Tagrix 80 mg is identified as a film-coated tablet containing osimertinib mesylate equivalent to 80 mg of osimertinib. Beacon Pharmaceuticals’ published product information lists Tagrix 40 and Tagrix 80 formulations and identifies the 80 mg product as a film-coated tablet.
Osimertinib is an EGFR tyrosine kinase inhibitor. Unlike a conventional cytotoxic chemotherapy medicine that broadly affects rapidly dividing cells, osimertinib is designed to inhibit specific EGFR signaling associated with selected molecular abnormalities in NSCLC.
Product identity
| Attribute | Information |
|---|---|
| Product | Tagrix 80 mg |
| Generic name | Osimertinib |
| Active substance | Osimertinib |
| Salt/form | Osimertinib mesylate |
| Strength | 80 mg osimertinib equivalent |
| Dosage form | Film-coated tablet |
| Route | Oral |
| Pharmacologic class | EGFR tyrosine kinase inhibitor |
| Therapeutic area | Oncology |
| Manufacturer | Beacon Pharmaceuticals PLC |
| Reference product | TAGRISSO |
| Reference-product company | AstraZeneca |
What is the significance of 80 mg?
The 80 mg designation refers to the amount of osimertinib equivalent in the tablet. Current U.S. TAGRISSO labeling uses 80 mg once daily as the standard recommended dose for the labeled NSCLC regimens, although dose modification to 40 mg may be required for certain adverse reactions.
The strength of a tablet does not determine whether the medicine is appropriate for a particular patient. Eligibility depends on the disease setting, EGFR biomarker status, previous treatment, organ function, concurrent medicines and applicable regulatory requirements.
Originator and reference product
Osimertinib was developed by AstraZeneca under the development code AZD9291. AstraZeneca‘s regulatory documentation identifies AZD9291 as osimertinib and TAGRISSO as the associated invented name.
TAGRISSO received its initial U.S. approval in 2015.
Tagrix versus TAGRISSO
Tagrix and TAGRISSO should not be treated as interchangeable brand names. Tagrix is manufactured by Beacon Pharmaceuticals, while TAGRISSO is an AstraZeneca product. The two products share the active ingredient osimertinib, but product-specific manufacturing, excipients, packaging and regulatory documentation can differ.
Safety
Osimertinib has important warnings concerning lung toxicity, QTc prolongation, cardiac dysfunction and other serious adverse reactions. These risks require clinical monitoring and are discussed in greater detail throughout this website.