Presentation Authors: Alexander Pastuszak*, Salt Lake City, UT, Yiqun Hu, Chace Wayne, Jeffrey Freid, Malvern, PA
Introduction: A Risk Evaluation and Mitigation Strategy (REMS) program was instituted for testosterone undecanoate because of the potential risk of pulmonary oil microembolism (POME) and/or anaphylaxis after intramuscular injection of testosterone undecanoate. This analysis examined the reporting rate of POME associated with the use of testosterone undecanoate (750 mg/3 mL) during postmarketing surveillance.
Methods: The Endo Pharmaceuticals Inc database was searched for reports of POME occurring from the time of testosterone undecanoate approval on March 5, 2014 through June 30, 2018. Each case was reviewed and adjudicated by a drug safety physician to confirm that the reported event had predefined clinical characteristics consistent with POME.
Results: During the 4.3-year period, 90,092 doses of intramuscular testosterone undecanoate were distributed via the REMS program to healthcare professionals for patient treatment. From a total of 633 individual case safety reports, 28 reported adverse events were classified as POME, for a calculated yearly per-injection POME rate of < 0.1%. Of these 28 cases, 21 (75.0%) resolved, and for those with a resolution time reported, 13 of 16 (81.2%) resolved in â‰¤30 minutes. Thirteen of the 21 cases that resolved (61.9%) required no medical intervention (ie, POME event resolved spontaneously). One fatality was reported 18 months after a documented POME event and appeared unrelated to the reported testosterone undecanoate injection or subsequent injections received after the POME event. In 4 POME cases with symptoms serious enough to require an emergency room visit, issues with the injection technique, incorrect product usage, or a preexisting medical condition (asthma) were identified as contributing factors.
Conclusions: POME events in men treated with testosterone undecanoate are rare, nonserious, and resolve quickly without medical intervention in the vast majority of cases. Most emergency department visits for POME have been the result of injection-related errors, reinforcing the importance of proper technique to minimize the risk of drug injection into the venous circulation and subsequent development of rare adverse events like POME.
Source of Funding: Source of Funding: Endo Pharmaceuticals Inc.