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Gemtuzumab Ozogamicin [Mylotarg]
Availability of ACE Drug Guidance
Yes
Biologics Drug Information Overview
No
Subsidy Information and Financing Scheme
Cancer Drug and Clinical Indication listed in the MediShield Life Outpatient Cancer Drug List
Medical Assistance Fund
Active ingredient: Gemtuzumab Ozogamicin
General information
Subsidy Information and Financing Scheme
[MAF] Gemtuzumab ozogamicin (Mylotarg) Concentrate For Infusion 5 mg
In combination with daunorubicin and cytarabine for patients with previously untreated de novo CD33-positive acute myeloid leukaemia (AML), if they:
• do not have acute promyelocytic leukaemia,
• only start induction therapy while waiting for cytogenetic test results or after confirming favourable, intermediate or unknown (due to inconclusive test results) cytogenetic risk, and
• start consolidation therapy after confirming favourable, intermediate, or unknown cytogenetic risk.
[MSHL] Gemtuzumab ozogamicin Powder For Concentrate For Solution For Infusion Vial 5 mg
In combination with daunorubicin and cytarabine for patients with previously untreated de novo CD33-positive acute myeloid leukaemia (AML), if they:
• do not have acute promyelocytic leukaemia,
• only start induction therapy while waiting for cytogenetic test results or after confirming favourable, intermediate or unknown (due to inconclusive test results) cytogenetic risk, and
• start consolidation therapy after confirming favourable, intermediate, or unknown cytogenetic risk.
Drug Guidance for Subsidy
01/06/2026 Gemtuzumab ozogamicin for untreated de novo CD33-positive acute myeloid leukaemia
The Ministry of Health’s Drug Advisory Committee has recommended:
Gemtuzumab ozogamicin 5 mg powder for concentrate for solution for infusion in combination with daunorubicin and cytarabine for patients with previously untreated de novo CD33-positive acute myeloid leukaemia (AML), if they:
do not have acute promyelocytic leukaemia,
only start induction therapy while waiting for cytogenetic test results or after confirming favourable, intermediate or unknown (due to inconclusive test results) cytogenetic risk, and
start consolidation therapy after confirming favourable, intermediate, or unknown cytogenetic risk.
Funding status
[R] Gemtuzumab ozogamicin 5 mg powder for concentrate for solution for infusion is recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication from 1 September 2022.
Clinical indication, subsidy class and MediShield Life claims eligibility for gemtuzumab ozogamicin is provided in the Annex.
General Availability in Public Healthcare Institution
Note:
General availability information reflected is based on the Public Healthcare Institutions’ (PHI) formulary on what is commonly used for treating their patient population and may or may not be available for patients not under the care of that institution. It does not reflect the PHI’s actual inventory availability and is subjected to change. Please consult the Public Hospitals or Polyclinics for details on availability and supply restrictions/considerations. General availability is not tied to any brand unless otherwise stated.
Users are to consult the respective PHIs for actual inventory availability and supply restrictions/consideration
Availability information
Formulation | Public Healthcare Institution |
|---|---|
Mylotarg Concentrate For Infusion 5 mg |
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Registered Product(s) Information
Clinical and product info
Clinical info | Product Info |
|---|---|
Information under the Indication, Dosage and Contraindication sections are extracted from the relevant Package Insert/Patient Information Leaflet of the product available on HSA Infosearch. For more information, please refer to the product's Package Insert/ Patient Information Leaflet available on HSA Infosearch. The information provided is for informational purposes only, and is not exhaustive. The information provided is not a substitute for professional medical advice. Please consult a qualified healthcare provider for any medical advice. | Information available here are product details as registered with the HSA. As this website is updated monthly, please refer to HSA Infosearch for the most updated product information. |
Intravenous
* Clinical information is available for this product.