In a recent editorial published in Blood Cancer Journal, researchers at the Department of Hematology and Medical Oncology at the Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA, recommended eliminating the post-injection monitoring period for subcutaneous daratumumab.
Daratumumab is “a first-in-class human IgG1 kappa CD38-targeted monoclonal antibody that has become a critical component in the treatment of newly diagnosed multiple myeloma (NDMM), relapsed and refractory multiple myeloma (RRMM), and AL Amyloidosis.” It has traditionally been given through intravenous (IV) infusions. The infusions typically take an average of 7.6 hours due to the high incidence of infusion-related reactions. These reactions can include cough, dyspnea, throat irritation, and congestion and are typically grade 2 or lower. Nevertheless, due to the amount of in-chair time required and the high potential for infusion-related reactions (IRRs), many centers are now giving the more recently approved subcutaneous (SC) form of daratumumab.
Subcutaneous daratumumab is associated with fewer IRRs than IV daratumumab and can be administered much more quickly. However, the directions for SC daratumumab recommend a post-injection monitoring period.
At Winship, the authors conducted a 16-week study involving 2 groups of patients given SC daratumumab divided into 2 observation groups. The first group was observed for 2 hours post-injection (group 1, n=29), and the second group was not observed after injection (group 2, n=35). Patients in both groups were given handouts and educated on the potential symptoms of an IRR.
Of the patients included in this study, 3 had an IRR (n=2, group 1; n=1, group 2). There were no grade 3 or 4 IRRs, and all were managed successfully with famotidine, acetaminophen, diphenhydramine, and/or hydrocortisone. None of the patients required hospitalization or emergency department admission.
Given the results of their study, the authors suggested eliminating the recommended post-injection monitoring period.
“We believe our data illustrate that patients can safely receive SC daratumumab with no observation period and patients prefer this administration route over IV,” the editorial concludes.
Eliminating the monitoring period with subcutaneous daratumumab: a single-center experience