{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T23:59:43Z","timestamp":1792627183126,"version":"4.5.0"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2024,6,26]],"date-time":"2024-06-26T00:00:00Z","timestamp":1719360000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,9,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Materials and Methods<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyae158","type":"journal-article","created":{"date-parts":[[2024,6,26]],"date-time":"2024-06-26T11:53:25Z","timestamp":1719402805000},"page":"806-810","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of administration-related reactions with subcutaneous daratumumab with and without premedication"],"prefix":"10.1093","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-5661-2992","authenticated-orcid":false,"given":"Kashyap","family":"Padmaraju","sequence":"first","affiliation":[{"name":"Department of Pharmacy, University of Chicago Medical Center , Chicago, IL , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaitlin","family":"Kelly","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, University of Chicago Medical Center , Chicago, IL , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrzej J","family":"Jakubowiak","sequence":"additional","affiliation":[{"name":"Section of Hematology\/Oncology, Department of Medicine, University of Chicago , Chicago, IL , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin A","family":"Derman","sequence":"additional","affiliation":[{"name":"Section of Hematology\/Oncology, Department of Medicine, University of Chicago , Chicago, IL , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,6,26]]},"reference":[{"issue":"13","key":"2024090704204081600_CIT0001","doi-asserted-by":"crossref","first-page":"1207","DOI":"10.1056\/NEJMoa1506348","article-title":"Targeting CD38 with daratumumab monotherapy in multiple myeloma","volume":"373","author":"Lokhorst","year":"2015","journal-title":"N Engl J 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is safe in multiple myeloma","volume":"32","author":"Barr","year":"2018","journal-title":"Leukemia"},{"issue":"5","key":"2024090704204081600_CIT0006","doi-asserted-by":"crossref","first-page":"e370","DOI":"10.1016\/S2352-3026(20)30070-3","article-title":"Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicenter, open-label, non-inferiority, randomized, phase 3 trial","volume":"7","author":"Mateos","year":"2020","journal-title":"Lancet Haematol"},{"issue":"2","key":"2024090704204081600_CIT0007","doi-asserted-by":"crossref","first-page":"1063144","DOI":"10.3389\/fonc.2023.1063144","article-title":"Benefits of switching from intravenous to subcutaneous daratumumab: Perspectives from UK healthcare providers","volume":"13","author":"Cook","year":"2023","journal-title":"Front 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centers","volume":"15","author":"Sugalski","year":"2019","journal-title":"J Oncol Pract"},{"issue":"8","key":"2024090704204081600_CIT0011","doi-asserted-by":"crossref","first-page":"936","DOI":"10.1182\/blood.2020005288","article-title":"Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial","volume":"136","author":"Voorhees","year":"2020","journal-title":"Blood"},{"issue":"1","key":"2024090704204081600_CIT0012","first-page":"10","article-title":"Optimizing daratumumab infusion: assessing the safety and feasibility of omitting preinfusion medications and decreasing infusion time","volume":"11","author":"Justine","year":"2021","journal-title":"J Hematol Oncol Pharm"},{"issue":"Supplement 1","key":"2024090704204081600_CIT0013","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1182\/blood-2020-141644","article-title":"Optimizing care: discontinuing medications prior to daratumumab and hyaluronidase-fihj 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