Osimertinib 80 mg is an oral tablet containing 80 mg of osimertinib, an EGFR tyrosine kinase inhibitor used in selected EGFR-mutated NSCLC.
Osimertinib is a targeted anticancer medicine that irreversibly inhibits selected mutant EGFR proteins.
Current U.S. indications include selected resected, unresectable stage III, metastatic and previously treated EGFR-mutated NSCLC settings.
Important labeled mutations include EGFR exon 19 deletions, exon 21 L858R and, in previously treated metastatic disease, T790M.
Tagrisso is the established osimertinib reference brand associated with AstraZeneca.
Tagrix is an osimertinib product identified by Beacon Pharmaceuticals, including an 80 mg tablet presentation.
Osicent is an osimertinib product from Incepta Pharmaceuticals. Incepta identifies Osicent 80 as containing osimertinib mesylate equivalent to 80 mg.
Osimert is an 80 mg osimertinib product identified in Everest Pharmaceuticals' product catalogue.
Osimertinib is a targeted EGFR tyrosine kinase inhibitor rather than a conventional cytotoxic chemotherapy medicine.
The standard labeled dose is 80 mg once daily for the U.S. indications.
Yes. Current U.S. labeling allows it to be taken with or without food.
The current U.S. label states not to make up a missed dose and to take the next dose as scheduled.
Diarrhea, rash, dry skin, nail toxicity and stomatitis are among commonly reported effects.
Serious risks include interstitial lung disease or pneumonitis, QTc prolongation, cardiomyopathy, keratitis and aplastic anemia.
Yes. QTc prolongation and cardiomyopathy are recognized risks. Cardiac monitoring is recommended in specified patients.
Yes. Interstitial lung disease and pneumonitis can occur and require prompt clinical evaluation when respiratory symptoms develop.
T790M is an EGFR resistance mutation associated with resistance to some earlier EGFR tyrosine kinase inhibitors.
FLAURA2 was a randomized study comparing osimertinib plus platinum-pemetrexed chemotherapy with osimertinib alone in previously untreated advanced EGFR-mutated NSCLC.
ADAURA was a phase III study of adjuvant osimertinib after complete tumor resection in EGFR-mutated stage IB–IIIA NSCLC.
LAURA was a phase III trial evaluating osimertinib after platinum-based chemoradiation in unresectable stage III EGFR-mutated NSCLC.
Yes. Patient selection for the labeled indications depends on demonstrating the relevant EGFR alteration using an appropriate diagnostic test.
Osimertinib can cause fetal harm. Pregnancy-related risks should be discussed with the treating healthcare professional before therapy.
Current U.S. labeling advises against breastfeeding during treatment and for the specified period after treatment.
A generic product can contain the same active ingredient, but its manufacturer, formulation, excipients, packaging and regulatory authorization can differ.