Consumer Medicine Information

LANVIS™

Thioguanine tablets 40mg

What is in this leaflet

Please read this leaflet carefully before you start taking LANVIS tablets.

This leaflet answers some common questions about LANVIS tablets. 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 expected benefits of you taking LANVIS against the risks this medicine could have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

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

What LANVIS is used for

LANVIS contains the active ingredient thioguanine.

LANVIS is used to treat acute myelogenous leukaemia and acute lymphoblastic leukaemia. It can also be used to treat chronic granulocytic leukaemia. These are different types of cancer affecting the blood. In people with blood cancer, abnormal blood cells are formed in the bone marrow which multiply uncontrollably, crowding out and interfering with the vital functions of normal healthy blood cells.

Your doctor may have prescribed LANVIS for another purpose.

LANVIS belongs to a group of medicines called anti-neoplastic agents. Within this group, LANVIS belongs to a class of medicines called purine antimetabolites. These medicines are used to treat blood cancers.

LANVIS is often given in combination with other medicines used to treat cancer of the blood.

LANVIS works by interfering with the function of the bone marrow and reducing the number of abnormal blood cells which are causing your illness.

Ask your doctor if you have any questions about why LANVIS has been prescribed for you.

LANVIS is available only with a doctor's prescription.

Use in children and elderly people

LANVIS is used in children, at doses similar to those used in adults.

LANVIS is also used in elderly people with acute leukaemia.

When you must not take LANVIS

Do not take LANVIS if:

• You have ever had an allergic reaction before to thioguanine or any of the ingredients in LANVIS listed at the end of this leaflet.
• The packaging is torn or shows signs of interference, or if the tablets appear to be broken, damaged or discoloured.
• The expiry date on the packaging has passed. If you take this medicine after the expiry date has passed, it may not work as well. If the pharmacist has repacked the medicine for you, there may not be an expiry date on the pack.

Before you start taking LANVIS

Tell your doctor if:

• You have taken LANVIS or a medicine called Puri-Nethol™ (mercaptopurine) before and it didn't work.
• You are pregnant, plan to become pregnant or plan to father a child.
  
  LANVIS may be harmful to the sperm, eggs and/or an unborn baby when taken by a pregnant woman or by the unborn baby's father. Reliable contraceptive precautions MUST be taken to avoid becoming pregnant while you or your partner are taking taking LANVIS.
  
  If you are already pregnant, your doctor will weigh up the expected benefits of LANVIS to you against the possible risks to your unborn baby.
  
  
• You are breastfeeding or planning to breastfeed.
  
  It is not known for certain that thioguanine, the active ingredient in LANVIS, does not pass into breast milk, so mothers taking LANVIS should not breastfeed.
  
  
• You have recently been vaccinated, or plan to be vaccinated with a live vaccine.
• You have any other health problems, especially:
  • Liver disease
  • Kidney disease
  • An enzyme deficiency called Lesch-Nyhan syndrome or you are deficient in the enzyme TPMT (thiopurine methyltransferase)
• You are allergic to any other medicines, foods, dyes or preservatives.

If you have not told your doctor about any of the above, please do so before taking LANVIS.

Taking other medicines

Some medicines may affect the way others work.

Tell your doctor if you are taking any other medicines, including the oral contraceptive pill or medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

If you are taking any of the following medicines, please tell your doctor before taking LANVIS:

• Olsalazine (Dipentum™)
• Mesalazine (Asacol™, Pentasa™)
• Sulphasalazine (Colizine™, Colizine EC™, Salazopyrin™)
• Busulphan (Myleran™)
• Mercaptopurine (Puri-Nethol™)
• Azathioprine (Azamun™, Imuran™, Thioprine™)

Your doctor will be able to tell you more about what to do when taking LANVIS with other medicines.

LANVIS is often used in combination with other medicines used to treat cancer.

Taking LANVIS

How much to take

Take LANVIS exactly as your doctor has prescribed.

Your doctor will tell you how many LANVIS tablets to take each day.

Your doctor will calculate the dose based on your body surface area (the area of skin you have). If you have liver or kidney problems, your doctor may decide to reduce your LANVIS dose.

In adults, LANVIS is usually given in doses of 100mg to 200mg per square metre of body surface area for 5 to 20 days, either once or twice daily. This happens at the beginning of treatment. Similar but sometimes lower doses are used in children.

When your blood cancer has come under control, LANVIS is usually continued at a lower dose between 60mg and 200mg per square metre of body surface area in both adults and children.

Lower doses are sometimes used in elderly patients because they tend to be more affected by drugs.

Never take more tablets than your doctor has prescribed.

Your doctor may vary your dose depending on your type of cancer and your response to LANVIS.

Your doctor may do regular blood and urine tests to make sure that LANVIS is working for you.

How to take it

Swallow tablets whole with a glass of water.

If you need to take half a tablet, protect your hands. Do not breathe in any powder from halved tablets.

If you forget to take it

Do not take an extra dose. Wait until the next dose and take your normal dose then.

Do not try to make up for the dose that you missed by taking more than one dose at a time.

If you are not sure what to do, ask your doctor or pharmacist.

In case of an overdose

Immediately telephone your doctor or the National Poisons Information Centre (0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else has taken too much LANVIS. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Keep phone numbers for these places handy.

An overdose of LANVIS could have serious effects on your bone marrow and blood cells.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking LANVIS

Things you must do

Tell all doctors, dentists and pharmacists treating you that you are taking LANVIS.

Tell your doctor if you become pregnant while taking LANVIS.

As with all medicines used to treat cancer, you should use reliable contraception when taking LANVIS, whether you are male or female.

Tell your doctor if, for any reason, you have not taken LANVIS exactly as prescribed. Otherwise, your doctor may think it is not working for you and change your medicine unnecessarily.

Tell your doctor if you feel that LANVIS is not helping your condition.

Things you must not do

Do not stop taking LANVIS or change the dose without first checking with your doctor.

Do not let yourself run out of medicine over the weekend or on holidays.

Do not give LANVIS to anyone else even if they have the same condition as you.

Do not take any other medicines whether they require a prescription or not without first asking your doctor or a pharmacist.

Do not drive a vehicle or operate machinery until you know how LANVIS affects you.

Side-Effects

All medicines can have unwanted side effects. Sometimes they may be serious, but often they are not. You may need medical treatment if you get some of the side effects.

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

Be sure that your doctor or pharmacist knows as soon as possible if you do not feel well while you are taking LANVIS.

If you think LANVIS is causing you to have an allergic (hypersensitivity) reaction, TELL YOUR DOCTOR IMMEDIATELY. Symptoms include:

• Severe skin rash, itching or hives.
• Swelling of the face, lips, mouth or throat.
• Difficulty breathing or swallowing.
• Fever.
• Low blood pressure (feeling dizzy and like you are about to faint, or fainting)

Tell your doctor if you notice any of the following:

• Damage to the lining of the intestines which may make you feel as if you have an upset stomach and possibly a burning sensation in your chest
• Abnormal liver function causing jaundice (yellowing of the skin)
• Damage to some of the blood vessels to the liver
• Diarrhoea
• Nausea (feeling as if you are about to vomit)
• Vomiting
• Sore mouth

Your doctor can prescribe helpful medication if you develop any of the above side effects.

LANVIS can also have side effects which affect your kidney function, bone marrow and blood count. This may make you feel tired and weak. It will also affect how well your blood clots. Your doctor will do regular blood and urine tests to check for these problems.

Your doctor may also recommend that you change your dose of LANVIS if you experience any of these side effects.

This is not a complete list of all possible side effects.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you do not understand anything on this list.

Do not be alarmed by the above list of possible side effects. Many of them are uncommon. You might not experience any of them.

After taking LANVIS

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.

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

Keep LANVIS away from light.

Do not store it, or take any other medicine, in a bathroom or near a sink.

Do not leave it in a car or on a window sill.

Heat and dampness can destroy some medicines.

Keep LANVIS where young 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 LANVIS, or the medicine has passed its expiry date, ask your pharmacist what to do with any tablets that are left over.

Product description

What LANVIS looks like

LANVIS 40mg tablets are round and yellow. They are engraved with WELLCOME U3B on one side and unmarked on the other.

Ingredients

Thioguanine, Lactose monohydrate, Potato starch, Acacia, Stearic acid, Magnesium stearate

Further information

Your doctor is the best person to give you advice on the treatment of your illness. You may also be able to find general information about your illness and its treatment from other sources, for example, books in public libraries and the Internet.

Manufacturer

LANVIS is supplied by:

GlaxoSmithKline NZ Ltd
Quay Tower
Cnr Albert & Customs Sts
Private Bag 106600
Downtown, Auckland
NEW ZEALAND

Ph (09) 367-2900
Fax (09) 367-2910

This leaflet was prepared in November 2004, Issue 2. It is copyrighted to GlaxoSmithKline (New Zealand) Ltd and may be reproduced but not altered in any way.

LANVIS is a trademark of the GlaxoSmithKline Group of Companies.