
doi: 10.1111/cts.13450
pmid: 36385738
pmc: PMC9926065
handle: 10230/56071 , 11351/9524 , 20.500.12530/96645
doi: 10.1111/cts.13450
pmid: 36385738
pmc: PMC9926065
handle: 10230/56071 , 11351/9524 , 20.500.12530/96645
AbstractAlthough rituximab is generally well‐tolerated, infusion‐related reactions (IRRs) are common with the initial dose when administered intravenously according to standard recommendations. To prevent IRRs, premedication and low‐speed infusion rates have been recommended. Consequently, intravenous (i.v.) infusion of rituximab can become a labor‐intensive process. Rapid i.v. rituximab infusion over 90 min has demonstrated a favorable safety profile for the second and subsequent infusions during the course of therapy. The aim of this study was to investigate the safety and tolerability of 90‐min rapid infusion of Sandoz rituximab biosimilar (SDZ‐RTX) for patients with CD20+ lymphoma or chronic lymphocytic leukemia (CLL). We retrospectively reviewed all patients with CD20+ lymphoma or CLL who received SDZ‐RTX infusions in 90 min from July 2019 to July 2021 at seven Spanish hospitals. The primary end point was the incidence of IRRs. We identified 124 patients and 576 rapid administrations of SDZ‐RTX, with an average of five rapid infusions per patient. Most rapid infusions of SDZ‐RTX were in combination with CHOP/CHOP‐like therapy (48.4%), followed by SDZ‐RTX alone (15.1%), in combination with bendamustine (14.5%), or with other regimens (22%). The 90‐min SDZ‐RTX infusion schedule was well‐tolerated with no grade 3/4 IRRs. The incidence of any grade IRR during the first rapid infusion was 1% (5 grade 1 IRRs and 1 grade 2 IRR). In conclusion, rapid 90‐min i.v. administration of SDZ‐RTX for the second and subsequent infusions during the course of therapy is well‐tolerated in patients with CD20+ lymphoma or CLL.
DISEASES::Neoplasms::Neoplasms by Histologic Type::Leukemia::Leukemia, Lymphoid::Leukemia, B-Cell::Leukemia, Lymphocytic, Chronic, B-Cell, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, RM1-950, Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos, Antibodies, Monoclonal, Murine-Derived, Medicaments--Efectes secundaris, Humans, Medicaments biològics - Efectes secundaris, ENFERMEDADES::neoplasias::neoplasias por tipo histológico::leucemia::leucemia linfoide::leucemia de células B::leucemia linfocítica crónica de células B, Biosimilar Pharmaceuticals, Leucèmia limfocítica crònica - Tractament, Retrospective Studies, Other subheadings::Other subheadings::Other subheadings::/drug therapy, CHEMICALS AND DRUGS::Complex Mixtures::Biological Products::Biosimilar Pharmaceuticals, Research, Trastorns limfoproliferatius - Tractament, Leukemia, Lymphocytic, Chronic, B-Cell, Other subheadings::Other subheadings::Other subheadings::/adverse effects, Therapeutics. Pharmacology, Public aspects of medicine, RA1-1270, COMPUESTOS QUÍMICOS Y DROGAS::mezclas complejas::productos biológicos::fármacos biosimilares, Immunoglobulines, Rituximab, Anticossos monoclonals
DISEASES::Neoplasms::Neoplasms by Histologic Type::Leukemia::Leukemia, Lymphoid::Leukemia, B-Cell::Leukemia, Lymphocytic, Chronic, B-Cell, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, RM1-950, Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos, Antibodies, Monoclonal, Murine-Derived, Medicaments--Efectes secundaris, Humans, Medicaments biològics - Efectes secundaris, ENFERMEDADES::neoplasias::neoplasias por tipo histológico::leucemia::leucemia linfoide::leucemia de células B::leucemia linfocítica crónica de células B, Biosimilar Pharmaceuticals, Leucèmia limfocítica crònica - Tractament, Retrospective Studies, Other subheadings::Other subheadings::Other subheadings::/drug therapy, CHEMICALS AND DRUGS::Complex Mixtures::Biological Products::Biosimilar Pharmaceuticals, Research, Trastorns limfoproliferatius - Tractament, Leukemia, Lymphocytic, Chronic, B-Cell, Other subheadings::Other subheadings::Other subheadings::/adverse effects, Therapeutics. Pharmacology, Public aspects of medicine, RA1-1270, COMPUESTOS QUÍMICOS Y DROGAS::mezclas complejas::productos biológicos::fármacos biosimilares, Immunoglobulines, Rituximab, Anticossos monoclonals
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