INDICATIONS AND USAGE（适应症）

ROS1-Positive Non-Small Cell Lung Cancer

ROZLYTREK is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.

NTRK Gene Fusion-Positive Solid Tumors

ROZLYTREK is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:

have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,

are metastatic or where surgical resection is likely to result in severe morbidity, and

have either progressed following treatment or have no satisfactory alternative therapy.

DOSAGE（服用剂量）

Recommended Dosage for ROS1-Positive Non-Small Cell Lung Cancer

The recommended dosage of ROZLYTREK is 600 mg orally once daily with or without food until disease progression or unacceptable toxicity.

Recommended Dosage for NTRK Gene Fusion-Positive Solid Tumors

Adults

The recommended dosage of ROZLYTREK in adults is 600 mg orally once daily with or without food until disease progression or unacceptable toxicity.

Pediatric Patients 12 Years and Older (Adolescents)

The recommended dosage of ROZLYTREK is based on body surface area (BSA). Take ROZLYTREK orally once daily with or without food until disease progression or unacceptable toxicity.

ADVERSE REACTIONS（不良反应）

Congestive Heart Failure

Central Nervous System Effects

Skeletal Fractures

Hepatotoxicity

Hyperuricemia

QT Interval Prolongation

Vision Disorders

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/c7c71b0c-2549-4495-86b6-c2807fa54908/spl-doc?hl=Rozlytrek

Rozlytrekinformation