INDICATIONS AND USAGE（适应症）

ALK- or ROS1-Positive Metastatic Non-Small Cell Lung Cancer

XALKORI is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.

Relapsed or Refractory, Systemic ALK-Positive Anaplastic Large Cell Lymphoma

XALKORI is indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.

Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

DOSAGE（服用剂量）

Select patients for the treatment of metastatic NSCLC with XALKORI based on the presence of ALK or ROS1 positivity in tumor specimens.

Recommended Dosage for ALK- or ROS1-Positive Metastatic Non-Small Cell Lung Cancer

The recommended dosage of XALKORI for patients with NSCLC is 250 mg orally twice daily, with or without food, until disease progression or no longer tolerated by the patient.

Swallow capsules whole. If a dose of XALKORI is missed, make up that dose unless the next dose is due within 6 hours. If vomiting occurs after taking a dose of XALKORI, take the next dose at the regular time.

Recommended Dosage for Relapsed or Refractory, Systemic ALK-Positive Anaplastic Large Cell Lymphoma

The recommended dosage of XALKORI for patients with ALCL is 280 mg/m2 orally twice daily until disease progression or unacceptable toxicity. The recommended dosage of XALKORI is based on body surface area (BSA). If needed, attain the desired dose by combining different strengths of XALKORI capsules.

Assess pediatric patients for their ability to swallow intact capsules before prescribing XALKORI. Administer XALKORI to pediatric patients under adult supervision.

Take XALKORI with or without food. Swallow capsules whole. If a dose of XALKORI is missed, make up that dose unless the next dose is due within 6 hours. If vomiting occurs after taking a dose of XALKORI, take the next dose at the regular time.

Concomitant Treatments for Patients with ALCL

Provide standard antiemetic and antidiarrheal agents for gastrointestinal toxicities. Antiemetics are recommended prior to and during treatment with XALKORI to prevent nausea and vomiting.

Consider intravenous or oral hydration for patients at risk of dehydration, and replace electrolytes as clinically indicated

ADVERSE REACTIONS（不良反应）

Hepatotoxicity

Interstitial Lung Disease/Pneumonitis

QT Interval Prolongation

Bradycardia

Severe Visual Loss

Gastrointestinal Toxicity in Patients with ALCL

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/2a51b0de-47d6-455e-a94c-d2c737b04ff7/spl-doc?hl=Crizotinib

Crizocentinformation