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VFEND is a brand name for Voriconazole, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VFEND (voriconazole) is indicated for: • Invasive aspergillosis • Candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall and wounds (see 14 CLINICAL TRIALS and 15 MICROBIOLOGY). 1.1 Pediatrics Pediatrics (<12 years of…
Verbatim from this product's HC label. Tap a section to expand.
2024-05 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ...............................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 7 4 DOSAGE AND ADMINISTRATION .................................................................................
14 5 OVERDOSAGE............................................................................................................ 14
, 4 DOSAGE AND ADMINISTRATION, 10 CLINICAL PHARMACOLOGY). 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 A and B) receiving voriconazole (see above under Hepatic/Biliary/Pancreatic, 8 ADVERSE REACTIONS, 4 DOSAGE AND ADMINISTRATION, 10 CLINICAL PHARMACOLOGY).
Safety and efficacy of reduced voriconazole dosing in this setting is not established. Due to the small number of subjects studied, close clinical monitoring is advised. Voriconazole has not been studied in patients with severe cirrhosis (Child-Pugh Class C).
Voriconazole 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. , recent chemotherapy, hematopoietic stem cell transplantation [HSCT]), should be monitored for development of pancreatitis during voriconazole treatment.
Monitoring and Laboratory Tests Patient management should include periodic laboratory evaluation of renal function (particularly serum creatinine). Product Monograph VFEND (voriconazole) Page 19 of 75 Patients receiving voriconazole must be carefully monitored for hepatic toxicity.
Clinical management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin) at the initiation of treatment with voriconazole and at least weekly for the first month of treatment. If treatment is continued, monitoring frequency can be reduced to monthly if there are no changes in the liver function tests.
Electrolyte disturbances such as hypokalemia, hypomagnesemia and hypocalcemia should be monitored and corrected, if necessary, prior to initiation of and during voriconazole therapy (see 4 DOSAGE AND ADMINISTRATION). Musculoskeletal Non-infectious periostitis with elevated fluoride and alkaline phosphatase levels has been reported in transplant patients.
, 14 CLINICAL TRIALS and 10 CLINICAL PHARMACOLOGY). 2 Geriatrics Evidence from clinical studies and experience suggests that safety and effectiveness of VFEND are similar in geriatric and adult subjects (see 7 WARNINGS AND PRECAUTIONS, 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY).
2 CONTRAINDICATIONS • VFEND is contraindicated in patients with known hypersensitivity to voriconazole or its excipients. For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph.
• There is no information regarding cross-sensitivity between voriconazole and other azole antifungal agents. Caution should be used when prescribing VFEND to patients with hypersensitivity to other azoles. • As an inhibitor of the cytochrome P450 isozymes CYP2C19, CYP2C9 and CYP3A4, voriconazole is contraindicated for coadministration with drugs that are highly dependent on these isozymes for clearance and for which elevated plasma concentrations are associated with serious and/or life threatening events.
These drugs are listed in Table 1. • As a substrate of the cytochrome P450 isozymes CYP2C19, CYP2C9 and CYP3A4, voriconazole is contraindicated for coadministration with drugs that significantly decrease voriconazole plasma concentrations due to induction of these isoenzymes, which may increase the potential for serious and/or life-threatening events (see 9 DRUG INTERACTIONS).
These drugs are listed in Table 1.
Product Monograph VFEND (voriconazole) Page 5 of 75 Table 1:
Drugs That Are Contraindicated with VFEND Drug class Drugs within class that are Contraindicated with VFEND Clinical comment Antiarrhythmic agents quinidine CONTRAINDICATED due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias Aldosterone antagonist finerenone CONTRAINDICATED since it may result in significant increases in finerenone exposure and the potential for serious adverse reactions Aldosterone antagonist eplerenone CONTRAINDICATED due to voriconazole’s effect in significantly increasing plasma exposure of eplerenone Anticonvulsants carbamazepine, long acting barbiturates CONTRAINDICATED due to potential to significantly reduce plasma voriconazole concentrations Antimycobacterial rifampin, rifabutin CONTRAINDICATED due to effect in significantly reducing plasma concentration of voriconazole Antipsychotic lurasidone, pimozide CONTRAINDICATED since voriconazole may result in significant increases in exposure and the potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
2026-04 2 CONTRAINDICATIONS 2024-12
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If a patient develops skeletal pain and radiologic findings compatible with fluorosis or periostitis, voriconazole should be discontinued. Ophthalmologic Voriconazole may cause visual symptoms including photophobia altered/enhanced visual perception, blurred vision and/or color vision change.
The majority of visual symptoms appeared to spontaneously resolve within 60 minutes. The effect of VFEND (voriconazole) on visual function is not known if treatment continues beyond 28 days. If treatment continues beyond 28 days, visual function including visual acuity, visual field and color perception should be monitored.
There has been a small number of post-marketing reports of vision loss (including decreased visual acuity or visual fields) where a relationship to voriconazole could not be excluded. These events mostly occurred in medically complex patients, where underlying disease processes and the primary infections themselves confound interpretation (see below under 8 ADVERSE REACTIONS).
There have been post-marketing reports of prolonged visual adverse events, including optic neuritis and papilledema. These events occurred primarily in severely ill patients who had underlying conditions and/or concomitant medications which may have caused or contributed to these events (see 8 ADVERSE REACTIONS – Post-Market Adverse Reactions).
Renal Acute renal failure has been observed in severely ill patients undergoing treatment with voriconazole. 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 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.
Renal function (including serum creatinine levels and creatinine clearance) should be closely monitored in these patients, and if significant changes occur, consideration should be given to changing to oral voriconazole therapy (see 4 DOSAGE AND ADMINISTRATION, 10 CLINICAL PHARMACOLOGY).
1. Pregnant Women). Product Monograph VFEND (voriconazole) Page 20 of 75 • Fertility No effects on fertility were observed in the rat study performed with VFEND at exposures similar to those obtained in humans at therapeutic doses. • Teratogenic Risk VFEND can cause fetal harm when administered to a pregnant woman.
In animals, voriconazole administration was associated with fetal malformation, embryotoxicity, increased gestational length, dystocia, and embryomortality (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicity). Sensitivity/Resistance Voriconazole does not have activity against Zygomycete spp in vitro (see 15 MICROBIOLOGY).
Cases of breakthrough zygomycosis, most fatal, have been reported in patients who had received voriconazole. 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. Other symptoms, including hypotension, were considered to be infusion related in the clinical trial setting.
Skin There have been cases of severe […]
BCL-2 Inhibitor venetoclax CONTRAINDICATED at initiation and during ramp-up phase of treatment with venetoclax Benzodiazepines triazolam and orally administered midazolam CONTRAINDICATED as it may result in significant increases in exposure and the potential for serious adverse reactions, including prolonged or increased sedation, respiratory depression and impaired coordination Ergot derivatives dihydroergotamine CONTRAINDICATED due to potential for serious and/or life-threatening reactions such as ergotism HCN Channel Blockers ivabradine CONTRAINDICATED due to potential for serious and/or life-threatening reactions such as cardiac arrhythmias Herbal Products St.
John’s Wort** CONTRAINDICATED due to its effect in Product Monograph VFEND (voriconazole) Page 6 of 75 Table 1: Drugs That Are Contraindicated with VFEND Drug class Drugs within class that are Contraindicated with VFEND Clinical comment (hypericum perforatum) significantly reducing plasma exposure of voriconazole Hypnotic eszopiclone CONTRAINDICATED in elderly patients (≥ 65 years of age) as concomitant administration might significantly increase plasma concentrations of eszopiclone and its sedative effect.
Immunosuppressant sirolimus CONTRAINDICATED due to voriconazole’s effect in significantly increasing plasma exposure of sirolimus Opioid receptor antagonist naloxegol CONTRAINDICATED due to voriconazole’s potential to significantly increase plasma concentrations of naloxegol which may precipitate opioid withdrawal symptoms Protease inhibitor ritonavir (high dose) CONTRAINDICATED due to its effect in significantly reducing plasma exposure of voriconazole Non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (doses of 400 mg once daily or higher) CONTRAINDICATED due to its effect in significantly reducing plasma exposure of voriconazole Statins lovastatin and simvastatin CONTRAINDICATED as it might increase the risk of statin-associated adverse reactions, including myopathy and rhabdomyolysis Vasopressin V2 receptor antagonist tolvaptan CONTRAINDICATED because voriconazole may significantly increase plasma concentrations of tolvaptan and the potential for serious adverse reactions ** also P-gp inducer Product Monograph VFEND (voriconazole) Page 7 of 75 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Drug Interactions (see 2 CONTRAINDICATIONS and 9 DRUG INTERACTIONS) - voriconazole significantly increases plasma concentrations of CYP450 substrates which may lead to serious or life threatening events - coadministration with CYP450 inducers significantly decreases plasma concentrations of voriconazole • Cardiovascular effects - QT interval prolongation VFEND has been associated with prolongation of the QT interval of the electrocardiogram in some patients.
Prolongation of QT interval may increase the risk of arrhythmia. During the clinical development and post-marketing surveillance, there have been rare cases of arrhythmias (including ventricular arrhythmia such as torsades de pointes), cardiac arrests and sudden deaths in patients taking voriconazole.
These cases usually involved patients with risk factors and concomitant medications that may have been contributory. Caution should be exercised if voriconazole is used in patients taking other drugs that may prolong the QT interval (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular) • Visual disturbances: Voriconazole […]