Systemic Anti-Cancer Therapy Regimen Library
Cycle 1, and subsequent cycles for patients who do not achieve CR or CRi (LEU ALL precursor B-cell Relapsed/Refractory - inotuzumab ozogamicin )
Treatment Overview
Cycle 1 is the same for all patients.
Subsequent cycles in this regimen is intended for patients who did not achieve CR or CRi in the previous cycle.
Total number of cycles (Cycle 1 and subsequent cycles):
- For patients proceeding to HSCT:
- The recommended duration of treatment is 2 cycles;
- A third cycle may be considered for patients who do not achieve a CR or CRi and MRD negativity after 2 cycles.
- For patients not proceeding to HSCT, a maximum of 6 cycles may be administered.
- Any patient who does not achieve a CR or CRi within 3 cycles should discontinue treatment.
Cycle 1 - 21 days
inotuzumab ozogamicin:
- Days of administration for doses on days 8 and 15 can be moved +/- 2 days (maintain a minimum of 6 days between doses).
- If required, to allow recovery from toxicity this cycle length may be extended to 28 days (i.e. 7-day treatment-free interval starting on day 21).
Cycles 2 to 3 - 28 days - Subsequent doses for patients who did not achieve CR or CRi
inotuzumab ozogamicin:
- Dosing is for patients who do not achieve CR or CRi in the previous cycle, if CR or CRi achieved after a cycle of treatment subsequent cycles should be given as per regimen for CR or CRi achieved.
- Days of administration for doses on days 8 and 15 can be moved +/- 2 days (maintain a minimum of 6 days between doses).
Cycle details
Cycle 1 - 21 days
| Medication | Dose | Route | Days | Max Duration |
|---|---|---|---|---|
| loratadine * | 10 mg | oral administration | 1, 8, 15 | |
| paracetamol * | 1000 mg flat dosing | oral administration | 1, 8, 15 | |
| dexamethasone * | 12 mg flat dosing | intravenous | 1, 8, 15 | 15 minutes |
| inotuzumab ozogamicin | 0.8 mg/m² | intravenous | 1 | 60 minutes |
| inotuzumab ozogamicin | 0.5 mg/m² | intravenous | 8, 15 | 60 minutes |
inotuzumab ozogamicin:
- Days of administration for doses on days 8 and 15 can be moved +/- 2 days (maintain a minimum of 6 days between doses).
- If required, to allow recovery from toxicity this cycle length may be extended to 28 days (i.e. 7-day treatment-free interval starting on day 21).
Cycles 2 to 3 - 28 days - Subsequent doses for patients who did not achieve CR or CRi
| Medication | Dose | Route | Days | Max Duration |
|---|---|---|---|---|
| loratadine | 10 mg | oral administration | 1, 8, 15 | |
| paracetamol * | 1000 mg flat dosing | oral administration | 1, 8, 15 | |
| dexamethasone * | 12 mg flat dosing | intravenous | 1, 8, 15 | 15 minutes |
| inotuzumab ozogamicin | 0.8 mg/m² | intravenous | 1 | 60 minutes |
| inotuzumab ozogamicin | 0.5 mg/m² | intravenous | 8, 15 | 60 minutes |
inotuzumab ozogamicin:
- Dosing is for patients who do not achieve CR or CRi in the previous cycle, if CR or CRi achieved after a cycle of treatment subsequent cycles should be given as per regimen for CR or CRi achieved.
- Days of administration for doses on days 8 and 15 can be moved +/- 2 days (maintain a minimum of 6 days between doses).
Full details
Cycle 1 - 21 days
Day: 1
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| loratadine * | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to inotuzumab ozogamicin. |
|
| paracetamol * | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to inotuzumab ozogamicin. |
|
| dexamethasone * | 12 mg flat dosing | intravenous | 15 minutes |
Instructions:
30 minutes prior to inotuzumab ozogamicin, or as per institutional practice. |
| inotuzumab ozogamicin | 0.8 mg/m² | intravenous | 60 minutes |
Instructions:
|
Day: 8
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| loratadine * | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to inotuzumab ozogamicin. |
|
| paracetamol * | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to inotuzumab ozogamicin. |
|
| dexamethasone * | 12 mg flat dosing | intravenous | 15 minutes |
Instructions:
30 minutes prior to inotuzumab ozogamicin, or as per institutional practice. |
| inotuzumab ozogamicin | 0.5 mg/m² | intravenous | 60 minutes |
Instructions:
|
Day: 15
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| loratadine * | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to inotuzumab ozogamicin. |
|
| paracetamol * | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to inotuzumab ozogamicin. |
|
| dexamethasone * | 12 mg flat dosing | intravenous | 15 minutes |
Instructions:
30 minutes prior to inotuzumab ozogamicin, or as per institutional practice. |
| inotuzumab ozogamicin | 0.5 mg/m² | intravenous | 60 minutes |
Instructions:
|
Cycles 2 to 3 - 28 days - Subsequent doses for patients who did not achieve CR or CRi
Day: 1
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| loratadine | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to inotuzumab ozogamicin. |
|
| paracetamol * | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to inotuzumab ozogamicin. |
|
| dexamethasone * | 12 mg flat dosing | intravenous | 15 minutes |
Instructions:
30 minutes prior to inotuzumab ozogamicin, or as per insitutional practice. |
| inotuzumab ozogamicin | 0.8 mg/m² | intravenous | 60 minutes |
Instructions:
|
Day: 8
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| loratadine | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to inotuzumab ozogamicin. |
|
| paracetamol * | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to inotuzumab ozogamicin. |
|
| dexamethasone * | 12 mg flat dosing | intravenous | 15 minutes |
Instructions:
30 minutes prior to inotuzumab ozogamicin, or as per insitutional practice. |
| inotuzumab ozogamicin | 0.5 mg/m² | intravenous | 60 minutes |
Instructions:
|
Day: 15
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| loratadine | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to inotuzumab ozogamicin. |
|
| paracetamol * | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to inotuzumab ozogamicin. |
|
| dexamethasone * | 12 mg flat dosing | intravenous | 15 minutes |
Instructions:
30 minutes prior to inotuzumab ozogamicin, or as per insitutional practice. |
| inotuzumab ozogamicin | 0.5 mg/m² | intravenous | 60 minutes |
Instructions:
|
Supportive Care Factors
| Factor | Value |
|---|---|
| Antifungal prophylaxis: | Routine antifungal prophylaxis recommended |
| Antiviral prophylaxis for herpes virus: | Routine antiviral prophylaxis recommended |
| Emetogenicity: | Low |
| Hypersensitivity / Infusion related reaction risk: | High - routine premedication recommended |
| Pneumocystis jirovecii pneumonia (PJP) prophylaxis: | Routine antibiotic prophylaxis recommended |
| Sinusoidal obstruction syndrome prophylaxis: | Sinsuoidal obstruction prophylaxis may be considered |
| Tumour lysis syndrome prophylaxis: | Variable |
Antifungal prophylaxis: Prophylaxis with azole antifungals should be withheld whilst being treated with inotuzumab ozogamicin (due to risk of sinusoidal obstruction syndrome).
Antiviral prophylaxis for hepatitis B virus: Guidance is limited to high-risk anti-cancer medicines. Clinicians will need to assess individual patient risk for other anti-cancer medicines.
Tumour lysis prophylaxis is recommended for first cycle of treatment and only for further cycles if not in complete remission.
References
Pfizer New Zealand Limited. Besponsa (inotuzumab ozogamicin) New Zealand Data Sheet. 23 December 2020. Available from: https://www.medsafe.govt.nz/profs/Datasheet/b/besponsainj.pdf (Accessed 25 March 2025).
* 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.