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ZIRABEV Index Section (bevacizumab-bvzr)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Metastatic Colorectal Cancer

1.2 First-Line Non-Squamous Non-Small Cell Lung Cancer

1.3 Recurrent Glioblastoma

1.4 Metastatic Renal Cell Carcinoma

1.5 Persistent, Recurrent, or Metastatic Cervical Cancer

1.6 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information

2.2 Metastatic Colorectal Cancer

2.3 First-Line Non-Squamous Non-Small Cell Lung Cancer

2.4 Recurrent Glioblastoma

2.5 Metastatic Renal Cell Carcinoma

2.6 Persistent, Recurrent, or Metastatic Cervical Cancer

2.7 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

2.8 Dosage Modifications for Adverse Reactions

2.9 Preparation and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Perforations and Fistulae

5.2 Surgery and Wound Healing Complications

5.3 Hemorrhage

5.4 Arterial Thromboembolic Events

5.5 Venous Thromboembolic Events

5.6 Hypertension

5.7 Posterior Reversible Encephalopathy Syndrome

5.8 Renal Injury and Proteinuria

5.9 Infusion-Related Reactions

5.10 Embryo-Fetal Toxicity

5.11 Ovarian Failure

5.12 Congestive Heart Failure (CHF)

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Immunogenicity

6.3 Postmarketing Experience

7 DRUG INTERACTIONS

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

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Metastatic Colorectal Cancer

14.2 Lack of Efficacy in Adjuvant Treatment of Colon Cancer

14.3 First-Line Non–Squamous Non–Small Cell Lung Cancer

14.4 Recurrent Glioblastoma

14.5 Metastatic Renal Cell Carcinoma

14.6 Persistent, Recurrent, or Metastatic Cervical Cancer

14.7 Stage III or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Following Initial Surgical Resection

14.8 Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

14.9 Platinum-Sensitive Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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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