Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

 

The following can all be signs of serious side effects:

• if you have chest pain, difficulty breathing, coughing and fainting
• if you experience unexpected bleeding or bruising without having an injury
• if you find blood in your vomit, stools or urine, or have black stools
• if you get signs of infections such as fever, severe chills
• if you get fever, sore mouth or throat, blistering or peeling of your skin and/or

mucous membranes

Contact your doctor immediately if you notice any of the above.

 

Very common side effects (may affect more than 1 in 10 people)

• Infections (including bacterial, viral and fungal)
• Heart and lungs: shortness of breath
• Digestive problems: diarrhoea, feeling or being sick (nausea, vomiting)
• Skin, hair, eye, general: skin rash, fever, swelling around the face, hands and feet,

headache, feeling tired or weak, bleeding

• Pain: pain in the muscles (during or after discontinuing treatment),

tummy (abdominal) pain

• Tests may show: low blood platelet count, low white blood cells count (neutropaenia), anaemia, fluid around the lungs

 

Common side effects (may affect up to 1 in 10 people)

• Infections: pneumonia, herpes virus infection (including cytomegalovirus – CMV),

upper respiratory tract infection, serious infection of the blood or tissues (including

uncommon cases with fatal outcomes)

• Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weak

heart muscle, high blood pressure, increased blood pressure in the lungs, cough

• Digestive problems: appetite disturbances, taste disturbance, bloated or distended

tummy (abdomen), inflammation of the colon, constipation, heartburn, mouth

ulceration, weight increase, weight decrease, gastritis

• Skin, hair, eye, general: skin tingling, itching, dry skin, acne, inflammation of the

skin, persistent noise in ears, hair loss, excessive perspiration, visual disorder

(including blurred vision and disturbed vision), dry eye, bruise, depression, insomnia,

flushing, dizziness, contusion (bruising), anorexia, somnolence, generalised oedema

• Pain: pain in joints, muscular weakness, chest pain, pain around hands and feet,

chills, stiffness in muscles and joints, muscle spasm

• Tests may show: fluid around the heart, fluid in the lungs, arrhythmia, febrile

neutropaenia, gastrointestinal bleeding, high uric acid levels in the blood

 

Uncommon side effects (may affect up to 1 in 100 people)

• Heart and lungs: heart attack (including fatal outcome), inflammation of the lining

(fibrous sack) surrounding the heart, irregular heartbeat, chest pain due to lack of

blood supply to the heart (angina), low blood pressure, narrowing of airway that may

cause breathing difficulties, asthma, increased blood pressure in the arteries (blood

vessels) of the lungs

• Digestive problems: inflammation of the pancreas, peptic ulcer, inflammation of the

food pipe, swollen tummy (abdomen), tear in the skin of the anal canal, difficulty in

swallowing, inflammation of the gallbladder, blockage of bile ducts, gastro-oesophageal

reflux (a condition where acid and other stomach contents come back up

into the throat)

• Skin, hair, eye, general: allergic reaction including tender, red lumps on the skin

(erythema nodosum), anxiety, confusion, mood swings, lower sexual drive, fainting,

tremor, inflammation of the eye which causes redness or pain, a skin disease

characterized by tender, red, well-defined blotches with the sudden onset of fever and

raised white blood cell count (neutrophilic dermatosis), loss of hearing, sensitivity to

light, visual impairment, increased eye tearing, disturbance in skin colour,

inflammation of fatty tissue under the skin, skin ulcer, blistering of the skin, nail

disorder, hair disorder, hand-foot disorder, renal failure, urinary frequency, breast

enlargement in men, menstrual disorder, general weakness and discomfort, low

thyroid function, losing balance while walking, osteonecrosis (a disease of reduced

blood flow to the bones, which can cause bone loss and bone death), arthritis, skin

swelling anywhere in the body

• Pain: inflammation of vein which can cause redness, tenderness and swelling,

inflammation of the tendon

• Brain: loss of memory
• Tests may show: abnormal blood test results and possibly impaired kidney function

caused by the waste products of the dying tumour (tumour lysis syndrome), low

levels of albumin in the blood, low levels of lymphocytes (a type of white blood cell)

in the blood, high level of cholesterol in the blood, swollen lymph nodes, bleeding in

the brain, irregularity of the electrical activity of the heart, enlarged heart,

inflammation of the liver, protein in the urine, raised creatine phosphokinase (an

enzyme mainly found in the heart, brain and skeletal muscles), raised troponin (an

enzyme mainly found in the heart and skeletal muscles), raised gamma-glutamyltransferase (an enzyme mainly found in the liver)

 

Rare side effects (may affect up to 1 in 1,000 people)

• Heart and lungs: enlargement of the right ventricle in the heart, inflammation of the

heart muscle, collection of conditions resulting from blockage of blood supply to the

heart muscle (acute coronary syndrome), cardiac arrest (stopping of blood flow from

the heart), coronary (heart) artery disease, inflammation of the tissue covering the

heart and lungs, blood clots, blood clots in the lungs

• Digestive problems: loss of vital nutrients such as protein from your digestive tract,

bowel obstruction, anal fistula (an abnormal opening from the anus to the skin around

the anus), impairment of kidney function, diabetes

• Skin, hair, eye, general: convulsion, inflammation of the optic nerve that may cause

a complete or partial loss of vision, blue-purple mottling of the skin, abnormally high

thyroid function, inflammation of the thyroid gland, ataxia (a condition associated

with lack of muscular coordination), difficulty walking, miscarriage, inflammation of

the skin blood vessels, skin fibrosis

• Brain: stroke, temporary episode of neurologic dysfunction caused by loss of blood

flow, facial nerve paralysis, dementia

• Immune system: severe allergic reaction
• Musculoskeletal and connective tissue: delayed fusion of the rounded ends that

form joints (epiphyses); slower or delayed growth

 

Other side effects that have been reported with frequency not known (cannot be

estimated from the available data)

• Inflammation of the lungs
• Bleeding in the stomach or bowels that can cause death
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in

the past (a liver infection)

• A reaction with fever, blisters on the skin, and ulceration of the mucous membranes
• Disease of the kidneys with symptoms including oedema and abnormal laboratory

test results such as protein in the urine and low protein level in the blood

• Damage to blood vessels known as thrombotic microangiopathy (TMA), including

decreased red blood cell count, decreased platelets, and formation of blood clots

 

Your doctor will check for some of these effects during your treatment.

 

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet.