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 IMBRUVICA?
IMBRUVICA contains the active ingredient ibrutinib. IMBRUVICA is used to treat the
following blood cancers in adults: Mantle Cell Lymphoma (MCL); Chronic Lymphocytic
Leukaemia (CLL), including Small Lymphocytic Lymphoma (SLL); Waldenström's macroglobulinemia
(WM)
For more information, see Section
1. Why am I using IMBRUVICA? in the full CMI.
2. What should I know before I use IMBRUVICA?
Do not use if you have ever had an allergic reaction to IMBRUVICA 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 IMBRUVICA? in the full CMI.
3. What if I am taking other medicines?
4. How do I use IMBRUVICA?
The recommended dose of IMBRUVICA for: MCL is 560 mg once a day and for WM and CLL/SLL
is 420 mg once a day. Follow your doctor's instructions on the dose appropriate for
you.
5. What should I know while using IMBRUVICA?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using IMBRUVICA
Your heart function will be checked before and during treatment with IMBRUVICA. Your
doctor will check your blood counts before or during the treatment.
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Things you should not do
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Do not change your dose or stop taking IMBRUVICA until your doctor tells you to.
Do not use preparations containing St John's Wort while you are taking IMBRUVICA.
Do not fall pregnant while you are taking IMBRUVICA.
Do not breast feed while you are taking IMBRUVICA.
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Driving or using machines
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You may feel tired or dizzy after taking IMBRUVICA, which may affect your ability
to drive or use any tools or machinery.
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Drinking alcohol
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No information on the effects of drinking alcohol with IMBRUVICA
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Looking after your medicine
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Store below 30°C. Keep capsules or tablets in the original container.
Do not store it or any medicines in the bathroom or near a sink.
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6. Are there any side effects?
The most common side effects include diarrhoea; feeling very tired; nausea; headache;
swollen hands, ankles or feet; being short of breath; dizziness; fainting; constipation;
infected nose, sinuses or throat (cold); fever; vomiting; decreased appetite; bleeding;
bruises; skin rash; muscle and joint pain; muscle spasms; indigestion (dyspepsia).
Call your doctor or healthcare professional if you have signs or symptoms of serious
bleeding, if you have any heart problems like chest discomfort, shortness of breath
or palpitations or signs of jaundice. 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):
ibrutinib
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using IMBRUVICA. 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 IMBRUVICA.
Where to find information in this leaflet:
1. Why am I using IMBRUVICA?
IMBRUVICA contains the active ingredient ibrutinib. IMBRUVICA is Bruton's tyrosine kinase inhibitor. By blocking this protein, IMBRUVICA
may help kill and reduce the number of cancer cells and may also slow the spread of
the cancer.
IMBRUVICA is used to treat the following blood cancers in adults: Mantle Cell Lymphoma
(MCL); Chronic Lymphocytic Leukaemia (CLL), including Small Lymphocytic Lymphoma (SLL);
Waldenström's macroglobulinemia (WM).
2. What should I know before I use IMBRUVICA?
Warnings
Do not use IMBRUVICA if:
you are allergic to ibrutinib, 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 use preparations containing St John's Wort
you are pregnant, think you may be pregnant or are planning to have a baby
you are breast feeding
Check with your doctor if you:
had unusual bruising or bleeding or are on any medicines or supplements that increase
your risk of bleeding
have had a history of high blood pressure, irregular heartbeat (atrial fibrillation,
ventricular tachyarrhythmia) or severe heart failure, or if you feel any of the following:
lightheadedness, dizziness, shortness of breath, chest discomfort, swollen legs, or
you faint
if you have liver or kidney problems
if you have or have had Hepatitis B infection
if you have recently had any surgery, especially if this might affect how you absorb
food or medicines from your stomach or gut
if you are planning to have any surgery - your doctor may ask you to stop taking IMBRUVICA
for a short time.
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
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.
Do not father a child while taking IMBRUVICA and for 3 months after stopping treatment.
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.
IMBRUVICA may make you bleed more easily. Tell your doctor if you take other medicines
that increases your risk of bleeding. These include the following medicines:
warfarin, heparin or other medicines to prevent blood clots.
aspirin and non-steroidal anti-inflammatories (NSAIDS) such as ibuprofen or naproxen
fish oil and supplements containing vitamin E
Some medicines may interfere with IMBRUVICA and affect how it works.
medicines called antibiotics to treat bacterial infections - clarithromycin, telithromycin,
ciprofloxacin, erythromycin, rifampin or azithromycin
medicines for fungal infections - ketoconazole, posaconazole, itraconazole, fluconazole
or voriconazole
medicines for HIV infection - ritonavir, cobicistat, indinavir, nelfinavir, saquinavir,
amprenavir, atazanavir, darunavir/ritonavir or fosamprenavir
aprepitant - medicine to prevent nausea and vomiting associated with chemotherapy
nefazodone - medicine for depression
medicines called kinase inhibitors for treatment of other cancers - crizotinib, imatinib
medicines called calcium channel blockers for high blood pressure or chest pain -
diltiazem, verapamil
medicines used to treat or prevent irregular heartbeat - amiodarone, dronedarone
fluvoxamine - medicine used to treat obsessive compulsive disorder
medicines to prevent seizures or to treat epilepsy or medicines to treat a painful
condition of the face called trigeminal neuralgia - carbamazepine, phenytoin
medicines called statins to treat high cholesterol - rosuvastatin
St. John's Wort - herbal medicine used for depression
If you are taking digoxin, a medicine used for heart problems, or methotrexate, a
medicine used to treat other cancers and to reduce the activity of the immune system
(e.g., for rheumatoid arthritis or psoriasis), it should be taken at least 6 hours
before or after IMBRUVICA.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect IMBRUVICA.
4. How do I use IMBRUVICA?
How much to take / use
The recommended dose of IMBRUVICA for:
MCL is 560 mg once a day.
WM and CLL/SLL is 420 mg once a day.
Follow your doctor's instructions on the dose appropriate for you.
When to take / use IMBRUVICA
Do not take IMBRUVICA with grapefruit or Seville oranges - this includes eating them,
drinking the juice, or taking supplements that might contain them. This is because
they can increase the amount of IMBRUVICA in your blood.
Swallow IMBRUVICA capsules whole with a glass of water. Do not open, break, or chew
them.
Swallow IMBRUVICA tablets whole with a glass of water. Do not break or chew them.
Try to take IMBRUVICA at the same time each day.
Follow the instructions provided and use IMBRUVICA until your doctor tells you to
stop. Do not change your dose or stop taking IMBRUVICA until your doctor tells you
to.
If you forget to use IMBRUVICA
IMBRUVICA should be used regularly at the same time each day. If you miss your dose
at the usual time, if it is more than 12 hours until your next dose, take the missed
dose as soon as possible. Then continue taking IMBRUVICA at the usual scheduled time..
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 use too much IMBRUVICA
If you think that you have used too much IMBRUVICA, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26
or in New Zealand 0800 POISON or 0800 764 766), 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 IMBRUVICA?
Things you should do
Be sure to keep all your doctor's appointments so your progress can be checked.
Call your doctor straight away if you:
have diarrhoea that lasts for more than a week, your doctor may need to give you a
fluid and salt replacement or another medicine.
Remind any doctor, dentist or pharmacist you visit that you are using IMBRUVICA.
Things you should not do
Do not take IMBRUVICA:
if the packaging is torn or shows signs of tampering.
if the expiry date (month and year) printed on the pack has passed. If you take IMBRUVICA
after the expiry date it may not work.
Effects on the heart
Treatment with IMBRUVICA may affect the heart, especially if you already have heart
diseases such as rhythm problems, heart failure, high blood pressure or have diabetes.
The effects may be severe and could cause death, including sometimes sudden death.
Your heart function will be checked before and during treatment with IMBRUVICA. Tell
your doctor immediately if you feel breathless, have difficulty breathing when lying
down, swelling of the feet, ankles or legs and weakness/tiredness during treatment
with IMBRUVICA – these may be signs of heart failure.
Tests and check-ups before and during treatment
Laboratory tests may show that your blood count contains more white blood cells (called
"lymphocytes"), in the first few weeks of treatment. This is expected and may last
for a few months. This does not necessarily mean that your blood cancer is getting
worse. Your doctor will check your blood counts before or during the treatment and
in rare cases they may need to give you another medicine. Talk to your doctor about
what your test results mean.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how IMBRUVICA
affects you.
IMBRUVICA may cause dizziness in some people which may affect your ability to drive
or use any tools or machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
We have no information on how alcohol affects IMBRUVICA.
Looking after your medicine
Store below 30°C. Keep capsules or tablets in the original container.
Follow the instructions in 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
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Less serious side effects
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What to do
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Gastrointestinal:
diarrhoea; nausea, constipation; vomiting; sore stomach; indigestion (dyspepsia);
sore or inflamed mouth; decreased appetite
Infections:
infected nose; sinuses or throat; fever; feeling tired; urinary tract infection; chills;
body aches; cold or flu symptoms; feel short of breath; yellowing of the skin or eyes
(jaundice); confusion
Musculoskeletal:
muscle and joint pain; muscle spasms
Skin:
rash, bruising; swollen hands or feet; bleeding
Nervous system:
dizziness, fainting; headache; blurred vision
Metabolism:
low blood sodium; high levels of uric acid or creatine in your blood
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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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Bleeding:
Bleeding in the eye or serious internal bleeding, such as bleeding in your stomach,
intestine, or brain may occur. Signs or symptoms of serious bleeding include blood
in your stools or urine or bleeding that lasts for a long time or that you cannot
control.
Interstitial lung disease (ILD):
Inflammation within the lungs that may lead to permanent damage has happened with
IMBRUVICA treatment. Contact your doctor if you have difficulty breathing or have
a persistent cough.
Haemophagocytic lymphohistiocytosis:
There have been rare reports of excessive activation of white blood cells associated
with inflammation, which can be fatal if not diagnosed and treated early. If you experience
multiple symptoms such as fever, swollen glands, bruising, or skin rash, contact your
doctor immediately.
Stroke:
Temporary or permanent decrease of brain or nerve function due to reduced blood flow
to the brain (mini-stroke or stroke).
Heart problems:
Irregular heartbeat (atrial fibrillation, ventricular tachyarrhythmia) and high blood
pressure have occurred with IMBRUVICA treatment. Tell your doctor or healthcare professional
if you have any heart problems like chest discomfort, shortness of breath or palpitations.
Heart failure has also been reported. Tell your doctor immediately if you notice breathlessness,
difficulty breathing when lying down, swelling of the feet, ankles or legs and weakness/tiredness
during treatment with IMBRUVICA.
Rupture of spleen:
Cases of splenic rupture have been reported after stopping IMBRUVICA treatment. Tell
your doctor immediately if you develop left upper belly (abdominal) pain, pain below
the rib cage or at the tip of your left shoulder.
Changes in blood cell counts:
IMBRUVICA may cause you to have a low number of red blood cells (anaemia), a low number
of neutrophils a type of white blood cell (neutropenia) or a low number of platelets
a type cell that help blood to clot (thrombocytopenia). You may experience an increase
in the number of white blood cells, specifically lymphocytes in your blood. In rare
cases, this increase may be severe, causing cells to clump together. Your doctor or
healthcare professional should check your blood counts regularly.
Liver problems:
Very rarely patients may experience changes in their liver function. Your doctor will
monitor your liver function by periodic blood tests. If you notice signs of jaundice
such as yellowing of the whites of the eyes please call your doctor immediately.
Other cancers:
New cancers have occurred in people taking IMBRUVICA, including skin cancer and other
cancers.
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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.
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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.
What IMBRUVICA capsules contain
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Active ingredient
(main ingredient)
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Ibrutinib
Each hard capsule contains 140 mg of ibrutinib.
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Other ingredients
(inactive ingredients)
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croscarmellose sodium
microcrystalline cellulose
sodium lauryl sulphate
magnesium stearate
gelatin
titanium dioxide (E171)
black ink
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Potential allergens
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None
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What IMBRUVICA tablets contain
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Active ingredient
(main ingredient)
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Ibrutinib
Each tablet contains 140 mg, 280 mg, 420 mg or 560 mg of ibrutinib
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Other ingredients
(inactive ingredients)
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colloidal anhydrous silica
croscarmellose sodium
lactose monohydrate
magnesium stearate
microcrystalline cellulose
povidone
sodium lauryl sulfate
The film-coating contains:
iron oxide black (140 mg, 280 mg and 420 mg tablets)
polyvinyl alcohol
macrogol
iron oxide red (280 mg and 560 mg tablets)
talc
titanium dioxide
iron oxide yellow (140 mg, 420 mg and 560 mg tablets)
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Potential allergens
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Contains lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What IMBRUVICA looks like
140 mg capsule: AUST R 228499
140 mg tablet: AUST R 319356
280 mg tablet: AUST R 319357
420 mg tablet: AUST R 319360
560 mg tablet: AUST R 319380
Capsules
The hard capsules are white opaque, with "ibr 140 mg" printed in black ink.
IMBRUVICA capsules are supplied in bottles containing 90 or 120 capsules. Not all
pack sizes may be marketed.
Tablets
140 mg tablets are yellow-green to green, round, debossed with “ibr” on one side and
“140” on the other.
280 mg tablets are purple, oblong-shaped, debossed with “ibr” on one side and “280”
on the other.
420 mg tablets are yellow-green to green, oblong-shaped debossed with “ibr” on one
side and “420” on the other.
560 mg tablets are yellow to orange, oblong-shaped, debossed with “ibr” on one side
and “560” on the other.
IMBRUVICA 140 mg, 280 mg, 420 mg and 560 mg tablets are supplied in cartons containing
30 tablets (3 cardboard wallets containing 10 film-coated tablets each).
Not all pack sizes may be marketed
Who distributes IMBRUVICA
Janssen-Cilag Pty Ltd
1-5 Khartoum Rd
Macquarie Park
NSW 2113 Australia
Telephone: 1800 226 334
NZ Office: Auckland, New Zealand
Telephone: 0800 800 806
This leaflet was prepared in March 2023.
®IMBRUVICA is a registered trademark of Janssen-Cilag.
Co-developed with Pharmacyclics.