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Home > LEU ALL precursor B-cell Relapsed/Refractory - inotuzumab ozogamicin

LEU ALL precursor B-cell Relapsed/Refractory - inotuzumab ozogamicin

First cycle, all patients:

  • The recommended total dose of inotuzumab ozogamicin is 1.8 mg/m2 per cycle, administered in 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2) of a 21 day cycle.
  • Cycle 1 may be extended to 28 days if the patient achieves a CR or CRi, and/or to allow recovery from toxicity.

Subsequent cycles:

  • For patients who achieved a CR or CRi, the recommended total dose of inotuzumab ozogamicin is 1.5 mg/m2 per cycle, administered in 3 divided doses on Day 1 (0.5 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2) of a 28 day cycle.
  • If patients do not achieve a CR or CRi, the recommended dose of inotuzumab ozogamicin is 1.8 mg/m2 per cycle administered in 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2) of a 28 day cycle.

Total number of cycles:

  • For patients proceeding to haematopoietic stem cell transplant (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.

CR = Complete Remission.

CRi = Complete Remission with incomplete haematological recovery.

MRD = Minimal Residual Disease.

Cycle 1, and subsequent cycles for patients who achieved CR or CRi
Cycle 1, and subsequent cycles for patients who do not achieve CR or CRi

If CR or CRi is achieved following a cycle, subsequent cycles should be given as for patients who achieved CR or CRi (above).

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

Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gökbuget N, O'Brien S, Wang K, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53., PMID: 27292104

Kantarjian HM, DeAngelo DJ, Stelljes M, Liedtke M, Stock W, Gökbuget N, O'Brien SM, Jabbour E, Wang T, Liang White J, Sleight B, Vandendries E, Advani AS. Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: Final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study. Cancer. 2019 Jul 15;125(14):2474-2487., PMID: 30920645

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.