Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you have any of the following:
- a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty),
- uncontrolled bleeding,
- seizures (convulsions),
- fever,
- a severe headache that does not go away.
Brastoryn treatment can cause a reduction in certain kinds of blood cells. This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections. The reduction in blood cell counts is usually short-lived. In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia). Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed. In some cases, your Brastoryn dose will be reduced or treatment stopped.
Side effects from clinical studies:
Brastoryn in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Patients receiving Brastoryn in combination with radiotherapy may experience different side effects than patients taking Brastoryn alone. The following side effects may occur, and may require medical attention.
Very common (may affect more than 1 in 10 people): loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Common (may affect up to 1 in 10 people): oral infections, wound infection, reduced number of blood cells (neutropenia,
thrombocytopenia, lymphopenia, leukopenia), increased sugar in the blood, loss of weight, change in mental status or alertness, anxiety/depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness, difficulty concentrating, inability to fall asleep or stay asleep, tingling sensation, bruising, shaking, abnormal or blurry vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea, stomach or abdominal pain, heartburn, upset stomach, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, painful joints, muscle aches and pains, frequent urination, difficulty with holding your urine, allergic reaction, fever, radiation injury, face swelling, pain, abnormal taste, abnormal liver function tests.
Uncommon (may affect up to 1 in 100 people): flu-like symptoms, red spots under the skin, appearance of a swollen face or muscle weakness, low potassium level in the blood, weight gain, mood swings, agitation, hallucination and memory impairment, partial paralysis, impaired coordination, difficulty swallowing, impaired sensations, partial loss of vision, dry or painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can feel your heart beat), blood clot in the lung, cerebral hemorrhage (stroke), high blood pressure, pneumonia, inflammation of your sinuses, bronchitis, a cold or the flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids, peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence, absent or
heavy menstrual periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your sense of smell, thirst, tooth disorder.
Brastoryn monotherapy in recurrent or progressive glioma
The following side effects may occur, and may require medical attention.
Very common(may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick in your stomach), constipation (difficulty passing stools).
Common(may affect up to 1 in 10 people): loss of weight, tiredness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste.
Uncommon (may affect up to 1 in 100 people): reduced number of blood cell counts (pancytopenia, anaemia, leukopenia).
Rare (may affect up to 1 in 1,000 people): cough, infections including pneumonia.
Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption, allergic reactions.
Other side effects:
Very rare cases of severe rash with skin swelling, including on the palms of the hands and soles of the feet, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed. Tell your doctor immediately if this occurs.
Very rare cases of lung side effects have been observed with Brastoryn. Patients usually present with shortness of breath and cough. Tell your doctor if you notice any of these symptoms.
In very rare cases, patients taking Brastoryn and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
There have been cases of hepatic side effects including elevations of liver enzymes, increased bilirubin, problems with bile flow (cholestasis) and hepatitis.
If you get any side effectstalk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
