Trevive Adverse Reactions

Patients with advanced stages of malignancies may have numerous confounding medical conditions that make causality of adverse reactions difficult to assess due to the variety of symptoms related to the underlying disease, its progression, and the co-administration of numerous medicinal products.
More myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease. Patients with unresectable and/or metastatic GIST, CTC grade ¾ GI bleeds, intra-tumoural bleeds or both were observed. GI tumour sites may have been the source of the GI bleeds. GI and tumoural bleeding may be serious and sometimes fatal. The most commonly reported drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash. Superficial oedemas were a common finding and were described primarily as periorbital or lower limb oedemas. However, these oedemas were rarely severe and may be managed with diuretics, other supportive measures, or by reducing the dose of Imatinib Tablets.
When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed. Considering the limited safety database, the adverse events thus far reported in children are consistent with the known safety profile in adult patients with Ph+ ALL. The safety database for children with Ph+ ALL is very limited though no new safety concerns have been identified. Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as "fluid retention". These reactions can usually be managed by withholding Imatinib Tablets temporarily and with diuretics and other appropriate supportive care measures. However, some of these reactions may be serious or life-threatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure. There were no special safety findings in paediatric.
Adverse reactions: Adverse reactions reported as more than an isolated case are listed as follows, by system organ class and by frequency. Frequency categories are defined using the following convention: very common, common, uncommon, rare, very rare, not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first. Adverse reactions and their frequencies are reported in Table 2. (See Table 2.)

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