INDICATIONS AND USAGE（适应症）

Non-Small Cell Lung Cancer (NSCLC)

Erlotinib tablets are indicated for:

The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

DOSAGE（服用剂量）

Select patients for the treatment of metastatic NSCLC with erlotinib tablets based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor or plasma specimens. If these mutations are not detected in a plasma specimen, test tumor tissue if available.

Recommended Dose - NSCLC

The recommended daily dose of erlotinib tablets for NSCLC is 150 mg taken on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.

Recommended Dose - Pancreatic Cancer

The recommended daily dose of erlotinib tablets for pancreatic cancer is 100 mg taken once daily in combination with gemcitabine. Take erlotinib tablets on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.

ADVERSE REACTIONS（不良反应）

Interstitial Lung Disease (ILD)

Renal Failure

Hepatotoxicity with or without Hepatic Impairment

Gastrointestinal Perforation

Bullous and Exfoliative Skin Disorders

Cerebrovascular Accident

Microangiopathic Hemolytic Anemia with Thrombocytopenia

Ocular Disorders

Hemorrhage in Patients Taking Warfarin

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/5d97f401-4853-4a9a-907d-21e8a4d16088/spl-doc?hl=Erlotinib

Erlonatinformation