Systemic Anti-Cancer Therapy Regimen Library
LYM NHL B-cell - R-GDP [RITUximab, gemcitabine, dexamethasone and cISplatin]
Treatment Overview
Number of cycles: 2 to 3; responding patients may be considered for high dose chemotherapy and autologous stem cell transplant otherwise, continue up to a total of 6 cycles, unless disease progression or unacceptable toxicity.
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.
Cycles 1 to 6 - 21 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.
If for stem cell harvest, mobilise as per institutional practice.
Cycle details
Cycles 1 to 6 - 21 days
| Medication | Dose | Route | Days | Max Duration |
|---|---|---|---|---|
| dexamethasone * | 40 mg flat dosing Once daily | oral administration | 1 to 4 | |
| paracetamol * | 1000 mg flat dosing | oral administration | 1 | |
| loratadine * | 10 mg | oral administration | 1 | |
| RITUximab | 375 mg/m² | intravenous | 1 | 6 hours |
| gemcitabine * | 1000 mg/m² | intravenous | 1, 8 | 30 minutes |
| magnesium sulfate heptahydrate | 10 mmol | intravenous | 1 | 60 minutes |
| cISplatin * | 75 mg/m² | intravenous | 1 | 60 minutes |
| sodium chloride * | 0.9 % | intravenous | 1 | 60 minutes |
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.
If for stem cell harvest, mobilise as per institutional practice.
Full details
Cycles 1 to 6 - 21 days
Day: 1
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| dexamethasone * | 40 mg flat dosing Once daily | oral administration |
Instructions:
Take in the morning with food, at least ONE hour prior to RITUximab. |
|
| 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:
First administration:
Further administrations:
|
| gemcitabine * | 1000 mg/m² | intravenous | 30 minutes | |
| magnesium sulfate heptahydrate | 10 mmol | intravenous | 60 minutes |
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion. |
| cISplatin * | 75 mg/m² | intravenous | 60 minutes |
Instructions:
|
| sodium chloride * | 0.9 % | intravenous | 60 minutes |
Quantity:1000 mL
Instructions:
After cISplatin infusion. If cISplatin is infused in 1000 mL, centres may choose to omit this bag of fluid. |
Day: 2
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| dexamethasone * | 40 mg flat dosing Once daily | oral administration |
Instructions:
Take in the morning with food. |
Day: 3
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| dexamethasone * | 40 mg flat dosing Once daily | oral administration |
Instructions:
Take in the morning with food. |
Day: 4
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| dexamethasone * | 40 mg flat dosing Once daily | oral administration |
Instructions:
Take in the morning with food. |
Day: 8
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| gemcitabine * | 1000 mg/m² | intravenous | 30 minutes |
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 may be considered |
| Emetogenicity: | Variable |
| Gastroprotection: | Gastroprotection may be considered |
| Hydration: | Routine hydration recommended |
| Hypersensitivity / Infusion related reaction risk: | High - routine premedication recommended |
| Pneumocystis jirovecii pneumonia (PJP) prophylaxis: | Routine antibiotic prophylaxis recommended |
| Tumour lysis syndrome prophylaxis: | Tumour lysis syndrome prophylaxis is recommended |
Emetogenicity: HIGH day 1; LOW day 8.
Tumour lysis syndrome prophylaxis: Recommended for cycle 1 and consider for subsequent cycles.
References
Castells, M.C., Matulonis, U.A., and Horton, TM. Infusion reactions to systemic chemotherapy. Savarese DMF and Feldweg AM, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com/contents/infusion-reactions-to-systemic-chemotherapy (Accessed 26 March 2021).
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.