What is it and how is it used?
VFEND belongs to a group of medicines called triazole antifungal agents. These medicines are used to treat a wide variety of fungal infections. VFEND works by killing or stopping the growth of the fungi that cause infections.
What fungal infections are treated with VFEND?
VFEND is used to treat serious fungal infections caused by Aspergillus, Scedosporium, Fusarium, fluconazole-resistant Candida, and candidaemia in patients with normal white blood cell counts.
This product should only be used under the supervision of a doctor.
VFEND is mainly for use in seriously ill patients.
What do you have to consider before using it?
Do not take VFEND:
It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription. Some medicines affect the way VFEND works, or VFEND may affect the way they work.
A list of the medicines that may affect VFEND is shown in the section ‘Taking other medicines with VFEND’. However, the medicines in the following list must not be taken during your VFEND treatment:
Take special care with VFEND:
Taking other medicines with VFEND:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those that are obtained without a prescription.
Some medicines, when taken at the same time as VFEND, may affect the way VFEND works or VFEND may affect the way they work. Tell your doctor if you are taking any of the following medicines, as VFEND must not be taken if you are already taking any of these medicines (See also Section 2 above ‘Do not take VFEND):
Tell your doctor if you are taking the following medicine, as treatment with VFEND at the same time should be avoided if possible:
Tell your doctor if you are taking either of the following medicines, as treatment with VFEND at the same time should be avoided if possible, and a dose adjustment of voriconazole may be required:
Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines and/ or VFEND are still having the desired effect:
effects such as nausea and menstrual disorders)
Before being treated with VFEND, tell your doctor if:
While being treated with VFEND:
Pregnancy and breast-feeding:
VFEND must not be used during pregnancy, unless indicated by your doctor. Effective contraception must be used in women of childbearing potential. Contact your doctor immediately if you become pregnant while being treated with VFEND.
VFEND must not be used during breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine whilst breast-feeding.
Driving and using machines:
VFEND may cause blurring of vision or uncomfortable sensitivity to light. While affected, do not drive or operate any tools or machines. Tell your doctor if you experience this.
Important information about some of the ingredients of VFEND
Each vial of VFEND contains 217.6 mg of sodium per vial. This should be taken into consideration if you are on a strictly controlled sodium diet.
How is it used?
Always take VFEND exactly as your doctor has told you. You should check with your doctor if you are not sure.
Your doctor will determine your dose depending on your weight and the type of infection you have.
Your doctor may change your dose depending on your condition.
The usual dose for adults (including elderly patients) is as follows:
Intravenous
6 mg/kg every 12 hours for
Dose for the first 24 hours the
(Loading Dose) first 24 hours
Depending on your response to treatment, your doctor may decrease the dose to 3 mg/kg twice daily. The doctor may decide to decrease the dose if you have mild to moderate cirrhosis.
VFEND powder for solution for infusion will be reconstituted and diluted to the correct concentration by your hospital pharmacist or nurse. (Please refer to the end of this leaflet for further information)
This will be given to you by intravenous infusion (into a vein) at a maximum rate of 3 mg/kg per hour over 1 to 2 hours.
VFEND treatment will continue for as long as your doctor advises, however duration of treatment with VFEND powder for solution for infusion should be no more than 6 months.
Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning.
You may be switched from the intravenous infusion to tablets once your condition improves.
If a dose of VFEND has been forgotten:
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However tell your doctor or pharmacist if you think that a dose has been forgotten.
If you stop taking VFEND:
When VFEND treatment is stopped by your doctor you should not experience any effects. However if you were taking medicines containing ciclosporin or tacrolimus you must mention this to your doctor, as the dose will need to be adjusted.
If you have any further questions on the use of this product, ask your doctor.
What are possible side effects?
Like all medicines, VFEND can cause side effects, although not everybody gets them. If any side effects occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.
Very common side effects (occurring in at least 1 in 10 patients) are:
-Visual disturbances (change in vision)
-Fever
-Rash
-Nausea, vomiting, diarrhoea
-Headache
-Swelling of the extremities
-Stomach pains.
Common side effects (occurring in at least 1 in 100 patients) are:
-Flu-like symptoms, sinusitis, chills, weakness
-Anaemia, low numbers of cells called platelets that help the blood to clot, low numbers of some types of white blood cells or of all types of blood cells, red or purple discoloration of the skin which may be caused by low platelet count , other blood cell changes
-Low blood sugar, low blood potassium
-Anxiety, depression, tingling, confusion, dizziness, agitation, trembling, hallucinations and other nervous symptoms
-Low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot)
-Breathing difficulty, chest pain, fluid accumulation in the lungs
-Jaundice, redness of the skin
-Swelling of the lips or face
-Allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reaction following exposure to light or sun
-Itchiness
-Hair loss
-Back pain
-Kidney failure, blood in the urine, changes in blood tests of kidney function
-Inflammation at injection sites
-Changes in blood tests of liver function
Uncommon side effects (occurring in at least 1 in 1,000 patients) are:
-Enlarged lymph glands (sometimes painful)
-Increase in a type of white blood cell which may be associated with allergic reaction, disorder of blood clotting system
-Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting -Depressed function of the adrenal gland
-Problem with coordination
-Swelling of the brain
-Double vision pain and inflammation of the eyes and eyelids, involuntary movement of the eye -Decreased sensitivity to touch
-Constipation, inflammation of upper small intestine, dyspepsia, pancreatitis, peritonitis -Gingivitis,
-Swelling and inflammation of the tongue
-Enlarged liver, hepatitis, liver failure, gallbladder disease, gallstones
-Joint pain
-Inflammation of the kidney, proteins in the urine -Abnormal electrocardiogram (ECG) -Blood chemistry changes
Rare side effects (occurring in at least 1 in 10,000 patients) are:
Reactions during the infusion have occurred uncommonly with VFEND (including flushing, fever, sweating, increased heart rate and shortness of breath). Your doctor may stop the infusion if this occurs.
As VFEND has been known to affect the liver and the kidney, your doctor should monitor the function of your liver and kidney by doing blood tests. Please advise your doctor if you have any stomach pains or if your stools have a different consistency.
If any of these side effects persist or are troublesome, please tell your doctor.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep VFEND out of the reach and sight of children. Do not use VFEND after the expiry date which is stated on the label. The expiry date refers to the last day of the month.
Once reconstituted, VFEND should be used immediately, but if necessary may be stored for up to 24 hours at 2°C - 8°C (in a refrigerator). Reconstituted VFEND needs to be diluted with a compatible infusion solution first before it is infused. (Please refer to the end of this leaflet for further information).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
