What is Voriconazole Accord - Voriconazole used for and what is it used for?
Voriconazole Accord is an antifungal medicine that contains the active substance voriconazole . It is used to treat adults and children over the age of two with:
- invasive aspergillosis (a type of fungal infection from Aspergillus);
- candidemia (a type of Candida fungal infection) in non-neutropenic patients (ie with a normal white blood cell count);
- severely invasive Candida infections, when the fungus is resistant to fluconazole (another anti-fungal medicine);
- severely invasive infections with Scedosporium or Fusarium (two different types of fungi
Voriconazole Accord is intended for patients with fungal infections that are worsening and potentially lethal. Voriconazole Accord is a "generic medicine". This means that Voriconazole Accord is similar to a 'reference medicine' already authorized in the European Union (EU) called Vfend. For more information on generic medicines, see the questions and answers by clicking here.
How is Voriconazole Accord - Voriconazole used?
Voriconazole Accord is available as tablets (50 mg and 200 mg) and is taken twice a day. The dose of Voriconazole Accord to be taken depends on the weight of the patient and the formulation of the medicine used. Therapy should be started with a higher starting dose (loading dose) on the first day of treatment. The purpose of the loading dose is to stabilize blood levels. The loading dose is then followed by a maintenance dose, which can be adjusted based on the patient's response, increasing or decreasing it based on the patient's response. In adults both doses of voriconazole, from loading and maintenance, can be administered by infusion or by mouth, using tablets or suspension; in children, however, it is recommended to start treatment with the infusion, considering whether to switch to suspension if an improvement is observed. Tablets and suspension should be taken at least one hour before or after meals. For more information, see the package leaflet. The medicine can only be obtained with a prescription.
How does Voriconazole Accord - Voriconazole work?
The active substance of Voriconazole Accord, voriconazole, is an antifungal medicine belonging to the group of "triazoles". It works by preventing the formation of ergosterol, an important constituent of fungi cell membranes. Without ergosterol the fungi die or are no longer able to spread. The list of fungi against which Voriconazole Accord is active is contained in the summary of product characteristics (included with EPAR).
How has Voriconazole Accord - Voriconazole been studied?
Because Voriconazole Accord is a generic medicine, studies in patients have been limited to tests to demonstrate its bioequivalence to the reference medicine, Vfend. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Voriconazole Accord - Voriconazole?
Because Voriconazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Voriconazole Accord - Voriconazole been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Voriconazole Accord has been shown to have comparable quality and to be bioequivalent to Vfend. Therefore, the CHMP considered that, as in the case of Vfend, the benefits outweigh the identified risks and recommended to approve the use of Voriconazole Accord in the EU.
What measures are being taken to ensure the safe and effective use of Voriconazole Accord - Voriconazole?
A risk management plan has been developed to ensure that Voriconazole Accord is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Voriconazole Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information on Voriconazole Accord - Voriconazole
On 16 May 2013, the European Commission issued a marketing authorization for Voriconazole Accord, valid throughout the European Union. For more information about Voriconazole Accord therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website. Last update of this summary: 05-2013.
