Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about IMBRUVICA capsules and 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 risks of you being
given IMBRUVICA against the benefits this medicine is expected to have for you.
If you have any concerns about being given IMBRUVICA ask your doctor or healthcare
Keep this leaflet while you are taking IMBRUVICA.
You may need to read it again.
What IMBRUVICA is used for
IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib.
IMBRUVICA is used to treat the following blood cancers in adults:
Mantle Cell Lymphoma (MCL), a type of cancer affecting the lymph nodes;
Chronic Lymphocytic Leukaemia (CLL), including Small Lymphocytic Lymphoma (SLL), a
type of cancer affecting a type of white blood cell called lymphocytes that also involve
the lymph nodes.
Waldenström's macroglobulinemia (WM), a very rare cancer affecting the lymphocytes
IMBRUVICA works by blocking a protein in the body that helps cancer cells live and
grow. This protein is called Bruton's tyrosine kinase. By blocking this protein, IMBRUVICA
may help kill and reduce the number of cancer cells and may also slow the spread of
Ask your doctor or healthcare professional if you have any questions about why IMBRUVICA
has been prescribed for you.
This medicine is available only with a doctor's prescription.
Before you take IMBRUVICA
When you must not use it:
Do not take IMBRUVICA:
if you are allergic (hypersensitive) to ibrutinib, or other ingredients of IMBRUVICA.
See Product Description at the end of this leaflet for a list of ingredients.
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.
Do not use preparations containing St John's Wort while you are taking IMBRUVICA.
Do not fall pregnant while you are taking IMBRUVICA.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask
your doctor or healthcare professional for advice before taking IMBRUVICA.
IMBRUVICA should not be used during pregnancy.
There is no information about the safety of IMBRUVICA in pregnant women.
Women of childbearing age must use an effective method of birth control during and
up to three month after receiving IMBRUVICA to avoid becoming pregnant while being
treated with IMBRUVICA. The time period following treatment with IMBRUVICA where it
is safe to become pregnant is not known.
Tell your doctor immediately if you become pregnant.
Do not breast feed while you are taking IMBRUVICA.
Do not father a child while taking IMBRUVICA and for 3 months after stopping treatment.
Use condoms and do not donate sperm during treatment and for 3 months after your treatment
has finished. If you plan to father a child, talk to your doctor or healthcare professional
before taking IMBRUVICA.
IMBRUVICA should not be used by anyone under 18 years of age because it has not been
studied in this age group.
Before you start to use it:
Tell your doctor if you have or have had any medical conditions, especially the following:
if you have ever had unusual bruising or bleeding or are on any medicines or supplements
that increase your risk of bleeding
if you have a history of high blood pressure, irregular heart beat (atrial fibrillation,
ventricular tachyarrhythmia) or severe heart failure, which makes you short of breath
and may lead to swollen legs
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.
you have any other medical condition
Taking other medicines:
IMBRUVICA may make you bleed more easily. Tell your doctor if you take other medicine
that increase 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
The effect of IMBRUVICA or other medicines may be influenced when taking IMBRUVICA
with some other medicines.
Tell your doctor if you take any of the following medicines:
medicines called antibiotics to treat bacterial infections - clarithromycin, telithromycin,
ciprofloxacin, erythromycin,rifampin or azithromycin.
medicines for fungal infections - ketoconazole, posaconazole, itraconazole, fluconazole
medicines for HIV infection - ritonavir, cobicistat, indinavir, nelfinavir, saquinavir,
amprenavir, atazanavir, darunavir/ritonavir or fosamprenavir
medicine to prevent nausea and vomiting associated with chemotherapy - aprepitant
medicine for depression - nefazodone
medicines called kinase inhibitors for treatment of other cancers - crizotinib, imatinib
medicines called calcium channel blockers for high blood pressure or chest pain -
medicine 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.
IMBRUVICA might interact with other medicines. This may result in greater or lesser
effects or even side effects from these medicines.
Tell your doctor if you are taking any other medicines, including medicines you can
buy without a prescription from a pharmacy, supermarket or health food shop.
Your doctor can tell you whether you can continue the medicines you are taking or
reduce the dose.
Always take IMBRUVICA exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
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.
How much IMBRUVICA to take:
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.
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
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.
How long to take
Take IMBRUVICA exactly as prescribed by your doctor or healthcare professional. Do
not change your dose or stop taking IMBRUVICA until your doctor tells you to.
What do I do if I forget to take IMBRUVICA?
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 less than 12 hours until your next dose, skip the missed dose. Then take
the next dose of IMBRUVICA at the usual scheduled time.
Do not take extra capsules or tablets to make up the missed dose.
If you are not sure what to do, contact your doctor or pharmacist.
What do I do if I take too much? (overdose):
If you think you or anybody else has taken too much IMBRUVICA, contact your doctor,
pharmacist or the Poisons Information Centre who will advise you what to do.
You can contact the Poisons Information Centre by dialling:
Australia: 13 11 26
New Zealand: 0800 POISON or 0800 764 766.
While you are taking IMBRUVICA
Things you must do:
Be sure to keep all your doctor's appointments so your progress can be checked.
Your doctor may order certain tests, including blood tests, from time to time to make
sure the medicine is working and to prevent unwanted side effects.
Be sure to follow up your doctor's instructions about other medicines you should take,
and other things you should do.
Tell any other doctors and pharmacists who are treating you that you are taking IMBRUVICA.
If you are about to be started on any new medicines, tell your doctor or pharmacist
that you are taking IMBRUVICA.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Things to be careful of
Driving and using machines
You may feel tired or dizzy after taking IMBRUVICA, which may affect your ability
to drive or use any tools or machinery.
Like all medicines, IMBRUVICA can cause side effects, although not everybody gets
them. The following side effects may happen with this medicine:
Bleeding: You may experience bruising or nosebleeds during treatment with IMBRUVICA.
Rarely, serious internal bleeding, such as bleeding in your stomach, intestine, or
brain may occur. Call your doctor or healthcare professional if you have signs or
symptoms of serious bleeding, such as blood in your stools or urine or bleeding that
lasts for a long time or that you cannot control.
Leukostasis: 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 will monitor your blood counts.
Infections: You may experience viral, bacterial, or fungal infections during treatment
with IMBRUVICA. Contact your doctor if you have fever, chills, body aches, cold or
flu symptoms, feel tired or feel short of breath, yellowing of the skin or eyes (jaundice),
confusion - these could be signs of an infection.
Decrease in blood cell counts: Use of 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).
Your doctor or healthcare professional should check your blood counts regularly.
Heart problems: Irregular heart beat (atrial fibrillation, ventricular tachyarrhythmia)
and high blood pressure has 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.
Other cancers: New cancers have occurred in people taking IMBRUVICA, including skin
cancer and other cancers.
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
Stroke: Temporary or permanent decrease of brain or nerve function due to reduced
blood flow to the brain (mini-stroke or stroke).
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.
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.
The most common side effects seen 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; low number of a neutrophils (neutropenia); low number of platelets (thrombocytopenia)
and low number of red blood cells (anaemia); bruises; skin rash; muscle and joint
pain; muscle spasms; low blood sodium levels; urinary tract infection; high blood
pressure; sore or inflamed mouth; blurred vision; sore stomach, high levels of uric
acid and increased creatine in your blood.
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.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
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.
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.
Heat and dampness can destroy some medicines.
Keep this medicine out of the sight and reach of children.
A locked cupboard at least one-and -a-half metres above the ground is a good place
to store medicines.
Do not use this medicine after the expiry date which is stated on the package after
What it looks like:
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.
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
Each hard capsule contains 140 mg of ibrutinib.
sodium lauryl sulphate
titanium dioxide (E171)
Each tablet contains 140 mg, 280 mg, 420 mg or 560 mg of ibrutinib.
colloidal anhydrous silica
sodium lauryl sulfate
The film-coating contains:
Iron oxide black (140 mg, 280 mg and 420 mg tablets)
iron oxide red (280 mg and 560 mg tablets)
iron oxide yellow (140 mg, 420 mg and 560 mg tablets)
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Rd
NSW 2113 Australia
Telephone: 1800 226 334
NZ Office: Auckland, New Zealand
Telephone: 0800 800 806
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
This leaflet was prepared in April 2021.
® IMBRUVICA is a registered trademark of Janssen-Cilag.
Co-developed with Pharmacyclics.