INDICATIONS AND USAGE（适应症）

ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

DOSAGE（服用剂量）

Select patients for the treatment of metastatic NSCLC with ALECENSA based on the presence of ALK positivity in tumor tissue or plasma specimens. If ALK rearrangements are not detected in a plasma specimen, test tumor tissue if feasible.

Dosing and Administration

The recommended dose of ALECENSA is 600 mg orally twice daily. Administer ALECENSA until disease progression or unacceptable toxicity.

The recommended dose of ALECENSA in patients with severe hepatic impairment (Child-Pugh C) is 450 mg orally twice daily.

ALECENSA should be taken with food. Do not open or dissolve the contents of the capsule. If a dose of ALECENSA is missed or vomiting occurs after taking a dose of ALECENSA, take the next dose at the scheduled time.

ADVERSE REACTIONS（不良反应）

Hepatotoxicity

Interstitial Lung Disease (ILD)/Pneumonitis

Renal Impairment

Bradycardia

Severe Myalgia and Creatine Phosphokinase (CPK) Elevation

Hemolytic Anemia

Embryo-Fetal Toxicity

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/42c49deb-713b-427a-9670-08af08adcffb/spl-doc?hl=Alectinib

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