Tazatred Adverse Reactions

Dasatinib as a single-agent therapy: In total, the clinical trial experience for dasatinib administered as single-agent therapy represents 2809 patients, of which 2712 were adult and 97 paediatric. In the 2712 adult patients with either chronic phase CML, advanced phase CML, or Ph+ ALL, the median duration of therapy was 19.2 months (range 0 to 93.2 months).
The majority of patients treated with dasatinib, regardless of dose or schedule, experienced adverse reactions at some time. In the overall population of 2712 dasatinib-treated adult subjects, 520 (19%) experienced adverse drug reactions leading to treatment discontinuation.
No dedicated clinical trials have been conducted investigating the safety of dasatinib in newly diagnosed Ph+ ALL as a primary outcome. The safety profile of dasatinib in 4 Phase II clinical trials in newly diagnosed patients with Ph+ALL was generally consistent with the safety profile in patients who were resistant or intolerant to prior therapy.
The following adverse reactions, excluding laboratory abnormalities, were reported in patients in dasatinib clinical trials where dasatinib was administered as single-agent therapy. These reactions are presented by system organ class and by frequency. Frequencies are defined as: 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 4.)

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Post-marketing Experience: The following additional adverse events have been identified during post approval use of dasatinib. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. (See Table 5.)

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