INDICATIONS AND USAGE（适应症）

Adjuvant Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC)

TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC

TAGRISSO is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC

TAGRISSO is indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

DOSAGE（服用剂量）

The recommended dosage of TAGRISSO is 80 mg tablet once a day. TAGRISSO can be taken with or without food.

If a dose of TAGRISSO is missed, do not make up the missed dose and take the next dose as scheduled.

Treat patients in the adjuvant setting until disease recurrence, or unacceptable toxicity, or for up to 3 years.

Treat patients with metastatic lung cancer until disease progression or unacceptable toxicity.

ADVERSE REACTIONS（不良反应）

Interstitial Lung Disease/Pneumonitis

QTc Interval Prolongation

Cardiomyopathy

Keratitis

Erythema multiforme and Stevens-Johnson syndrome

Cutaneous Vasculitis

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/5e81b4a7-b971-45e1-9c31-29cea8c87ce7/spl-doc?hl=Osimertinib

Osieminformation