Active Substance: voriconazole
Common Name: voriconazole
ATC Code: J02AC03
Marketing Authorisation Holder: Hospira UK limited
Active Substance: voriconazole
Authorisation Date: 2015-05-27
Therapeutic Area: Aspergillosis Bacterial Infections and Mycoses Candidiasis
Pharmacotherapeutic Group: Antimycotics for systemic use
Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
- treatment of invasive aspergillosis;
- treatment of candidaemia in 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.
Voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT)
What is Voriconazole Hospira and what is it used for?
Voriconazole Hospira is an antifungal medicine used for the treatment of adults and children over the age of two years who have the following infections caused by a fungus:
- invasive aspergillosis (a type of fungal infection due to Aspergillus);
- candidaemia (a type of fungal infection due to Candida) in patients with a normal white blood cell count;
- other 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).
When used for treating fungal infections, Voriconazole Hospira is intended mainly for patients with infections that are worsening and possibly life-threatening.
Voriconazole Hospira is also used to prevent fungal infections in patients who have had haematopoietic (blood) stem-cell transplantation (a transplant of a type of stem cells that can develop into blood cells) and are at high risk of infection.
Voriconazole Hospira contains the active substance voriconazole. It is a ‘generic medicine’. This means that Voriconazole Hospira is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Vfend.
How is Voriconazole Hospira used?
Voriconazole Hospira is available as a powder to be made up into a solution for infusion (drip) into a vein. It is given twice a day. The dose of Voriconazole Hospira depends on the weight of the patient.
Patients need to receive an initial higher dose (loading dose) on the first day. The aim of the loading dose is to attain effective blood levels quickly. The loading dose is then followed by a maintenance dose that can be adjusted according to the patient’s response. The dose may be increased or decreased according to how the patient responds.
Both the loading and the maintenance doses are given by infusion, but once patients improve prescribers should consider switching patients to a voriconazole medicine that can be given by mouth.
The medicine can only be obtained with a prescription.
How does Voriconazole Hospira work?
The active substance in Voriconazole Hospira, voriconazole, belongs to the ‘triazole’ class of antifungal medicines. It works by disrupting 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 Voriconazole Hospira is active can be found in the summary of product characteristics (also part of the EPAR).
How has Voriconazole Hospira been studied?
The company provided data from the published literature on voriconazole. No additional studies were needed as Voriconazole Hospira is a generic medicine that is given by infusion and contains the same active substance as the reference medicine Vfend.
What are the benefits and risks of Voriconazole Hospira?
Because Voriconazole Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Why is Voriconazole Hospira approved?
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Voriconazole Hospira has been shown to be comparable to Vfend. Therefore, the CHMP’s view was that, as for Vfend, the benefit outweighs the identified risk. The Committee recommended that Voriconazole Hospira be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Voriconazole Hospira?
A risk management plan has been developed to ensure that Voriconazole Hospira 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 Hospira, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information can be found in the summary of the risk management plan.
Other information about Voriconazole Hospira
The European Commission granted a marketing authorisation valid throughout the European Union for Voriconazole Hospira on 27 May 2015.
For more information about treatment with Voriconazole Hospira, 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.