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Home > LYM NHL B-cell - bendamustine and oBINUTUZumab > LYM - bendamustine and oBINUTUZumab
This regimen is a component of LYM NHL B-cell - bendamustine and oBINUTUZumab

bendamustine and oBINUTUZumab Induction (LYM NHL B-cell - bendamustine and oBINUTUZumab)

Treatment Overview

Cycle 1 - 28 days

Cycle length:
28

oBINUTUZumab:

  • For patients receiving the first dose of oBINUTUZumab and considered at very high risk of infusion-related reaction (e.g. lymphocytes > 25 x109/L) consider additional premedication with montelukast 10 mg and famotidine 20 mg ONE hour prior to oBINUTUZumab, and consider additional doses of dexamethasone, montelukast and famotidine 12 hours prior to oBINUTUZumab.
  • Consider withholding routine anti-hypertensives for 12 hours prior to, during, and for one hour after each oBINUTUZumab infusion.

loratadine, subsequent infusions:

  • May be omitted if no infusion-related reaction occurred during the previous infusion.

Intravenous dexamethasone, subsequent infusions:

  • Must be given if a Grade 3 infusion-related reaction occurred during the previous infusion OR the lymphocyte count > 25 x 109/L prior to next treatment.
  • May be omitted if no or a Grade 1–2 infusion-related reaction occurred during the previous infusion.

bendamustine, subsequent doses:

  • Administer appropriate premedications if patient had a previous infusion-related reaction of a grade where re-challenge is possible.

Cycles 2 to 6 - 28 days

Cycle length:
28

loratadine: May be omitted if no infusion-related reaction occurred during the previous infusion.


Intravenous dexamethasone:

  • Must be given if a Grade 3 infusion-related reaction occurred during the previous infusion OR the lymphocyte count > 25 x 109/L prior to next treatment.
  • May be omitted if no or a Grade 1–2 infusion-related reaction occurred during the previous infusion.

oBINUTUZumab: Consider withholding routine anti-hypertensives for 12 hours prior to, during, and for one hour after each oBINUTUZumab infusion.


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, 8, 15
loratadine * 10 mg oral administration 1, 8, 15
dexamethasone * 20 mg flat dosing intravenous 1, 8, 15 15 minutes
oBINUTUZumab 1000 mg flat dosing intravenous 1, 8, 15 6 hours
bendamustine * 90 mg/m² intravenous 1, 2 60 minutes

oBINUTUZumab:

  • For patients receiving the first dose of oBINUTUZumab and considered at very high risk of infusion-related reaction (e.g. lymphocytes > 25 x109/L) consider additional premedication with montelukast 10 mg and famotidine 20 mg ONE hour prior to oBINUTUZumab, and consider additional doses of dexamethasone, montelukast and famotidine 12 hours prior to oBINUTUZumab.
  • Consider withholding routine anti-hypertensives for 12 hours prior to, during, and for one hour after each oBINUTUZumab infusion.

loratadine, subsequent infusions:

  • May be omitted if no infusion-related reaction occurred during the previous infusion.

Intravenous dexamethasone, subsequent infusions:

  • Must be given if a Grade 3 infusion-related reaction occurred during the previous infusion OR the lymphocyte count > 25 x 109/L prior to next treatment.
  • May be omitted if no or a Grade 1–2 infusion-related reaction occurred during the previous infusion.

bendamustine, subsequent doses:

  • Administer appropriate premedications if patient had a previous infusion-related reaction of a grade where re-challenge is possible.

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
dexamethasone 20 mg flat dosing intravenous 1 15 minutes
oBINUTUZumab 1000 mg flat dosing intravenous 1 6 hours
bendamustine * 90 mg/m² intravenous 1, 2 60 minutes

loratadine: May be omitted if no infusion-related reaction occurred during the previous infusion.


Intravenous dexamethasone:

  • Must be given if a Grade 3 infusion-related reaction occurred during the previous infusion OR the lymphocyte count > 25 x 109/L prior to next treatment.
  • May be omitted if no or a Grade 1–2 infusion-related reaction occurred during the previous infusion.

oBINUTUZumab: Consider withholding routine anti-hypertensives for 12 hours prior to, during, and for one hour after each oBINUTUZumab infusion.


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 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 1000 mg flat dosing intravenous 6 hours
Instructions:
  • Consider withholding routine anti-hypertensives for 12 hours prior to, during, and for one hour after oBINUTUZumab 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.
bendamustine * 90 mg/m² intravenous 60 minutes

Day: 2

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

Administer appropriate premedications if patient had a previous infusion-related reaction of a grade where re-challenge is possible.

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 during 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, during, and for one hour after oBINUTUZumab infusion.

If NO or a Grade 1 infusion-related reaction occurred 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 a Grade 2 or higher 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
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 during 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, during, and for one hour after oBINUTUZumab infusion.

If NO or a Grade 1 infusion-related reaction occurred 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 a Grade 2 or higher 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.

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 oBINUTUZumab.
loratadine * 10 mg oral administration
Instructions:

30 to 60 minutes prior to oBINUTUZumab.

  • Omit if no infusion-related reactions occurred during 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, during, and for one hour after oBINUTUZumab infusion.

If NO or a Grade 1 infusion-related reaction occurred 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 a Grade 2 or higher 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.

Short duration infusion ONLY for patients with follicular lymphoma and NO Grade 3 or higher infusion-related reaction occurred during Cycle 1:

  • Start at 100 mg/hour for 30 minutes. If tolerated, increase rate to 900 mg/hour.
  • If an infusion-related reaction of Grade 1-2 with ongoing symptoms, or a Grade 3 or higher occurs with the short duration infusion all subsequent infusions should be given at the standard rates (above).
bendamustine * 90 mg/m² intravenous 60 minutes
Instructions:

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:

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 may be considered
Emetogenicity: Variable
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 may be considered

Emetogenicity: MEDIUM days 1 and 2; MINIMAL days 8 and 15.


Tumour lysis syndrome (TLS) prophylaxis: 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

Roche Products (New Zealand) Limited Gazyva® New Zealand data sheet 21 July 2022 https://www.medsafe.govt.nz/profs/datasheet/g/GazyvaInfusion.pdf (accessed 17 October 2023).

* 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.