This page summarizes regulatory dosing information and is not an individualized dosing recommendation. The prescribing clinician should determine the appropriate regimen.
Standard adult dose
For the major adult indications in the U.S. prescribing information, the recommended osimertinib dose is:
80 mg orally once daily.
Depending on the indication, treatment continues until disease progression, unacceptable toxicity, or, in the adjuvant setting, for a total of up to three years.
| Treatment setting | U.S. labeled dose |
| Adjuvant EGFR-mutated NSCLC | 80 mg once daily |
| Locally advanced unresectable stage III after platinum-based chemoradiation | 80 mg once daily |
| First-line metastatic EGFR-mutated NSCLC | 80 mg once daily |
| First-line locally advanced/metastatic disease with pemetrexed + platinum chemotherapy | 80 mg once daily |
| Previously treated metastatic EGFR T790M-positive NSCLC | 80 mg once daily |
Food
The 80 mg tablet may be taken with or without food.
Missed dose
If a dose is missed, the current U.S. prescribing information says not to make up the missed dose. The next dose should be taken at its scheduled time.
Dose reductions
Dose modifications can be necessary when clinically significant adverse reactions occur.
The U.S. prescribing information includes a reduced 40 mg once-daily regimen in specified circumstances. Examples include certain clinically significant QTc prolongation or other severe adverse reactions after appropriate management.
Interstitial lung disease
For patients without recent definitive platinum-based chemoradiation, diagnosed ILD/pneumonitis generally requires permanent discontinuation under U.S. labeling. Different instructions apply in the post-chemoradiation setting, where grade 1 disease may be managed differently and grade 2 or higher requires permanent discontinuation.
Strong CYP3A4 inducers
Strong CYP3A4 inducers should be avoided where possible. If concomitant use is unavoidable, U.S. labeling describes an increased osimertinib dose of 160 mg daily during coadministration, followed by return to 80 mg three weeks after the inducer is discontinued. This is a prescribing-information instruction and must not be interpreted as a self-adjustment recommendation.
Renal impairment
Regulatory labeling provides specific information for renal impairment. The U.S. label does not recommend a dose adjustment for mild-to-moderate renal impairment, while data are limited in severe renal impairment and end-stage renal disease.
Hepatic impairment
Dose selection in hepatic impairment should follow the applicable prescribing information because evidence and recommendations depend on the severity of impairment.
Combination therapy
When osimertinib is combined with pemetrexed and platinum chemotherapy, dosing of the accompanying chemotherapy is governed by the respective prescribing information, while osimertinib modifications follow its own label.
Pediatric use
Safety and effectiveness in pediatric patients are not established for the approved adult indications.
Important warning
Do not use this page to determine a personal dose. Cancer treatment requires individualized medical assessment.