AML 19 Patient Trial Number
Haematology / Page 1 of 4
AML 19Induction
FLAG-Ida with gemtuzumab x2
Course 1 Arm B / Height / cm / Attach patient sticker
Weight / kg
BSA / m2
AML 19 patient trial number:
Destination / BMTU / Date / Limits / Hypersensitivities/AllergiesPRN antiemetics
± Domperidone 10 mg PO QID
± Cyclizine 25 mg - 50 mg IV / PO TDS / Agent
Gemtuzumab
Fludarabine
Cytarabine
Idarubicin
DOSE MODIFIED:No YesNoYes / Round
0.1 mg
2.5mg
100mg
1mg
WCC / 30 x 109/L
AST / 2.5 x ULN
ALT / 2.5 x ULN
Reference: AML 19 trial protocol V7.0 Feb 2018 / Bili / 2 x ULN
CrCl / 70 mL/min for full dose fludarabine
BLOODBANK NOTIFIED OF PURINE ANALOGUE USE. Sign______Date______
Day / Date / Time / Agent / Dose / Route / Instructions / Doctor / Nurse / Check / Start / Stop1-7 / (Day 1) / Filgrastim / 300 / micro
grams / subcut / Chart on regular medication chart daily for 7 days
2 / 1000 / Methylprednisolone / 100 / mg / IV / In 100 mL sodium chloride 0.9% over 15 mins
1000 / Paracetamol / 1000 / mg / PO / Premed 1 hour prior to gemtuzumab
1000 / Loratadine / 20 / mg / PO / Premed 1 hour prior to gemtuzumab
1100 / Gemtuzumab 3 mg/m2
(max 5mg) / mg / IV / In 100 mL sodium chloride 0.9 % over 2 hours. Administer via 1.2 micron filter.
- You must read the protocol before prescribing this chemotherapy.
- Patients allocated to receive gemtuzumab must not have a white count >30 x 109/L at the time of gemtuzumab administration because of the risk of tumour lysis. See protocol.
- Patients with a white count≥30 x 109/L should have filgrastim omitted until the white count has fallen to <30 AND both doses of gemtuzumab have been administered.
- Patients with AST or ALT > 2.5 x ULN, or bilirubin >2 x ULN, are not eligible for the gemtuzumab randomisation.
- Gemtuzumab must be protected from light. Give through a 1.2 micron filter.
- Blood obs required during gemtuzumab infusion and for a least 4 hours post. Consider hydrocortisone or chlorphenamine if signs of infusion reaction.
- NB. Gemtuzumab is given on days 1 and 4 of chemotherapy, ie. days 2 and 5 in this course.
- Gemtuzumab timing may be adjusted only if necessary for logistical reasons, with the 1st dose delayed up to day 4. If so, the interval between doses must remain the same.
PRN medications for hypersensitivity reactions to gemtuzumab(paracetamol only if 4 or more hours since last dose)
Date / Medication / Dose / Route / Doctor / Time / Nurse / CheckHydrocortisone / 100 mg / Slow IV bolus / Consultant:
Chlorphenamine / 10 mg / Slow IV bolus / NZMC Reg No:
Paracetamol / 1000 mg / PO
AML 19Induction
FLAG-Ida with gemtuzumab x2
Course 1 Arm B / Height / cm / Attach patient sticker
Weight / kg
BSA / m2
Day / Date / Time / Agent / Dose / Route / Instructions / Doctor / Nurse / Check / Start / Stop
2 / Ondansetron / 8 / mg / PO/IV / Give 1 hour prior to chemotherapy
T = 0hr / Fludarabine 30mg/m2 / mg / IV / In 100 mLsodium chloride 0.9% over 30 minutes
Cytarabine must be administered 4 hours after the start of fludarabine.
T +4hr / Cytarabine*
2000 mg/m2 (< 60 yrs)
1000 mg/m2 (≥ 60 yrs) / mg / IV / In 500mL sodium chloride 0.9% over 4 hours
2000 / Ondansetron / 8 / mg / PO/IV
3 / 0800 / Ondansetron / 8 / mg / PO/IV / Give 1 hour prior to chemotherapy
T = 0hr / Fludarabine 30mg/m2 / mg / IV / In 100 mLsodium chloride 0.9% over 30 minutes
Cytarabine must be administered 4 hours after the start of fludarabine.
T +4hr / Cytarabine*
2000 mg/m2 (< 60 yrs)
1000 mg/m2 (≥ 60 yrs) / mg / IV / In 500mL sodium chloride 0.9% over 4 hours
2000 / Ondansetron / 8 / mg / PO/IV
* The dose of Cytarabine in FLAG-Ida should be reduced to 1000 mg/m2 on days 2-6 for patients 60+ years of age.
- Chart Prednisolone 1% eyedrops1 drop TDS both eyes starting 12 hours before cytarabine and continue for 5 days after completion. Chart on regular medication chart.
- Fludarabine doses should be given at least 22 hours apart
AML 19Induction
FLAG-Ida with gemtuzumab x2
Course 1 Arm B / Height / cm / Attach patient sticker
Weight / kg
BSA / m2
Day / Date / Time / Agent / Dose / Route / Instructions / Doctor / Nurse / Check / Start / Stop
4 / 0800 / Ondansetron / 8 / mg / PO/IV
Idarubicin 8mg/m2 / mg / IV / In 50 mL sodium chloride 0.9 % and infuse over 20 minvia central line (if peripheral, free flow – DO NOT PUMP - via side arm of fast running sodium chloride 0.9 %)
T = 0hr / Fludarabine 30mg/m2 / mg / IV / In 100 mLsodium chloride 0.9% over 30 minutes
Cytarabine must be administered 4 hours after the start of fludarabine.
T +4hr / Cytarabine*
2000 mg/m2 (< 60 yrs)
1000 mg/m2 (≥ 60 yrs) / mg / IV / In 500mL sodium chloride 0.9% over 4 hours
2000 / Ondansetron / 8 / mg / PO/IV
5 / 0800 / Ondansetron / 8 / mg / PO/IV
1000 / Loratadine / 20 / mg / PO / Premed 1 hour prior to gemtuzumab
1100 / Gemtuzumab 3mg/m2(max 5mg) / mg / IV / In 100 mL sodium chloride 0.9% over 2 hours. Administer via 1.2 micron filter.
* The dose of Cytarabine in FLAG-Ida should be reduced to 1000 mg/m2 on days 2-6 for patients 60+ years of age.
- Chart Prednisolone 1% eyedrops1 drop TDS both eyes starting 12 hours before cytarabine and continue for 5 days after completion. Chart on regular medication chart.
- Fludarabine doses should be given at least 22 hours apart
- Gemtuzumab must be protected from light. Give through a 1.2 micron filter.
- Blood obs required during gemtuzumab infusion and for a least 4 hours post. Consider hydrocortisone or chlorphenamine if signs of infusion reaction.
- NB. Gemtuzumab is given on days 1 and 4 of chemotherapy, ie. days 2 and 5 in this course.
- Gemtuzumab timing may be adjusted only if necessary for logistical reasons, with the 1st dose delayed up to day 4. If so, the interval between does must remain the same.
PRN medications for hypersensitivity reactions to gemtuzumab
Date / Time / Medication / Dose / Route / Doctor / Nurse / CheckHydrocortisone / 100mg / Slow IV bolus
Chlorphenamine / 10mg / Slow IV bolus
AML 19Induction
FLAG-Ida with gemtuzumab x2
Course 1 Arm B / Height / cm / Attach patient sticker
Weight / kg
BSA / m2
Day / Date / Time / Agent / Dose / Route / Instructions / Doctor / Nurse / Check / Start / Stop
5 / Idarubicin 8mg/m2 / mg / IV / In 50 mL sodium chloride 0.9 % and infuse over 20 minvia central line (if peripheral, free flow – DO NOT PUMP - via side arm of fast running sodium chloride 0.9%)
T = 0hr / Fludarabine 30mg/m2 / mg / IV / In 100mLsodium chloride 0.9% over 30 minutes
Cytarabine must be administered 4 hours after the start of fludarabine.
T +4hr / Cytarabine*
2000 mg/m2 (< 60 yrs)
1000 mg/m2 (≥ 60 yrs) / mg / IV / In 500 mL sodium chloride 0.9% over 4 hours
2000 / Ondansetron / 8 / mg / PO/IV
6 / 0800 / Ondansetron / 8 / mg / PO/IV
Idarubicin 8mg/m2 / mg / IV / In 50 mL sodium chloride 0.9 % and infuse over 20 minvia central line (if peripheral, free flow – DO NOT PUMP - via side arm of fast running sodium chloride 0.9%)
T = 0hr / Fludarabine 30mg/m2 / mg / IV / In 100mLsodium chloride 0.9% over 30 minutes
Cytarabine must be administered 4 hours after the start of fludarabine.
T +4hr / Cytarabine*
2000 mg/m2 (< 60 yrs)
1000 mg/m2 (≥ 60 yrs) / mg / IV / In 500 mL sodium chloride 0.9% over 4 hours
2000 / Ondansetron / 8 / mg / PO/IV
7 / 0800 / Ondansetron / 8 / mg / PO/IV
2000 / Ondansetron / 8 / mg / PO/IV
* The dose of Cytarabine in FLAG-Ida should be reduced to 1000 mg/m2 on days 2-6 for patients 60+ years of age.
- Chart Prednisolone 1% eyedrops1 drop TDS both eyes starting 12 hours before cytarabine and continue for 5 days after completion. Chart on regular medication chart.
- Fludarabine doses should be given at least 22 hours apart
Authorised by: Dr R Spearing Pharmacists: C Innes / B Harden Amended: F Stone (Pharmacist) and T Vincent (Pharmacist) Issued: March 2016 Version 4Amended: October 2018 G:\Division\HAE\REDBOOK\Chemotherapy Prescriptions\AML\AML19\AML 19 proformas\Approved\FLAG-Ida with gemtuzumab x 2 (Arm B) V4
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