IMBRUVICA can cause side effects. Not all side effects reported for IMBRUVICA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking IMBRUVICA, please consult your doctor, pharmacist or other health care provider for advice.
Stop taking IMBRUVICA and tell a doctor straight away if you notice any of the following side effects:
- Allergic reaction: symptoms may include a swollen face, lip, mouth, tongue or throat, difficulty swallowing or breathing, itchy rash (hives), redness of the skin. These are very serious side effects. If you have them, you may have had a serious allergic reaction to IMBRUVICA. Stop using IMBRUVICA and get medical help.
The following are serious side effects which may need urgent medical attention.
If you notice or have been tested for any of the following side effects tell your doctor immediately:
- Bleeding problems: 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, sometimes resulting in death. If you take other medicines or supplements that increase your risk of bleeding, see Other medicines and IMBRUVICA. 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 (see Warnings and precautions). Your doctor will monitor your blood counts.
- Infections: including viral, bacterial, fungal or severe infections throughout the body (sepsis) have been reported. Contact your doctor if you have fever, chills, weakness, confusion, body aches, feeling tired, cold or flu symptoms, being short of breath. 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 type of white blood cells (neutrophils) or platelets (cells that help blood to clot). Your doctor or healthcare professional should check your blood counts regularly.
- 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.
- Heart rhythm problems: Heart rhythm problems have happened with IMBRUVICA treatment. Tell your doctor or healthcare professional if you have any symptoms of heart rhythm problems such as feeling as if your heartbeat is fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort or you faint.
Tumour lysis syndrome (TLS): characterised by 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). 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.
Non-melanoma skin cancers: Types of skin cancers that are not melanoma, most frequently squamous cell or basal cell skin cancers, have happened in people taking IMBRUVICA.
High blood pressure: New or worsening high blood pressure has been reported in people treated with IMBRUVICA. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
Frequently reported side effects include:
- Infections of the lung, nose, sinuses or throat (upper respiratory tract infections), or urinary tract or sinus, or skin
- severe infections throughout the body (sepsis)
- non-melanoma skin cancer
- low number of ‘platelets’ (cells that help blood to clot.
- low white blood cell counts with fever (febrile neutropenia)
- 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
- headache or feeling dizzy
- blurred vision
- fast heart rate, missed heartbeats, weak or uneven pulse (symptoms of heart rhythm problems)
- bleeding
- bruising or an increased tendency of bruising
- nose bleeds, small red or purple spots caused by bleeding under the skin
- high blood pressure
- diarrhoea (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)
- mouth sores
- nausea and/or vomiting
- constipation
- skin rash, redness and itchiness of the skin
- joint pain, muscle cramps, aches or spasms
- fever, swollen hands, ankles or feet
- an increased level of creatinine in the blood.
Less frequently reported side effects include:
- severely increased white blood cell count that may cause cells to clump together (leukostasis syndrome)
- allergic reaction (may include swelling and itchy rash)
- Hepatitis B reactivation
- unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells (tumour lysis syndrome)
The following post-marketing side effects have been reported:
- bleeding in the eye
- inflammation within the lungs that may lead to permanent damage
- unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells (tumour lysis syndrome)
- liver failure, including events with fatal outcome
- severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens - Johnson syndrome)
- breaking of the nails
- heart rhythm problems
- Inflammation of the fatty tissue underneath the skin
- Weakness, numbness, tingling or pain in your hands or feet or other parts of the body (peripheral neuropathy)
- temporary or permanent decrease of brain or nerve function due to reduced blood flow to the brain (mini-stroke or stroke)
- tender or painful bumps or ulcers on the skin, sometimes with a fever (neutrophilic dermatoses).
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. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/index/8. By reporting side effects, you can help provide more information on the safety of IMBRUVICA. Alternatively, you may report side effects experienced with IMBRUVICA directly to Janssen Pharmaceutica (see section ‘Holder of the Certificate of Registration’ for contact details or visit www.janssen.com).
