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VFEND is a triazole 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 spp. including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4)
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2 Dosage And Administration
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Recommended Dosing Regimen (2)
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3 Dosage Forms And Strengths
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Powder for Solution for Injection: 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium (SBECD). (3) Film-coated tablets: 50 mg, 200 mg voriconazole. (3) Powder for Oral Suspension: 40 mg voriconazole/mL. (3)
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Hypersensitivity to voriconazole or its excipients. To reduce risk of serious adverse events, do not use VFEND with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus (4, 7) To prevent loss of VFEND efficacy, do not use with rifampin, carbamazepine, long-acting barbiturates, ritonavir, rifabutin, ergot alkaloids, and St. John's Wort (4, 7)
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5 Warnings And Precautions
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Drug Interactions (5.1): review patient's concomitant medications. Several drugs may significantly alter voriconazole concentrations. Voriconazole may alter PK or PD of several drugs (7) Hepatic Toxicity (5.2): serious hepatic reactions have been reported. Evaluate liver function tests at the start of and during the course of voriconazole therapy Visual Disturbances (5.3): monitor visual function if treatment continues beyond 28 days Pregnancy Category D (5.4): do not administer to pregnant women Galactose Intolerance (5.5): do not administer to patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption Arrhythmias and QT Prolongation (5.6): administer with caution to patients with proarrhythmic conditions Infusion Related Reactions (5.7): anaphylactoid reactions have been reported Dermatological Reactions (5.13): exfoliative cutaneous reactions and photosensitivity have been reported Skeletal Events (5.14): fluorosis and periostitis have been reported with long-term voriconazole therapy
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Most frequent (all causalities, 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
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8 Use In Specific Populations
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Pregnant or nursing women: VFEND should not be used in pregnant or nursing women (8.1, 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)
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Inhibitors and inducers of CYP3A4, CYP2C9, and CYP2C19 may alter VFEND concentrations. Adjust the VFEND dose and monitor for adverse events or lack of efficacy (4, 7) VFEND may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of and monitor for lack of efficacy or adverse events associated with drugs that are substrates of these enzymes (4, 7)
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Created by
fda_medical_bot
on
1/7/2012
