Like all medicines, MabThera can cause side effects, although not everybody gets them. Most side effects are mild to moderate but some may be serious and require treatment. Rarely, some of these reactions have been fatal.
Infusion reactions
During or within the first 2 hours of the first infusion you may develop fever, chills and shivering. Less frequently, some patients may experience blisters, itching, sickness, tiredness, headache, breathing difficulties, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets. If you have heart disease or angina, these reactions might get worse. Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped for a while. You may require additional treatment such as an antihistamine or paracetamol. When these symptoms go away, or improve, the infusion can be continued. These reactions are less likely to happen after the second infusion.
Infections
Tell your doctor after your MabThera treatment if you get any symptoms of an infection, for example fever, cough, sore throat, burning pain when passing urine, or you start to feel weak or generally unwell. You might get infections more easily following MabThera therapy. Often these are colds, but there have been cases of pneumonia or urinary infections.
Very rarely, some patients taking MabThera have had a serious brain infection, which has been fatal. Tell your doctor immediately if you have memory loss, trouble thinking, difficulty with walking or loss of vision.
If you are being treated for rheumatoid arthritis, you will also find this information in the Patient Alert Card you have been given by your doctor. It is important that you keep this Alert Card and show it to your partner or caregiver.
Other reactions
a) If you are being treated for non-Hodgkin?s Lymphoma or chronic lymphocytic leukaemia The most commonly reported side effects due to MabThera (reported in more than 1 out of 10 patients are:
- infections such as pneumonia (bacterial) and herpes (viral) or bronchial tube inflammation (bronchitis)
- low number of white blood cells, with or without fever, low number of platelets in the blood
- allergic reactions after infusion
- nausea
- skin rashes, itching ,bald spots on the scalp fever, chills, physical weakness, headache
- decreased immunity (decreased IgG levels)
Common side effects due to MabThera (reported in more than 1 out of 100 patients) include:
- infectionssuch as sepsis and pneumonia (bacterial), herpes and hepatitis B (viral) or candidal (fungal) bronchial tube and sinuses inflammation, or other general infections of unknown origin
- low number of red blood cells, low number of red and white blood cells and platelets
- allergic reactions (hypersensitivity)
- high sugar level in the blood, weight loss, excess fluid in the face and the body, increased blood levels of the enzyme (LDH), low blood level of calcium
- abnormal sensations of the skin, such as numbness, tingling, pricking, burning, a creeping skin sensation, decreased sense of touch. Feeling restless, difficulty falling asleep, becoming red in the face and bruising of the skin as a consequence of dilation of the blood vessels, dizziness, anxiety
- an increased production of tears, secretion and shedding disorders, inflammation of the eye (conjunctivitis)
- ringing sound in the ears, ear pain
- heart disorders (heart attack, irregular heart rate, abnormally fast heart rate)
- high or low blood pressure, a decrease in blood pressure upon assuming an upright posture
- inflammation, irritation and / or tightness of the lungs, throat and / or sinuses, shortness of breath, too little oxygen reaching the body organs, coughing
- vomiting, diarrhoea, pain in the abdomen, irritation and /or ulceration of the throat and the mouth,difficulties in swallowing, constipation, indigestion. Eating disorders: decrease in the amount of food eaten with a consequential dangerous loss in weight
- skin disorders, burning sensation of the skin, itching, increased perspiration, night sweats
- musculoskeletaldisorders , abnormal increase in tightness of muscle tone, pain, joint pain, muscle pain, back and neck pain
- general disorders,tumour pain, becoming markedly red in the face and other areas of the skin, general discomfort or uneasiness, flu syndrome, fatigue, shaking, multi-organ dysfunction
Uncommon side effects due to MabThera (reported in more than 1 out of 1000 patients) include:
- abnormal clotting, decrease of blood cells production, autoimmune decrease of red blood cells, swollen/enlarged lymph nodes
- low mood and loss of interest or pleasure in usual activities, nervousness
- taste changes
- heart disorder (heart attack, abnormally fast heart rate, reduced heart rate, irregular heart rate, chest pain) inflammation, irritation and/or thightness of the lungs, asthma, shortness of breath
- enlargement of the abdomen
- pain at the infusion site
b) If you are being treated for rheumatoid arthritis The most commonly reported side effects due to MabThera (reported in more than 1 out of 10 patients) are:
- Infections such as pneumonia (bacterial)
- Pain on passing water (urinary tract infection)
- Allergic reactions after infusion
- Changes in blood pressure, nausea, rash, fever, feeling itchy, runny or block nose and sneezing, shaking, rapid heart beat, and tiredness
- Headache
Commonly side effects due to MabThera (reported in more than 1 out of 100 patients) include:
- Infections such as bronchial tube inflammation (bronchitis)
- A feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis), pain in the abdomen, vomiting and diarrhoea, breathing problems
- Fungal foot infection (athlete?s foot)
- High cholesterol levels in the blood
- Abnormal sensations of the skin, such as numbness, tingling, pricking or burning, sciatica, migraine, dizziness
- Loss of hair
- Anxiety, depression
- Indigestion, diarrhoea, acid reflux, irritation and /or ulceration of the throat and the mouth
- Pain in the tummy, back, muscles and/or joints
Uncommon side effects due to MabThera (reported in more than 1 out of 1000 patients) include:
- Excess fluid retention in the face and body
- Inflammation, irritation and / or tightness of the lungs, and throat, coughing
- Skin reactions including hives, itching and rash
- Allergic reactions including wheezing or shortness of breath, swelling of the face and tongue, collapse Very rare side effects due to MabThera (reported in less than 1 in 10,000 patients) include:
- A complex of symptoms occurring within a few weeks of an infusion of MabThera including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever
If you are receiving MabThera in combination with other medicines, some of the side effects you may experience may be due to the other medicine.
If any of the side effects gets serious, or, if you notice any side effects not listed in this leaflet, please inform your doctor, nurse or pharmacist (chemist) immediately.
