o tumour recurrence, intracranial infection, or necrosis) may necessitate re-operation and, in some cases, removal of GLIADEL Implant or its remnants.
Communication between the surgical resection cavity and the ventricular system should be avoided to prevent the implants from migrating into the ventricular system and possibly causing obstructive hydrocephalus. If a communication larger than the diameter of the implant exists, it should be closed prior to GLIADEL Implant implantation.
Computed tomography and magnetic resonance imaging may demonstrate enhancement in the brain tissue surrounding the resection cavity after placement of GLIADEL Implants. This enhancement may represent oedema and inflammation caused by GLIADEL Implants or tumour progression.
4.5 Interaction with other medicinal products and other forms of interaction
Interactions of GLIADEL Implant with other drugs or chemotherapy have not been formally eva luated.
4.6 Pregnancy and lactation
Pregnancy:
There are no studies of GLIADEL Implant in pregnant women and no studies assessing the reproductive toxicity of GLIADEL Implant.
Carmustine, the active component of GLIADEL Implant, when administered systemically, can have genotoxic effects and can adversely affect foetal development. GLIADEL Implant, therefore, should not be used during pregnancy. If the use of GLIADEL Implant during pregnancy is still considered, the patient should be informed of the potential risk to the foetus. Women of childbearing potential should be advised to avoid pregnancy while receiving GLIADEL Implant. In case of patients getting pregnant during treatment with GLIADEL Implant, the opportunity for genetic advice should be seized.
Lactation:
It is not known if GLIADEL Implant components are excreted in human milk. Since some drugs are excreted in human milk and because of the potential risk of serious adverse reactions of carmustine in nursing infants, breast-feeding is contra-indicated.
4.7 Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed. However, driving is not advisable following treatment
4.8 Undesirable effects
The spectrum of undesirable effects observed in patients with newly-diagnosed high-grade malignant glioma and recurrent malignant gliomas was generally consistent with that encountered in patients undergoing craniotomy for malignant gliomas.
Very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100) adverse reactions reported in patients receiving GLIADEL Implant during the clinical trials are listed below.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Primary Surgery
The following data are the most frequently occurring adverse events observed in 5% or more of the 120 newly-diagnosed malignant glioma patients receiving GLIADEL Implant during the trial.
Common Adverse Events Observed in ≥ 5% of Patients Receiving GLIADEL Implant at Initial Surgery
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Class organ
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Adverse events
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Endocrine disorders
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common
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Diabetes mellitus
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Metabolism and nutrition disorders
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very common
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Healing abnormal
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|
|
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