Abstract
The aim of the study was to evaluate the safety profile of nilotinib administered to chronic myeloid leukemia (CML) at patients. The study was conducted from March 2018 to May 2019 and it included 20 patients with CML in chronic phase. Of these 20 patients, 17 had previously been treated with imatinib and 3 with hydroxyurea. The mean duration of treatment with Nilotinib was 6.75 months. In nine patients treated with nilotinib (400 mg), 55% complained of fatigue, 33% of headache and 22.2% of pruritus. In five patients treated with Nilotinib (600 mg), 20% complained of headache, 40% of fatigue and 20% of pruritus. In addition, in six patients treated with nilotinib (800 mg), 50% complained of headache and fatigue, 17% with pruritus and visual disorder was observed in 20% of cases. In the study, the adverse reactions were observed between the age of 20 and 40 and it was 7.1%, in contrast to the group of patients between the age of 40 and 60 where the incidence of adverse reactions was 21.42%. The incidence of adverse reactions in patients in the age group over 60 years it was 57.1%. In terms of gender, the incidence of adverse reactions was equal to 50% for both men and women. In conclusion, this study showed that treatment with nilotinib was well tolerated, with adverse reactions of an easy degree. Future evaluation is necessary in order to understanding the adverse reaction of nilotinib in comparison with other tyrosine kinase inhibitors. Keywords: nilotinib, pharmacovigilance, safety, chronic myeloid leukemia
Highlights
The aim of the study was to evaluate the safety profile of nilotinib administered to chronic myeloid leukemia (CML) at patients
From 135 patients with CML, previously treated with imatinib and hydroxyurea, 20 patients were treated with nilotinib
In the other two patients who were on treatment with imatinib (800mg), in 50% there was an occurrence of pruritus, leg pain, periorbital edema, erythema of the skin, and disorder of hematological response for each adverse reaction individual (Fig. 1)
Summary
Nilotinib belongs to the second generation of TKIs that has an extremely important role in the treatment of CML. It is one of the three drugs categorized in this category together with dasatinib and bosutinib (Etienne et al, 2010).). We must agree that nilotinib has a leading role in the current management of CML, and has established its efficacy as a drug in the first and second line. The aim of this study was to elaborate and present the most common adverse reactions effects of nilotinib and to evaluate the safety profile of nilotinib administered to CML patients at the University Clinic for Hematology in Skopje, North Macedonia.
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