title: Peri-infusional adverse reactions to rituximab in patients with non-Hodgkin's lymphoma.
abstract: OBJECTIVE
  Rituximab is effective in the treatment of B-cell lymphoid malignances and some autoimmune diseases. Most patients receiving the first infusion of rituximab experience symptoms that decrease with subsequent infusions. It is assumed that the first dose of rituximab should be infused slowly during a 6-h period and during 4-h periods subsequently. The aim of the study was to evaluate the frequency and severity of adverse reactions to rituximab in patients with non-Hodgkin's lymphoma.
  
  
  METHODS
  This was an intensive pharmacovigilance prospective, observational, open labeled, multicenter cohort study conducted in 12 hospitals. Adults requiring treatment with rituximab (375 mg/m(2) body surface area) alone or with chemotherapy were included. Adverse reactions were graded according to the National Cancer Institute scale, whereas causality was established using the Naranjo algorithm. Infusions were classified as fast (0-90 min) and slow (>91 min). Fast infusions were used to analyze the associated adverse reactions.
  
  
  RESULTS
  We included 550 adult patients. Total infusion episodes were 1,749 and 52 adverse reactions were reported in 22 patients (4%). Thirty-one of 52 adverse reactions occurred during the first infusion. The risk of adverse reactions was lower with the fast infusions (10/52 adverse reactions [19.23%]). All adverse effects were mild. Twenty-three adverse effects were possibly related to rituximab.
  
  
  CONCLUSIONS
  Rituximab can be infused at a fast rate without an increase in adverse reactions. Peri-infusional adverse reactions are similar to those described for other populations but the incidence rate is lower. Rituximab has a favorable safety profile in patients with non-Hodgkin's lymphoma.
authors.affiliation: Departamento de Farmacología, CINVESTAV, IPN, Mexico City, Mexico.
authors.forename: Teresa
authors.initials: T
authors.lastname: Arredondo-Garza
authors.forename: Abraham
authors.initials: A
authors.lastname: Majluf-Cruz
authors.forename: Jorge
authors.initials: J
authors.lastname: Vela-Ojeda
authors.forename: Ignacio
authors.initials: I
authors.lastname: Mariscal-Ramírez
authors.forename: Luis
authors.initials: L
authors.lastname: Solis-Anaya
authors.forename: José Refugio
authors.initials: JR
authors.lastname: Lopez-Gutiérrez
authors.forename: César Hernández
authors.initials: CH
authors.lastname: Guadarrama
authors.forename: Enrique
authors.initials: E
authors.lastname: Rico-Curiel
authors.forename: Jorge Antonio
authors.initials: JA
authors.lastname: Armenta-San Sebastián
authors.forename: Gilberto
authors.initials: G
authors.lastname: Castañeda-Hernández
mesh_terms: D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001402:B-Lymphocytes / Q000276:immunology; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008800:Mexico; D008875:Middle Aged; D060735:Pharmacovigilance; D011446:Prospective Studies; D000069283:Rituximab
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab
keywords: Adverse reaction; Non-Hodgkin's lymphoma; Pharmacovigilance; Rituximab