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XALKORI®Index Section (crizotinib)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

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

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

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

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

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

2.4 Concomitant Treatments for Patients with ALCL

2.5 Dosage Modifications for Adverse Reactions

2.6 Dosage Modifications for Moderate and Severe Hepatic Impairment

2.7 Dosage Modification for Severe Renal Impairment

2.8 Dosage Modification for Concomitant Use of Strong CYP3A Inhibitors

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hepatotoxicity

5.2 Interstitial Lung Disease/Pneumonitis

5.3 QT Interval Prolongation

5.4 Bradycardia

5.5 Severe Visual Loss

5.6 Gastrointestinal Toxicity in Patients with ALCL

5.7 Embryo-Fetal Toxicity

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on XALKORI

7.2 Effect of XALKORI on Other Drugs

7.3 Drugs That Prolong the QT Interval

7.4 Drugs That Cause Bradycardia

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

8.7 Renal Impairment

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

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

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

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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