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VFEND®(voriconazole)
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Our medical information is accurate, up to date, and scientifically balanced.
VFEND® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Invasive Aspergillosis
VFEND is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions for Use in All Patients
Administer VFEND Tablets or Oral Suspension at least one hour before or...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Powder for Solution for Injection
VFEND I.V. for Injection is supplied in a single-dose vial as a sterile...
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Contraindications
4 CONTRAINDICATIONS
- VFEND is contraindicated in patients with known hypersensitivity to voriconazole or its excipients. There is no information regarding cross-sensitivity between VFEND (voriconazole) and other azole...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hepatic Toxicity
In clinical trials, there have been uncommon cases of serious hepatic reactions during treatment with VFEND (including...
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Adverse Reactions
6 ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
Hepatic Toxicity [see Warnings and Precautions (5.1)]
...
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Drug Interactions
7 DRUG INTERACTIONS
Voriconazole is metabolized by cytochrome P450 isoenzymes, CYP2C19, CYP2C9, and CYP3A4. Therefore, inhibitors or inducers of these isoenzymes may increase or decrease voriconazole plasma concentrations,...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Voriconazole can cause...
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Overdosage
10 OVERDOSAGE
In clinical trials, there were three cases of accidental overdose. All occurred in pediatric patients who received up to five times the recommended intravenous dose of voriconazole. A single adverse reaction of...
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Description
11 DESCRIPTION
VFEND (voriconazole), an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Voriconazole is an antifungal drug [see Microbiology (12.4)]....
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Two-year carcinogenicity studies were conducted in rats and mice. Rats were given...
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Clinical Studies
14 CLINICAL STUDIES
Voriconazole, administered orally or parenterally, has been evaluated as primary or salvage therapy in 520 patients aged 12 years and older with infections caused by Aspergillus...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Powder for Solution for Injection...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Visual...
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Instructions For Use
INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE
VFEND® (VEE-fend)
(voriconazole)
for oral suspension
Read this Instructions for Use before you start taking VFEND and each time you get a refill. There may be...
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