Systemic Anti-Cancer Therapy Regimen Library
LEU CLL - chlorambucil and oBINUTUZumab
Treatment Overview
Cycle 1 - 28 days
oBINUTUZumab, first dose: For patients receiving first dose oBINUTUZumab and considered at very high risk of infusion-related reaction (e.g. lymphocytes greater than 25 x109/L) consider additional premedication with montelukast 10mg and famotidine 20mg ONE hour prior to oBINUTUZumab, and consider additional doses of dexamethasone, montelukast and famotidine 12 hours prior to oBINUTUZumab.
oBINTUZumab: Consider withholding routine anti-hypertensives for 12 hours prior to oBINTUZumab dose.
Cycle 2 - 28 days
oBINUTUZumab: Consider withholding routine anti-hypertensives for 12 hours prior to oBINUTUZumab.
Cycles 3 to 6 - 28 days
oBINUTUZumab: Consider withholding routine anti-hypertensives for 12 hours prior to oBINUTUZumab.
Intravenous dexamethasone premedication cycles 3 to 6: Administer dexamethasone 20 mg IV ONE hour prior to oBINUTUZumab or as per institutional practice ONLY if a grade 3 infusion-related reaction occurred with the previous infusion OR the lymphocyte count greater than 25 x109/L prior to next treatment.
Cycle details
Cycle 1 - 28 days
| Medication | Dose | Route | Days | Max Duration |
|---|---|---|---|---|
| chlorambucil * | 0.5 mg/kg | oral administration | 1, 15 | |
| paracetamol | 1000 mg flat dosing | oral administration | 1, 2, 8, 15 |
|
| loratadine * | 10 mg | oral administration | 1, 2, 8, 15 |
|
| dexamethasone * | 20 mg flat dosing | intravenous | 1, 2, 8, 15 |
15 minutes |
| oBINUTUZumab | 100 mg flat dosing | intravenous | 1 | 4 hours |
| oBINUTUZumab | 900 mg flat dosing | intravenous | 2 | 6 hours |
| oBINUTUZumab | 1000 mg flat dosing | intravenous | 8, 15 | 6 hours |
oBINUTUZumab, first dose: For patients receiving first dose oBINUTUZumab and considered at very high risk of infusion-related reaction (e.g. lymphocytes greater than 25 x109/L) consider additional premedication with montelukast 10mg and famotidine 20mg ONE hour prior to oBINUTUZumab, and consider additional doses of dexamethasone, montelukast and famotidine 12 hours prior to oBINUTUZumab.
oBINTUZumab: Consider withholding routine anti-hypertensives for 12 hours prior to oBINTUZumab dose.
Cycle 2 - 28 days
| Medication | Dose | Route | Days | Max Duration |
|---|---|---|---|---|
| chlorambucil * | 0.5 mg/kg | oral administration | 1, 15 | |
| paracetamol | 1000 mg flat dosing | oral administration | 1 | |
| loratadine * | 10 mg | oral administration | 1 | |
| dexamethasone * | 20 mg flat dosing | intravenous | 1 | 15 minutes |
| oBINUTUZumab | 1000 mg flat dosing | intravenous | 1 | 6 hours |
oBINUTUZumab: Consider withholding routine anti-hypertensives for 12 hours prior to oBINUTUZumab.
Cycles 3 to 6 - 28 days
| Medication | Dose | Route | Days | Max Duration |
|---|---|---|---|---|
| chlorambucil * | 0.5 mg/kg | oral administration | 1, 15 | |
| paracetamol | 1000 mg flat dosing | oral administration | 1 | |
| loratadine * | 10 mg | oral administration | 1 | |
| oBINUTUZumab | 1000 mg flat dosing | intravenous | 1 | 6 hours |
oBINUTUZumab: Consider withholding routine anti-hypertensives for 12 hours prior to oBINUTUZumab.
Intravenous dexamethasone premedication cycles 3 to 6: Administer dexamethasone 20 mg IV ONE hour prior to oBINUTUZumab or as per institutional practice ONLY if a grade 3 infusion-related reaction occurred with the previous infusion OR the lymphocyte count greater than 25 x109/L prior to next treatment.
Full details
Cycle 1 - 28 days
Day: 1
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| chlorambucil * | 0.5 mg/kg | oral administration |
Instructions:
Always take at the same time in relation to food; preferably take at least one hour before or 3 hours after food, or take with food if significant gastric toxicity occurs. Round dose to closest multiple of 2 mg tablets. KEEP IN FRIDGE - DO NOT FREEZE. |
|
| paracetamol | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to oBINUTUZumab. |
|
| loratadine * | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to oBINUTUZumab. |
|
| dexamethasone * | 20 mg flat dosing | intravenous | 15 minutes |
Instructions:
ONE hour prior to oBINUTUZumab or as per institutional practice. |
| oBINUTUZumab | 100 mg flat dosing | intravenous | 4 hours |
Instructions:
Consider withholding routine anti-hypertensives for 12 hours prior to oBINUTUZumab. For patients considered at very high risk of infusion-related reaction (e.g. lymphocytes > 25 x109/L) consider additional premedication with montelukast 10mg and famotidine 20mg ONE hour prior to oBINUTUZumab, and consider additional doses of dexamethasone, montelukast and famotidine 12 hours prior to oBINUTUZumab. Administer at a rate of 25 mg/hour over 4 hours. Do not increase rate. |
Day: 2
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| paracetamol | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to oBINUTUZumab. |
|
| loratadine * | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to oBINUTUZumab. |
|
| dexamethasone * | 20 mg flat dosing | intravenous | 15 minutes |
Instructions:
ONE hour prior to oBINUTUZumab or as per institutional practice. |
| oBINUTUZumab | 900 mg flat dosing | intravenous | 6 hours |
Instructions:
Consider withholding routine anti-hypertensives for 12 hours prior to oBINUTUZumab. If NO infusion-related reaction during previous infusion: 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. If an infusion-related reaction occurred during previous infusion: Start at 25 mg/hour. If tolerated, rate can be increased by 50 mg/hour every 30 minutes to a maximum rate of 400 mg/hour. |
Day: 8
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| paracetamol | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to oBINUTUZumab. |
|
| loratadine * | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to oBINUTUZumab. Omit if no infusion-related reactions occurred with the previous infusion. |
|
| dexamethasone * | 20 mg flat dosing | intravenous | 15 minutes |
Instructions:
ONE hour prior to oBINUTUZumab or as per institutional practice. Must be given if a grade 3 infusion-related reaction occurred with the previous infusion OR the lymphocyte count > 25 x 109/L prior to next treatment. Omit in patients with no or a grade 1 or 2 infusion-related reaction during previous infusion. |
| oBINUTUZumab | 1000 mg flat dosing | intravenous | 6 hours |
Instructions:
Consider withholding routine anti-hypertensives for 12 hours prior to oBINUTUZumab. If NO infusion-related reaction during previous infusion and the final infusion rate was ≥ 100 mg/hour: 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. If an infusion-related reaction occurred during previous infusion: 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. |
Day: 15
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| chlorambucil * | 0.5 mg/kg | oral administration |
Instructions:
Always take at the same time in relation to food; preferably take at least one hour before or 3 hours after food, or take with food if significant gastric toxicity occurs. Round dose to closest multiple of 2 mg tablets. KEEP IN FRIDGE - DO NOT FREEZE. |
|
| paracetamol | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to oBINUTUZumab. |
|
| loratadine * | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to oBINUTUZumab. Omit if no infusion-related reactions occurred with the previous infusion. |
|
| dexamethasone * | 20 mg flat dosing | intravenous | 15 minutes |
Instructions:
ONE hour prior to oBINUTUZumab or as per institutional practice. Must be given if a grade 3 infusion-related reaction occurred with the previous infusion OR the lymphocyte count > 25 x 109/L prior to next treatment. Omit in patients with no or a grade 1 or 2 infusion-related reaction during previous infusion. |
| oBINUTUZumab | 1000 mg flat dosing | intravenous | 6 hours |
Instructions:
Consider withholding routine anti-hypertensives for 12 hours prior to oBINUTUZumab. If NO infusion-related reaction during previous infusion and the final infusion rate was ≥ 100 mg/hour: 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. If an infusion-related reaction occurred during previous infusion: 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. |
Cycle 2 - 28 days
Day: 1
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| chlorambucil * | 0.5 mg/kg | oral administration |
Instructions:
Always take at the same time in relation to food; preferably take at least one hour before or 3 hours after food, or take with food if significant gastric toxicity occurs. Round dose to closest multiple of 2 mg tablets. KEEP IN FRIDGE - DO NOT FREEZE. |
|
| paracetamol | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to oBINUTUZumab. |
|
| loratadine * | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to oBINUTUZumab. Omit if no infusion-related reactions occurred with the previous infusion. |
|
| dexamethasone * | 20 mg flat dosing | intravenous | 15 minutes |
Instructions:
ONE hour prior to oBINUTUZumab or as per institutional practice. Must be given if a grade 3 infusion-related reaction occurred with the previous infusion OR the lymphocyte count > 25 x 109/L prior to next treatment. Omit in patients with no or a grade 1 or 2 infusion-related reaction during previous infusion. |
| oBINUTUZumab | 1000 mg flat dosing | intravenous | 6 hours |
Instructions:
Consider withholding routine anti-hypertensives for 12 hours prior to oBINUTUZumab. If NO infusion-related reaction during previous infusion and the final infusion rate was ≥ 100 mg/hour: 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. If an infusion-related reaction occurred during previous infusion: 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. |
Day: 15
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| chlorambucil * | 0.5 mg/kg | oral administration |
Instructions:
Always take at the same time in relation to food; preferably take at least one hour before or 3 hours after food, or take with food if significant gastric toxicity occurs. Round dose to closest multiple of 2 mg tablets. KEEP IN FRIDGE - DO NOT FREEZE. |
Cycles 3 to 6 - 28 days
Day: 1
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| chlorambucil * | 0.5 mg/kg | oral administration |
Instructions:
Always take at the same time in relation to food; preferably take at least one hour before or 3 hours after food, or take with food if significant gastric toxicity occurs. Round dose to closest multiple of 2 mg tablets. KEEP IN FRIDGE - DO NOT FREEZE. |
|
| paracetamol | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to oBINUTUZumab. |
|
| loratadine * | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to oBINUTUZumab. Omit if no infusion-related reactions occurred with the previous infusion. |
|
| oBINUTUZumab | 1000 mg flat dosing | intravenous | 6 hours |
Instructions:
Consider withholding routine anti-hypertensives for 12 hours prior to oBINUTUZumab. If NO infusion-related reaction during previous infusion and the final infusion rate was ≥ 100 mg/hour: 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. If an infusion-related reaction occurred during previous infusion: 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. |
Day: 15
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| chlorambucil * | 0.5 mg/kg | oral administration |
Instructions:
Always take at the same time in relation to food; preferably take at least one hour before or 3 hours after food, or take with food if significant gastric toxicity occurs. Round dose to closest multiple of 2 mg tablets. KEEP IN FRIDGE - DO NOT FREEZE. |
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: | Variable |
| Hypersensitivity / Infusion related reaction risk: | High - routine premedication recommended |
| Pneumocystis jirovecii pneumonia (PJP) prophylaxis: | Routine antibiotic prophylaxis may be considered |
| Tumour lysis syndrome prophylaxis: | Tumour lysis syndrome prophylaxis is recommended |
Emetogenicity: MINIMAL to LOW (chlorambucil); MINIMAL (oBINUTUZumab).
Tumour lysis syndrome prophylaxis: Recommended for cycle 1 and consider for subsequent cycles.
References
Roche Products (New Zealand) Limited Gazya New Zealand Data Sheet 3 February 2021. https://www.medsafe.govt.nz/profs/Datasheet/g/GazyvaInfusion.pdf (accessed 14 December 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.