Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking TYKERB?
TYKERB contains the active ingredient lapatinib. TYKERB is used to treat breast cancer
that may have spread to other parts of your body. For more information, see Section
1. Why am I taking TYKERB? in the full CMI.
2. What should I know before I take TYKERB?
Do not use if you have ever had an allergic reaction to TYKERB or any of the ingredients
listed at the end of the CMI. TYKERB may also be used with other medicines including
trastuzumab, paclitaxel, capecitabine or other medicines called "aromatase inhibitors"
so it is important to read the Consumer Medicine Information (CMI) for these medicines
as well.
Talk to your doctor if you have any other medical conditions affecting your heart,
lungs, or liver. Your doctor will want to monitor these closely and will send you
for regular blood tests to check how you are responding to treatment. Tell your doctor
if you 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 take TYKERB? in the full CMI.
3. What if I am taking other medicines?
Some medicines interfere with TYKERB and affect how it works. Grapefruit in any form
will also affect how well TYKERB 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 take TYKERB?
Your doctor will decide how much TYKERB you will need to take. This may change depending
on how your body responds or whether you are taking any additional medicines for your
breast cancer.
TYKERB must be taken on an empty stomach at least 1 hour before or 1 hour after eating.
5. What should I know while taking TYKERB?
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Things you should do
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Remind any doctor, dentist, or pharmacist you visit that you are taking TYKERB.
Use effective contraception to avoid becoming pregnant.
Tell your doctor immediately if you are pregnant or think you are pregnant.
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Things you should not do
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Do not stop taking this medicine suddenly.
Do not take TYKERB with grapefruit or grapefruit juice of any kind
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Driving or using machines
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Tykerb can cause tiredness and may make you unfit to drive. Talk to your doctor.
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Looking after your medicine
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Keep TYKERB tablets in its original packaging until it is time to take them.
Store in a cool, dry place below 30°C.
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6. Are there any side effects?
Common side effects include feeling sick, dizzy, or tired, weight loss, diarrhoea,
tummy pain, sore throat, dry, cracked skin/nails, hair loss, nose bleeds, feeling
sore, sore/red mouth, back pain, trouble sleeping, rash, red/irritated and itchy skin.
More serious side effects include trouble breathing, wheezing, fainting, chest pain,
blue lips or skin, yellowing of skin or eyes, blistering or swelling of skin, eyes,
lips or tongue, changes to heart rate, severe tummy pain/diarrhoea, tingling or numbness
in hands, feet or limbs, trouble doing a wee; cracked lips and skin while feeling
very thirsty, weakness, chills, pale skin, being more sick than usual.
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.
Active ingredient(s):
lapatinib (La·pa·tee-nib)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking TYKERB. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking TYKERB.
Where to find information in this leaflet:
1. Why am I taking TYKERB?
TYKERB contains the active ingredient lapatinib. TYKERB is a medicine known as a 'protein kinase inhibitor' meaning when used with
other medicines, it may slow or stop the spread of cancer cells that have originated
from your breast.
TYKERB is used with other medicines to treat breast cancer that may or may not yet
have spread to other parts of your body. When cancer cells spread to other parts of
your body (a process called "metastasis") they may be growing because of hormones
(chemicals) that are naturally produced in your body such as oestrogen and progesterone.
2. What should I know before I take TYKERB?
Warnings
Do not take TYKERB if:
You are allergic to lapatinib, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine.
The expiry date has passed on the packaging or shows evidence of tampering.
You are under 18 years of age
Some signs of an allergic reaction may include difficulty breathing or shortness of
breath leading to pale or blue lips/skin. Other signs can include swelling of the
lips, face, or tongue as well as skin problems including rash, hives or painful and
itchy red skin that are sudden and spreading.
Check with your doctor if you:
have a heart condition for example an irregular heartbeat
have any lung problems or breathing difficulties
have a liver condition
are taking other medicines to treat infections (such as ketoconazole, itraconazole,
rifampin) or epilepsy (carbamazepine, phenytoin). See section "what if I am taking
other medicines"
have any allergies to food, preservatives, dyes or other medicines
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?
Monitoring
Your doctor may want to monitor your heart and lungs while you are on treatment with
TYKERB.
Your doctor may also send you for blood tests before starting treatment or once you
have started treatment to monitor your liver function.
These blood tests may also be looking for the number of white blood cells in your
body as TYKERB when used with some medicines may reduce the number of white blood
cells in your body. This can make you more likely to get sick.
Your doctor may alter your treatment plan depending on your results.
Changes to toilet habits
Tell your doctor immediately if you have noticeable changes to your toilet habits
including severe diarrhoea or if you are unable to go to the toilet at all. Your doctor
may choose to stop TYKERB treatment if the problem persists or prescribe you with
additional medicines to treat diarrhoea.
Skin reactions
Tell your doctor immediately if you have a rash on your skin that is spreading/getting
worse. Your doctor may choose to stop treatment with TYKERB based on this.
Birth control
You should avoid becoming pregnant while taking TYKERB. TYKERB may harm your unborn
baby.
You must use a reliable form of birth control (contraception) during treatment with
TYKERB and for at least 5 days after your last dose. Your doctor can provide you advice
on the most effective method.
Taking TYKERB with other medicines
TYKERB is generally taken with other medicines for cancer including trastuzumab, paclitaxel,
capecitabine or other medicines called "aromatase inhibitors" (see section "What if
I am taking other medicines"). You should also read the "Consumer Medicine Information"
for these medicines carefully.
Taking TYKERB with food
TYKERB must be taken on an empty stomach at least 1 hour before OR 1 hour after eating.
You should not drink grapefruit juice or eat grapefruit during your treatment with
TYKERB. It may make this medicine less effective and possibly increase the chance
of side effects.
Pregnancy and breastfeeding
Tell your doctor straight away if you are pregnant or think you may be pregnant. Talk
to your doctor before starting treatment with TYKERB if you intend to become pregnant.
Do not breastfeed while taking TYKERB and for at least 5 days after stopping treatment
with TYKERB as it may harm your baby.
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.
Taking TYKERB with a medicine called 'trastuzumab'
Trastuzumab is given to you in a hospital and can also be used to treat breast cancer
where the cancer may have spread to other parts of your body. Your doctor may consider
your dose of TYKERB carefully if you are taking trastuzumab.
Taking TYKERB with a medicine called 'paclitaxel'
Paclitaxel is given to you in a hospital and can also be used to treat breast cancer
where the cancer may have spread to other parts of your body. TYKERB may increase
the effect of paclitaxel on your body. When taken together, it may cause more severe
diarrhoea and changes to your blood test results.
Your doctor may consider your dose of TYKERB carefully if you are also taking paclitaxel.
Taking TYKERB with a medicine called 'capecitabine'
Capecitabine can also be used to treat breast cancer where the cancer may have spread
to other parts of your body. Your doctor may consider your dose of TYKERB carefully
if you are also taking capecitabine.
Taking TYKERB with medicines called 'aromatase inhibitors'
Aromatase inhibitors (such as medicines containing 'letrozole') can also be used to
treat breast cancer that may have spread to other parts of your body. Your doctor
may consider your dose of TYKERB carefully if you are also taking letrozole or any
other similar medicine.
Other medicines that may affect how well TYKERB works
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).
Esomeprazole or other drugs that decrease stomach acidity (used to treat stomach ulcers
or indigestion).
Medicines used for sedation before surgery (anaesthesia), such as midazolam.
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 (herb extract used to treat depression)
Cyclosporin (used to prevent the rejection of transplanted organs)
Topotecan, irinotecan, docetaxel (used to treat cancer).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TYKERB.
4. How do I take TYKERB?
How much TYKERB to take
Follow all instructions from your doctor.
Your doctor will decide how much TYKERB you need to take. Depending on how well you
respond to treatment or if you have any side effects, your doctor may change your
dose or stop treatment.
You may be taking other medicines for your breast cancer in addition to TYKERB. See
below for the usual amount of TYKERB you would be taking in those settings.
Taking TYKERB with a medicine called 'trastuzumab'
The usual amount is 4 (four) TYKERB tablets taken once a day continuously (a total
daily dose of 4 x 250 mg tablets is 1000 mg a day) along with the amount of trastuzumab
your doctor tells you to.
Taking TYKERB with a medicine called 'paclitaxel'
The usual amount is 6 (six) TYKERB tablets taken once a day continuously (a total
daily dose of 6 x 250 mg tablets is 1500 mg each day) along with the amount of paclitaxel
your doctor tells you to.
Taking TYKERB with a medicine called 'capecitabine'
The usual amount is 5 (five) TYKERB tablets taken once a day continuously (a total
daily dose of 5 x 250 mg tablets which is 1250 mg each day) along with the amount
of capecitabine your doctor tells you to.
Taking TYKERB with other medicines known as 'aromatase inhibitors'
The usual amount is 6 (six) TYKERB tablets taken once a day continuously (a total
daily dose of 6 x 250 mg tablets is 1500 mg each day) along with the amount of aromatase
inhibitor your doctor tells you to.
Your doctor will tell you how much trastuzumab, paclitaxel, capecitabine, or aromatase
inhibitor you should take and when you should take it. These medicines may have a
different schedule to TYKERB that you will also need to follow.
How to take TYKERB
TYKERB must be taken on an empty stomach at least 1 hour before OR 1 hour after eating.
TYKERB tablets need to be swallowed whole with a glass of water. You must not chew,
crush, or split the tablets before you swallow it.
When to take TYKERB
Take TYKERB at the same time every day to help you remember to take it regularly.
TYKERB must be taken at least one hour before or after you eat.
How long to take TYKERB
Keep taking TYKERB until your doctor tells you to stop.
If you forget to take TYKERB
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you take too much TYKERB
If you think that you have used too much TYKERB, 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 taking TYKERB?
Things you should do
Attend all your appointments with your doctor as well as any other ones where your
heart, lungs or kidneys are being checked.
Get your blood tests done promptly so your doctor can check how your body is responding
to TYKERB.
Continue taking TYKERB as well as any other medicines you may be taking as directed
by your doctor for as long as they tell you to.
Use effective birth control to avoid becoming pregnant (see section on "Pregnancy
and breastfeeding").
Make sure you take TYKERB on an empty stomach. At least one hour before OR 1 hour
after eating.
Call your doctor straight away if you:
Are pregnant or think you may be pregnant.
Are experiencing a sudden angry-looking rash, hives or blisters on your skin that
is spreading.
Are experiencing check pain, trouble breathing or shortness of breath.
Are experiencing noticeable changes to your toilet habits.
Are experience swelling of your lips, tongue or face
Remind any doctor, dentist, or pharmacist you visit that you are taking TYKERB.
Things you should not do
Do not drink grapefruit juice or eat grapefruits while you are taking TYKERB.
Do not give this medicine to someone else.
Do not stop taking this medicine suddenly.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TYKERB
affects you.
TYKERB can cause tiredness and may make you unfit to drive.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep TYKERB tablets in its original packaging until it is time to use it.
Store in a cool, dry place below 30°C.
Do not store TYKERB in the bathroom or near a sink. Do not store in the car or on
a windowsill.
Keep it where young children cannot reach it.
When to discard your medicine
You must only discard this medicine if your Doctor tells you to stop taking TYKERB
or if the expiry date on the packaging has passed.
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
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Less serious side effects
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What to do
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Tummy problems:
Tummy discomfort/indigestion
Loss of appetite
Constipation (unable to poo)
General well-being:
Feeling tired
Feeling dizzy
Feeling or being sick (vomiting)
Trouble sleeping
Nose bleeds
Headaches
Mouth sores (ulcer) or redness
Hair loss
Weight loss
Muscle problems
Sore muscles
Back pain
Pain in limbs
Skin and nail problems:
Dry or cracked skin
Dry nails
Infected nails or swelling of nails
Itchy skin
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Breathing problems
Shortness of breath or wheezing
Blue lips or tongue
Feeling faint, weak, light-headed, or fainting
Heart problems:
Irregular heartbeat or chest pain
Changes to your heart's electrical rhythm
Tingling ('pins and needles') numbness of the arms and legs
Liver problems:
Yellow eyes
Tummy problems:
Severe/uncontrolled diarrhoea
Severe tummy pain
Kidney problems:
Very dark wee, pain when going to the toilet, unable to go to the toilet.
Skin problems:
Yellow skin
Blistering (especially on the lips, eyes, or mouth) or hives
Red itchy rash that is spreading or skin peeling.
Tingling, pain, swelling or redness on your hands and feet, your lips, tongue, eyes,
or face.
Infections and blood problems:
Feeling sick or weak constantly
Fever, chills, sore throat
Pale skin
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Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
As you will likely be taking TYKERB with another medicine you may experience effects
related to TYKERB or one of these other medicines.
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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.
Each TYKERB tablet contains the active ingredient lapatinib ditosilate monohydrate,
equivalent to 250 mg of lapatinib.
What TYKERB contains
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Active ingredient
(main ingredient)
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Lapatinib ditosilate monohydrate (lapatinib)
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Other ingredients
(inactive ingredients)
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Microcrystalline cellulose (E460)
Povidone (E1201)
Sodium starch glycollate type A
Magnesium stearate (E572) (vegetable origin)
Hypromellose (E464)
Titanium dioxide (E171)
Macrogol (E1521)
Polysorbate (E433)
Iron oxide yellow (E172)
Iron oxide red (E172)
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Potential allergens
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TYKERB tablets do not contain lactose, sucrose, tartrazine, or any other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What TYKERB looks like
TYKERB is supplied in plastic bottles containing 70 tablets.
TYKERB 250 mg tablets are oval, rounded on both sides, yellow film-coated, and with
GS XJG imprinted on one side (AUST R 185997).
Who distributes TYKERB
Tykerb is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
54 Waterloo Road,
Macquarie Park, NSW 2113, Australia
Telephone 1 800 671 203
ABN 18 004 244 160
® = Registered Trademark
This leaflet was prepared in November 2023.
Internal document code:
tyk270522c_v2 based on PI tyk270522i.