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Systemic Anti-Cancer Therapy Regimen Library

LYM NHL B-cell - RITUximab Maintenance Q8W

Treatment Overview

This regimen contains a medicine where one or more biosimilars may exist. Any biosimilars used have been reviewed by the regulator (Medsafe) and relevant specialists were consulted nationally. Where regulators, in consultation with relevant specialists, have agreed that there are no clinically significant differences in either safety or effectiveness between a biosimilar and originator product, these drugs may be used interchangeably.

Cycle 1 - 56 days

Cycle length:
56

RITUximab, first dose:

If patient has recently completed a RITUximab containing regimen, consider following RITUximab instructions for cycle 2, otherwise:

  • Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • For patients at high risk of infusion-related reaction, consider additional pre-medications such as an extra antihistamine dose the day before, an H2 receptor antagonist and montelukast.

Cycles 2 to 12 - 56 days

Cycle length:
56

RITUximab: Consider administering corticosteroid premedication prior to RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.

Cycle details

Cycle 1 - 56 days

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1
loratadine * 10 mg oral administration 1
dexamethasone * 12 mg flat dosing intravenous 1 15 minutes
RITUximab 375 mg/m² intravenous 1 6 hours

RITUximab, first dose:

If patient has recently completed a RITUximab containing regimen, consider following RITUximab instructions for cycle 2, otherwise:

  • Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • For patients at high risk of infusion-related reaction, consider additional pre-medications such as an extra antihistamine dose the day before, an H2 receptor antagonist and montelukast.

Cycles 2 to 12 - 56 days

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1
loratadine * 10 mg oral administration 1
RITUximab 375 mg/m² intravenous 1 6 hours

RITUximab: Consider administering corticosteroid premedication prior to RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.

Full details

Cycle 1 - 56 days

Day: 1

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:

30 to 60 minutes prior to RITUximab.

loratadine * 10 mg oral administration
Instructions:

30 to 60 minutes prior to RITUximab.

dexamethasone * 12 mg flat dosing intravenous 15 minutes
Instructions:

30 to 60 minutes prior to RITUximab, or as per institutional practice.

RITUximab 375 mg/m² intravenous 6 hours
Instructions:

If patient has recently completed a RITUximab containing regimen, consider following instructions for cycle 2, otherwise:

  • Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • For patients at high risk of infusion-related reaction, consider additional pre-medications such as an extra antihistamine dose the day before, an H2 receptor antagonist and montelukast.
  • Start infusion at 50 mg/hour. If tolerated, rate can be increased by 50 mg/hour every 30 minutes to a maximum rate of 400 mg/hour.

Cycles 2 to 12 - 56 days

Day: 1

Medication Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:

30 to 60 minutes prior to RITUximab.

loratadine * 10 mg oral administration
Instructions:

30 to 60 minutes prior to RITUximab.

RITUximab 375 mg/m² intravenous 6 hours
Instructions:

Consider administering corticosteroid premedication if previous doses not well tolerated, or if clinically indicated as per institutional practice.

Start at 100 mg/hour. If tolerated, rate can be increased by 100 mg/hour every 30 minutes to a maximum rate of 400 mg/hour, or as per institutional practice.

Supportive Care Factors

Factor Value
Antiviral prophylaxis for hepatitis B virus: Required for anti–HBc positive patients at risk of reactivation
Emetogenicity: Minimal
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended

References

van Oers, M.H.J., R. Klasa, R.E. Marcus, et al. 2006. "Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without Rituximab during induction: results of a prospective randomized phase 3 intergroup trial." Blood 108(10):3295-3301., PMID: 16873669

van Oers, M. H., M. Van Glabbeke, L. Giurgea, et al. 2010. "Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study." J Clin Oncol 28(17):2853-2858., PMID: 20439641

Salles, G., J. F. Seymour, F. Offner, et al. 2011. "Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to Rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial." Lancet 377(9759):42-51., PMID: 21176949

Hochster, H., E. Weller, R. D. Gascoyne, et al. 2009. "Maintenance Rituximab after cyclophosphamide, vincristine, and prednisone prolongs progression-free survival in advanced indolent lymphoma: results of the randomized phase III ECOG1496 Study." J Clin Oncol 27(10):1607-1614., PMID: 19255334

Hornberger, J., C. Reyes, A. Shewade, et al. 2012. "Cost-effectiveness of adding Rituximab to fludarabine and cyclophosphamide for the treatment of previously untreated chronic lymphocytic leukemia." Leuk Lymphoma 53(2):225-234., PMID: 21824050

Pettengell, R., N. Schmitz, C. Gisselbrecht, et al. 2013. "Rituximab purging and/or maintenance in patients undergoing autologous transplantation for relapsed follicular lymphoma: a prospective randomized trial from the lymphoma working party of the European group for blood and marrow transplantation." J Clin Oncol 31(13):1624-1630., PMID: 23547078

Taverna, C., G. Martinelli, F. Hitz, et al. 2016. "Rituximab Maintenance for a Maximum of 5 Years After Single-Agent Rituximab Induction in Follicular Lymphoma: Results of the Randomized Controlled Phase III Trial SAKK 35/03." J Clin Oncol 34(5):495-500., PMID: 26712227

Kahl, B. S., J. M. Burke, R. van der Jagt, et al. 2017. "Assessment of Maintenance Rituximab after First-Line Bendamustine-Rituximab in Patients with Follicular Lymphoma: An Analysis from the BRIGHT Trial." Blood 130:484;

Vidal, L., A. Gafter-Gvili, G. Salles, et al. 2017. "Rituximab maintenance improves overall survival of patients with follicular lymphoma-Individual patient data meta-analysis." Eur J Cancer 76:216-225, PMID: 28336303

Chaudhary, L., M. A. Kharfan-Dabaja, P. Hari, et al. 2013. "Is hematopoietic cell transplantation still a valid option for mantle cell lymphoma in first remission in the chemoimmunotherapy-era?" Bone Marrow Transplant., PMID: 23584438

Le Gouill, S., C. Thieblemont, L. Oberic, et al. 2017. "Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma." N Engl J Med 377(13):1250-1260., PMID: 28953447

Fowler, N. H. 2011. "Role of maintenance Rituximab (rituxan) therapy in the treatment of follicular lymphoma." P T 36(9):590-598., PMID: 22346327

Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AMM, Eniu A, Jassem J, Pentheroudakis G, Peters S, Rauh S, Zielinski CC, Stahel RA, Voest E, Douillard JY, McGregor K, Ciardiello F. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142. , PMID: 28848668

Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD, Schilsky RL. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018 Apr 20;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14., PMID: 29443651

Laudati C, Clark C, Knezevic A, Zhang Z, Barton-Burke M. Hypersensitivity Reactions: Priming Practice Change to Reduce Incidence in First-Dose Rituximab Treatment. Clin J Oncol Nurs. 2018 Aug 1;22(4):407-414. doi: 10.1188/18.CJON.407-414. , PMID: 30035788

Doyle J, Raggatt M, Slavin M, McLachlan SA, Strasser SI, Sasadeusz JJ, Howell J, Hajkowicz K, Nandurkar H, Johnston A, Bak N, Thompson AJ. Hepatitis B management during immunosuppression for haematological and solid organ malignancies: an Australian consensus statement. Med J Aust. 2019 Jun;210(10):462-468. doi: 10.5694/mja2.50160. Epub 2019 May 19., PMID: 31104328

Medicines and Hepatitis B Reactivation Prescriber Update 38(1): 2-3 March 2017 https://medsafe.govt.nz/profs/PUArticles/March2017/MedicinesAndHepatitisB.htm

Rituximab and Hepatitis B Reactivation Prescriber Update 34(3):27 September 2013 https://www.medsafe.govt.nz/profs/PUArticles/Sept2013RituximabHepB.htm

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.