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Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration
Xiangchun Xu1, Xuzheng Guo1, Jinhui Chen1
1Department of Pharmacy, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Abstract:
BackgroundAbemaciclib, an oral kinase inhibitor, is used to treat hormone receptor-positive and HER2-negative breast cancer patients. However, there has been a decrease in studies reporting adverse reactions to abemaciclib-related kidney injuries. Thus, this study was aimed at assessing its safety profile using a large-scale pharmacovigilance database.MethodsAbemaciclib-related adverse drug reaction reports from the Food and Drug Administration Adverse Event Reporting System were obtained and scrutinized, and adverse drug reactions were selected using reporting odds ratio, the proportional reporting ratio methods, empirical Bayes geometric mean and UK Medicines and Healthcare products Regulatory Agency methods.ResultsWe selected 10,757 matched reports associated with abemaciclib, among which we found eight adverse reactions about kidney injuries correlated with abeamciclib, such as increased blood creatinine, renal disorder, decreased glomerular filtration rate, increased blood urea, hydronephrosis, abnormal renal function test, increased creatinine renal clearance and increased cystatin C. A demographic analysis of reported cases of abemaciclib-associated renal injury revealed that the majority were female, aged ≥46 years and had taken the drug ≥30 days.ConclusionThis study highlights the characteristics of adverse reactions with abemaciclib and those associated with renal damage, which are crucial for safety studies on the clinical use of this drug.
Insights
This study analyzed kidney injury reports for abemaciclib, a breast cancer drug. It identified eight renal adverse events, emphasizing the need for careful safety monitoring in patients.
Area of Science:
- Pharmacology
- Oncology
- Nephrology
Background:
- Abemaciclib is an oral kinase inhibitor for hormone receptor-positive, HER2-negative breast cancer.
- A decline in studies on abemaciclib-related kidney injuries necessitates safety profile assessment.
Purpose of the Study:
- To assess the safety profile of abemaciclib concerning kidney injuries.
- To identify and characterize adverse drug reactions related to abemaciclib in a large pharmacovigilance database.
Main Methods:
- Utilized the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
- Analyzed 10,757 abemaciclib-associated adverse drug reaction reports.
- Employed statistical methods including reporting odds ratio, proportional reporting ratio, empirical Bayes geometric mean, and UK's MHRA methods to identify kidney-related events.
Main Results:
- Identified eight adverse reactions associated with abemaciclib and kidney injury.
- Specific events included increased blood creatinine, renal disorder, decreased glomerular filtration rate, increased blood urea, hydronephrosis, abnormal renal function tests, increased creatinine renal clearance, and increased cystatin C.
- Demographic analysis indicated that most affected patients were female, aged 46 years or older, and had taken abemaciclib for at least 30 days.
Conclusions:
- Highlights key characteristics of abemaciclib-associated renal adverse reactions.
- Provides crucial insights for ongoing safety evaluations and clinical management of patients receiving abemaciclib.
- Underscores the importance of pharmacovigilance in monitoring drug safety profiles.
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