Sixty-minute infusion rituximab protocol allows for safe and efficient workflow.
Dotson Emily,Crawford Brooke,Phillips Gary,Jones Jeffrey
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
PURPOSE:Rituximab is a chimeric monoclonal antibody approved to treat B cell non-Hodgkin's lymphoma (NHL). Infusion reactions among NHL patients are common during the first exposure but decrease with subsequent infusions. We sought to assess the safety and feasibility of a rituximab rapid infusion protocol in the outpatient treatment area of a comprehensive cancer center. PATIENTS AND METHODS:Patients with indolent and intermediate B cell NHL were invited to enroll in this prospective, single-institution study if they had received the first dose of rituximab according to the manufacturer-labeled standard titration schedule without grade >2 infusion reaction. The subsequent infusion proceeded without the use of steroid premedication at 100 mg/h administered over 15 min, with the remaining dose given over 45 min. Time savings between rapid infusion and standard titration were calculated. RESULTS:Fifty patients received 60-min rituximab infusions during the second drug administration. No infusion-related reactions of any grade were observed with the rapid infusion protocol (0%, one-sided 97.5% CI 0-7.1%). The mean time for the rapid rituximab infusion was 62.4 min (95% CI 61.2-63.6). When compared to the standard second dose infusion recommendation, a mean time of 94.2 min (95% 90-98.4) was saved with rapid infusion. Nursing surveys demonstrated 100% satisfaction with the rapid infusion protocol. CONCLUSIONS:Subsequent rituximab infusions can be safely administered over 60 min and without steroid premedication in an experienced outpatient infusion center when patients are appropriately screened. The faster infusions can reduce resource utilization and increase nursing satisfaction. TRIAL REGISTRATION:NCT01206777.
Efficacy and safety of an anti-CD20 monoclonal antibody, rituximab, for lupus nephritis: A meta-analysis.
Teng Siyuan,Tian Yu,Luo Nan,Zheng Qiang,Shao Mingfang,Li Lei
International journal of rheumatic diseases
BACKGROUND:The efficacy and safety of rituximab (RTX) for lupus nephritis are still a controversial issue. METHODS:We systematically searched MEDLINE, EMBASE, and the Cochrane Library databases for all clinical controlled studies. RESULTS:Six studies with 588 patients were included in our meta-analysis. RTX increased total renal remission rates (TR, odds ratio [OR] 2.16, 95% CI 1.31 to 3.55, P = .003) and complete renal remission rate (CR, OR 2.42, 95% CI 1.18 to 4.94, P = .02) compared with the control group. Subgroup analyses showed that rituximab was more effective at increasing the rate of TR and CR for lupus nephritis patients compared with mycophenolate mofetil (TR, OR 4.6, 95% CI 1.29 to 16.47, P = .02; CR, OR 2.56, 95% CI 1.19 to 5.47, P = .02) and cyclophosphamide (TR, OR 2.89, 95% CI 1.31 to 6.40, P = .009; CR, OR 2.75, 95% CI 1.19 to 6.4, P = .02). Rituximab also had advantage in reducing Systemic Lupus Erythematosus Disease Activity Index score (-2.49, 95% CI -3.77 to -1.22, P = .0001). There were no significant differences between the RTX group and control group on the change of proteinuria (-0.36 g/d, 95% CI -0.71 to -0.00 g/d, P = .05) and serum creatinine (0.13 mg/dL, 95% CI -0.15 to 0.42 mg/dL, P = .36). RTX treatment did not increase the risk of adverse events compared to the control group. CONCLUSIONS:This study provides clear beneficial effects of RTX in patients with lupus nephritis. In addition, RTX therapy did not increase the risk of adverse events compared to the control group.
Hypersensitivity Reactions: Priming Practice Change to Reduce Incidence in First-Dose Rituximab Treatment.
Laudati Carissa,Clark Caroline,Knezevic Andrea,Zhang Zhigang,Barton-Burke Margaret
Clinical journal of oncology nursing
BACKGROUND:Strategies to reduce hypersensitivity reaction (HSR) incidence with rituximab include premedications and slow titration. Literature is lacking on the priming method used when preparing rituximab IV lines and the potential impact on HSR incidence. OBJECTIVES:The primary objective is to evaluate HSR incidence in titrated first-dose rituximab infusions when priming IV lines with rituximab, as compared to priming with diluent. METHODS:A retrospective, comparative, descriptive study with two arms (rituximab- versus diluent-primed) was conducted. Variables were HSR incidence in relation to priming method, age, sex, diagnosis, and premedications. For patients with HSR, severity, time to onset, and infusion rate were examined. FINDINGS:HSR incidence was significantly higher in the diluent- versus the drug-primed arm. Other significant findings included higher HSR incidence in women and lower HSR incidence in patients premedicated with dexamethasone.
Rituximab for subcutaneous delivery: Clinical management principles from a nursing perspective.
Carlson Julia,Cox Keith,Bedwell Kylie,Ku Mathew
International journal of nursing practice
Nurses play an integral role in administering treatments to patients with non-Hodgkin's lymphomas. Intravenous (IV) rituximab was approved by the Australian Therapeutic Goods Administration in 1998, and a novel subcutaneous (SC) formulation was approved in 2014. Fixed-dose SC rituximab is highly concentrated; co-formulation with a fully human recombinant vorhyaluronidase alfa enzyme helps overcome the physiological barriers of the SC space, facilitating drug dispersion. Despite a different pharmacokinetic profile to the IV preparation, SC rituximab demonstrates a comparable efficacy/safety profile. Most frequently occurring rituximab-related adverse events include neutropenia, nausea and constipation, and administration-related reactions are more frequent with the SC preparation. Compared with IV, SC delivery reduces treatment times and nurse workload, and patients report greater comfort and convenience. This article sets out nursing considerations for optimal administration of SC rituximab, including premedication, drug handling/preparation, injection technique, after-care and management of adverse events, particularly administration-related reactions.
Rituximab Faster Infusion for Patients With Non-Hodgkin's Lymphoma in the United States: Implications for Nursing Practice.
Journal of infusion nursing : the official publication of the Infusion Nurses Society
The majority of follicular non-Hodgkin's lymphoma patients in the United States receive an initial treatment strategy that includes the infusion of rituximab. Data from a phase III multicenter clinical trial led to the 2012 US Food and Drug Administration approval of a 90-minute infusion of rituximab (Rituxan) starting at Cycle 2 for patients with non-Hodgkin's lymphoma who did not experience a Grade 3 or 4 infusion-related adverse event during Cycle 1. A review of literature was undertaken to identify existing evidence regarding both the safety of rituximab faster infusion and its impact on nursing practice. The aim of this article is to stimulate discussion and lead to implementation of evidence-based nursing practices to improve the delivery of patient care.