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Tykerb

film coated tablets

Lapatinib ditosilate
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Tykerb. It does not contain all the information that is known about Tykerb. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What is Tykerb used for?

Tykerb is used to treat certain types of breast cancer. It may slow or stop cancer cells from growing, or may kill them.
Tykerb is prescribed for the treatment of patients with advanced or metastatic breast cancer who have tumours that produce large amounts of a protein called human epidermal growth factor receptor-2 (HER2, also known as ErbB2).
While taking Tykerb for this condition, you will also take another medicine. This could be tablets containing capecitabine (Xeloda®), or a medicine called paclitaxel which is given as an infusion in a hospital or clinic.
For tumours which are hormone sensitive, Tykerb may be given with an aromatase inhibitor tablet.
Information about these other medicines is described in separate Consumer Medicine Information leaflets.
Please ensure you read the information for the other medicines you are prescribed.
Your doctor may have prescribed Tykerb for another reason.
This medicine is available only with a doctor's prescription.
Tykerb is not addictive.

Before you take Tykerb

Do not take if:

You must not take Tykerb if:
you have ever had a severe allergic (hypersensitive) reaction to Tykerb (lapatinib).
Check with your doctor if you think this may apply to you.
you have ever had an allergic reaction to any of the ingredients listed toward the end of this leaflet
(See "Ingredients")
the expiry date (EXP) printed on the pack has passed
the packaging is torn or shows signs of tampering.

Tell your doctor if:

Before you take Tykerb your doctor needs to know:
If you have any heart problems.
If you have any lung problems or problems breathing.
If you have any liver problems.
Check with your doctor if you think any of these may apply to you.
You may need extra tests to check that your heart and liver are working properly. Your doctor may decide to adjust your dose or stop treatment based on the results of these tests.

Other medicines and Tykerb

Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines including any medicines you bought without a prescription.
This includes herbal medicines.
Some medicines may affect the way Tykerb works or Tykerb may affect how other medicines work. These include:
erythromycin, ketoconazole, itraconazole, posaconazole, voriconazole, rifabutin, rifampicin, telithromycin (used to treat infections)
ritonavir, saquinavir (used to treat HIV)
cisapride (used to treat digestive system problems)
drugs that decrease stomach acidity (used to treat stomach ulcers or indigestion)
quinidine, digoxin (used to treat heart problems)
verapamil (used to treat high blood pressure or angina)
rosuvastatin (used to treat high cholesterol)
repaglinide (used to treat diabetes)
phenytoin, carbamazepine (used to treat seizures)
pimozide (used to treat mental health problems)
nefazodone (used to treat depression)
St John's Wort (a herb extract used to treat depression)
cyclosporine (used to suppress the immune system for example after organ transplantations)
topotecan, paclitaxel, irinotecan, docetaxel (used to treat cancer)
Tell your doctor if you are taking any of these.

Taking Tykerb with food and drink

Tykerb is affected by food intake (See How to Take Tykerb).
You should not drink grapefruit juice while you are being treated with Tykerb as this may increase the chance of side effects.

Pregnancy and breast-feeding

Use a reliable method of contraception to avoid becoming pregnant while you're taking Tykerb.
If you are pregnant or think you could be, talk to your doctor about the risks and benefits of taking Tykerb.
Your doctor may recommend that you don't take Tykerb while you are pregnant.
Breast-feeding is not recommended during treatment with Tykerb. Ask your doctor for advice.

Driving and using machines

Tykerb can cause tiredness and may make you unfit to drive.
Do not drive or operate machinery unless you're feeling well.

How do I take Tykerb?

Always take Tykerb exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.

How much to take

In combination with capecitabine:
The usual dose is 5 Tykerb tablets (a total dose of 1250 mg) taken once a day.
In combination with paclitaxel:
The usual dose is 6 Tykerb tablets (a total dose of 1500 mg) taken once a day.
In combination with an aromatase inhibitor:
The usual dose is 6 Tykerb tablets (a total dose of 1500 mg) taken once a day.

How to take it

Swallow the tablets whole with water, one after the other, at about the same time each day.
It is important that you take Tykerb either at least one hour before or at least one hour after food.
If you are being treated with a combination of Tykerb and:
paclitaxel
your doctor will advise you about the dose of paclitaxel, and how often you will receive it.
capecitabine
your doctor will advise you about the dose of capecitabine, when to take it and how often.
an aromatase inhibitor
your doctor will advise you about the dose of the aromatase inhibitor, when to take it and how often.
Depending on your response to treatment, your doctor may recommend lowering your dose of Tykerb or temporarily stopping it.

If you forget to take Tykerb

Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.

How long to take it for

Take Tykerb for as long as your doctor recommends. Don't stop unless your doctor advises you to.

What do I do if I take too much? (Overdose)

Immediately telephone your doctor or Poisons Information Centre (In Australia call 131126 for advice, if you think you or anyone else may have taken too much Tykerb, even if there are no signs of discomfort or poisoning. If you are not sure what to do, contact your doctor or pharmacist.

While you are taking Tykerb

Things you must do

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.
Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use Tykerb to treat any other complaints unless your doctor says to.

What are the side effects?

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking Tykerb, even if the problem is not listed below.
Like all medicines, Tykerb can cause side effects, although not everybody gets them. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.
These side effects have occurred with Tykerb alone, or in combination with capecitabine, paclitaxel or letrozole (an aromatase inhibitor).

Severe allergic reaction

This rare side effect may affect up to 1 in 1000 people and develop rapidly.
Symptoms may include:
skin rash (including itchy, bumpy rash)
unusual wheezing, or difficulty in breathing
swollen eyelids, lips or tongue
pains in muscles or joints
collapse or blackout.
Tell your doctor immediately if you get any of these symptoms.
Do not take any more tablets.

Very common side effects

These may affect more than 1 in 10 people:
diarrhoea (which if severe can be life-threatening). Contact your doctor immediately at the first sign of diarrhoea (loose stool), as it is important that this is treated right away. Also tell your doctor immediately if your diarrhoea worsens.
low levels of white blood cells and red blood cells
muscle pain
numbness, tingling or weakness of the arms and legs
loss of appetite
indigestion or stomach pain
feeling or being sick (nausea or vomiting)
constipation
tiredness
unusual hair loss or thinning
nose bleed
sore mouth or mouth ulcers
trouble sleeping (insomnia)
back pain
rash or dry skin
a skin reaction or pain on the palms of the hands or soles of the feet (including tingling, numbness, pain, swelling or reddening).

Common side effects

These may affect up to 1 in 10 people:
an effect on how your heart works - this may cause an irregular heartbeat and shortness of breath
liver problems - this may cause itching, yellow eyes or skin (jaundice), dark urine or pain or discomfort in the right upper area of the stomach
headache
nail disorders - such as a tender infection and swelling of the cuticles.

Uncommon side effects

These may affect up to 1 in 100 people:
swelling of the lungs - this may cause coughing or shortness of breath.

Rare side effects

These may affect up to 1 in 1000 people:
severe allergic reactions (See the beginning of this section).

If you get side effects

Tell your doctor or pharmacist if any of the side effects listed become severe or troublesome, or if you notice any side effects not listed in this leaflet.

How do I store Tykerb?

Keep this medicine where children cannot reach it, such as in a locked cupboard.
Do not store above 30°C.
Do not leave in a car, on a window sill or in a bathroom.
Do not use Tykerb after the expiry date which is stated on the carton.
Keep Tykerb in its original contained until it's time to take it.

Disposal

If you have any unwanted tablets don't put them in wastewater or household rubbish.
Ask your pharmacist how to dispose of tablets you do not need.
This will help to protect the environment.

Product description

What Tykerb looks like

Tykerb is presented in bottle packs of 70 tablets.
Tykerb tablets are oval, biconvex, yellow film-coated, and with GS XJG debossed on one side.

Ingredients

Tykerb contains the active ingredient lapatinib ditosilate monohydrate. Each film-coated tablet contains 250 mg of lapatinib.
Tykerb also contains:
cellulose - microcrystalline (E460)
povidone (E1201)
sodium starch glycolate
magnesium stearate (E572)
hypromellose (E464)
titanium dioxide (E171)
macrogol (E1521)
polysorbate (E433)
iron oxide yellow (E172)
iron oxide red (E172)

Sponsor

Tykerb is supplied by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road, Macquarie Park NSW 2113 Australia
Telephone 1 800 671 203
www.novartis.com.au
® Registered Trademark
This leaflet was prepared in
September 2016
Australian Registration Number:
AUST R 185997: Tykerb 250 mg bottle pack
Internal document code
(tyk060916c based on PI tyk060916i)