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.
Nogron 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 Nogron dose will be reduced or treatment stopped.
Side effects from clinical studies:
Side effects may occur with certain frequencies, which are defined as follows:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- not known: frequency cannot be estimated from the available data.
Nogron in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Patients receiving Nogron in combination with radiotherapy may experience different side effects than patients taking Nogron alone. The following side effects may occur, and may require medical attention.
Very common: loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Common: 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, convulsions, 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: 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, hallucination and memory impairment, partial paralysis, impaired coordination, 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, 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.
Nogron monotherapy in recurrent or progressive glioma
The following side effects may occur, and may require medical attention.
Very common: 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: 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: reduced number of blood cell counts (pancytopenia, anaemia, leukopenia).
Rare: cough, infections including pneumonia.
Very rare: skin redness, urticaria (hives), skin eruption, allergic reactions (including anaphylaxis /swelling of the face, lips, mouth or throat (difficulty in swallowing), difficulty in breathing, extreme tiredness, urticaria, etc./ or angioedema /itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing).
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 Nogron. 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 Nogron 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.
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. 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.
