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
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:
|
Day: 9
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
Day: 10
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
Day: 11
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
Day: 12
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
Day: 13
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
Day: 14
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
Day: 15
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
Day: 16
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
Day: 17
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
Day: 18
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
Day: 19
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
Day: 20
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
Day: 21
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| midostaurin | 50 mg Twice daily | oral administration |
Instructions:
|
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.