Real-World Pharmacovigilance Analysis of Lenvatinib Use in Qatar

Introduction: Lenvatinib is a Tyrosine Kinase Inhibitor (TKI) that has been approved for different solid tumors including hepatocellular carcinoma (HCC), renal cell carcinoma, endometrial and thyroid cancer (1-4). Objective: A Medication use evaluation (MUE) was performed for Lenvatinib. MUE is a systematic and interdisciplinary performance improvement method with an overarching goal of optimizing patient outcomes via ongoing evaluation and improvement of medication utilization (5). Methods: The electronic health record identified of patients who received Lenvatinib between January 2020 and November 2021 were reviewed. Results: A total of 28 patients were identified. Most of the patients used the Lenvatinib as a first or second line. Lenvatinib was used as monotherapy in 10 cases while as combination therapy in 18 cases: with pembrolizumab, everolimus or nivolumab. Lenvatinib was used as first line in 9 cases, second line in 8 cases, third line in 6 cases, fourth line in 3 cases and as fifth line in 2 cases. Three patients received Lenvatinib for non-FDA/non-EMA approved indications, including cholangiocarcinoma and metastatic melanoma (in combination with Nivolumab). Oncologists chose to start with lower doses than approved ones in 57 % of patients. Despite that, nearly 90 % of patients had multiple-dose reductions due to adverse drug reactions (ADRs) development. 60% of the patients were still alive during the review period; 82 % of them (14 out of 17) still receiving Lenvatinib while 18 % (3 out of 17) progressed. Unfortunately, 22% (6 out of 28) deceased while 18 % lost follow-up. Mortality was within less than or equal to 30 days post Lenvatinib initiation in one patient with HCC. A total number of 26 ADRs were identified. All ADRs were documented by Clinical pharmacists. The most-reported ADRs were cardiovascular and dermatological followed by endocrine ADRs. A list of reported ADRs is summarized in table 1. In more than 50 % of cases; monitoring parameters were not done as baseline or follow up (especially ECG, ECHO, dental clearance, and protein urine dipstick), which in some cases leads to toxicities and ADRs development. Conclusion: Lenvatinib is a vital oncology medication but it has been badly tolerated in our center. Utilizing this medication as indicated with performing the appropriate monitoring parameters as recommended can benefit patients. Encouraging all health care providers to document ADRs will lead to a better patient experience. A m