LAUSR

Abstract Background/Aim: Pomalidomide is an immunomodulatory drug that is used to treat multiple myeloma. We examined the time-to-onset and outcome of lung adverse events (LAEs) related to pomalidomide in Japanese patients based on information obtained from the spontaneous reporting system of the Japanese Adverse Drug Event Report database (JADER) of the Pharmaceuticals and Medical Devices Agency. Patients and Methods: We analyzed adverse events (AEs) reports recorded between April 2004 and March 2021 from JADER. Data on LAEs were extracted, and the relative risk of AEs was estimated using the reporting odds ratio and 95% confidence interval. We analyzed 1,772,494 reports and identified 2,918 reports of AEs caused by pomalidomide. Of these, 253 LAEs were reportedly associated with pomalidomide. Results: Signals were detected for five LAEs: pneumonia, pneumocystis jirovecii pneumonia, bronchitis, pneumonia bacterial, and pneumonia pneumococcal. Pneumonia was the most frequently mentioned condition (68.8%). The median time-to-onset of pneumonia was 66 days, but some cases of pneumonia occurred as late as 20 months after the start of administration. Fatal outcomes were observed in two of the five AEs wherein signals were detected and were due to pneumonia and bacterial pneumonia. Conclusion: Serious outcomes can occur after pomalidomide administration. It has been suggested that these LAEs occur relatively early after pomalidomide administration. Since some situations can result in fatal consequences, patients should be monitored for the emergence of these AEs over a prolonged period of time, especially for pneumonia.