Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

CompletedOBSERVATIONAL
Enrollment

1,002

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Systemic Mycosis
Interventions
DRUG

Voriconazole

"Voriconazole Intravenous Solution 200 mg:~Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults.~Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg:~administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward.~Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased.~However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily.~In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward.~Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY