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Film-coated tablets (50mg and 200mg):
VFEND film-coated tablets are to be taken at least one hour before, or one hour following, a meal.
Powder for oral suspension:
VFEND oral suspension (40mg/mL) is to be taken at least one hour before, or two hours following, a meal.
Powder for solution for infusion:
VFEND requires reconstitution and dilution (see section 6.6) prior to administration as an intravenous infusion. Not for bolus injection.
It is recommended that VFEND is administered at a maximum rate of 3 mg/kg per hour over 1 to 2 hours.
Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.4).
VFEND must not be infused into the same line or cannula concomitantly with other intravenous products. VFEND must not be administered simultaneously with any blood product or any short-term infusion of concentrated solutions of electrolytes, even if the two infusions are running in separate lines. Total parenteral nutrition (TPN) need not be discontinued when prescribed with VFEND, but does need to be infused through a separate line (see section 6.2).
Use in adults and adolescents (12 to 16 years of age)
Therapy must be initiated with the specified loading dose regimen of either intravenous or oral VFEND to achieve plasma concentrations on Day 1 that are close to steady state. On the basis of the high oral bioavailability (96 %; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
Detailed information on dosage recommendations is provided in the following table:
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Intravenous
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Oral (Tablets and Suspension)
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Patients 40 kg and above
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Patients less than 40 kg
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Loading Dose Regimen (first 24 hours)
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6 mg/kg every 12 hours (for the first 24 hours)
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400 mg (10 ml) every 12 hours (for the first 24 hours)
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200 mg (5 ml) every 12 hours (for the first 24 hours)
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Maintenance Dose (after first 24 hours)
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4 mg/kg twice daily
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200 mg (5 ml) twice daily
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100 mg (2.5 ml) twice daily
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Dosage adjustment
Film-coated tablets & Powder for oral suspension:
If patient response is inadequate, the maintenance dose may be increased to 300 mg twice daily for oral administration. For patients less than 40 kg the oral dose may be increased to 150 mg twice daily.
If patients are unable to tolerate treatment at these higher doses reduce the oral dose by 50 mg steps to the 200 mg twice daily (or 100 mg twice daily for patients less than 40 kg) maintenance dose.
Phenytoin may be co-administered with voriconazole if the maintenance dose of voriconazole is increased from 200 mg to 400 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Rifabutin may be co-administered with voriconazole if the maintenance dose of voriconazole is increased from 200 mg to 350 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Efavirenz may be co-administered with voriconazole if the maintenance dose of voriconazole is increased to 400 mg every 12 hours and the efavirenz dose is reduced by 50%, i.e. to 300 mg once daily. When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see sections 4.4 and 4.5).
Treatment should be as short as possible depending on the patients' clinical and mycological response.
For long term treatment greater than 6 months, a careful assessment of the benefit-risk balance should be considered. See section 4.4 Special warnings and precautions for use (Dermatological adverse events) and section 5.1 Pharmacodynamic properties (Duration of treatment).
Powder for solution for infusion: |
