe liver injury.

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about STIVARGA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking STIVARGA against the benefits they expect it will have for you.

If you have any concerns, or are unsure about taking this medicine, ask your doctor or pharmacist for more advice.

Keep this leaflet with the medicine. You may need to read it again.

WHAT STIVARGA IS USED FOR

STIVARGA is a medicine used to treat cancer by slowing down the growth and spread of cancer cells. STIVARGA cuts off the blood supply that keeps cancer cells growing.

STIVARGA is used to treat:

  • colon, rectal or bowel cancer that has spread to other parts of the body in patients who have previously received other treatments;
  • gastrointestinal stromal tumour (GIST) in patients who have previously received other treatments.
  • liver cancer in patients who have been previously treated with another anticancer medicine (sorafenib)

GIST is a cancer of the stomach and bowel. It is caused by the uncontrolled growth of cells in the wall of the stomach or bowel.

STIVARGA belongs to a group of medicines called antineoplastic (anti-cancer) agents.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

STIVARGA is not addictive.

BEFORE YOU TAKE STIVARGA

When you must not take it

Do not take STIVARGA if you have an allergy to:

  • regorafenib, the active ingredient in STIVARGA
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not take this medicine if you are pregnant or think you might be pregnant.

Do not give this medicine to children and adolescents. Safety and effectiveness in children and adolescents have not been established.

Do not take this medicine after the expiry date printed on the bottle. The expiry date is printed on the carton and bottle after “EXP” (e.g. 11 18 refers to November 2018). The expiry date refers to the last day of that month. If it has expired return it to your pharmacist for disposal.

Do not take this medicine if the packaging is torn or shows signs of tampering. If the packaging is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any medicines, foods, preservatives or dyes.

Tell your doctor if you think you are pregnant, may be pregnant or plan on becoming pregnant. STIVARGA should not be used during pregnancy unless necessary. Your doctor will discuss the potential risk of taking STIVARGA during pregnancy.

Avoid becoming pregnant while taking STIVARGA, as this medicine may harm your unborn baby. Your doctor will advise you about using contraception during treatment and for at least eight weeks after treatment if you are of child bearing age.

STIVARGA may reduce fertility in both men and women. Your doctor will advise you of your options prior to starting treatment.

Do not breast-feed while taking STIVARGA. Tell your doctor if you are breast-feeding or planning to breast-feed. This medicine may interfere with the growth and development of your baby.

Tell your doctor if you:

  • Have liver problems including Gilbert’s syndrome. Before you start STIVARGA your doctor will perform blood tests to monitor your liver to see how your liver is working. Treatment with STIVARGA may lead to a higher risk of liver problems.
  • Get an infection with signs such as high fever, severe cough with or without an increase in mucus (sputum) production, severe sore throat, shortness of breath, burning / pain when urinating, unusual vaginal discharge or irritation, redness, swelling and/or pain in any part of the body. Your doctor may temporarily stop your treatment.
  • Had or have any bleeding problems and you are taking warfarin or a medicine that thins the blood to prevent blood clots. Treatment with STIVARGA may lead to a higher risk of bleeding. Before you start STIVARGA your doctor may conduct blood tests.
  • Have chest pain or any heart problems. Before you start STIVARGA and during treatment your doctor will check how well your heart is working. Increased heart problems are reported more often in patients over 75 years old.
  • Have high blood pressure. STIVARGA can raise your blood pressure and your doctor will monitor your blood pressure prior to and during the treatment and may give you a medicine to treat high blood pressure.
  • Are going to have surgery or you have had an operation recently. STIVARGA might affect the way your wounds heal. Your doctor may stop you taking STIVARGA until your wound heals.
  • Develop a severe and persistent headache, visual disturbances, seizures or altered mental status.
  • Have severe stomach and bowel problems. Your doctor may decide to discontinue treatment.
  • Have skin problems. Your doctor may recommend the use of creams and/or the use of shoe cushions and gloves. Your doctor may also change the dose or stop treatment until your condition improves.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking STIVARGA. You may need treatment and additional tests.

Taking other medicines

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

Some medicines and STIVARGA may interfere with each other. These include:

  • medicines used to treat infections such as antibiotics (e.g. rifampicin, neomycin); antifungals (e.g. ketoconazole)
  • St John’s Wort
  • medicines used to treat epilepsy such as phenytoin, primidone, barbiturates (e.g. phenobarbitone), carbamazepine
  • medicines used to treat cancer, such as methotrexate
  • medicines used to treat high cholesterol such as rosuvastatin, fluvastatin, atorvastatin
  • medicines used to thin your blood such as warfarin
  • medicines used to treat pain (e.g. mefenamic acid).

These medicines may be affected by STIVARGA, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines that you need to be careful with or avoid while taking this medicine.

HOW TO TAKE STIVARGA

Always take STIVARGA exactly as your doctor has told you to.

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions printed on the pharmacy label, ask your doctor or pharmacist for help.

How much to take

The usual dose of STIVARGA is four (40 mg tablets) daily. This is equivalent to 160 mg total daily dose. Your doctor will usually prescribe STIVARGA for three weeks and then stop for one week. This three week on, one week off treatment period is one cycle of treatment.

Your doctor may change your dose. Take the dose of STIVARGA that your doctor prescribes for you.

How to take it

Take four STIVARGA tablets at the same time each day after a low fat meal (ideally at breakfast). A low fat meal contains less than 30% fat. Example of a low fat meal include one cup of cereal, 250 mL or one glass of skimmed milk, one slice of toast with jam, apple juice and one cup of coffee or tea.

Swallow the tablets whole with a glass of water.

Do not drink grapefruit juice while taking STIVARGA.

How long to take it

Your doctor will continue to treat you with STIVARGA as long as you are receiving benefit from therapy. Your doctor may need to reduce your dose or may decide to stop treatment if you experience serious side effects.

If you do not understand the instructions provided, ask your doctor or pharmacist for help.

If you forget to take it

It is important that you take your prescribed dose as recommended by your doctor. If you have any questions or concerns about your medication, ask your doctor or pharmacist for help.

If you miss a dose take it as soon as you remember. Do not take two doses of STIVARGA on the same day to make up for a missed dose from the previous day. Tell your doctor about any missed dose.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (Australia: 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much STIVARGA. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much STIVARGA it may make the side effects more severe, especially skin reactions (rash, blisters, redness, pain, swelling, itching or peeling of your skin), dysphonia (voice changes or hoarseness), diarrhoea (frequent or loose bowel movements), mucosal inflammation (mouth sores), dry mouth, decreased appetite, hypertension (high blood pressure) and fatigue (excessive tiredness).

WHILE YOU ARE TAKING STIVARGA

Things you must do

Tell all doctors, dentists and pharmacists who treat you that you are taking STIVARGA.

Tell your doctor immediately if you become pregnant during treatment with STIVARGA, or plan to become pregnant.

Tell your doctor if you are breast-feeding while being treated with STIVARGA.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Tell your doctor if you are planning to have surgery or you have a wound that is not healing properly.

Things you must not do

Do not take STIVARGA to treat any other conditions, unless your doctor tells you to.

Do not give your medicine to anyone else.

Do not stop taking your medicine or change the dosage without checking with your doctor.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking STIVARGA.

This medicine helps most people, but it may have unwanted side effects in a few people.

Your doctor may need to change your dose or advise you to stop taking STIVARGA.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

If you notice any of the following side effects and they worry you, tell your doctor or pharmacist:

  • infection
  • bruise easily
  • bleeding e.g. nosebleed
  • anaemia (tiredness, pale skin)
  • decreased appetite and food intake
  • high blood pressure
  • changes in your voice or hoarseness
  • diarrhoea
  • painful or dry mouth, painful tongue, mouth sores
  • hyperbilirubinemia (an increase in bilirubin, a substance produced by the liver)
  • decreased activity of the thyroid gland
  • hand-foot skin reactions (redness, pain, blisters and swelling of the palms of the hands or soles of the feet)
  • dry skin
  • hair loss (alopecia)
  • changes to the nail such as ridges and/or splitting
  • weakness, lack of strength and energy, excessive tiredness and unusual sleepiness
  • ringing in your ears
  • dizziness
  • pain
  • muscle spasm
  • loss of balance
  • impaired ability to feel
  • fever
  • tremor (shaking)
  • headache
  • nausea, vomiting
  • weight loss
  • heartburn
  • stomach pain
  • infection or irritation of the stomach and intestines
  • rash or rash with flaking or peeling of skin
  • changes in taste.

These are the more common side effects, other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

If you experience any of the following, tell your doctor immediately, or go to the Emergency Department at your nearest hospital:

  • Chest pain or discomfort which may spread beyond your chest to your shoulders, arms, back, neck, teeth, jaw or stomach and may come and go
  • Shortness of breath
  • Sudden outbreak of a cold sweat with clammy skin
  • Lightheaded or feeling faint
  • Nausea or vomiting
  • Heartburn.
    (The side effects listed above are possible signs of a heart attack or decreased blood flow to the heart).
  • Headache, confusion, seizures, loss of orientation and visual loss associated with or without high blood pressure
    (The side effects listed above are possible signs of a condition called posterior reversible encephalopathy syndrome)
  • Severely elevated blood pressure causing headache, confusion, blurry vision, nausea, vomiting and fits
    (The side effects listed above are possible signs of hypertensive crisis)
  • yellowish discoloration of the skin and the whites of the eyes
  • dark urine
  • excessive tiredness and unusual sleepiness
  • nausea or vomiting or loss of appetite
  • confusion and/or disorientation
  • bruise easily
  • pain on the right side of your stomach.
    (The side effects listed above are possible signs of severe liver injury).
  • Passing blood in the stools or passing black stools
  • Passing blood in the urine
  • Stomach pain
  • Coughing/vomiting up blood.
    (The side effects listed above are possible signs of bleeding in the digestive system).
  • Diarrhoea
  • Dehydration
  • Severe pain in your stomach
  • Red or black stools
  • Fever
  • Chills
  • Nausea or vomiting.
    (The side effects listed above are possible signs of gastrointestinal (bowel) perforation or fistula (severe stomach problems))
  • Redness, pain, swelling and blisters of the palms of the hands or soles of the feet.
    (The side effects listed above are possible signs of the hand-foot skin reaction)
  • Painful blisters and fever including detachment of the skin.
    (The side effects listed above are severe skin reactions)
  • High fever,
  • Severe cough with or without an increase in mucus (sputum) production,
  • Severe sore throat
  • Shortness of breath
  • Burning / pain when urinating,
  • Unusual vaginal discharge or irritation
  • Redness, swelling and/or pain in any part of the body
    (The side effects listed above are possible signs of an infection)
  • Inflammation of the pancreas (pain in the stomach, nausea, vomiting and fever)
  • Multiple skin eruptions
  • Certain skin cancers.

These are very serious side effects of STIVARGA. You may need urgent medical attention or hospitalisation. Serious side effects may be fatal.

Tell your doctor or pharmacist if you feel unwell.

Other side effects not listed on the following pages may also occur in some people.

AFTER TAKING STIVARGA

Storage

Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well. Do not remove the desiccant from the bottle.

Once the bottle is opened the medicine is to be discarded after 28 days.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill.

Do not leave it in the car. Heat and damp can destroy some medicines.

Keep STIVARGA where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Return any unused medicine to your pharmacist.

PRODUCT DESCRIPTION

What it looks like

STIVARGA is available in 28, 28 (starter pack) or 3 x 28 tablet bottles. The tablets are light pink, oval embossed with ‘BAYER’ on one side and ‘40’ on the other side.

Ingredients

Each STIVARGA tablet contains:

Active ingredient:
40 mg regorafenib (as monohydrate)

Inactive ingredients:

  • microcrystalline cellulose
  • croscarmellose sodium
  • magnesium stearate
  • povidone
  • silica colloidal anhydrous
  • iron oxide red
  • iron oxide yellow
  • lecithin
  • macrogol 3350
  • polyvinyl alcohol
  • purified talc
  • titanium dioxide.

Supplier

Made in Germany for:

Bayer Australia Ltd
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073

Australian Registration Number

AUST R 200553

Date of Preparation

December 2017

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.

® Registered Trademark of Bayer group, Germany.

© Bayer Australia Ltd All rights reserved.

Published by MIMS March 2018

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