Imbruvica
ibrutinib
ibrutinib
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What IMBRUVICA is and what it is used for
What you need to know before you take IMBRUVICA
How to take IMBRUVICA
Possible side effects
How to store IMBRUVICA
Contents of the pack and other information
IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib. It belongs to a class of medicines called protein kinase inhibitors.
It is used to treat the following blood cancers in adults:
Mantle cell lymphoma (MCL), a type of cancer affecting the lymph nodes, when the disease has come back or has not responded to treatment.
Chronic lymphocytic leukaemia (CLL) a type of cancer affecting white blood cells called lymphocytes that also involves the lymph nodes. IMBRUVICA is used in patients who have not previously been treated for CLL or when the disease has come back or has not responded to treatment.
Waldenström’s macroglobulinaemia (WM), a type of cancer affecting white blood cells called lymphocytes. It is used in patients who have not previously been treated for WM or when the disease has come back or has not responded to treatment or in patients for whom chemotherapy given together with an antibody is not a suitable therapy.
In MCL, CLL and WM, IMBRUVICA works by blocking Bruton's tyrosine kinase, a protein in the body that helps these cancer cells grow and survive. By blocking this protein, IMBRUVICA helps kill and reduce the number of cancer cells. It also slows down the worsening of the cancer.
if you are allergic to ibrutinib or any of the other ingredients of this medicine (listed in section 6)
if you are taking a herbal medicine called St. John’s Wort, used for depression. If you are not sure about this, talk to your doctor, pharmacist or nurse before taking this medicine.
Talk to your doctor, pharmacist or nurse before taking IMBRUVICA:
if you have ever had unusual bruising or bleeding or are on any medicines or supplements that increase your risk of bleeding (see section “Other medicines and IMBRUVICA”)
if you have irregular heart beat or have a history of irregular heart beat or severe heart failure, or if you feel any of the following: shortness of breath, weakness, dizziness, light-headedness, fainting or near fainting, chest pain or swollen legs
if you have liver problems, including if you ever had or now have a hepatitis B infection (a liver infection)
if you have high blood pressure
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 (3 to 7 days) before and after your surgery
if you have kidney problems.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before or while taking this medicine (see section “Possible side effects”).
When taking IMBRUVICA, tell your doctor immediately if you notice or someone notices in you: memory loss, trouble thinking, difficulty walking or sight loss – these may be due to a very rare but serious brain infection which can be fatal (Progressive Multifocal Leukoencephalopathy or PML).
Tell your doctor immediately if you notice or someone notices in you: sudden numbness or weakness in the limbs (especially on one side of the body), sudden confusion, trouble speaking or understanding speech, sight loss, difficulty walking, loss of balance or lack of coordination, sudden severe headache with no known cause. These may be signs and symptoms of stroke.
Tell your doctor immediately if you develop left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder (these may be symptoms of rupture of the spleen) after you stop taking IMBRUVICA.
Tell your doctor immediately if you notice breathlessness, difficulty breathing when lying down, swelling of the feet, ankles or legs and weakness/tiredness (these may be signs of heart failure) during treatment with IMBRUVICA.
You may experience viral, bacterial, or fungal infections during treatment with IMBRUVICA. Contact your doctor if you have fever, chills, weakness, confusion, body aches, cold or flu symptoms, feel tired or feel short of breath, yellowing of the skin or eyes (jaundice). These could be signs of an infection.
Haemophagocytic lymphohistiocytosis
There have been rare reports of excessive activation of white blood cells associated with inflammation (haemophagocytic lymphohistiocytosis), 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.
Tumour lysis syndrome (TLS): Unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened during treatment of cancer and sometimes even without treatment. This may lead to changes in kidney function, abnormal heartbeat, or seizures. Your doctor or another healthcare provider may do blood tests to check for TLS.
Lymphocytosis: Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood 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.
Events related to the liver: Your doctor will do some blood tests to check whether your liver is working properly or that you do not have a liver infection, known as viral hepatitis, or whether hepatitis B has become active again, which could be fatal.
IMBRUVICA should not be used in children and adolescents. This is because it has not been studied in these age groups.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, herbal medicines and supplements. This is because IMBRUVICA may affect the way some other medicines work. Also some other medicines can affect the way IMBRUVICA works.
acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen or naproxen
blood thinners such as warfarin, heparin or other medicines for blood clots
supplements that may increase your risk of bleeding such as fish oil, vitamin E or flaxseed.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.
medicines called antibiotics to treat bacterial infections – clarithromycin, telithromycin, ciprofloxacin, erythromycin or rifampicin
medicines for fungal infections – posaconazole, ketoconazole, itraconazole, fluconazole or voriconazole
medicines for HIV infection – ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir, atazanavir, or fosamprenavir
medicines to prevent nausea and vomiting associated with chemotherapy - aprepitant
medicines for depression - nefazodon
medicines called kinase inhibitors for treatment of other cancers – crizotinib or imatinib
medicines called calcium channel blockers for high blood pressure or chest pain – diltiazem or verapamil
medicines called statins to treat high cholesterol - rosuvastatin
heart medicines/anti-arrhythmics – amiodarone or dronedarone
medicines to prevent seizures or to treat epilepsy, or medicines to treat a painful condition of the face called trigeminal neuralgia – carbamazepine or phenytoin.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.
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.
Do not get pregnant while you are taking this medicine. 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 a highly effective method of birth control during and up to three months after receiving IMBRUVICA, to avoid becoming pregnant while being treated with IMBRUVICA.
Tell your doctor immediately if you become pregnant.
Do not breast-feed while you are taking this medicine.
You may feel tired or dizzy after taking IMBRUVICA, which may affect your ability to drive or use any tools or machines.
IMBRUVICA contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
The recommended dose of IMBRUVICA is four capsules (560 mg) once a day.
The recommended dose of IMBRUVICA is three capsules (420 mg) once a day. Your doctor may adjust your dose.
Take the capsules orally (by mouth) with a glass of water.
Take the capsules about the same time each day.
Swallow the capsules whole. Do not open, break or chew them.
If you take more IMBRUVICA than you should, talk to a doctor or go to a hospital straight away. Take the capsules and this leaflet with you.
If you miss a dose, it can be taken as soon as possible on the same day with a return to the normal schedule the following day.
Do not take a double dose to make up for a forgotten dose.
If you are not sure, talk to your doctor, pharmacist or nurse about when to take your next dose.
Do not stop taking this medicine unless your doctor tells you.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat – you may be having an allergic reaction to the medicine.
fever, chills, body aches, feeling tired, cold or flu symptoms, being short of breath – these could
be signs of an infection (viral, bacterial or fungal). These could include infections of the nose, sinus or throat (upper respiratory tract infection), or lung, or skin
bruising or increased tendency of bruising
mouth sores
feeling dizzy
headache
constipation
feeling or being sick (nausea or vomiting)
diarrhoea, your doctor may need to give you a fluid and salt replacement or another medicine
skin rash
painful arms or legs
back pain or joint pain
muscle cramps, aches or spasms
low number of cells that help blood clot (platelets), very low number of white blood cells – shown in blood tests
an increase in the number or proportion of white blood cells shown in blood tests
high level of “uric acid” in the blood (shown in blood tests), which may cause gout
swollen hands, ankles or feet
high blood pressure
increased level of “creatinine” in the blood.
severe infections throughout the body (sepsis)
infections of the urinary tract
nose bleeds, small red or purple spots caused by bleeding under the skin
blood in your stomach, gut, stools or urine, heavier periods, or bleeding that you cannot stop from an injury
heart failure
fast heart rate, missed heart beats, weak or uneven pulse, lightheadedness, shortness of breath, chest discomfort (symptoms of heart rhythm problems)
low white blood cell counts with fever (febrile neutropenia)
non-melanoma skin cancer, most frequently squamous cell and basal cell skin cancer
blurred vision
redness of the skin
inflammation within the lungs that may lead to permanent damage
breaking of the nails
weakness, numbness, tingling or pain in your hands or feet or other parts of the body (peripheral neuropathy).
liver failure, including events with fatal outcome
severe fungal infections
confusion, headache with slurred speech or feeling faint – these could be signs of serious internal bleeding in your brain
unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened during treatment of cancer and sometimes even without treatment (tumour lysis syndrome)
allergic reaction, sometimes severe, that may include a swollen face, lip, mouth, tongue or throat, difficulty swallowing or breathing, itchy rash (hives)
inflammation of the fatty tissue underneath the skin
temporary episode of decreased brain or nerve function caused by loss of blood flow, stroke
bleeding in the eye (in some cases associated with loss of vision)
painful skin ulceration (pyoderma gangrenosum) or red, raised painful patches on the skin, fever and an increase in white blood cells (these may be signs of acute febrile neutrophilic dermatosis or Sweet’s syndrome).
severely increased white blood cell count that may cause cells to clump together.
severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is ibrutinib. Each hard capsule contains 140 mg of ibrutinib.
The other ingredients are:
capsule content: croscarmellose sodium, magnesium stearate, microcrystalline cellulose and sodium lauril sulfate (E487)
capsule shell: gelatin and titanium dioxide (E171)
printing ink: shellac, black iron oxide (E172), and propylene glycol (E1520).
IMBRUVICA are white opaque, hard capsules marked with “ibr 140 mg” in black ink on one side. The capsules are provided in a plastic bottle with a child resistant polypropylene closure. Each bottle contains either 90 or 120 capsules. Each pack contains one bottle.
B-2340 Beerse
Belgium
Janssen Pharmaceutica NV Turnhoutseweg 30
B-2340 Beerse Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88
„Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00
Janssen-Cilag NV Tél/Tel: +32 14 64 94 11
Janssen-Cilag A/S Tlf: +45 4594 8282
AM MANGION LTD. Tel: +356 2397 6000
Janssen-Cilag GmbH Tel: +49 2137 955 955
Janssen-Cilag B.V. Tel: +31 76 711 1111
UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410
Janssen-Cilag AS Tlf: +47 24 12 65 00
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Tηλ: +30 210 80 90 000
Janssen-Cilag Pharma GmbH Tel: +43 1 610 300
Janssen-Cilag, S.A. Tel: +34 91 722 81 00
Janssen-Cilag Polska Sp. z o.o. Tel.:+48 22 237 60 00
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600
Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700
Johnson & Johnson România SRL Tel: +40 21 207 1800
Janssen Sciences Ireland UC Tel: +353 1 800 709 122
Johnson & Johnson d.o.o. Tel.: +386 1 401 18 00
Janssen_safety_slo@its.jnj.com
Janssen-Cilag AB c/o Vistor hf
Sími: +354 535 7000
Janssen-Cilag SpA
Tel: 800 688 777 / +39 02 2510 1
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
Βαρνάβας Χατζηπαναγής Λτδ Τηλ: +357 22 207 700
Janssen-Cilag AB Tfn: +46 8 626 50 00
UAB "JOHNSON & JOHNSON" filiāle Latvijā Tel: +371 678 93561
Janssen Sciences Ireland UC Tel: +44 1 494 567 444