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Systemic Anti-Cancer Therapy Regimen Library

High dose cytarabine and midostaurin consolidation [under 60 years] (LEU AML - DAUNOrubicin, cytarabine and midostaurin induction, high dose cytarabine and midostaurin consolidation followed by midostaurin maintenance [FLT3 mutated] [under 60 years])

Treatment Overview

Cycles 1 to 4 - 28 days

Cycle length:
28

midostaurin: Cardiovascular risk factor assessment is recommended—consult prescribing information for details.

Cycle details

Cycles 1 to 4 - 28 days

Medication Dose Route Days Max Duration
cytarabine 3000 mg/m² Twice daily intravenous 1, 3, 5 3 hours
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye 1 to 7
midostaurin 50 mg Twice daily oral administration 8 to 21

midostaurin: Cardiovascular risk factor assessment is recommended—consult prescribing information for details.

Full details

Cycles 1 to 4 - 28 days

Day: 1

Medication Dose Route Max duration Details
cytarabine 3000 mg/m² Twice daily intravenous 3 hours
Instructions:

Every 12 hours for 2 doses on day 1.

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 1 to 7.

Day: 2

Medication Dose Route Max duration Details
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 1 to 7.

Day: 3

Medication Dose Route Max duration Details
cytarabine 3000 mg/m² Twice daily intravenous 3 hours
Instructions:

Every 12 hours for 2 doses on day 3.

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 1 to 7.

Day: 4

Medication Dose Route Max duration Details
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 1 to 7.

Day: 5

Medication Dose Route Max duration Details
cytarabine 3000 mg/m² Twice daily intravenous 3 hours
Instructions:

Every 12 hours for 2 doses on day 5.

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 1 to 7.

Day: 6

Medication Dose Route Max duration Details
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 1 to 7.

Day: 7

Medication Dose Route Max duration Details
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 1 to 7.

Day: 8

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 9

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 10

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 11

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 12

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 13

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 14

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 15

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 16

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 17

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 18

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 19

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 20

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 21

Medication Dose Route Max duration Details
midostaurin 50 mg Twice daily oral administration
Instructions:
  • Take with food. Swallow whole with a glass of water, do not crush, chew. 
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Supportive Care Factors

Factor Value
Antifungal prophylaxis: Routine antifungal prophylaxis recommended
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Emetogenicity: Variable
Growth factor support: Variable
Ocular toxicity risk: High - administer corticosteroid eyedrops to minimise corneal toxicity

Antifungal prophylaxis: Azole antifungals may reduce the clearance of midostaurin and increase its toxicity. Avoid combination or monitor for midostaurin toxicity.


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 days 1, 3 and 5;
  • MEDIUM to HIGH (oral) days 8 to 21.

Growth factor support: If in complete remission consider pegFILGRASTIM 6 mg subcutaneous on day 6.

References

Novartis New Zealand Limited Rydapt Data sheet 14 May 2021 https://www.medsafe.govt.nz/profs/Datasheet/r/rydaptcap.pdf (accessed 14 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.