Evaluation of administration-related reactions with subcutaneous daratumumab with and without premedication.
Oncologist
; 29(9): 806-810, 2024 Sep 06.
Article
in En
| MEDLINE
| ID: mdl-38920281
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 ANDMETHODS:
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Premedication
/
Antibodies, Monoclonal
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Multiple Myeloma
Limits:
Adult
/
Aged
/
Aged80
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Female
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Humans
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Male
/
Middle aged
Language:
En
Journal:
Oncologist
Journal subject:
NEOPLASIAS
Year:
2024
Document type:
Article
Affiliation country:
Country of publication: