Systemic Anti-Cancer Therapy Regimen Library
LYM NHL B-cell MCL - R-BAC [RITUximab, bendamustine and cytarabine]
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
RITUximab, first dose:
- 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 6 - 28 days
RITUximab: Consider administering corticosteroid premedication prior to RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.
bendamustine: Administer appropriate premedications if patient had a previous infusion-related reaction of a grade where re-challenge is possible.
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 * | 70 mg/m² Once daily | intravenous | 2, 3 | 60 minutes |
| cytarabine * | 500 mg/m² Once daily | intravenous | 2, 3, 4 | 120 minutes |
| pegFILGRASTIM | 6 mg | subcutaneous injection | 7 |
RITUximab, first dose:
- 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 6 - 28 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 |
| bendamustine * | 70 mg/m² Once daily | intravenous | 2, 3 | 60 minutes |
| cytarabine * | 500 mg/m² Once daily | intravenous | 2, 3, 4 | 120 minutes |
| pegFILGRASTIM | 6 mg | subcutaneous injection | 7 |
RITUximab: Consider administering corticosteroid premedication prior to RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.
bendamustine: Administer appropriate premedications if patient had a previous infusion-related reaction of a grade where re-challenge is possible.
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:
|
Day: 2
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| bendamustine * | 70 mg/m² Once daily | intravenous | 60 minutes | |
| cytarabine * | 500 mg/m² Once daily | intravenous | 120 minutes |
Instructions:
Starting 2 hours after the bendamustine infusion. |
Day: 3
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| bendamustine * | 70 mg/m² Once daily | intravenous | 60 minutes | |
| cytarabine * | 500 mg/m² Once daily | intravenous | 120 minutes |
Instructions:
Starting 2 hours after the bendamustine infusion. |
Day: 4
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| cytarabine * | 500 mg/m² Once daily | intravenous | 120 minutes |
Day: 7
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| pegFILGRASTIM | 6 mg | subcutaneous injection |
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 | 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 infusion 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. |
Day: 2
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| bendamustine * | 70 mg/m² Once daily | intravenous | 60 minutes |
Instructions:
Administer appropriate premedications if patient had a previous infusion-related reaction of a grade where re-challenge is possible. |
| cytarabine * | 500 mg/m² Once daily | intravenous | 120 minutes |
Instructions:
Starting 2 hours after the bendamustine infusion. |
Day: 3
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| bendamustine * | 70 mg/m² Once daily | intravenous | 60 minutes |
Instructions:
Administer appropriate premedications if patient had a previous infusion-related reaction of a grade where re-challenge is possible. |
| cytarabine * | 500 mg/m² Once daily | intravenous | 120 minutes |
Instructions:
Starting 2 hours after the bendamustine infusion. |
Day: 4
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| cytarabine * | 500 mg/m² Once daily | intravenous | 120 minutes |
Day: 7
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| pegFILGRASTIM | 6 mg | subcutaneous injection |
Supportive Care Factors
| Factor | Value |
|---|---|
| Antifungal prophylaxis: | Routine antifungal prophylaxis may be considered |
| Antiviral prophylaxis for hepatitis B virus: | Required for anti–HBc positive patients at risk of reactivation |
| Antiviral prophylaxis for herpes virus: | Routine antiviral prophylaxis may be considered |
| Emetogenicity: | Variable |
| Growth factor support: | Recommended for primary prophylaxis |
| Hypersensitivity / Infusion related reaction risk: | High - routine premedication recommended |
| Irradiated blood components: | Irradiation of blood components is recommended |
| Pneumocystis jiroveci pneumonia (PJP) prophylaxis: | Routine antibiotic prophylaxis may be considered |
| Tumour lysis syndrome prophylaxis: | Tumour lysis syndrome prophylaxis may be considered |
Emetogenicity: MINIMAL day 1, MEDIUM days 2, 3 and 4.
Tumour lysis syndrome (TLS) prophylaxis:
- Recommended for cycle 1 and consider 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
Branca, A., I. Gianesello, L. Brugnaro, et al. 2016. "Rituximab-Bendamustine Cytarabine (R-BAC) As Frontline Therapy in Mantle Cell Lymphoma: A Single-Center Experience" Blood 126(23):2710.
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).
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.