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VFEND®Highlights (voriconazole)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use VFEND safely and effectively. See full prescribing information for VFEND.

VFEND® (voriconazole) tablets, for oral use
VFEND® (voriconazole) for oral suspension
VFEND® (voriconazole) for injection, for intravenous use
Initial U.S. Approval: 2002

RECENT MAJOR CHANGES

Contraindications (4)4/2021
Warnings and Precautions (5.5)9/2020
Warnings and Precautions (5.8)1/2021

INDICATIONS AND USAGE

VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with:

  • Invasive aspergillosis (1.1)
  • Candidemia in non-neutropenics and other deep tissue Candida infections (1.2)
  • Esophageal candidiasis (1.3)
  • Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4)

DOSAGE AND ADMINISTRATION

  • Dosage in Adults (2.3)
InfectionLoading doseMaintenance Dose
Intravenous infusionIntravenous infusionOral
Invasive Aspergillosis6 mg/kg every 12 hours for the first 24 hours4 mg/kg every 12 hours200 mg every 12 hours
Candidemia in nonneutropenics and other deep tissue Candida infections3–4 mg/kg every 12 hours200 mg every 12 hours
Scedosporiosis and Fusariosis4 mg/kg every 12 hours200 mg every 12 hours
Esophageal CandidiasisNot EvaluatedNot Evaluated200 mg every 12 hours
  • Adult patients weighing less than 40 kg: oral maintenance dose 100 mg or 150 mg every 12 hours
  • Hepatic Impairment: Use half the maintenance dose in adult patients with mild to moderate hepatic impairment (Child-Pugh Class A and B) (2.5)
  • Renal Impairment: Avoid intravenous administration in adult patients with moderate to severe renal impairment (creatinine clearance <50 mL/min) (2.6)
  • Dosage in Pediatric Patients 2 years of age and older (2.4)
  • For pediatric patients 2 to less than 12 years of age and 12 to 14 years of age weighing less than 50 kg see Table below.
InfectionLoading DoseMaintenance Dose
Intravenous infusionIntravenous infusionOral
Invasive Aspergillosis 9 mg/kg every12 hours for the first 24 hours8 mg/kg every 12 hours after the first 24 hours9 mg/kg every 12 hours
(maximum dose of 350 mg every 12 hours)
Candidemia in nonneutropenics and other deep tissue Candida infections
Scedosporiosis and Fusariosis
Esophageal CandidiasisNot Evaluated4 mg/kg every 12 hours9 mg/kg every 12 hours
(maximum dose of 350 mg every 12 hours)
  • For pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight use adult dosage. (2.4)
  • Dosage adjustment of VFEND in pediatric patients with renal or hepatic impairment has not been established (2.5, 2.6)
  • See full prescribing information for instructions on reconstitution of VFEND lyophilized powder for intravenous use and reconstitution of VFEND oral suspension and important administration instructions (2.1, 2.6, 2.7)

DOSAGE FORMS AND STRENGTHS

  • Tablets: 50 mg, 200 mg (3)
  • For Oral Suspension: 40 mg/mL (200 mg/5 mL) when reconstituted (3)
  • For Injection: Lyophilized powder containing 200 mg of voriconazole and 3,200 mg of sulfobutyl ether beta-cyclodextrin sodium (SBECD); after reconstitution 10 mg/mL of voriconazole and 160 mg/mL of SBECD (3)

CONTRAINDICATIONS

  • Hypersensitivity to voriconazole or its excipients (4)
  • Coadministration with cisapride, pimozide, quinidine, sirolimus or ivabradine 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)
  • Coadministration with naloxegol due to risk of adverse reactions (4, 7)
  • Coadministration with tolvaptan due to risk of adverse reactions (4, 7)
  • Coadministration of voriconazole with venetoclax at initiation and during the ramp-up phase in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) due to increased risk of adverse reactions (4, 7)

WARNINGS AND PRECAUTIONS

  • Hepatic Toxicity: Serious hepatic reactions reported. Evaluate liver function tests at start of and during VFEND therapy (5.1)
  • Arrhythmias and QT Prolongation: Correct potassium, magnesium and calcium prior to use; caution patients with proarrhythmic conditions (5.2)
  • Infusion Related Reactions (including anaphylaxis): Stop the infusion (5.3)
  • Visual Disturbances (including optic neuritis and papilledema): Monitor visual function if treatment continues beyond 28 days (5.4)
  • Severe Cutaneous Adverse Reactions: Discontinue for exfoliative cutaneous reactions (5.5)
  • Photosensitivity: Avoid sunlight due to risk of photosensitivity (5.6)
  • Adrenal Dysfunction: Carefully monitor patients receiving VFEND and corticosteroids (via all routes of administration) for adrenal dysfunction both during and after VFEND treatment. Instruct patients to seek immediate medical care if they develop signs and symptoms of Cushing's syndrome or adrenal insufficiency (5.8)
  • Embryo-Fetal Toxicity: Voriconazole can cause fetal harm when administered to a pregnant woman. Inform pregnant patients of the potential hazard to the fetus. Advise females of reproductive potential to use effective contraception during treatment with VFEND (5.9, 8.1, 8.3)
  • Skeletal Adverse Reactions: Fluorosis and periostitis with long-term voriconazole therapy. Discontinue if these adverse reactions occur (5.12)
  • Clinically Significant Drug Interactions: Review patient's concomitant medications (5.13, 7)
  • Patients with Hereditary Galactose Intolerance, Lapp Lactase Deficiency or Glucose-Galactose Malabsorption: VFEND tablets should not be given to these patients because it contains lactose (5.14)

ADVERSE REACTIONS

  • Adult Patients: The most common adverse reactions (incidence ≥2%) were visual disturbances, fever, nausea, rash, vomiting, chills, headache, liver function test abnormal, tachycardia, hallucinations (6)
  • Pediatric Patients: The most common adverse reactions (incidence ≥5%) were visual disturbances, pyrexia, vomiting, epistaxis, nausea, rash, abdominal pain, diarrhea, hypertension, hypokalemia, cough, headache, thrombocytopenia, ALT abnormal, hypotension, peripheral edema, hyperglycemia, tachycardia, dyspnea, hypocalcemia, hypophosphatemia, LFT abnormal, mucosal inflammation, photophobia, abdominal distention, constipation, dizziness, hallucinations, hemoptysis, hypoalbuminemia, hypomagnesemia, renal impairment, upper respiratory tract infection (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.

DRUG INTERACTIONS

  • 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, 2.7, 7)

USE IN SPECIFIC POPULATIONS

  • Pediatrics: Safety and effectiveness in patients younger than 2 years has not been established (8.4)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 4/2021

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