VFEND 200 mg film-coated tablets

ATC Code
J02AC03
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About this drug

Admission country
Manufacturer Pfizer Limited
Narcotic drug No
Psychotropic No
Anatomical group Antiinfektiva zur systemischen anwendung
Therapeutic group Antimykotika zur systemischen anwendung
Pharmacological group Antimykotika zur systemischen anwendung
Chemical group Triazol-derivate
Substance Voriconazol

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All to know

Author

Pfizer Limited

What is it?

VFEND contains the active substance voriconazole. It is available as white tablets, which contain 50 mg or 200 mg of voriconazole, as an oral suspension, which contains 40 mg/ml of voriconazole, and as a white powder to be made into a solution for infusion (drip into a vein).

What is it used for?

VFEND is an antifungal medicine. It is used for the treatment of patients (adults and children over the age of 2) with:

  • invasive aspergillosis (a type of fungal infection due to Aspergillus sp ),
  • candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients with a normal white blood cells count),
  • serious invasive Candida sp. infections when the fungus is resistant to fluconazole (another antifungal medicine),
  • serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi). VFEND is intended for patients with worsening, possibly life-threatening, fungal infections. The medicine can only be obtained with a prescription.

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How is it used?

VFEND is given twice daily. The dosage of VFEND to use depends on the weight of the patient and on the presentation used; for the full information, please see the Package Leaflet. Patients need to receive a loading dose on the first day of treatment. The aim of the loading dose is to reach ?steady state? (stable) blood levels. The loading dose is then followed by a maintenance dose that can be adjusted according to the patient?s response. There is no need of a loading dose in children aged between 2 and 12 years.
Both the loading and the maintenance dose can be given by infusion or orally, using either the tablets or the suspension, but the use of the suspension is recommended in children aged between 2 and 12 years. The tablets and suspension are to be taken at least one hour before, or one hour following, a meal.

How does it work?

The active substance in VFEND, voriconazole, is an antifungal medicine that belongs to the group of the triazoles. 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.

How has it been studied?

The study of VFEND in invasive aspergillosis involved 277 immunocompromised patients (their immune system was not working properly). VFEND was compared with amphotericin B (another antifungal medicine). The study of VFEND in candidaemia (370 patients) compared VFEND with a treatment of amphotericin B followed by fluconazole. VFEND has also been studied in serious refractory Candida infections (55 patients), in scedosporiosis (38 patients) and in fusariosis (21 patients) . Most patients receiving VFEND treatment for these rare infections did not tolerate or did not respond to prior treatment with other antifungal therapy. VFEND has also been studied in 61 children. The main measure of effectiveness in all studies was complete or partial response to treatment.

What benefits has it shown during the studies?

In invasive aspergillosis, the percentage 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 24/55 (43.6%) subjects with serious refractory Candida infections. In most of these (15/24), the response was complete. In the treatment of scedosporiosis and fusariosis, the overall response was 28/59 patients.

What is the risk associated?

The most commonly reported side effects are visual disturbances, fever, rash, nausea, vomiting, diarrhoea, headache, and swelling of the extremities. Stomach pains and changes in stools should be reported to a doctor. For the full list of all side effects reported with VFEND, please see the Package Leaflet.
VFEND should not be used in people who may be hypersensitive (allergic) to voriconazole or any of the other ingredients. VFEND should not be used in patients who are taking any of the following medicines:

  • Terfenadine, astemizole (used for allergy)
  • 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)
  • Phenobarbital (used for severe insomnia and seizures)
  • Ergot alkaloids (e.g. ergotamine, dihydroergotamine; used for migraine)
  • Sirolimus (used in transplant patients)
  • Efavirenz (used to treat HIV infection)
  • Ritonavir (used to treat HIV infection) in doses of 400 mg or more twice daily Caution is also needed when VFEND is taken at the same time as other medicines, see the Package Leaflet for full details.

Why has it been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that VFEND?s benefits are greater than its risks for treatment of serious fungal infections, especially in patients with life-threatening infection. They recommended that VFEND be given marketing authorisation.

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