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INLYTA®Index Section (axitinib)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 First-Line Advanced Renal Cell Carcinoma

1.2 Second-Line Advanced Renal Cell Carcinoma

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

2.2 Dose Modification Guidelines

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypertension and Hypertensive Crisis

5.2 Arterial Thromboembolic Events

5.3 Venous Thromboembolic Events

5.4 Hemorrhage

5.5 Cardiac Failure

5.6 Gastrointestinal Perforation and Fistula Formation

5.7 Thyroid Dysfunction

5.8 Risk of Impaired Wound Healing

5.9 Reversible Posterior Leukoencephalopathy Syndrome

5.10 Proteinuria

5.11 Hepatotoxicity

5.12 Use in Patients with Hepatic Impairment

5.13 Major Adverse Cardiovascular Events (MACE)

5.14 Embryo-Fetal Toxicity

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 CYP3A4/5 Inhibitors

7.2 CYP3A4/5 Inducers

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

10 OVERDOSAGE

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 First-Line Advanced RCC

14.2 Second-Line Advanced RCC

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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