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Home > LEU ALL precursor B-cell BCR-ABL1+ - HyperCVAD with daSATinib Part A and B followed by Maintenance [60 years and under] > LEU - HyperCVAD with daSATinib [60 years and under] Part B with CNS prophylaxis for Unknown Risk [default]
This regimen is a component of LEU ALL precursor B-cell BCR-ABL1+ - HyperCVAD with daSATinib Part A and B followed by Maintenance [60 years and under]

HyperCVAD with daSATinib [60 years and under] - Part B with CNS prophylaxis for Unknown Risk [default] (LEU ALL precursor B-cell BCR-ABL1+ - HyperCVAD with daSATinib Part A and B followed by Maintenance [60 years and under])

Treatment Overview

Alternates with a cycle of Part A every 21 days, or sooner if counts have recovered.

Intrathecal therapy included in this regimen is for CNS prophylaxis for patients with Unknown Risk [default].


High dose metHOTREXATe

  • metHOTREXATe levels MUST be measured once every 24 hours.
  • Intravenous alkalinized fluids MUST be commenced at least 6 hours before the start of metHOTREXATe infusion and MUST continue until the metHOTREXATe serum level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice). Additional oral alkalinization can be considered as Ural® 2 sachets orally the night before and 2 sachets the morning of high dose metHOTREXATe infusion.
  • Before commencing the high dose metHOTREXATe infusion, urinary pH MUST be 7.5 or above (pH 7.5 to 8.0).
  • Closely monitor renal function, electrolytes, fluid balance, and weight.
  • foliNIc acid MUST start 36 hours after start of metHOTREXATe infusion and MUST continue to be administered until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).

This regimen contains a medicine where one or more biosimilars may exist. Any biosimilars used have been reviewed by the regulator (Medsafe) and relevant specialists were consulted nationally. Where regulators, in consultation with relevant specialists, have agreed that there are no clinically significant differences in either safety or effectiveness between a biosimilar and originator product, these drugs may be used interchangeably.

Cycles 1 to 2 - 21 days

Cycle length:
21

daSATinib: Dose may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.


foliNIc acid: MUST start 36 hours after start of metHOTREXATe infusion and MUST continue to be administered every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).


Intrathecal metHOTREXATe: For Ommaya reservoir reduce dose to 6 mg intraventricularly.


cytarabine: Check metHOTREXATe level and renal function post high dose metHOTREXATe prior to administration of cytarabine:

  • If metHOTREXATe level greater than 20 µmol/L post completion of metHOTREXATe infusion, OR
  • Urine output is reduced, OR
  • Serum creatinine has increased, cytarabine dose should be withheld and reviewed by the haematologist, and either:
  • Reduce cytarabine dose to at least 1000 mg/m2.
  • OR delay cytarabine dose until renal recovery is achieved.
  • OR omit cytarabine in the event of severe neurotoxicity.

filgrastim: Give filgrastim 5 micrograms/kg subcutaneously ONCE daily from Day 4 until neutrophil recovery past the nadir.

Cycles 3 to 4 - 21 days

Cycle length:
21

daSATinib: Dose may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.


foliNIc acid: MUST start 36 hours after start of metHOTREXATe infusion and MUST continue to be administered every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).


cytarabine: Check metHOTREXATe level and renal function post high dose metHOTREXATe prior to administration of cytarabine:

  • If metHOTREXATe level greater than 20 µmol/L post completion of metHOTREXATe infusion, OR
  • Urine output is reduced, OR
  • Serum creatinine has increased, cytarabine dose should be withheld and reviewed by the haematologist, and either:
  • Reduce cytarabine dose to at least 1000 mg/m2.
  • OR delay cytarabine dose until renal recovery is achieved.
  • OR omit cytarabine in the event of severe neurotoxicity.

filgrastim: Give filgrastim 5 micrograms/kg subcutaneously ONCE daily from Day 4 until neutrophil recovery past the nadir.

Cycle details

Cycles 1 to 2 - 21 days

Medication Dose Route Days Max Duration
daSATinib * 70 mg Once daily oral administration 1 to 21
methylprednisolone 50 mg Twice daily intravenous 1, 2, 3 1 minutes
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous 1 to 4
sodium bicarbonate 50 mmol intravenous 1 to 4
acetazolamide * 250 mg Four times daily oral administration 1 to 4
metHOTREXATe 200 mg/m² intravenous 1 120 minutes
metHOTREXATe 800 mg/m² intravenous 1 22 hours
foliNIc acid (as calcium folinate) 50 mg flat dosing intravenous 2 2 minutes
foliNIc acid (as calcium folinate) 30 mg flat dosing Every six hours intravenous 2, 3, 4 2 minutes
cytarabine 3000 mg/m² Twice daily intravenous 2, 3 3 hours
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye 2 to 5
metHOTREXATe 12 mg flat dosing intrathecal injection 2
filgrastim 5 microgram/kg Once daily subcutaneous injection 4
cytarabine 100 mg flat dosing intrathecal injection 8

daSATinib: Dose may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.


foliNIc acid: MUST start 36 hours after start of metHOTREXATe infusion and MUST continue to be administered every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).


Intrathecal metHOTREXATe: For Ommaya reservoir reduce dose to 6 mg intraventricularly.


cytarabine: Check metHOTREXATe level and renal function post high dose metHOTREXATe prior to administration of cytarabine:

  • If metHOTREXATe level greater than 20 µmol/L post completion of metHOTREXATe infusion, OR
  • Urine output is reduced, OR
  • Serum creatinine has increased, cytarabine dose should be withheld and reviewed by the haematologist, and either:
  • Reduce cytarabine dose to at least 1000 mg/m2.
  • OR delay cytarabine dose until renal recovery is achieved.
  • OR omit cytarabine in the event of severe neurotoxicity.

filgrastim: Give filgrastim 5 micrograms/kg subcutaneously ONCE daily from Day 4 until neutrophil recovery past the nadir.

Cycles 3 to 4 - 21 days

Medication Dose Route Days Max Duration
daSATinib * 70 mg Once daily oral administration 1 to 21
methylprednisolone 50 mg Twice daily intravenous 1, 2, 3 1 minutes
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous 1 to 4
sodium bicarbonate 50 mmol intravenous 1 to 4
acetazolamide * 250 mg Four times daily oral administration 1 to 4
metHOTREXATe 200 mg/m² intravenous 1 120 minutes
metHOTREXATe 800 mg/m² intravenous 1 22 hours
foliNIc acid (as calcium folinate) 50 mg flat dosing intravenous 2 2 minutes
foliNIc acid (as calcium folinate) 30 mg flat dosing Every six hours intravenous 2, 3, 4 2 minutes
cytarabine 3000 mg/m² Twice daily intravenous 2, 3 3 hours
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye 2 to 5
filgrastim 5 microgram/kg Once daily subcutaneous injection 4

daSATinib: Dose may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.


foliNIc acid: MUST start 36 hours after start of metHOTREXATe infusion and MUST continue to be administered every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).


cytarabine: Check metHOTREXATe level and renal function post high dose metHOTREXATe prior to administration of cytarabine:

  • If metHOTREXATe level greater than 20 µmol/L post completion of metHOTREXATe infusion, OR
  • Urine output is reduced, OR
  • Serum creatinine has increased, cytarabine dose should be withheld and reviewed by the haematologist, and either:
  • Reduce cytarabine dose to at least 1000 mg/m2.
  • OR delay cytarabine dose until renal recovery is achieved.
  • OR omit cytarabine in the event of severe neurotoxicity.

filgrastim: Give filgrastim 5 micrograms/kg subcutaneously ONCE daily from Day 4 until neutrophil recovery past the nadir.

Full details

Cycles 1 to 2 - 21 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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.
methylprednisolone 50 mg Twice daily intravenous 1 minutes
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous
Instructions:
  • To each 1000 mL bag admix 50 mmol sodium bicarbonate.
  • Or an alternative alkalinized intravenous infusion may be used as per institutional practice.
  • Commence at least 6 hours prior to metHOTREXATe infusion and run continuously until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
sodium bicarbonate 50 mmol intravenous
Instructions:
  • Admix 50 mmol sodium bicarbonate to each 1000 mL bag of potassium chloride 20 mmol + sodium chloride 0.18% + glucose 4%.
  • Dose of sodium bicarbonate is approximately 6 mmol/m2/hour when admixed bag is infused at 125 mL/m2/hour.
acetazolamide * 250 mg Four times daily oral administration
Instructions:

When required.

  • Administer immediately if urinary pH drops below 7.5 during metHOTREXATe infusion and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
metHOTREXATe 200 mg/m² intravenous 120 minutes
metHOTREXATe 800 mg/m² intravenous 22 hours
Instructions:

Starting immediately after the 120 minute metHOTREXATe infusion.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.
methylprednisolone 50 mg Twice daily intravenous 1 minutes
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous
Instructions:
  • To each 1000 mL bag admix 50 mmol sodium bicarbonate.
  • Or an alternative alkalinized intravenous infusion may be used as per institutional practice.
  • Run continuously until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
sodium bicarbonate 50 mmol intravenous
Instructions:
  • Admix 50 mmol sodium bicarbonate to each 1000 mL bag of potassium chloride 20 mmol + sodium chloride 0.18% + glucose 4%.
  • Dose of sodium bicarbonate is approximately 6 mmol/m2/hour when admixed bag is infused at 125 mL/m2/hour.
acetazolamide * 250 mg Four times daily oral administration
Instructions:

When required.

  • Administer immediately if urinary pH drops below 7.5 during metHOTREXATe infusion and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
foliNIc acid (as calcium folinate) 50 mg flat dosing intravenous 2 minutes
Instructions:

Administer 36 hours after start of metHOTREXATe infusion for 1 dose, follow with 30 mg dosing every 6 hours.
foliNIc acid (as calcium folinate) 30 mg flat dosing Every six hours intravenous 2 minutes
Instructions:
  • Starting 6 hours after foliNIc acid 50 mg dose and continue to administer every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • If metHOTREXATe elimination is impaired the dose of foliNIc acid will need to be increased. Consult prescribing information.
cytarabine 3000 mg/m² Twice daily intravenous 3 hours
Instructions:

Every 12 hours.

Check metHOTREXATe level and renal function post high dose metHOTREXATe prior to administration of cytarabine:

  • If metHOTREXATe level greater than 20 µmol/L post completion of metHOTREXATe infusion, OR
  • Urine output is reduced, OR
  • Serum creatinine has increased, cytarabine dose should be withheld and reviewed by the haematologist, and either:
  • Reduce cytarabine dose to at least 1000 mg/m2.
  • OR delay dose until renal recovery is achieved.
  • OR omit in the event of severe neurotoxicity.
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 5.
metHOTREXATe 12 mg flat dosing intrathecal injection
Instructions:
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.
methylprednisolone 50 mg Twice daily intravenous 1 minutes
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous
Instructions:
  • To each 1000 mL bag admix 50 mmol sodium bicarbonate.
  • Or an alternative alkalinized intravenous infusion may be used as per institutional practice.
  • Run continuously until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
sodium bicarbonate 50 mmol intravenous
Instructions:
  • Admix 50 mmol sodium bicarbonate to each 1000 mL bag of potassium chloride 20 mmol + sodium chloride 0.18% + glucose 4%.
  • Dose of sodium bicarbonate is approximately 6 mmol/m2/hour when admixed bag is infused at 125 mL/m2/hour.
acetazolamide * 250 mg Four times daily oral administration
Instructions:

When required.

  • Administer immediately if urinary pH drops below 7.5 during metHOTREXATe infusion and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
foliNIc acid (as calcium folinate) 30 mg flat dosing Every six hours intravenous 2 minutes
Instructions:
  • Administer every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • If metHOTREXATe elimination is impaired the dose of foliNIc acid will need to be increased. Consult prescribing information.
cytarabine 3000 mg/m² Twice daily intravenous 3 hours
Instructions:

Every 12 hours.
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 5.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous
Instructions:
  • To each 1000 mL bag admix 50 mmol sodium bicarbonate.
  • Or an alternative alkalinized intravenous infusion may be used as per institutional practice.
  • Run continuously until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • Administration may continue past Day 4 if metHOTREXATe level is still elevated.
sodium bicarbonate 50 mmol intravenous
Instructions:
  • Admix 50 mmol sodium bicarbonate to each 1000 mL bag of potassium chloride 20 mmol + sodium chloride 0.18% + glucose 4%.
  • Dose of sodium bicarbonate is approximately 6 mmol/m2/hour when admixed bag is infused at 125 mL/m2/hour.
  • Administration may continue past Day 4 if metHOTREXATe level is still elevated.
acetazolamide * 250 mg Four times daily oral administration
Instructions:

When required.

  • Administer immediately if urinary pH drops below 7.5 during metHOTREXATe infusion and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • Administration may continue past Day 4 if metHOTREXATe level is still elevated.
foliNIc acid (as calcium folinate) 30 mg flat dosing Every six hours intravenous 2 minutes
Instructions:
  • Administer every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • If metHOTREXATe elimination is impaired the dose of foliNIc acid will need to be increased. Consult prescribing information.
  • Administration may continue past Day 4 if metHOTREXATe level is still elevated.
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 5.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Give ONCE daily from Day 4 until neutrophil recovery past the nadir.

  • Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 5.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.
cytarabine 100 mg flat dosing intrathecal injection
Instructions:

Adhere to local institution policy for intrathecal administration.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

Cycles 3 to 4 - 21 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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.
methylprednisolone 50 mg Twice daily intravenous 1 minutes
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous
Instructions:
  • To each 1000 mL bag admix 50 mmol sodium bicarbonate.
  • Or an alternative alkalinized intravenous infusion may be used as per institutional practice.
  • Commence at least 6 hours prior to metHOTREXATe infusion and run continuously until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
sodium bicarbonate 50 mmol intravenous
Instructions:
  • Admix 50 mmol sodium bicarbonate to each 1000 mL bag of potassium chloride 20 mmol + sodium chloride 0.18% + glucose 4%.
  • Dose of sodium bicarbonate is approximately 6 mmol/m2/hour when admixed bag is infused at 125 mL/m2/hour.
acetazolamide * 250 mg Four times daily oral administration
Instructions:

When required.

  • Administer immediately if urinary pH drops below 7.5 during metHOTREXATe infusion and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
metHOTREXATe 200 mg/m² intravenous 120 minutes
metHOTREXATe 800 mg/m² intravenous 22 hours
Instructions:

Starting immediately after the 120 minute metHOTREXATe infusion.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.
methylprednisolone 50 mg Twice daily intravenous 1 minutes
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous
Instructions:
  • To each 1000 mL bag admix 50 mmol sodium bicarbonate.
  • Or an alternative alkalinized intravenous infusion may be used as per institutional practice.
  • Run continuously until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
sodium bicarbonate 50 mmol intravenous
Instructions:
  • Admix 50 mmol sodium bicarbonate to each 1000 mL bag of potassium chloride 20 mmol + sodium chloride 0.18% + glucose 4%.
  • Dose of sodium bicarbonate is approximately 6 mmol/m2/hour when admixed bag is infused at 125 mL/m2/hour.
acetazolamide * 250 mg Four times daily oral administration
Instructions:

When required.

  • Administer immediately if urinary pH drops below 7.5 during metHOTREXATe infusion and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
foliNIc acid (as calcium folinate) 50 mg flat dosing intravenous 2 minutes
Instructions:

Administer 36 hours after start of metHOTREXATe infusion for 1 dose, follow with 30 mg dosing every 6 hours.
foliNIc acid (as calcium folinate) 30 mg flat dosing Every six hours intravenous 2 minutes
Instructions:
  • Starting 6 hours after foliNIC acid 50 mg dose and continue to administer every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • If metHOTREXATe elimination is impaired the dose of foliNIc acid will need to be increased. Consult prescribing information.
cytarabine 3000 mg/m² Twice daily intravenous 3 hours
Instructions:

Every 12 hours.

Check metHOTREXATe level and renal function post high dose metHOTREXATe prior to administration of cytarabine:

  • If metHOTREXATe level greater than 20 µmol/L post completion of metHOTREXATe infusion, OR
  • Urine output is reduced, OR
  • Serum creatinine has increased, cytarabine dose should be withheld and reviewed by the haematologist, and either:
  • Reduce cytarabine dose to at least 1000 mg/m2.
  • OR delay dose until renal recovery is achieved.
  • OR omit in the event of severe neurotoxicity.
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 5.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.
methylprednisolone 50 mg Twice daily intravenous 1 minutes
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous
Instructions:
  • To each 1000 mL bag admix 50 mmol sodium bicarbonate.
  • Or an alternative alkalinized intravenous infusion may be used as per institutional practice.
  • Run continuously until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
sodium bicarbonate 50 mmol intravenous
Instructions:
  • Admix 50 mmol sodium bicarbonate to each 1000 mL bag of potassium chloride 20 mmol + sodium chloride 0.18% + glucose 4%.
  • Dose of sodium bicarbonate is approximately 6 mmol/m2/hour when admixed bag is infused at 125 mL/m2/hour.
acetazolamide * 250 mg Four times daily oral administration
Instructions:

When required.

  • Administer immediately if urinary pH drops below 7.5 during metHOTREXATe infusion and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
foliNIc acid (as calcium folinate) 30 mg flat dosing Every six hours intravenous 2 minutes
Instructions:
  • Administer every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • If metHOTREXATe elimination is impaired the dose of foliNIc acid will need to be increased. Consult prescribing information.
cytarabine 3000 mg/m² Twice daily intravenous 3 hours
Instructions:

Every 12 hours.
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 5.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous
Instructions:
  • To each 1000 mL bag admix 50 mmol sodium bicarbonate
  • Or an alternative alkalinized intravenous infusion may be used as per institutional practice.
  • Run continuously until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • Administration may continue past Day 4 if metHOTREXATe level is still elevated.
sodium bicarbonate 50 mmol intravenous
Instructions:
  • Admix 50 mmol sodium bicarbonate to each 1000 mL bag of potassium chloride 20 mmol + sodium chloride 0.18% + glucose 4%.
  • Dose of sodium bicarbonate is approximately 6 mmol/m2/hour when admixed bag is infused at 125 mL/m2/hour.
  • Administration may continue past Day 4 if metHOTREXATe level is still elevated.
acetazolamide * 250 mg Four times daily oral administration
Instructions:

When required.

  • Administer immediately if urinary pH drops below 7.5 during metHOTREXATe infusion and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • Administration may continue past Day 4 if metHOTREXATe level is still elevated.
foliNIc acid (as calcium folinate) 30 mg flat dosing Every six hours intravenous 2 minutes
Instructions:
  • Administer every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • If metHOTREXATe elimination is impaired the dose of foliNIc acid will need to be increased. Consult prescribing information.
  • Administration may continue past Day 4 if metHOTREXATe level is still elevated.
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 5.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Give ONCE daily from Day 4 until neutrophil recovery past the nadir.

  • Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 5.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

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 may be reduced to 50 mg ONCE daily when complete molecular remission is achieved or if not tolerated.

Supportive Care Factors

Factor Value
Antifungal prophylaxis: Routine antifungal prophylaxis recommended
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Diarrhoea risk: Consider prescribing antidiarrhoeals with this treatment
Emetogenicity: Variable
Folinic acid rescue for high dose methotrexate: Mandatory
Gastroprotection: Gastroprotection is recommended
Growth factor support: Recommended for primary prophylaxis
Hydration: Routine hydration recommended
Ocular toxicity risk: High - administer corticosteroid eyedrops to minimise corneal toxicity
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis recommended
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis may be considered

Antifungal prophylaxis: Inhibition of CYP3A4 by azole antifungals may lead to reduced daSATinib clearance and increased toxicities. Consider 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.


Emetogenicity:

  • MEDIUM day 1 to 3, high dose metHOTREXATe may be highly emetogenic in certain patients.
  • MINIMAL to LOW days 4 to 21.

Gastroprotection:

  • Gastroprotective agents are only intended for short term use while patient is receiving corticosteroid treatment doses.
  • 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. Do not use proton pump inhibitors with high dose metHOTREXATe. Consider using an antacid as an alternative.

PJP prophylaxis: If trimethoprim + sulfamethoxazole is used as prophylaxis, it is recommended to withhold at least 48 hours prior to high dose metHOTREXATe administration and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1µmol/L (as per institutional practice).


Tumour lysis syndrome prophylaxis: May be considered if not in complete remission.

References

Bristol-Myers Squibb (NZ) LTD. Sprycel New Zealand Datasheet 24 November 2023. https://www.medsafe.govt.nz/profs/datasheet/s/Spryceltab.pdf (Accessed 30 April 2024).

Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AMM, Eniu A, Jassem J, Pentheroudakis G, Peters S, Rauh S, Zielinski CC, Stahel RA, Voest E, Douillard JY, McGregor K, Ciardiello F. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142., PMID: 28848668

Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD, Schilsky RL. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018 Apr 20;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14., PMID: 29443651

* 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.