INDICATIONS AND USAGE（适应症）

VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that:

have a neurotrophic receptor tyrosine 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 no satisfactory alternative treatments or that have progressed following treatment.

Select patients for therapy based on an FDA-approved test.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

DOSAGE（服用剂量）

Select patients for treatment with VITRAKVI based on the presence of a NTRK gene fusion in tumor specimens.

Recommended Dosage

Recommended Dosage in Adult and Pediatric Patients with Body Surface Area of at Least 1.0 Meter-Squared

The recommended dosage of VITRAKVI is 100 mg orally twice daily, with or without food, until disease progression or until unacceptable toxicity.

Recommended Dosage in Pediatric Patients with Body Surface Area Less Than 1.0 Meter-Squared

The recommended dosage of VITRAKVI is 100 mg/m2 orally twice daily, with or without food, until disease progression or until unacceptable toxicity.

ADVERSE REACTIONS（不良反应）

Central Nervous System Effects

Skeletal Fractures

Hepatotoxicity

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/0c8ca614-58b2-4aa4-83d3-0387a8f782fd/spl-doc?hl=Vitrakvi

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