VFEND is an azole antifungal drug indicated for use in the treatment of:

• Invasive aspergillosis (1.1)
• Candidemia (nonneutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall, and wounds (1.2)
• Esophageal candidiasis (1.3)
• Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4)

• Adult patients weighing less than 40 kg: oral maintenance dose 100 or 150 mg q12 hours
• See full prescribing information for instructions on reconstitution of lyophilized powder for intravenous use and reconstitution of oral suspension and important administration instructions (2.5, 2.6)

• Tablets: 50 mg, 200 mg (3)
• For Oral Suspension: 45 grams of powder; after reconstitution 40 mg/mL (3)
• For Injection: lyophilized powder containing 200 mg voriconazole and 3200 mg of sulfobutyl ether beta-cyclodextrin sodium (SBECD); after reconstitution 10 mg/mL of voriconazole and 160 mg/mL of SBECD (3)

• Hypersensitivity to voriconazole or its excipients (4)
• Coadministration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions (4, 7)
• Coadministration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids, and St. John's Wort due to risk of loss of efficacy (4, 7)

• Clinically Significant Drug Interactions: Review patient's concomitant medications (5.1, 7)
• Hepatic Toxicity: Serious hepatic reactions reported. eva luate liver function tests at start of and during voriconazole therapy (5.2)
• Visual Disturbances (including optic neuritis and papilledema): Monitor visual function if treatment continues beyond 28 days (5.3)
• Embryo-Fetal Toxicity: Do not administer to pregnant women unless the benefit to the mother outweighs the risk to the fetus. Inform pregnant patient of hazard (5.4, 8.1)
• Patients with Hereditary Galactose Intolerance Lapp Lactase Deficiency or Glucose-Galactose Malabsorption: Do not use (5.5)
• Arrhythmias and QT Prolongation: Correct potassium, magnesium and calcium prior to use; caution patients with proarrhythmic conditions (5.6)
• Infusion Related Reactions (including anaphylaxis): Stop the infusion (5.7)
• Dermatological Reactions: Discontinue for exfoliative cutaneous reactions or phototoxicity. Avoid sunlight due to risk of photosensitivity (5.13)
• Skeletal Events: Fluorosis and periostitis with long-term voriconazole therapy. Discontinue if these events occur (5.14)

Most common adverse reactions (incidence ≥2%): visual disturbances, fever, nausea, rash, vomiting, chills, headache, liver function test abnormal, tachycardia, hallucinations (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

• CYP3A4, CYP2C9, and CYP2C19 inhibitors and inducers: Adjust VFEND dosage and monitor for adverse reactions or lack of efficacy (4, 7)
• VFEND may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce dosage of these other drugs and monitor for adverse reactions (4, 7)
• Phenytoin or Efavirenz: with co-administration, increase maintenance oral and intravenous dosage of VFEND (2.3, 7)

• Pregnant women: Do not administer to pregnant women unless the benefit to the mother outweighs the risk to the fetus. Inform pregnant woman of risk (8.1)
• Nursing women: Discontinue VFEND or discontinue nursing (8.3)
• Pediatrics: Safety/effectiveness in patients <12 years has not been established (8.4)
• Hepatic impairment: Use half the maintenance dose in patients with mild to moderate hepatic impairment (Child-Pugh Class A and B) (2.7)
• Renal impairment: Avoid intravenous administration in patients with moderate to severe renal impairment (creatinine clearance <50 mL/min) (2.8)