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Nilotinib displays some adverse drug reactions (ADRs) including haematological disorders, and cardiovascular events and less commonly transient pancreatic hyperenzymemia. Nevertheless, whether nilotinib induces symptomatic acute pancreatitis (AP) remains to be elucidated, especially that the literature is scarce on well-documented cases of nilotinib-induced acute pancreatitis (NIAP).<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">A 45-year-old male patient had a 10-year history of bipolar disorder for which he was treated with lithium, and a one-year history of CML with suspected resistance to imatinib. Regimen therapy was switched therefore to nilotinib (400<span class="elsevierStyleHsp" style=""></span>mg twice/day). Four months later, while he was on nilotinib and lithium therapy, the patient presented to the emergency unit with a two-day history of acute abdominal pain radiating to the back and nausea with no fever. Physical examination revealed normal vital signs and epigastric tenderness on abdominal palpation with no peritoneal irritation. Biological tests objected elevated serum lipase levels (SLL) of 970<span class="elsevierStyleHsp" style=""></span>UI/L (>18 times higher than the upper limit of normal (ULN)) (grade 4 of CTCAE) and amylase levels (SAL) of 626<span class="elsevierStyleHsp" style=""></span>U/L (>5<span class="elsevierStyleHsp" style=""></span>ULN) (grade 4 of CTCAE). Serum bilirubin and liver enzyme levels were within normal limits. Therefore, AP was suspected. Abdominal ultrasonography revealed a morphologically normal pancreas, with neither peri-pancreatic fluid collections nor biliary dilatation. Since, common etiologies of AP were ruled out, drug-induced AP (DIAP) was mostly considered, and all his ongoing medications (lithium and nilotinib) were withdrawn. The patient was supportively treated with fluid and pain management. Abdominal pain resolved, two days later and SSL (47<span class="elsevierStyleHsp" style=""></span>UI/L)/SAL (110<span class="elsevierStyleHsp" style=""></span>UI/L) returned to normal levels, within two weeks. As his SLL (30<span class="elsevierStyleHsp" style=""></span>UI/L) and SAL (85<span class="elsevierStyleHsp" style=""></span>UI/L) were within normal ranges three days before nilotinib initiation, his long-term medication “lithium” was therefore, renewed with no recurrence of symptoms. Thus, nilotinib was incriminated in our case to trigger AP (Naranjo score<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>6, ‘probable’) considering the suggestive temporal relationship between drug intake and reaction onset, the regression of symptoms after discontinuation of the treatment, and especially, the exclusion of other aetiologies. Regarding lithium, the absence of recurrence of clinical symptoms upon its re-exposure ruled out its responsibility.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Accounting for approximately 1–2% of cases overall, DIAP is a rare but potential aetiology of AP, induced mainly by tetracyclines, sulfonamides and azathioprine. In fact, DIAP is a challenging diagnosis, depending on the exclusion of other common etiologies, mainly biliary gallstones, alcoholism, metabolic disorders, viral infections, autoimmune and trauma. Pancreatic hyperenzymemia with TKIs has been well-recognised as a transient and self-limited ADR resolving spontaneously, within 1–2 weeks, despite continued therapy with or without dose reduction. However, few reports have implicated nilotinib in causing clinically apparent AP.</p><p id="par0020" class="elsevierStylePara elsevierViewall">Five case reports of patients experiencing NIAP,<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">1,3–5</span></a> in which the potential causes of AP were ruled out. In all cases, revised Atlanta classification criteria were fulfilled. Most of cases reported an onset of symptoms within the first week of nilotinib therapy. Only one case<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> described NPAP with a delayed onset time of four years. Similarly, a long latency period of four months was outlined in our case. Indeed, in case of DIAP, time from initiation of therapy to the onset of AP symptoms varies depending on the causative drug and can occur within a short time after administration of the first dose to years after therapy begins. DIAP can be severe, with 5–15% of patients experiencing life-threatening complications. However, our patient had a favourable outcome as the culprit drug was promptly discontinueated. Unlike many other drugs, no fatalities have reported with nilotinib-induced AP. None of the reported cases, including ours, attempted to rechallenge the imputable drug.</p><p id="par0025" class="elsevierStylePara elsevierViewall">A plausible mechanism, by which nilotinib can induce pancreatitis has yet to be determined. Many hypotheses have been proposed regarding the increase in the serum pancreatic enzyme levels. <span class="elsevierStyleSmallCaps">C</span>-Abl inhibition, affecting calcium release responsible of exocrine pancreatic secretion or pancreatic auto-digestion caused by the accumulation of fatty acids inside pancreatic acinar cells are the main pathogenic mechanism involved, nilotinib-induced AP.</p><p id="par0030" class="elsevierStylePara elsevierViewall">While NIAP remains a rare phenomenon, close monitoring of pancreatic enzymes levels should be performed routinely during its administration while paying attention to the clinical symptoms of pancreatitis.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Authors’ contributions</span><p id="par0035" class="elsevierStylePara elsevierViewall">Khadija Mansour and Bouraoui Ouni wrote the manuscript, made the diagnosis, patient's supervision and follow-up. Nesrine Ben Sayed performed literature search. All authors read and approved the final manuscript.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Statements of ethics</span><p id="par0040" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Study approval statement</span>: Ethics approval was not required in case of publishing a case report by local committee.</p><p id="par0045" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Consent to publish statement</span>: Written informed consent was obtained from the patient for publication of this case report and any accompanying images.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Data availability statement</span><p id="par0050" class="elsevierStylePara elsevierViewall">All data generated or analysed during this study are available on author request.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Funding sources</span><p id="par0055" class="elsevierStylePara elsevierViewall">No funds, grants, or other support was received to assist with the preparation of this manuscript.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conflict of interest</span><p id="par0060" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:6 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Authors’ contributions" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Statements of ethics" ] 2 => array:2 [ "identificador" => "sec0015" "titulo" => "Data availability statement" ] 3 => array:2 [ "identificador" => "sec0020" "titulo" => "Funding sources" ] 4 => array:2 [ "identificador" => "sec0025" "titulo" => "Conflict of interest" ] 5 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0030" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Symptomatic acute pancreatitis induced by nilotinib: a report of two cases" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:5 [ 0 => "T. 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Letter to the Editor
Symptomatic acute pancreatitis induced by nilotinib in a patient with chronic myeloid leukaemia
Pancreatitis aguda sintomática inducida por nilotinib en un paciente con leucemia mieloide crónica