The official prescribing information should be consulted for complete instructions. The summary below is based primarily on current U.S. TAGRISSO labeling and should not be treated as a replacement for the official document.
Indications
Current U.S. labeling includes:
- Adjuvant treatment after resection of EGFR exon 19 deletion or exon 21 L858R NSCLC.
- Treatment of locally advanced unresectable stage III EGFR exon 19 deletion or exon 21 L858R NSCLC after chemoradiation.
- First-line metastatic EGFR exon 19 deletion or exon 21 L858R NSCLC.
- First-line locally advanced or metastatic EGFR exon 19 deletion or exon 21 L858R NSCLC in combination with pemetrexed and platinum chemotherapy.
- Previously treated metastatic EGFR T790M-positive NSCLC after progression on or following EGFR TKI therapy.
Dosage
The labeled standard dose is 80 mg once daily.
Dosage form
Tagrisso is available as 40 mg and 80 mg film-coated tablets.
Major warnings
Important warnings include:
- Interstitial lung disease/pneumonitis
- QTc prolongation
- Cardiomyopathy
- Keratitis
- Severe skin reactions
- Aplastic anemia
- Embryo-fetal toxicity
Interactions
Strong CYP3A4 inducers should generally be avoided. Other medicines should be reviewed by a healthcare professional before treatment.
Complete label
The complete, current label should always be consulted for detailed dose modifications, laboratory information, drug interactions and special-population instructions.