Obinutuzumab: Known uses and market status in Australia
Summary
The TxGNN deep-learning model (score ≥ 0.99) produced candidates for Obinutuzumab, but every candidate that can be traced to a source is already a known use. There is therefore currently no new predicted indication for this drug. The two known uses below are in the same disease category as an approved indication, and neither is listed as approved in its own right.
Quick overview
Item
Content
New predicted indications
None (all traceable model candidates are known uses)
Known uses among model candidates
2
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 among the model’s candidates
Approved (supported by a licence or label)
Indication
Source
none
none
Related to an approved indication (same disease category)
Indication
Approved category
pregerminal center chronic lymphocytic leukemia/small lymphocytic lymphoma
cll
chronic lymphocytic leukemia/small lymphocytic lymphoma with immunoglobulin heavy chain variable-region gene somatic hypermutation
cll
Relations recorded in the knowledge graph (no approval found)
Indication
none
Australia Market Information
Licence
Product
Dosage form
Status
10407R
Gazyva
Solution for I.V. infusion 1000 mg in 40
Valid
Cytotoxicity
Item
Content
Cytotoxicity Classification
Targeted immunotherapy (anti-CD20 monoclonal antibody), not a conventional cytotoxic
Myelosuppression Risk
Please refer to the Product Information (PI) warnings and precautions (the literature suggests cytopenias should be monitored)
Emetogenicity Classification
Please refer to the Product Information (PI) warnings and precautions
Monitoring Items
FBC with differential, infusion reactions, infections, hepatitis B status
Handling Protection
Please refer to the Product Information (PI) and local institutional policy
Safety Considerations
Warnings and contraindications from the product label were not available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for these. The prediction notes suggest monitoring for infusion reactions, cytopenias, infections and hepatitis B reactivation.
Drug Interactions: 81 interactions were identified. Examples include: