Ponaxen is presented on this website as a product containing ponatinib in stated 15 mg and 45 mg strengths.
Product identity
| Characteristic | Information |
|---|---|
| Product | Ponaxen |
| Active ingredient | Ponatinib |
| Stated strengths | 15 mg and 45 mg |
| Drug class | Tyrosine kinase inhibitor |
| Therapeutic category | Antineoplastic medicine |
| Route | Oral, subject to product documentation |
| Reference product | ICLUSIG |
| Original developer | ARIAD Pharmaceuticals |
| Specific Ponaxen manufacturer | Everest Pharmaceuticals Ltd. |
Ponatinib targets BCR::ABL1 and has clinically important activity against the T315I mutation.
Reference product
ICLUSIG is the established reference product containing ponatinib. The original U.S. NDA was submitted by ARIAD Pharmaceuticals.
Regulatory information
Current U.S. labeling includes selected CML and Ph+ ALL indications, while European authorization has its own criteria.
Safety
Ponatinib has major vascular, cardiovascular and hepatic risks. The U.S. boxed warning addresses arterial occlusive events, venous thromboembolism, heart failure and hepatotoxicity.
Product verification
The actual package, manufacturer, authorization information and batch details should be checked before use.