Active Substance: voriconazole
Common Name: voriconazole
ATC Code: J02AC03
Marketing Authorisation Holder: Pfizer Limited
Active Substance: voriconazole
Authorisation Date: 2002-03-19
Therapeutic Area: Aspergillosis Candidiasis Mycoses
Pharmacotherapeutic Group: Antimycotics for systemic use
Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated as follows:
- treatment of invasive aspergillosis;
- treatment of in candidaemia non-neutropenic patients;
- treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);
- Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.
Vfend should be administered primarily to patients with progressive, possibly life-threatening infections.
What is Vfend?
Vfend is a medicine that contains the active substance voriconazole. It is available as tablets (50 mg or 200 mg), as an oral suspension (40 mg/ml) and as a powder to be made up into a solution for infusion (drip into a vein).
What is Vfend used for?
Vfend is an antifungal medicine. It is used for the treatment of adults and children over the age of two years with:
- invasive aspergillosis (a type of fungal infection due to Aspergillus);
- candidaemia (another type of fungal infection due to Candida) in non-neutropenic patients (patients with a normal white-blood-cell count);
- serious invasive Candida infections when the fungus is resistant to fluconazole (another antifungal medicine);
- serious fungal infections caused by Scedosporium or Fusarium (two different types of fungus).
Vfend is intended for patients with worsening, possibly life-threatening, fungal infections.
The medicine can only be obtained with a prescription.
How is Vfend used?
Vfend is given twice a day. The dose of Vfend to use depends on the weight of the patient and on which formulation of the medicine is used. Patients need to receive an initial higher dose (loading dose) on the first day of treatment. The aim of the loading dose is to reach stable blood levels. The loading dose is then followed by a maintenance dose that can be adjusted according to the patientâ€™s response. The dose may be increased or decreased according to how the patient responds.
In adults, both the loading and the maintenance doses can be given by infusion or by mouth using either the tablets or the suspension, but in children it is recommended to start treatment with the infusion and to consider switching to the suspension if an improvement is seen. The tablets and suspension are to be taken at least one hour before or after a meal.
For full information, see the package leaflet.
How does Vfend work?
The active substance in Vfend, voriconazole, is an antifungal medicine that belongs to the â€˜triazoleâ€™ group. It works by preventing the formation of ergosterol, which is an important part of fungal cell membranes. Without ergosterol, the fungus is killed or prevented from spreading. The list of fungi against which Vfend is active can be found in the summary of product characteristics (also part of the EPAR).
How has Vfend been studied?
The study of Vfend in invasive aspergillosis involved 277 immunocompromised patients (patients whose immune system was not working properly). Vfend was compared with amphotericin B (another antifungal medicine).
The study of Vfend in candidaemia compared Vfend with a treatment of amphotericin B followed by fluconazole in 370 patients.
Vfend has also been studied in serious refractory Candida infections in 55 patients, in scedosporiosis in 38 patients, and in fusariosis in 21 patients. â€˜Refractoryâ€™ means that the infections were not responding to treatment. Most patients receiving Vfend treatment for these rare infections did not tolerate or did not respond to prior treatment with other antifungal medicines.
Vfend has also been studied in 285 children.
The main measure of effectiveness in all studies was the number of patients who had a complete or partial response to treatment.
What benefit has Vfend shown during the studies?
In invasive aspergillosis, the proportion of patients responding to treatment was higher with Vfend than with amphotericin B (53% versus 31%). The survival for voriconazole was significantly greater than that for amphotericin B.
For candidaemia, the percentage of responders to Vfend treatment at the end of therapy was the same as for the comparator (72%).
A successful outcome was seen in 44% of the patients with serious refractory Candida infections (24 out of 55). In most of these (15 out of 24), the response was complete.
In the treatment of scedosporiosis and fusariosis, 28 out of 59 patients had a complete or partial response to treatment.
What is the risk associated with Vfend?
The most common side effects with Vfend (seen in more than 1 patient in 10) are peripheral oedema (swelling of the arms and legs), headache, visual disturbances (including blurred vision, changes in colour perception and excessive sensitivity to light), abdominal pain (stomach ache), nausea (feeling sick), vomiting, diarrhoea, rash and pyrexia (fever). For the full list of all side effects reported with Vfend, see the package leaflet.
Vfend must not be used in people who are hypersensitive (allergic) to voriconazole or any of the other ingredients. Vfend must not be used in patients who are taking any of the following medicines:
- terfenadine, astemizole (commonly used for allergy â€“ these medicines may be available without a prescription);
- cisapride (used for stomach problems);
- pimozide (used to treat mental illnesses);
- quinidine (used for irregular heart beat);
- rifampicin (used to treat tuberculosis);
- carbamazepine (used to treat seizures [fits]);
- phenobarbital (used for severe insomnia and seizures);
- ritonavir (used to treat HIV infection) at doses of 400 mg or more twice a day;
- ergot alkaloids such as ergotamine and dihydroergotamine (used to treat migraine headache);
- sirolimus (used in transplant patients);
- St Johnâ€™s wort (a herbal preparation used to treat depression);
- high-dose efavirenz (used to treat HIV infection).
Caution is also needed when Vfend is taken at the same time as other medicines. See the package leaflet for full details.
Why has Vfend been approved?
The CHMP decided that Vfendâ€™s benefits are greater than its risks and recommended that it be given marketing authorisation.
Other information about Vfend
The European Commission granted a marketing authorisation valid throughout the European Union for Vfend on 19 March 2002.
For more information about treatment with Vfend, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.