Systemic Anti-Cancer Therapy Regimen Library
LEU CLL - FCR [IV] fludarabine, CYCLOPHOSPHamide and RITUximab
Treatment Overview
Usually 6 cycles, depending on response and toxicity fewer than 6 cycles may be given.
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.
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).
Cycles 2 to 6 - 28 days
RITUximab: Consider administering corticosteroid premedication before RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.
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 |
| fludarabine * | 25 mg/m² Once daily | intravenous | 1, 2, 3 | 30 minutes |
| CYCLOPHOSPHamide | 250 mg/m² Once daily | intravenous | 1, 2, 3 | 60 minutes |
| pegFILGRASTIM | 6 mg | subcutaneous injection | 4 |
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).
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 |
| fludarabine * | 25 mg/m² Once daily | intravenous | 1, 2, 3 | 30 minutes |
| CYCLOPHOSPHamide | 250 mg/m² Once daily | intravenous | 1, 2, 3 | 60 minutes |
| pegFILGRASTIM | 6 mg | subcutaneous injection | 4 |
RITUximab: Consider administering corticosteroid premedication before RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.
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:
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. 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). |
| fludarabine * | 25 mg/m² Once daily | intravenous | 30 minutes | |
| CYCLOPHOSPHamide | 250 mg/m² Once daily | intravenous | 60 minutes |
Day: 2
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| fludarabine * | 25 mg/m² Once daily | intravenous | 30 minutes | |
| CYCLOPHOSPHamide | 250 mg/m² Once daily | intravenous | 60 minutes |
Day: 3
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| fludarabine * | 25 mg/m² Once daily | intravenous | 30 minutes | |
| CYCLOPHOSPHamide | 250 mg/m² Once daily | intravenous | 60 minutes |
Day: 4
| 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 | 500 mg/m² | intravenous | 6 hours |
Instructions:
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. Consider administering corticosteroid premedication before RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice. |
| fludarabine * | 25 mg/m² Once daily | intravenous | 30 minutes | |
| CYCLOPHOSPHamide | 250 mg/m² Once daily | intravenous | 60 minutes |
Day: 2
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| fludarabine * | 25 mg/m² Once daily | intravenous | 30 minutes | |
| CYCLOPHOSPHamide | 250 mg/m² Once daily | intravenous | 60 minutes |
Day: 3
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| fludarabine * | 25 mg/m² Once daily | intravenous | 30 minutes | |
| CYCLOPHOSPHamide | 250 mg/m² Once daily | intravenous | 60 minutes |
Day: 4
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| pegFILGRASTIM | 6 mg | subcutaneous injection |
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 |
| 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 jirovecii pneumonia (PJP) prophylaxis: | Routine antibiotic prophylaxis recommended |
| Tumour lysis syndrome prophylaxis: | Tumour lysis syndrome prophylaxis is recommended |
Tumour lysis syndrome prophylaxis: Recommended for cycle 1 and consider for subsequent cycles.
References
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).
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.