This page summarizes important information from official regulatory labeling. It is not a replacement for the complete official prescribing information.
Indications
Depending on jurisdiction, osimertinib is approved for selected adults with EGFR-mutated NSCLC in settings including:
- Adjuvant treatment after tumor resection
- Locally advanced unresectable stage III disease after definitive platinum-based chemoradiation
- First-line metastatic disease
- First-line locally advanced or metastatic disease with pemetrexed and platinum chemotherapy
- Previously treated metastatic EGFR T790M-positive disease
The exact wording and scope vary by regulator.
Dosage
The standard U.S. dose for the listed adult indications is 80 mg orally once daily, with or without food.
Dosage forms
The U.S. reference product is available as 40 mg and 80 mg tablets.
Contraindications
The U.S. label lists no contraindications.
Important warnings
The major warnings and precautions include:
- ILD/pneumonitis
- QTc prolongation
- Cardiomyopathy
- Keratitis
- Serious cutaneous reactions
- Cutaneous vasculitis
- Aplastic anemia
- Embryo-fetal toxicity
Drug interactions
Strong CYP3A4 inducers should generally be avoided. QT-prolonging drugs may require additional assessment because osimertinib itself can prolong QTc.
Laboratory and clinical monitoring
Depending on patient risk and treatment setting, monitoring may include:
- ECG
- Electrolytes
- Cardiac function/LVEF
- Blood counts
- Liver-related laboratory tests
- Respiratory symptoms
- Ocular symptoms
- Other clinically indicated assessments
Special populations
The official label provides information for pregnancy, lactation, reproductive potential, pediatric use, geriatric use, renal impairment and hepatic impairment.
Complete official information
For prescribing decisions, healthcare professionals should consult the latest official label from the relevant regulatory authority.