The standard labeled osimertinib dose in the current U.S. prescribing information is 80 mg orally once daily for the approved indications.
| Treatment setting | U.S. labeled regimen |
|---|---|
| Adjuvant EGFR-mutated NSCLC | 80 mg once daily, up to 3 years or until recurrence/unacceptable toxicity |
| Unresectable stage III after chemoradiation | 80 mg once daily until progression/unacceptable toxicity |
| First-line metastatic EGFR-mutated NSCLC | 80 mg once daily |
| First-line locally advanced/metastatic disease with chemotherapy | 80 mg once daily with pemetrexed and platinum chemotherapy |
| Previously treated metastatic T790M-positive NSCLC | 80 mg once daily |
Administration
Osimertinib can be taken with or without food. A missed dose should not be made up; the next dose should be taken as scheduled.
Dose modification
For certain serious adverse reactions, the prescribing information allows treatment interruption, dose reduction to 40 mg daily or permanent discontinuation depending on the toxicity.
Strong CYP3A inducers
Strong CYP3A4 inducers should generally be avoided. If unavoidable, the U.S. label provides a specific temporary 160 mg daily strategy, followed by return to 80 mg after the inducer has been discontinued for the specified period. This is a label-directed interaction management strategy and should never be self-applied.
Important limitation
This information summarizes the U.S. Tagrisso label. It is not an individualized prescription and should not replace the applicable local prescribing information.