2022
DOI: 10.2196/39229
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Photosensitivity From Avapritinib: Pharamacovigilance Analysis

Abstract: Certain protein kinase inhibitors have been reported to cause photosensitivity. Avapritinib is a tyrosine kinase inhibitor that was approved in January 2020. The aim of this analysis was to determine if a statistically significant signal exists between Avapritinib and photosensitivity in the real-world population. A disproportionality analysis was conducted using the Food and Drug Administration Adverse Event Reporting System (FAERS) from January 1, 2020, to December 31, 2021. A literature review was also perf… Show more

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“…In accordance with the disproportionality analyses, all ADRs with a higher frequency for AVA and SU have already been reported in their SmPC as very common [ 9 , 18 ]. In detail, the photosensitivity reactions with AVA may share a similar mechanism to the skin toxicities of other TKIs, such as IM, for the potent inhibition of the KIT gene [ 42 ]. Blood disorders, including neutropenia and thrombocytopenia, can be induced by SU through binding to Fms-like tyrosine kinase 3 (FLT-3) expressed on the surface of hematopoietic cells [ 43 ].…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…In accordance with the disproportionality analyses, all ADRs with a higher frequency for AVA and SU have already been reported in their SmPC as very common [ 9 , 18 ]. In detail, the photosensitivity reactions with AVA may share a similar mechanism to the skin toxicities of other TKIs, such as IM, for the potent inhibition of the KIT gene [ 42 ]. Blood disorders, including neutropenia and thrombocytopenia, can be induced by SU through binding to Fms-like tyrosine kinase 3 (FLT-3) expressed on the surface of hematopoietic cells [ 43 ].…”
Section: Discussionmentioning
confidence: 99%
“…Despite its strengths, the SRS database has some intrinsic limitations, such as the underreporting phenomena, the absence of denominators (i.e., the total number of GIST patients who have undergone treatment with TKIs), and the poor quality of information listed in each ICSR (i.e., seriousness and outcome, previous/current medical conditions, additional suspected or concomitant drugs) that could potentially affect the occurrence of analyzed ADRs [ 65 ]. In contrast to other SRS database studies, the use of the EV database does not allow the detection of all ICSR information, making it impossible to compute disproportionality analyses for all ICSRs related to SOC Nervous system disorders and Psychiatric disorders [ 42 , 66 , 67 ]. Therefore, further ad hoc studies are essential to establish the real neuropsychiatric safety profile of TKIs used in GISTs.…”
Section: Discussionmentioning
confidence: 99%