This site contains promotional information intended only for healthcare professionals resident in the United Kingdom

Visit Pfizer Medical site

Menu

Close

Sign InLog Out
  • EN
Single LinkDropdownLabelLinkLinkLinkLinkLinked DropdownLabelLinkLinkLinkLinkMega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Linked Mega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
EN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias

Menu

Close

Sign InLog Out
  • EN
Single LinkDropdownLabelLinkLinkLinkLinkLinked DropdownLabelLinkLinkLinkLinkMega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Linked Mega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
EN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias
Search

Menu

Close

Sign In or RegisterLog Out
Pfizer MedicinesTherapy AreasExplore ContentEventsVideosMaterialsFeatured ArticlesLet’s ConnectSupplyAlliance HealthcareOff-contract claims

Adverse event reporting can be found at the bottom of the page

Menu

Close

EfficacyEfficacyEfficacyKey HighlightsSafetySafetySafetySelected Adverse EventsDosingDosingDosingAdditional Administration informationSupport & resourcesSupport & resourcesResource overviewPatient SupportGuidelinesELN 2022 GuidelinesKey topics in AML video seriesEfficacy and Safety videoPubExplainer videos

Patient Fitness in AML

The content of this website has been produced in line with the MYLOTARG® (gemtuzumab ozogamicin) Summary of Product Characteristics for Great Britain and is intended for Healthcare Professionals based in Great Britain. For  MYLOTARG® (gemtuzumab ozogamicin) and cytarabine Prescribing Information Click here. Adverse event reporting information can be found at the bottom of the page.

ELN 2022 AML Guidelines

Treatment recommendations for newly diagnosed patients with CD33-positive AML who are fit for intensive chemotherapy include GO for patients with intermediate risk cytogenetics1

 Patients with CD33-positive AML, favourable or intermediate cytogenetic risk

Induction therapy (3+7)1

Daunorubicin (60 mg/m2 IV, Days 1–3) + cytarabine (100–200 mg/m2/day continuous IV infusion, Days 1–7) + MYLOTARG (3 mg/m2 [max. one 5 mg vial] IV, Days 1, 4 and 7)Λ, Re-induction (if not in CR/CRh/CRi) may be with daunorubicin 60 mg/mIV days 1–2 and cytarabine 1000 mg/m2 IV (500–1000 mg/m2 if ≥60 years old) over 3 hours q12h Days 1–3 without MYLOTARG. 

The MYLOTARG SmPC states that for induction, the recommended dose of MYLOTARG is 3 mg/m2/dose (up to a maximum of one 5 mg vial) infused over a 2-hour period on Days 1, 4, and 7 in combination with daunorubicin 60 mg/m2/day infused over 30 minutes on Day 1 to Day 3, and cytarabine 200 mg/m2/day by continuous infusion on Day 1 to Day 7. If a second induction is required, MYLOTARG should not be  administered during second induction therapy. Only daunorubicin and cytarabine should be administered during the second induction cycle, at the following recommended dosing: daunorubicin 35 mg/m2/day on Days 1 and 2, and cytarabine 1 g/m2 every 12 hours, on Days 1–32.
 

Consolidation therapy1:

For <60 years old:

2–4 cycles of intermediate-dose cytarabine
(1000–1500 mg/m2 IV over 3 hours q12h on Days 1–3).
MYLOTARG 3 mg/m2 (max. one 5 mg vial) may be added on Day 1 (in up to 2 cycles)∧ß

For ≥60 years old:

2–4 cycles of intermediate-dose cytarabine
(500–1000 mg/m2 IV over 3 hours q12h on Days 1–3).
MYLOTARG 3 mg/m2 (max. one 5 mg vial) may 
be added on Day 1 (in up to 2 cycles)∧ß

The MYLOTARG SmPC states that for consolidation, up to 2 consolidation courses of IV daunorubicin (60 mg/m2 for 1 day [first course] or 2 days [second course]) in combination with IV cytarabine (1 g/m2 per 12 hours, infused over 2 hours on Day 1 to Day 4) with IV MYLOTARG (3 mg/m2/dose infused over 2 hours up to a maximum dose of one 5 mg vial on Day 1) are recommended2.
 

More Information

For more information on treatment recommendations for AML with FLT3 mutation, non-FLT3 mutant AML and treatment-related AML, please refer to the ELN 2022 guidelines1

Cytogenetic risk categories1

Patient cytogenetics are determined through FISH and RT-PCR, and are used to stratify patients into three risk categories: favourable, intermediate and adverse.

Explore more Efficacy and Safety of MYLOTARG video

Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA study.


 

Learn moreLoading
Treating Patients with de novo AML in the DGH Setting

Watch Dr. Sreetharan Munisamy discuss the current treatment landscape for de novo AML in Video 1 of the Key Topics in the Management of de novo AML video series. Click the link below to explore the rest of the on-demand series.

Learn moreLoading

AML, acute myeloid leukaemia;  CD, cluster of differentiation;  CR, complete remission;  CRh, complete remission with partial haematologic recovery;  CRi, complete remission with incomplete haematologic recovery; DGH, District General Hospital;  ELN, European LeukemiaNET; FISH, flourescence in-situ hybridisation;  FLT3, fms-like tyrosine kinase 3; GO, gemtuzumab ozogamicin; HCT, hematopoietic cell transplantation;  IV, intravenous;  MRD, minimal residual disease; NICE, National Institute for Health and Care Excellence; q12h, every 12 hours;  RT-PCR, revserse-transcriptase polymerase chain reaction;  SMC, Scottish Medicines Consortium

∧ In up to 2 cycles; ß Consider omitting MYLOTARG if allogeneic HCT is planned to reduce the risk of veno-occlusive disease. 
*Mainly based on results observed in intensively-treated patients. Initial risk assignment may change during the treatment course based on the results from analyses of measurable residual disease;  †Concurrent KIT and/or FLT3 gene mutation does not alter risk categorisation; ‡AML with NPM1 mutation and adverse-risk cytogenetic abnormalities are categorised as adverse-risk; §Only in-frame mutations affecting the basic leucine zipper (bZIP) region of CEBPA, irrespective of whether they occur as monoallelic or biallelic mutations, have been associated with favorable outcome; |The presence of t(9;11 (p21.3;q23.3) takes precedence over rare, concurrent adverse risk gene mutations; ¶Excluding KMT2A partial tandem duplication (PTD); #Complex karyotype: ≥3 unrelated  chromosome abnormalities in the absence of other class-defining recurring genetic abnormalities; excludes hyperdiploid karyotypes with three or more trisomies (or polysomies) without structural  abnormalities; **Monosomal karyotype: presence of two or more distinct monosomies (excluding loss of X or Y), or one single autosomal monosomy in combination with at least one structural chromosome abnormality (excluding core-binding factor AML); ††For the time being, these markers should not be used as an adverse prognostic marker if they co-occur with favorable-risk AML subtypes; ‡‡TP53 mutation at a variant allele fraction of at least 10%, irrespective of the TP53 allelic status (mono- or biallelic mutation): TP53 mutations are significantly associated with AML with  complex and monosomal karyotype

 

References

Döhner H, et al. Blood 2022;140:1345–1377MYLOTARG Summary of Product Characteristics for Great Britain click here. MYLOTARG Summary of Product Characteristics for Northern Ireland click here.
PP-MYL-GBR-0794. July 2023
Supporting Content

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

PfizerPro Account

To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.

Sign In or RegisterAccountSign Out

This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc

 

This website is brought to you by Pfizer Limited, a company registered in England 

and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ

 

Copyright © 2024 Pfizer Limited. All rights reserved.

 

VAT registration number GB201048427

PP-UNP-GBR-7866. January 2024
For UK Healthcare Professionals*

These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

I confirm that I am a healthcare professional* resident in the United Kingdom.

If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-UNP-GBR-7812. January 2024

YesNo
You are now leaving PfizerPro​​​​​

​​​​​​​You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned or controlled by Pfizer Ltd. 

Pfizer accepts no responsibility for the content or services of the linked site.​​​​​​​​​​​​​​

​​​​​​​PP-PFE-GBR-3858. November 2021​​​​​​​
​​​​​​​
You are now leaving PfizerPro
​​​​​​​
​​​​​​​You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer Ltd. 

Pfizer accepts no responsibility for the content or services of the linked site other than the information or other materials relating to ​​​​​Pfizer medicines or 
business which it has provided or reviewed.

PP-PFE-GBR-3859. November 2021
​​​​​​​