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Home > LEU CLL - RITUximab and bendamustine

LEU CLL - RITUximab and bendamustine

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 - 28 days

Cycle length:
28

RITUximab, first dose:

  • Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • In patients with lymphocytes 25 x109/L or higher, consider additional premedication with montelukast 10 mg orally and famotidine 20 mg orally both ONE hour prior to RITUximab, and/or consider splitting RITUximab dose over two days (100mg on day 1, remainder of the dose on day 2).

bendamustine: Consider dose reduction of bendamustine to 70 mg/m2 IV days 1 and 2 for frail patients or those who have been previously treated with purine analogs.

Cycles 2 to 6 - 28 days

Cycle length:
28

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


bendamustine: Consider dose reduction of bendamustine to 70 mg/m2 IV days 1 and 2 for frail patients or those who have been previously treated with purine analogs.

Cycle details

Cycle 1 - 28 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
bendamustine * 90 mg/m² intravenous 1, 2 60 minutes

RITUximab, first dose:

  • Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • In patients with lymphocytes 25 x109/L or higher, consider additional premedication with montelukast 10 mg orally and famotidine 20 mg orally both ONE hour prior to RITUximab, and/or consider splitting RITUximab dose over two days (100mg on day 1, remainder of the dose on day 2).

bendamustine: Consider dose reduction of bendamustine to 70 mg/m2 IV days 1 and 2 for frail patients or those who have been previously treated with purine analogs.

Cycles 2 to 6 - 28 days

Medication Dose Route Days Max Duration
paracetamol 1000 mg flat dosing oral administration 1
loratadine * 10 mg oral administration 1
RITUximab 500 mg/m² intravenous 1 6 hours
bendamustine * 90 mg/m² intravenous 1, 2 60 minutes

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


bendamustine: Consider dose reduction of bendamustine to 70 mg/m2 IV days 1 and 2 for frail patients or those who have been previously treated with purine analogs.

Full details

Cycle 1 - 28 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:
  • Consider withholding routine anti-hypertensives for 12 hours prior to RITUximab.
  • In patients with lymphocytes 25 x109/L or higher, consider additional premedication with montelukast 10 mg and famotidine 20 mg both orally ONE hour prior to RITUximab, and/or splitting RITUximab dose over two days (100mg on day 1, remainder of the dose on day 2).
  • Start 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.
bendamustine * 90 mg/m² intravenous 60 minutes
Instructions:

Consider dose reduction to 70 mg/m2 IV days 1 and 2 for frail patients or those who have been previously treated with purine analogs.

Day: 2

Medication Dose Route Max duration Details
bendamustine * 90 mg/m² intravenous 60 minutes
Instructions:

Consider dose reduction to 70 mg/m2 IV days 1 and 2 for frail patients or those who have been previously treated with purine analogs.

Cycles 2 to 6 - 28 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 500 mg/m² intravenous 6 hours
Instructions:
  • Consider administering corticosteroid premedication before RITUximab 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.
bendamustine * 90 mg/m² intravenous 60 minutes
Instructions:
  • Consider dose reduction to 70 mg/m2 IV days 1 and 2 for frail patients or those who have been previously treated with purine analogs.
  • Administer appropriate premedications if patient had a previous infusion related reaction of a grade where re-challenge is possible.

Day: 2

Medication Dose Route Max duration Details
bendamustine * 90 mg/m² intravenous 60 minutes
Instructions:
  • Consider dose reduction to 70 mg/m2 IV days 1 and 2 for frail patients or those who have been previously treated with purine analogs.
  • Administer appropriate premedications if patient had a previous infusion related reaction of a grade where re-challenge is possible.

Supportive Care Factors

Factor Value
Antiviral prophylaxis for hepatitis B virus: Required for anti–HBc positive patients at risk of reactivation
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Emetogenicity: Medium
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended
Irradiated blood components: Irradiation of blood components is recommended
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis may be considered
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis is recommended

Tumour lysis syndrome (TLS) prophylaxis: Recommended for cycle 1 and considered for subsequent cycles. Allopurinol use should be restricted to patients at moderate or high risk of TLS and kept as short as possible to reduce risk of Stephens-Johnson Syndrome and toxic epidermal necrolysis.

References

Eichhorst B., A. Fink, and J. Bahlo et al. 2016. "First-line chemoimmunotherapy with bendamustine and rituximab versus fludarabine, cyclophosphamide, and rituximab in patients with advanced chronic lymphocytic leukaemia (CLL10): an international, open-label, randomised, phase 3, noninferiority trial." Lancet Oncol. 2016 Jul;17(7):928-942, PMID: 27216274

New Zealand Blood Service Transfusion Medicine Handbook Third Edition, 2016 https://www.nzblood.co.nz/assets/Transfusion-Medicine/PDFs/111G122.pdf (accessed 3/2/2022).

Novartis New Zealand Limited Riximyo New Zealand Datasheet 6 July 2020 https://www.medsafe.govt.nz/profs/datasheet/r/riximyoinf.pdf (Accessed 29 March 2022).

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., 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 (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.