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Systemic Anti-Cancer Therapy Regimen Library

Home > LEU APL - APML4 induction, consolidation 1 and 2 followed by maintenance [60 years and under] > LEU - APML4 consolidation 2 [60 years and under]
This regimen is a component of LEU APL - APML4 induction, consolidation 1 and 2 followed by maintenance [60 years and under]

APML4 [60 years and under] - Consolidation 2 (LEU APL - APML4 induction, consolidation 1 and 2 followed by maintenance [60 years and under])

Treatment Overview

Starts 3 to 4 weeks after completion of Consolidation 1.

Cycle 1 - 35 days

Cycle length:
35

tretinoin:

  • Consider dose reduction of tretinoin to 25 mg/m2 daily in TWO divided doses in patients under the age of 20 years to reduce risk of pseudotumour cerebri.
  • Teratogenic—Ensure pregnant women are not exposed to tretinoin. Consult prescribing information.

arsenic trioxide: May prolong QTc interval and close monitoring is recommended. Avoid or reduce risk factors for QTc prolongation.

Cycle details

Cycle 1 - 35 days

Medication Dose Route Days Max Duration
tretinoin * 45 mg/m² Daily in divided doses oral administration 1 to 7,
15 to 21,
29 to 35
arsenic trioxide 0.15 mg/kg Once daily intravenous 1 to 5,
8 to 12,
15 to 19,
22 to 26,
29 to 33		 120 minutes

tretinoin:

  • Consider dose reduction of tretinoin to 25 mg/m2 daily in TWO divided doses in patients under the age of 20 years to reduce risk of pseudotumour cerebri.
  • Teratogenic—Ensure pregnant women are not exposed to tretinoin. Consult prescribing information.

arsenic trioxide: May prolong QTc interval and close monitoring is recommended. Avoid or reduce risk factors for QTc prolongation.

Full details

Cycle 1 - 35 days

Day: 1

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 2

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 3

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 4

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 5

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 6

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:

Day: 7

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:

Day: 8

Medication Dose Route Max duration Details
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 9

Medication Dose Route Max duration Details
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 10

Medication Dose Route Max duration Details
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 11

Medication Dose Route Max duration Details
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 12

Medication Dose Route Max duration Details
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 15

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 16

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 17

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 18

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 19

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 20

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:

Day: 21

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:

Day: 22

Medication Dose Route Max duration Details
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 23

Medication Dose Route Max duration Details
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 24

Medication Dose Route Max duration Details
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 25

Medication Dose Route Max duration Details
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 26

Medication Dose Route Max duration Details
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 29

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 30

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 31

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 32

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 33

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:
arsenic trioxide 0.15 mg/kg Once daily intravenous 120 minutes

Day: 34

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:

Day: 35

Medication Dose Route Max duration Details
tretinoin * 45 mg/m² Daily in divided doses oral administration
Instructions:

Daily in TWO divided doses.

  • Take with food. Swallow whole do not crush or chew.
  • Consider dose reduction to 25 mg/m2 daily in patients under 20 years.
  • Round dose to closest multiple of 10 mg capsules.
Additional details:

Additional details

Section 1: Teratogenic effects

Ensure pregnant women are not exposed to tretinoin. Consult prescribing information.

Supportive Care Factors

Factor Value
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Emetogenicity: Variable

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.


Emetogenicity:

  • LOW (IV); MINIMAL to LOW (oral).

References

Phebra NZ Limited Phenasen® New Zealand data sheet 23 July 2019 https://www.medsafe.govt.nz/profs/datasheet/p/phenaseninj.pdf (accessed 15 July 2022).

Pharmaco (NZ) Ltd Vesanoid® New Zealand data sheet 21 April 2022 https://www.medsafe.govt.nz/profs/datasheet/v/Vesanoidcap.pdf (accessed 15 July 2022).

* 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.