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Systemic Anti-Cancer Therapy Regimen Library

This regimen is a component of LEU ALL BCR-ABL1+ - UKALL60+ with daSATinib

UKALL60+ with daSATinib Phase 1 Induction (LEU ALL BCR-ABL1+ - UKALL60+ with daSATinib)

Treatment Overview

Cycle 1 - 28 days

Cycle length:
28

daSATinib: Take continuously during treatment, an increase or reduction of dose is recommended based on individual patient response and tolerability.


dexamethasone: Some centres may choose to cap dose of dexamethasone at 6 mg daily.


Intrathecal metHOTREXATe:

  • Day of administration can be moved +/- 3 days.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Cycle details

Cycle 1 - 28 days

Medication Dose Route Days Max Duration
daSATinib * 70 mg Once daily oral administration 1 to 28
dexamethasone 3 mg/m² Once daily oral administration 1, 2, 3
IDArubicin * 3 mg/m² intravenous 1 15 minutes
vinCRISTine 1 mg/m² Cap dose per administration at: 2 mg intravenous 1 10 minutes
metHOTREXATe 12 mg flat dosing intrathecal injection 8, 15, 22

daSATinib: Take continuously during treatment, an increase or reduction of dose is recommended based on individual patient response and tolerability.


dexamethasone: Some centres may choose to cap dose of dexamethasone at 6 mg daily.


Intrathecal metHOTREXATe:

  • Day of administration can be moved +/- 3 days.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Full details

Cycle 1 - 28 days

Day: 1

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
dexamethasone 3 mg/m² Once daily oral administration
Instructions:

Take with food in the morning.

Some centres may choose to cap dose at 6 mg.

IDArubicin * 3 mg/m² intravenous 15 minutes
Instructions:

Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.

vinCRISTine 1 mg/m² Cap dose per administration at: 2 mg intravenous 10 minutes
Instructions:
  • Diluted in a minibag.
  • FOR INTRAVENOUS USE ONLY – fatal if given by any other routes.
  • Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.

Day: 2

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
dexamethasone 3 mg/m² Once daily oral administration
Instructions:

Take with food in the morning.

Some centres may choose to cap dose at 6 mg.

Day: 3

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
dexamethasone 3 mg/m² Once daily oral administration
Instructions:

Take with food in the morning.

Some centres may choose to cap dose at 6 mg.

Day: 4

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 5

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 6

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 7

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 8

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
metHOTREXATe 12 mg flat dosing intrathecal injection
Instructions:
  • Day of administration can be moved +/- 3 days.
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Day: 9

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 10

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 11

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 12

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 13

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 14

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 15

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
metHOTREXATe 12 mg flat dosing intrathecal injection
Instructions:
  • Day of administration can be moved +/- 3 days.
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Day: 16

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 17

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 18

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 19

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 20

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 21

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 22

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
metHOTREXATe 12 mg flat dosing intrathecal injection
Instructions:
  • Day of administration can be moved +/- 3 days.
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Day: 23

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 24

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 25

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 26

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 27

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 28

Medication Dose Route Max duration Details
daSATinib * 70 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Supportive Care Factors

Factor Value
Antifungal prophylaxis: Routine antifungal prophylaxis recommended
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Constipation risk: Variable
Diarrhoea risk: Variable
Emetogenicity: Variable
Gastroprotection: Gastroprotection is recommended
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis recommended
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis is recommended

Antifungal prophylaxis: Inhibition of CYP3A4 by azole antifungals may lead to reduced vinCRISTine and daSATinib clearance and increased toxicities. Strategies to avoid this interaction may include a washout period after azole administration or using a non-azole antifungal for prophylaxis. If an azole is used the daSATinib dose must be reduced – consult prescribing information.


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.


Constipation/Diarrhoea risk: vinCRISTine may cause constipation and daSATinib may cause diarrhoea. Monitor gastrointestinal symptoms. 


Emetogenicity: MEDIUM day 1; MINIMAL to LOW days 2 to 28.


Gastroprotection:

  • Gastroprotective agents such as proton pump inhibitors and H2 receptor antagonists are not recommended to be used with daSATinib because they may reduce exposure to daSATinib by increasing gastric pH. Consider using an antacid as an alternative.
  • Gastroprotective agents are only intended for short term use while patient is receiving corticosteroid treatment doses.

References

Bristol-Myers Squibb (NZ) Limited. Sprycel New Zealand Data Sheet 17 August 2022. https://www.medsafe.govt.nz/profs/datasheet/s/Spryceltab.pdf (Accessed 17 October 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.