nnot be determined.
Common Adverse Events in 1% to 4% of Patients Receiving GLIADEL Implant
Class organ
Adverse events
Blood and lymphatic system disorders
common
Thrombocytopenia, leukocytosis
Metabolism and nutrition disorders
common
Hyponatraemia, hyperglycaemia, hypokalaemia
Nervous system disorders
common
Hydrocephalus, depression, abnormal thinking, ataxia, dizziness, insomnia, hemiplegia, coma, amnesia, diplopia, paranoid reaction
uncommon
Cerebral haemorrhage, cerebral infarct
Eye Disorders
common
Visual defect, eye pain
Cardiac and vascular Disorders
common
Hypertension, hypotension
Respiratory, thoracic and mediastinal disorders
common
Infection, aspiration pneumonia
Gastrointestinal disorders
common
Diarrhoea, constipation, dysphagia, gastrointestinal haemorrhage, faecal incontinence
Skin and subcutaneous tissue disorders
common
Rash
Musculoskeletal and connective tissue disorders
common
Infection
Renal and urinary disorders
common
Urinary incontinence
General disorders and administration site conditions
common
Peripheral oedema, neck pain, accidental injury, back pain, allergic reaction, asthenia, chest pain, sepsis
The following four categories of adverse events are possibly related to treatment with GLIADEL Implant.
Seizures
In the initial surgery trial, the incidence of seizures within the first 5 days after implantation was 2.5% in the GLIADEL Implant group.
In the surgery for recurrent disease trial, the incidence of post-operative seizures was 19% in patients receiving GLIADEL Implant. 12/22 (54%) of patients treated with GLIADEL Implant experienced the first new or worsened seizure within the first five post-operative days. The median time to onset of the first new or worsened post-operative seizure was 3.5 days in patients treated with GLIADEL Implant.
Brain Oedema
Development of brain oedema with mass effect (due to tumour recurrence, intracranial infection, or necrosis) may necessitate re-operation and, in some cases, removal of GLIADEL Implant or its remnants (see section 4.4).
Healing Abnormalities
The following healing abnormalities have been reported in clinical trials of GLIADEL Implant: wound dehiscence, delayed wound healing, subdural, subgaleal or wound effusions, and cerebrospinal fluid leak.
In the initial surgery trial, cerebrospinal fluid leaks occurred in 5% of GLIADEL Implant recipients. During surgery, a water-tight dural closure should be obtained to minimise the risk of cerebrospinal fluid leak (see section 4.4)
Intracranial Infection
In the initial surgery trial, the incidence of brain abscess or meningitis was 5% in patients treated with GLIADEL Implant.
In the recurrent setting, the incidence of brain abscess or meningitis was 4% in patients treated with GLIADEL Implant.
In a published clinical study, cyst formation after GLIADEL Implant treatment has been reported.
This reaction occurred in 10% of the patients observed in the study, however, the formation of cysts is possible after resection of a malignant glioma.
4.9 Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, ATC C |
