1. Evaluation of administration-related reactions with subcutaneous daratumumab with and without premedication.
- Author
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Padmaraju K, Kelly K, Jakubowiak AJ, and Derman BA
- Subjects
- Humans, Male, Female, Aged, Middle Aged, Injections, Subcutaneous, Aged, 80 and over, Immunoglobulin Light-chain Amyloidosis drug therapy, Adult, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal pharmacology, Antibodies, Monoclonal administration & dosage, Premedication methods, Multiple Myeloma drug therapy
- Abstract
Background: Daratumumab-hyaluronidase-fihj (Dara-SQ) is frequently used in the treatment of plasma cell disorders and is associated with improved outcomes. Dara-SQ was shown to be non-inferior to intravenous daratumumab (Dara-IV) in efficacy, safety, and associated with fewer administration-related reactions (ARRs). Despite the lower ARR risk with Dara-SQ, package labeling still recommends indefinite premedication. In this study, we investigated the safety of premedication discontinuation after one cycle of Dara-SQ., Materials and Methods: This pre-post interventional quality improvement study included all patients aged 18 years and older diagnosed with multiple myeloma or light chain (AL) amyloidosis who received at least one dose of Dara-SQ. Patients in Arm 1 received Dara-SQ per package labeling, while patients in Arm 2 had premedication omitted (excluding dexamethasone) after cycle 1. The primary endpoint was the incidence of ARR after cycle 1. Overall ARR rate and therapy time saved were also evaluated., Results: A total of 102 patients (63 in Arm 1 and 39 in Arm 2) were included. There were zero reactions in either arm after cycle 1 across 1479 Dara-SQ doses administered over a 30-month period with or without premedication omission. The overall ARR rate was 2.9% (3/102), which all occurred prior to premedication omission. Therapy timed saved from premedication omission was 194 hours in a 6-month period, equating to approximately $140 000 USD., Conclusion: ARRs to Dara-SQ were rare, mild, and occurred during cycle 1 prior to premedication omission. Omission of noncorticosteroid premedication is safe, feasible, and carries substantial time and cost savings for patients and infusion centers., (© The Author(s) 2024. Published by Oxford University Press.)
- Published
- 2024
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