Gemtuzumab Ozogamicin
| Evidence Level: N/A | Predicted Indications: 0 |
Table of Contents
- Gemtuzumab Ozogamicin
Gemtuzumab Ozogamicin: Known uses and market status in Australia
Summary
The TxGNN deep-learning model has no candidate with a score of 0.99 or higher for Gemtuzumab Ozogamicin, so there is currently no new predicted indication. The drug’s own recorded uses are listed below. These are existing records, not model candidates.
Quick overview
| Item | Content |
|---|---|
| New predicted indications | None (no model candidate scored 0.99 or higher) |
| Known uses recorded for this drug | 15 |
| Evidence level | Not applicable |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
Known uses recorded for this drug
Approved (supported by a licence or label)
| Indication | Source |
|---|---|
| leukemia, myeloid, acute | licence in another country |
Related to an approved indication (same disease category)
| Indication | Approved category |
|---|---|
| none | none |
Relations recorded in the knowledge graph (no approval found)
| Indication |
|---|
| acute myeloblastic leukemia with maturation |
| acute myeloblastic leukemia without maturation |
| acute myeloid leukemia with cebpa somatic mutations |
| acute myeloid leukemia with inv3(p21;q26.2) or t(3;3)(p21;q26.2) |
| acute myeloid leukemia with minimal differentiation |
| acute myeloid leukemia with npm1 somatic mutations |
| acute myeloid leukemia with t(6;9)(p23;q34) |
| acute myeloid leukemia with t(8;16)(p11;p13) translocation |
| acute myeloid leukemia with t(8;21)(q22;q22) translocation |
| acute myeloid leukemia with t(9;11)(p22;q23) |
| inherited acute myeloid leukemia |
| myeloid leukemia |
| therapy related acute myeloid leukemia and myelodysplastic syndrome |
| unclassified acute myeloid leukemia |
Australia Market Information
| Licence | Product | Dosage form | Status |
|---|---|---|---|
| 12844B | Mylotarg | Powder for injection 5 mg | Valid |
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Antibody-drug conjugate with a cytotoxic payload (calicheamicin, a DNA-damaging agent) |
| Myelosuppression Risk | High (expected given the myeloid target and cytotoxic payload); please refer to the Product Information (PI) |
| Emetogenicity Classification | Please refer to the Product Information (PI) warnings and precautions |
| Monitoring Items | Full blood count, liver function (including bilirubin and transaminases), signs of hepatic veno-occlusive disease/sinusoidal obstruction syndrome |
| Handling Protection | Follow local cytotoxic drug handling requirements |
Safety Considerations
- Hepatotoxicity: Published case series report hepatic veno-occlusive disease/sinusoidal obstruction syndrome, including in patients who have not had a stem cell transplant. Around 20% of patients in one series had grade 3-4 hyperbilirubinaemia or raised transaminases (PMID 11466696, PMID 11895761).
- Drug Interactions: 100 interactions were identified in the interaction database. Examples:
- Major: deferiprone, samarium (153Sm) lexidronam, adalimumab, baricitinib
- Moderate: naltrexone, palifermin, strontium chloride Sr-89, roflumilast, chloramphenicol, zidovudine, alemtuzumab, azathioprine, asparaginase products, and some vaccines (e.g. tetanus toxoid, anthrax)
- Minor: levofloxacin
Many of the major and moderate interactions involve additive myelosuppression or immunosuppression. Review the full list before any use.
Please refer to the TGA-approved Product Information (PI) for full warnings and contraindications.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.