Ibruxen is a 140 mg capsule containing ibrutinib, manufactured by Everest Pharmaceuticals Ltd.
Product identity
| Product characteristic | Information |
|---|---|
| Product | Ibruxen |
| Active ingredient | Ibrutinib |
| Strength | 140 mg |
| Dosage form | Capsule |
| Route | Oral |
| Drug class | Bruton tyrosine kinase inhibitor |
| Therapeutic category | Targeted cancer therapy |
| Manufacturer | Everest Pharmaceuticals Ltd. |
| Reference brand | IMBRUVICA |
Active ingredient
Ibrutinib is a covalent BTK inhibitor. It interferes with B-cell signaling pathways involved in proliferation, survival and migration.
Manufacturer
Everest Pharmaceuticals’ product database identifies Ibruxen as an Ibrutinib INN 140 mg product.
Reference product
IMBRUVICA is the established branded ibrutinib medicine associated with the original U.S. approval of ibrutinib in 2013.
Product relationship
Ibruxen and IMBRUVICA contain the same active ingredient but should not be represented as the same commercial product. Product manufacturer, formulation, excipients, packaging and regulatory documentation can differ.
Safety
Ibrutinib is associated with clinically important risks including hemorrhage, infections, cardiac arrhythmias, cardiac failure, hypertension, cytopenias and hepatotoxicity.
Regulatory information
The authorization of a specific Ibruxen product should be determined from the applicable national regulatory documentation. General ibrutinib approvals should not automatically be presented as Ibruxen-specific approvals.
Product verification
Packaging, manufacturer information, batch number, expiry date and other product identifiers should be checked through reliable pharmaceutical channels.