5-aminolevulinic acid hydrochloride

HOS-094624 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile Adverse reactions observed after the use of this medicinal product for fluorescence-guided glioma resection are divided into the following two categories: - immediate reactions occurring after oral administration of the medicinal product before anaesthesia (= active substance-specific side effects) - combined effects of 5-ALA, anaesthesia, and tumour resection (= procedure-specific side effects). Most serious side effects include anaemia, thrombocytopenia, leukocytosis, neurological disorders and thromboembolism. Further frequently observed side effects are vomiting, nausea and increase of blood bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and blood amylase. Tabulated summary of adverse reactions Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10 000 to <1/1 000) Very rare (<1/10 000) Not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Substance-specific side effects: Cardiac disorders Uncommon: hypotension Gastrointestinal disorders Uncommon: nausea Skin and subcutaneous tissue disorders Uncommon: photosensitivity reaction, photodermatosis 4 Procedure-related side effects The extent and frequency of procedure-related neurological side effects depends on the localisation of the brain tumour and the degree of resection of tumour tissue lying in eloquent brain areas (see section 4.4). Blood and lymphatic system disorders Very common: anaemia, thrombocytopenia, leukocytosis Nervous system disorders Common: neurological disorders (e.g. hemiparesis, aphasia, convulsions, hemianopsia) Uncommon: brain oedema Very rare: hypaesthesia Cardiac disorders Uncommon: hypotension Vascular disorders Common: thromboemboli

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094620 · has-contraindication-information · PDF-Seite 3

• Hypersensitivity to the active substance or porphyrins. • Acute or chronic types of porphyria. • Pregnancy (see sections 4.6 and 5.3).

HOS-094619 · has-indication-information · PDF-Seite 2

Gliolan is indicated in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV).

HOS-094622 · has-interaction-information · PDF-Seite 4

Patients should not be exposed to any photosensitising agent up to 2 weeks after administration of Gliolan.

HOS-094623 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no or limited amount of data from the use of 5-ALA in pregnant women. Some limited animal studies suggest an embryotoxic activity of 5-ALA plus light exposure (see section 5.3). Therefore, Gliolan should not be used during pregnancy. Breast-feeding It is unknown whether 5-ALA or its metabolite protoporphyrin IX (PPIX) is excreted in human milk. The excretion of 5-ALA or PPIX in milk has not been studied in animals. Breast-feeding should be interrupted for 24 hours after treatment with this medicinal product. Fertility There are no data available regarding the influence of 5-ALA on fertility.

HOS-094621 · has-warning-information · PDF-Seite 3

5-ALA-induced fluorescence of brain tissue does not provide information about the tissue’s underlying neurological function. Therefore, resection of fluorescing tissue should be weighed up carefully against the neurological function of fluorescing tissue. Special care must be taken in patients with a tumour in the immediate vicinity of an important neurological function and pre-existing focal deficits (e.g. aphasia, vision disturbances and paresis) that do not improve on corticosteroid treatment. Fluorescence-guided resection in these patients has been found to impose a higher risk of critical neurological deficits. A safe distance to eloquent cortical areas and subcortical structures of at least 1 cm should be maintained independent of the degree of fluorescence. In all patients with a tumour in the vicinity of an important neurological function, either pre- or intraoperative measures should be used to localise that function relative to the tumour in order to maintain safety distances. False negative and false positive results may occur with the use of 5-ALA for intraoperative visualisation of malignant glioma. Non-fluorescing tissue in the surgical field does not rule out the presence of tumour in patients with glioma. On the other hand fluorescence may be seen in areas of abnormal brain tissue (such as reactive astrocytes, atypical cells), necrotic tissue, inflammation, infections (such as fungal or bacterial infections and abscesses), CNS lymphoma or metastases from other tumour types. After administration of this medicinal product, exposure of eyes and skin to strong light sources (e.g. operating illumination, direct sunlight or brightly focused indoor light) should be avoided for 24 hours. Co-administration with other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) should be avoided (see also section 5.3). Within 24 hours after administration, other potentially hepatotoxic medicinal products should be avoided. In patients with pre-existing cardiovascular disease, this medicinal product should be used with caution since literature reports have shown decreased systolic and diastolic blood pressure, pulmonary artery systolic and diastolic pressure as well as pulmonary vascular resistance. 3