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VFEND®Index Section (voriconazole)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Invasive Aspergillosis

1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections

1.3 Esophageal Candidiasis

1.4 Scedosporiosis and Fusariosis

1.5 Usage

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions for Use in All Patients

2.2 Use of VFEND I.V. With Other Parenteral Drug Products

2.3 Recommended Dosing Regimen in Adults

2.4 Recommended Dosing Regimen in Pediatric Patients

2.5 Dosage Modifications in Patients With Hepatic Impairment

2.6 Dosage Modifications in Patients With Renal Impairment

2.7 Dosage Adjustment When Co-Administered With Phenytoin or Efavirenz

2.8 Preparation and Intravenous Administration of VFEND for Injection

2.9 Preparation and Administration of VFEND Oral Suspension

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hepatic Toxicity

5.2 Arrhythmias and QT Prolongation

5.3 Infusion Related Reactions

5.4 Visual Disturbances

5.5 Severe Cutaneous Adverse Reactions

5.6 Photosensitivity

5.7 Renal Toxicity

5.8 Adrenal Dysfunction

5.9 Embryo-Fetal Toxicity

5.10 Laboratory Tests

5.11 Pancreatitis

5.12 Skeletal Adverse Reactions

5.13 Clinically Significant Drug Interactions

5.14 Galactose Intolerance

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience in Adult and Pediatric Patients

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

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.4 Microbiology

12.5 Pharmacogenomics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Invasive Aspergillosis (IA)

14.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections

14.3 Esophageal Candidiasis (EC)

14.4 Other Serious Fungal Pathogens

14.5 Pediatric Studies

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage

17 PATIENT COUNSELING INFORMATION

*
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