title: Managing Infusion-Related Reactions for Patients With Chronic Lymphocytic Leukemia Receiving Obinutuzumab.
abstract: BACKGROUND
  In patients with previously untreated chronic lymphocytic leukemia (CLL) and comorbidities, treatment with the glycoengineered, type II anti-CD20 monoclonal antibody obinutuzumab (Gazyva®) (GA101) plus chlorambucil (Leukeran®) was associated with superior outcomes to rituximab (Rituxan®) plus chlorambucil, with a similar safety profile. However, a higher occurrence of infusion-related reactions (IRRs) was reported with obinutuzumab. These reactions typically require additional management.
  
  
  OBJECTIVE
  The focus of this article is to provide oncology nurses and physicians with advice for obinutuzumab IRR management based on clinical trial data and nursing experience.
  
  
  METHODS
  The authors reviewed the published management strategies for IRRs with obinutuzumab that were identified during the phase III CLL11 trial and an expanded access phase IIb study (ML28979). Practical advice for obinutuzumab IRR management was developed based on available clinical trial information and nursing experience.
  
  
  RESULTS
  IRRs with obinutuzumab are generally manageable. Most IRRs (all grades), and all grade 3-4 IRRs, occurred during the first infusion. Therefore, IRR management could be improved substantially with extra vigilance at this early stage.
authors.affiliation: Genentech, Inc.
authors.forename: Keith
authors.initials: K
authors.lastname: Dawson
authors.affiliation: Ohio State University Comprehensive Cancer Center.
authors.forename: Mollie
authors.initials: M
authors.lastname: Moran
authors.affiliation: Genentech, Inc.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Guindon
authors.affiliation: F. Hoffmann-La Roche Ltd.
authors.forename: Hui
authors.initials: H
authors.lastname: Wan
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects*; D017326:Clinical Trials, Phase III as Topic; D019468:Disease Management; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions / Q000451:nursing* / Q000503:physiopathology; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D009859:Oncology Nursing; D011379:Prognosis; D012720:Severity of Illness Index; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C543332:obinutuzumab
keywords: infusion-related reaction; obinutuzumab; premedication; rituximab; slow infusion; split dose