Voriconazole (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Overview
Voriconazole (injection) is an antifungal triazole that is FDA approved for the treatment of invasive aspergillosis, candidemia in non-neutropenic patients, esophageal candidiasis, serious fungal infections caused by Scedosporium apiospermum and Fusarium spp. including fusarium solani, in patients intolerant of, or refractory to, other therapy. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Voriconazole (injection) FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Voriconazole in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Voriconazole in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Voriconazole (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Voriconazole in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Voriconazole in pediatric patients.
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 antifungal agents. Caution should be used when prescribing VFEND to patients with hypersensitivity to other azoles.
- Coadministration of terfenadine, astemizole, cisapride, pimozide or quinidine with VFEND is contraindicated because increased plasma concentrations of these drugs can lead to QT prolongation and rare occurrences of torsade de pointes.
- Coadministration of VFEND with sirolimus is contraindicated because VFEND significantly increases sirolimus concentrations
- Coadministration of VFEND with rifampin, carbamazepine and long-acting barbiturates is contraindicated because these drugs are likely to decrease plasma voriconazole concentrations significantly.
- Coadministration of standard doses of voriconazole with efavirenz doses of 400 mg q24h or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. *Voriconazole also significantly increases efavirenz plasma concentrations.
- Coadministration of VFEND with high-dose ritonavir (400 mg q12h) is contraindicated because ritonavir (400 mg q12h) significantly decreases plasma voriconazole concentrations. Coadministration of voriconazole and low-dose ritonavir (100 mg q12h) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.
- Coadministration of VFEND with rifabutin is contraindicated since VFEND significantly increases rifabutin plasma concentrations and rifabutin also significantly decreases voriconazole plasma concentrations.
- Coadministration of VFEND with ergot alkaloids (ergotamine and dihydroergotamine) is contraindicated because VFEND may increase the plasma concentration of ergot alkaloids, which may lead to ergotism.
- Coadministration of VFEND with St. John's Wort is contraindicated because this herbal supplement may decrease voriconazole plasma concentration.
Warnings
5.1 Drug Interactions See TABLE 7 for a listing of drugs that may significantly alter voriconazole concentrations. Also, see TABLE 8 for a listing of drugs that may interact with voriconazole resulting in altered pharmacokinetics or pharmacodynamics of the other drug [see CONTRAINDICATIONS (4), and DRUG INTERACTIONS (7)].
5.2 Hepatic Toxicity In clinical trials, there have been uncommon cases of serious hepatic reactions during treatment with VFEND (including clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities). Instances of hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly hematological malignancy). Hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors. Liver dysfunction has usually been reversible on discontinuation of therapy [see WARNINGS AND PRECAUTIONS (5.8), and ADVERSE REACTIONS (6.3)].
Monitoring of hepatic function: Liver function tests should be evaluated at the start of and during the course of VFEND therapy. Patients who develop abnormal liver function tests during VFEND therapy should be monitored for the development of more severe hepatic injury. Patient management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin). Discontinuation of VFEND must be considered if clinical signs and symptoms consistent with liver disease develop that may be attributable to VFEND [see WARNINGS AND PRECAUTIONS (5.8), DOSAGE AND ADMINISTRATION (2.4, 2.6), and ADVERSE REACTIONS (6.3)].
5.3 Visual Disturbances The effect of VFEND on visual function is not known if treatment continues beyond 28 days. There have been post-marketing reports of prolonged visual adverse events, including optic neuritis and papilledema. If treatment continues beyond 28 days, visual function including visual acuity, visual field and color perception should be monitored [see ADVERSE REACTIONS (6.2)].
5.4 Embryo-Fetal Toxicity Voriconazole can cause fetal harm when administered to a pregnant woman.
In animals, voriconazole administration was associated with teratogenicity, embryotoxicity, increased gestational length, dystocia and embryomortality. Please refer to section 8.1 (Use in Pregnancy) for additional details.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to the fetus.
5.5 Arrhythmias and QT Prolongation Some azoles, including voriconazole, have been associated with prolongation of the QT interval on the electrocardiogram. During clinical development and post-marketing surveillance, there have been rare cases of arrhythmias, (including ventricular arrhythmias such as torsade de pointes), cardiac arrests and sudden deaths in patients taking voriconazole. These cases usually involved seriously ill patients with multiple confounding risk factors, such as history of cardiotoxic chemotherapy, cardiomyopathy, hypokalemia and concomitant medications that may have been contributory.
Voriconazole should be administered with caution to patients with these potentially proarrhythmic conditions.
Rigorous attempts to correct potassium, magnesium and calcium should be made before starting voriconazole [see CLINICAL PHARMACOLOGY (12.3)].
5.6 Infusion Related Reactions During infusion of the intravenous formulation of voriconazole in healthy subjects, anaphylactoid-type reactions, including flushing, fever, sweating, tachycardia, chest tightness, dyspnea, faintness, nausea, pruritus and rash, have occurred uncommonly. Symptoms appeared immediately upon initiating the infusion. Consideration should be given to stopping the infusion should these reactions occur.
5.7 Laboratory Tests Electrolyte disturbances such as hypokalemia, hypomagnesemia and hypocalcemia should be corrected prior to initiation of VFEND therapy.
Patient management should include laboratory evaluation of renal (particularly serum creatinine) and hepatic function (particularly liver function tests and bilirubin).
5.8 Patients With Hepatic Impairment It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B) receiving VFEND [see CLINICAL PHARMACOLOGY (12.3), and DOSAGE AND ADMINISTRATION (2.6)].
VFEND has not been studied in patients with severe cirrhosis (Child-Pugh Class C). VFEND has been associated with elevations in liver function tests and clinical signs of liver damage, such as jaundice, and should only be used in patients with severe hepatic insufficiency if the benefit outweighs the potential risk. Patients with hepatic insufficiency must be carefully monitored for drug toxicity.
5.9 Patients With Renal Impairment In patients with moderate to severe renal dysfunction (creatinine clearance <50 mL/min), accumulation of the intravenous vehicle, SBECD, occurs. Oral voriconazole should be administered to these patients, unless an assessment of the benefit/risk to the patient justifies the use of intravenous voriconazole. Serum creatinine levels should be closely monitored in these patients, and if increases occur, consideration should be given to changing to oral voriconazole therapy [see CLINICAL PHARMACOLOGY (12.3), and DOSAGE AND ADMINISTRATION (2.7)].
5.10 Monitoring of Renal Function Acute renal failure has been observed in patients undergoing treatment with VFEND. Patients being treated with voriconazole are likely to be treated concomitantly with nephrotoxic medications and have concurrent conditions that may result in decreased renal function.
Patients should be monitored for the development of abnormal renal function. This should include laboratory evaluation, particularly serum creatinine.
5.11 Monitoring of Pancreatic Function Patients with risk factors for acute pancreatitis (e.g., recent chemotherapy, hematopoietic stem cell transplantation [HSCT]) should be monitored for the development of pancreatitis during VFEND treatment.
5.12 Dermatological Reactions Serious exfoliative cutaneous reactions, such as Stevens-Johnson syndrome, have been reported during treatment with VFEND. If a patient develops an exfoliative cutaneous reaction, VFEND should be discontinued.
In addition VFEND has been associated with photosensitivity skin reaction. Patients should avoid intense or prolonged exposure to direct sunlight during VFEND treatment. In patients with photosensitivity skin reactions squamous cell carcinoma of the skin and melanoma have been reported during long-term therapy. If a patient develops a skin lesion consistent with squamous cell carcinoma or melanoma, VFEND should be discontinued.
5.13 Skeletal Adverse Events Fluorosis and periostitis have been reported during long-term voriconazole therapy. If a patient develops skeletal pain and radiologic findings compatible with fluorosis or periostitis, voriconazole should be discontinued [see ADVERSE REACTIONS (6.4)].
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Voriconazole (injection) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Voriconazole (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Voriconazole (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Voriconazole (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Voriconazole (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Voriconazole (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Voriconazole (injection) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Voriconazole (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Voriconazole (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Voriconazole (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Voriconazole (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Voriconazole (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Voriconazole (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Voriconazole (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Voriconazole (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Voriconazole (injection) Administration in the drug label.
Monitoring
There is limited information regarding Voriconazole (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Voriconazole (injection) and IV administrations.
Overdosage
There is limited information regarding Voriconazole (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Voriconazole (injection) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Voriconazole (injection) Mechanism of Action in the drug label.
Structure
There is limited information regarding Voriconazole (injection) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Voriconazole (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Voriconazole (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Voriconazole (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Voriconazole (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Voriconazole (injection) How Supplied in the drug label.
Storage
There is limited information regarding Voriconazole (injection) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Voriconazole (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Voriconazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Voriconazole (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Voriconazole (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
For patient information, click here.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [4]
Overview
Category
Antifungal drug
US Brand Names
Vfend®
FDA Package Insert
Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Overdosage | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages