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Systemic Anti-Cancer Therapy Regimen Library

LEU AML Relapsed - FLAG-amsacrine [fludarabine, cytarabine, filgrastim and amsacrine] [60 years and over]

Treatment Overview

Frequency: Every 28 days or on count recovery.


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.

Cycle 1 - 28 days

Cycle length:
28

Cycle details

Cycle 1 - 28 days

Medication Dose Route Days Max Duration
filgrastim * 300 microgram Once daily subcutaneous injection 1 to 7
amsacrine 100 mg/m² Once daily intravenous 2, 3, 4 60 minutes
fludarabine * 30 mg/m² Once daily intravenous 2 to 6 30 minutes
cytarabine 1000 mg/m² Once daily intravenous 2 to 6 4 hours
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye 2 to 8

Full details

Cycle 1 - 28 days

Day: 1

Medication Dose Route Max duration Details
filgrastim * 300 microgram Once daily subcutaneous injection

Day: 2

Medication Dose Route Max duration Details
filgrastim * 300 microgram Once daily subcutaneous injection
amsacrine 100 mg/m² Once daily intravenous 60 minutes
Instructions:

Must be diluted in glucose 5%. Incompatible with sodium chloride 0.9%.

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

fludarabine * 30 mg/m² Once daily intravenous 30 minutes
cytarabine 1000 mg/m² Once daily intravenous 4 hours
Instructions:

Commence 4 hours after the fludarabine infusion.

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 8.

Day: 3

Medication Dose Route Max duration Details
filgrastim * 300 microgram Once daily subcutaneous injection
amsacrine 100 mg/m² Once daily intravenous 60 minutes
Instructions:

Must be diluted in glucose 5%. Incompatible with sodium chloride 0.9%.

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

fludarabine * 30 mg/m² Once daily intravenous 30 minutes
cytarabine 1000 mg/m² Once daily intravenous 4 hours
Instructions:

Commence 4 hours after the fludarabine infusion.

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 8.

Day: 4

Medication Dose Route Max duration Details
filgrastim * 300 microgram Once daily subcutaneous injection
amsacrine 100 mg/m² Once daily intravenous 60 minutes
Instructions:

Must be diluted in glucose 5%. Incompatible with sodium chloride 0.9%.

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

fludarabine * 30 mg/m² Once daily intravenous 30 minutes
cytarabine 1000 mg/m² Once daily intravenous 4 hours
Instructions:

Commence 4 hours after the fludarabine infusion.

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 8.

Day: 5

Medication Dose Route Max duration Details
filgrastim * 300 microgram Once daily subcutaneous injection
fludarabine * 30 mg/m² Once daily intravenous 30 minutes
cytarabine 1000 mg/m² Once daily intravenous 4 hours
Instructions:

Commence 4 hours after the fludarabine infusion.

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 8.

Day: 6

Medication Dose Route Max duration Details
filgrastim * 300 microgram Once daily subcutaneous injection
fludarabine * 30 mg/m² Once daily intravenous 30 minutes
cytarabine 1000 mg/m² Once daily intravenous 4 hours
Instructions:

Commence 4 hours after the fludarabine infusion.

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 8.

Day: 7

Medication Dose Route Max duration Details
filgrastim * 300 microgram Once daily subcutaneous injection
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 8.

Day: 8

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 2 to 8.

Supportive Care Factors

Factor Value
Antifungal prophylaxis: Routine antifungal prophylaxis recommended
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Emetogenicity: Medium
Irradiated blood components: Irradiation of blood components is 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: 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. 

PJP prophylaxis with co-trimoxazole: Consider starting after count recovery.

Tumour lysis syndrome prophylaxis: Recommended for first cycle of treatment and only for further cycles if not in complete remission.

References

Fong CY, Grigoriadis G, Hocking J, Coutsouvelis J, Muirhead J, Campbell P, Paul E, Walker P, Avery S, Patil S, Spencer A, Schwarer A, Wei A. Fludarabine, cytarabine, granulocyte-colony stimulating factor and amsacrine: an effective salvage therapy option for acute myeloid leukemia at first relapse. Leuk Lymphoma. 2013 Feb;54(2):336-41. doi: 10.3109/10428194.2012.713479. Epub 2012 Sep 8., PMID: 22812445

Eurocept International BV Amsidine Summary of product characteristics 30 March 2022 https://www.medicines.org.uk/emc/product/13279/smpc#gref (accessed 11 July 2022).

New Zealand Blood Service Transfusion Medicine Handbook Third Edition, 2016 https://www.nzblood.co.nz/assets/Transfusion-Medicine/PDFs/111G122.pdf (accessed 13/7/2022).

Regimen details sometimes vary slightly from the published literature after recommendation by expert committee consensus.

* 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.