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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.

Additional Administration Information
  • MYLOTARG must not be used during pregnancy unless the potential benefit to the mother outweighs the potential risks to the foetus. Women or partners of women with childbearing potential should use two methods of contraception during treatment and for at least 7 months (females) or 4 months (males) after the last dose
  • Female patients should avoid breast feeding while receiving MYLOTARG and for ≥ 1 month after the final dose
  • Before administering each dose of MYLOTARG, complete blood counts should be assessed, as well as baseline liver function tests (ALT, AST, total bilirubin and ALP levels) to monitor for hepatotoxicity, including VOD
  • Premedication with a corticosteroid, antihistamine and paracetamol is recommended 1 hour prior to MYLOTARG dosing to ameliorate infusion-related reactions
  • MYLOTARG is light sensitive and should be protected from UV light during reconstitution, dilution and administration
  • Following reconstitution and dilution, MYLOTARG should be administered by IV infusion over a 2-hour period and should not be administered as an IV push or bolus
  • Infusion of MYLOTARG should be performed under close clinical monitoring, including pulse rate, blood pressure and temperature
  • Patients receiving MYLOTARG should be monitored for clinical signs and symptoms of infection, bleeding/haemorrhage, or other effects of myelosuppression and tumour lysis syndrome. Additionally, due to the risk of VOD/SOS, signs and symptoms of VOD/SOS should be closely monitored; these may include elevations in ALT, AST, total bilirubin, and alkaline phosphatase, which should be monitored prior to each dose of MYLOTARG, hepatomegaly (which may be painful), rapid weight gain, and ascites. Monitoring only total bilirubin may not identify all patients at risk of VOD/SOS. For patients who develop abnormal liver tests, more frequent monitoring of liver tests and clinical signs and symptoms of hepatotoxicity is recommended
  • Once cytogenetic testing results are available, consider the risk-benefit of continuing treatment with MYLOTARG; the efficacy of MYLOTARG has been demonstrated in AML patients with favourable- and intermediate-risk cytogenetics, but not in patients with adverse cytogenetics
 Please refer to the MYLOTARG Summary of Product Characteristics for full details Loading Pharmacy Guide

Download the Pharmacy booklet which is a guide to treatment with MYLOTARG. SmPC should be consulted for full guidance.

 Download Pharmacy Guide Loading Fast Facts Download the fast facts PDF document to aid your understanding of MYLOTARG View Fast Facts PDF Loading

ALP, alkaline phosphatase; ALT, alanine aminotransferase; AML, acute myeloid leukaemia; ANC, absolute neutrophil count; AST, aspartate aminotransferase;  IV, intravenous; SmPC, Summary of Product Characteristics; SOS, Sinusoidal Obstruction Syndrome; UV, ultraviolet; VOD, veno-occlusive disease.

Reference:MYLOTARG Summary of Product Characteristics for Great Britain click here. MYLOTARG Summary of Product Characteristics for Northern Ireland click here.
PP-MYL-GBR-0686. April 2023
 For further details on dosing and schedule Dosing Guide Loading

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

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