Evaluation of ambulatory use of daratumumab hyaluronidase injection.

Abstract

IntroductionDaratumumab is a therapeutic cornerstone of the management of multiple myeloma, exerting its anti-myeloma activity through targeting of the cell surface glycoprotein CD38 on plasma cells. While originally given intravenously, the subcutaneous formulation, daratumumab hyaluronidase injection (Dara SC), has been associated with non-inferior efficacy and lower infusion-related reaction rates (IRRs) in the treatment of multiple myeloma and light chain amyloidosis. A noted benefit of Dara SC is a short administration time; however, the optimal observation time post injection to ensure patient safety is unclear from the drug labeling. Our institutional monitoring protocol states to monitor for 6 h after the first dose, 2 h after the second dose, and no monitoring required for the third and subsequent doses.MethodsWe conducted a retrospective analysis of all adult patients with multiple myeloma and light chain amyloidosis who initiated Dara SC treatment in the outpatient setting at our Scripps Clinic infusion rooms. The primary outcome was the cumulative incidence of any-grade infusion-related and injection-site reactions within the first three doses of Dara SC. Secondary outcomes included severity and time to onset of reactions, incidence of reaction in relation to dose number, and reaction rates in Dara-naïve versus Dara-experienced patients.ResultsA total of 97 patients were identified for inclusion in the study. The incidence of infusion- and injection-related reactions in the first three doses were 7 (7.2%) and 2 (2.1%), respectively. The severity grade of reactions were mostly Grade 1 with a single Grade 2 reaction, and time to onset of reaction for infusion-related reactions was 6 h (0-48) and 22.5 h (1-44) for injection-related reactions. All infusion-related reactions were associated with Dose 1 and the injection-related reactions were associated with Dose 2 and 3. No reactions were identified in the Dara-experienced population.ConclusionDara SC infusion- and injection-related reactions were mild and reversible with limited use of additional supportive care medications to alleviate symptoms. Thus given its safety profile and our clinical experience, a robust monitoring protocol similar to clinical trials may not be warranted when administered in the outpatient infusion setting.