VFEND^®

Active ingredient(s): VORICONAZOLE (vori-con-a-zole)

This leaflet provides important information about using VFEND. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using VFEND.

Where to find information in this leaflet:

1. Why am I using VFEND?
2. What should I know before I use VFEND?
3. What if I am taking other medicines?
4. How do I use VFEND?
5. What should I know while using VFEND?
6. Are there any side effects?
7. Product details

VFEND contains the active ingredient voriconazole. VFEND belongs to a group of medicines called triazole antifungals.

This medicine works by preventing the growth of fungal and yeast organisms causing your infection.

VFEND is used to treat fungal and yeast infections such as:

• invasive aspergillosis (as-pur-ji-losis), a fungal infection caused by a fungus called Aspergillus (as-pur-jilus), which usually begins in the respiratory tract (in the nose, sinuses or lungs). Aspergillus is harmless in most healthy people; however, in people with poor immune systems (such as people who have had organ transplants and people with cancer or HIV/AIDS) invasive aspergillosis can be serious and spread to other tissues and organs.
• serious Candida (can-did-da) infections, including Candida infections of the oesophagus (food pipe or gullet) and those that have spread into the blood stream or to other parts of the body.
• serious fungal infections caused by Scedosporium (ski-doe-spore-rium) species and Fusarium (few-saa-rium) species.
• other serious fungal infections in patients who do not respond to, or cannot tolerate, other antifungal medicines.

VFEND is also used to prevent invasive fungal infections in patients who are at risk of developing such infections.

Warnings

Do not use VFEND if:

1. you are allergic to voriconazole, any similar medicines, or any of the ingredients listed at the end of this leaflet.
   Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; skin rash, itching or hives.
2. Always check the ingredients to make sure you can use this medicine.
3. Do not use VFEND if you are taking any of the following medicines:

• Medicines to treat mental illness:
  - pimozide, a medicine used to treat mental illness.
  - St John's Wort (a herbal medicine).
  - lurasidone, a medicine to treat schizophrenia and bipolar disorder.
• Medicines used to manage heart health
  - quinidine, a medicine used to treat irregular heartbeat.
  - ivabradine, a medicine used to treat heart problems.
• Medicines used to treat infections
  - rifampicin, a medicine used to treat tuberculosis and other infections.
  - rifabutin an antibiotic.
  - efavirenz (e.g., Stocrin) (a medicine used to treat HIV infection) in doses of 400 mg or more once a day.
  - ritonavir (a medicine used to treat HIV infection) in doses of 400 mg or more twice a day.
• Medicines used for seizures, insomnia or migraines
  - carbamazepine, a medicine used to treat seizures.
  - long-acting barbiturates such as phenobarbitone, medicines used to treat severe insomnia and seizures.
  - ergotamine or dihydroergotamine, medicines used to treat migraine.
• Other medicines:
  - sirolimus, a medicine used in transplant patients.
  - naloxegol, a medicine used to treat constipation caused by opioids (narcotic pain medicines).
  - tolvaptan used to treat low levels of sodium in your blood or for kidney problems).
  - venetoclax, a medicine used to treat blood cancers.
  - Lemborexant, a medicine used to help manage insomnia

VFEND should not be given to a child under the age of 2 years. Safety and effectiveness in children younger than 2 years has not been established.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Check with your doctor if you:

• have any other medical conditions, including:
  - heart problems.
  - any problems affecting your kidneys.
  - any problems affecting your liver. If you have liver disease your doctor may prescribe a lower dose.
  - recent chemotherapy or stem cell transplant.
  - take any medicines for any other condition
• have allergies to foods, preservatives or dyes or any other medicines, especially antifungal medicines such as itraconazole, fluconazole, posaconazole or ketoconazole.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

VFEND should not be used during pregnancy, unless indicated by your doctor. Effective contraception should be used in women of childbearing potential. Your doctor can discuss with you the risks and benefits involved.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

VFEND should not be used whilst breastfeeding, unless indicated by your doctor. It is not known if the active ingredient voriconazole passes into breast milk. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines should NOT be taken with VFEND. Please see Section 2 above for a list of those medicines.

Some medicines and VFEND may interfere with each other. These include (not all brands given):

• Medicines used to treat infections
  - fluconazole, a medicine used to treat fungal infections.
  - flucloxacillin, a medicine used to treat bacterial infections.
  - indinavir and some other medicines used to treat HIV infection.
• Medicines used for cancer treatment:
  - everolimus, a medicine used to treat cancer
  - other cancer drugs such as glasdegib, axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib, dasatinib, sunitinib.
  - tretinoin, a medicine used for the treatment of acne and acute promyelocytic leukemia.
  - Vincristine, vinblastine or vinorelbine, medicines used in treating cancer.
• Medicines used in management of organ transplant:
  - ciclosporin, a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system.
  - tacrolimus, a medicine used in patients who have had a liver or kidney transplant.
  - letermovir used to prevent viral infections after bone marrow transplant).
• Medicines for management of diabetes and other heart-related conditions:
  - warfarin, a medicine used to stop blood clots.
  - sulphonylureas, medicines used to treat diabetes such as glibenclamide, gliclazide and glipizide.
  - statins, medicines used for lowering cholesterol.
• Medicines for management of mental health
  - benzodiazepines, medicines used to treat insomnia or anxiety.
  - eszopiclone, a medicine used to treat insomnia.
• Medicines used for pain management:
  - strong pain killers such as alfentanil, fentanyl and oxycodone.
  - non-steroidal anti-inflammatory drugs, medicines used to treat pain and inflammation such as ibuprofen and diclofenac.
• Other medicines:
  - ivacaftor, a medicine used to treat cystic fibrosis.
  - phenytoin, a medicine used to treat epilepsy.
  - some antihistamines, medicines used to treat hayfever, allergic skin reactions, itching.
  - theophylline, a medicine used to treat asthma.
  - omeprazole, a medicine used to treat indigestion, reflux and stomach or duodenal ulcers.
  - methadone (used to treat heroin addiction).
  - oral contraceptives (the Pill)
  - methotrexate, a medicine used to treat arthritis and cancers.

These medicines may be affected by VFEND or may affect how well it works. You may need different amounts of your medicines or you may need to take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect VFEND.

How much to take / use

Your doctor will tell you how much to use depending on your weight.

Adults

Treatment of invasive fungal infections

The usual dose of VFEND Tablets in adults weighing 40 kg and greater is 400 mg (two 200 mg tablets twice a day) for the first day and then 200 to 300 mg twice a day thereafter.

The usual dose of VFEND Oral Suspension in adults weighing 40 kg and greater is 10 mL twice a day for the first day and then 5 mL twice a day.

In adults weighing less than 40 kg the dose of VFEND Tablets and Oral Suspension is halved.

The usual dose of VFEND Powder for Injection is 6 mg/kg every 12 hours for the first day. The dose is then adjusted to 3 mg/kg or 4 mg/kg every 12 hours, depending on the type of infection you have.

In adults weighing less than 40 kg the dose of VFEND Tablets and Oral Suspension is halved.

Children

VFEND should not be given to a child under the age of 2 years.

Your doctor will determine the dose of VFEND required for your child.

Depending on how serious the infection is and how your child reacts to the medicine, your doctor may increase or decrease the dose.

Adolescents (12-16 years of age)

Adolescents aged 12-16 years of age are usually given the same dose as adults.

How to take / use VFEND

VFEND Tablets

Swallow the tablets whole with a full glass of water.

VFEND Oral Suspension

Your pharmacist should advise you how to measure VFEND Oral Suspension using the multi-dosing syringe provided in the pack.

VFEND Oral Suspension should not be mixed with any other medication.

Please see instructions below before using VFEND Oral Suspension.

1. Shake the bottle well before use.
2. Remove cap and insert the tip of the syringe into the adaptor while the bottle is upright.
3. Turn the bottle upside down while holding the syringe in place. Slowly pull back the plunger of the syringe until the required amount of VFEND Oral Suspension is withdrawn from the bottle.
4. If large bubbles can be seen, slowly push the plunger back into the syringe. This will force the medicine back into the bottle. Repeat step 3 again.
5. Turn the bottle back upright and then remove the syringe.
6. Put the tip of the syringe into the mouth and point towards the inside of the cheek. SLOWLY push down the plunger of the syringe. Do not squirt the suspension out quickly.
   If the medicine is to be given to a child, make sure the child is sitting or is held upright.
7. Replace the bottle cap.

Cleaning and storing the syringe:

1. The syringe should be rinsed after each dose. Pull the plunger out of the syringe and wash both parts by holding under warm running water.
2. Dry the two parts. Push the plunger back into the syringe. Keep it in a clean safe place with the medicine.

VFEND Powder for Injection

VFEND Powder for Injection is given as an intravenous infusion by a doctor or trained nurse.

VFEND Powder for Injection is a powder which is mixed with Water for Injections and then diluted by your pharmacist or doctor. It is then given as an intravenous infusion into a vein.

When to take / use VFEND

• VFEND Tablets and Oral Suspension
• Take your medicine at about the same time each day.
• Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
• Take your medicine 1 hour before food after a meal.

How long to take it

• The length of time you take VFEND will depend on the type of infection you have.
• If you have a weakened immune system or a difficult infection, you may need long-term treatment to prevent the infection from returning.
• You may be switched from the intravenous infusion to VFEND Tablets or Oral Suspension once your condition improves.
• Continue taking VFEND for as long as your doctor or pharmacist recommends. Do not stop taking VFEND because you are feeling better.
  If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

If you forget to take VFEND

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

VFEND Powder for injection will be given to you 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 take too much VFEND

If you think that you have taken too much VFEND, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Symptoms of an overdose may include upset stomach, diarrhoea, headache and sensitivity to light.

Things you should do

• If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
• Avoid going out in the sun for long periods of time while you are taking VFEND. VFEND can cause sensitivity to sunlight.
• Make sure you follow your doctor's instructions and keep all appointments, including blood tests.
  Your doctor should monitor the function of your liver and kidneys using blood tests. If you have liver disease, your doctor might lower your dose of VFEND or stop your VFEND treatment. Your doctor might also monitor the function of your pancreas.
• If you are about to have any blood tests, tell your doctor that you are taking this medicine.
  It may interfere with the results of some tests.

Call your doctor straight away if you:

• notice any changes to your skin while you are taking VFEND.
• develop a rash or blisters while taking VFEND. If this rash worsens, VFEND may need to be stopped.
• suffer from chronic, or long-lasting fatigue, muscle weakness, loss of appetite, weight loss or abdominal pain while on VFEND.
• notice the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
• become pregnant while taking VFEND, tell your doctor immediately. If you are a woman of child-bearing age, you should avoid becoming pregnant while taking VFEND.

Remind any doctor or dentist you visit that you are using VFEND.

Things you should not do

• Do not stop taking your medicine or lower the dosage without checking with your doctor.
• If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return
• Do not use VFEND to treat any other complaints unless your doctor tells you to.
• Do not give your medicine to anyone else even if they have the same condition as you or if their symptoms seem similar to yours.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how VFEND affects you.

You may experience changes to your vision, such as blurriness, colour changes or uncomfortable sensitivity to light.

If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous. Do not drive at night.

Children should be careful when riding bicycles or climbing.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

VFEND Tablets

Keep your tablets in the pack until it is time to take them.

If you take the tablets out of the blister pack, they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

VFEND Oral Suspension

Your pharmacist will store VFEND Oral Suspension in a powder form at 2°C to 8°C in the refrigerator before reconstitution.

Store prepared suspension in a cool dry place where the temperature stays below 30°C.

VFEND Powder for Injection

VFEND Powder for Injection will be stored in the pharmacy or on the hospital ward and is kept below 30°C.

Discard suspension 14 days after preparation.

Do not use this medicine after the expiry date.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

This medicine is only available with a doctor's prescription.

What VFEND contains

Do not take this medicine if you are allergic to any of these ingredients.

What VFEND looks like

VFEND Tablets

VFEND 50 mg Tablets are white to off-white, round convex, film coated tablets debossed Pfizer on one side and VOR50 on the reverse (AUST R 82507).

VFEND 200 mg Tablets are white to off-white, capsule-shaped film coated tablets, debossed Pfizer on one side and VOR200 on the reverse (AUST R 82505).

VFEND Oral Suspension

Once reconstituted, VFEND Oral Suspension is a white to off-white orange flavoured suspension. Each bottle contains 70 mL of suspension (AUST R 99016).

VFEND Powder for Injection

White powder in a clear, colourless, glass vial which contains 200 mg of voriconazole (AUST R 82503).

Who distributes VFEND

Pfizer Australia Pty Ltd
Sydney, NSW
Toll Free Number: 1800 675 229.
www.pfizermedicalinformation.com.au

This leaflet was prepared in November 2023.

^® = Registered Trademark.

© Copyright

Published by MIMS January 2024