VALCYTE contains the active ingredient valganciclovir. In the body valganciclovir rapidly changes to ganciclovir.
VALCYTE belongs to a class of medicines used to prevent the growth of viruses.
VALCYTE acts against a virus called cytomegalovirus or CMV (a type of herpes virus). It prevents this virus from growing and multiplying in the body. CMV causes infections, mainly in people with poor immunity. Poor immunity can be caused by HIV/AIDS or by medications taken after an organ transplant.
VALCYTE is used to treat CMV eye infections (known as CMV retinitis) in AIDS patients, which, if left untreated can cause blindness. It is not a cure for CMV eye infections.
VALCYTE is not effective against any underlying HIV infection.
VALCYTE is also used to prevent CMV infection in patients following organ transplantation.
Your doctor, however, may have prescribed VALCYTE for another purpose.
Ask your doctor if you have any questions about why VALCYTE has been prescribed for you.
VALCYTE is not addictive.
This medicine is available only with a doctor's prescription.
Animal and other laboratory studies have shown VALCYTE causes infertility, birth defects and cancer. It is possible that these effects may also occur in humans.
Do not take VALCYTE if
1. you have had an allergic reaction to VALCYTE, ganciclovir, valaciclovir or aciclovir or any ingredients listed at the end of this leaflet
2. you have very low blood counts for platelets (which help clotting), neutrophils (a type of white blood cell which defends against infection) or low haemoglobin (oxygen carrying substance in the blood)
3. the package is torn or shows signs of tampering
4. the expiry date (EXP) printed on the pack has passed.
If you are not sure if you should be taking VALCYTE, talk to your doctor.
There is limited information on the safety and effectiveness of the use of VALCYTE in children. Your doctor will advise you whether VALCYTE is suitable for your child.
Tell your doctor if
1. you are allergic to any other medicines, foods, dyes or preservatives.
2. you have any other health problems, especially the following:
3. you are pregnant or intend to become pregnant
4. you are breast-feeding or intend to breast-feed
If you have not told your doctor about any of the above, tell them before you start taking VALCYTE.
Tell your doctor if you are taking any other medicines, including any that you have bought without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with VALCYTE. These medicines include:
These medicines may be affected by VALCYTE, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking VALCYTE.
Ask your doctor or pharmacist if you are not sure about this list of medicines.
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
Take VALCYTE solution exactly as your doctor has prescribed.
Your doctor will tell you how much VALCYTE solution to take.
Treatment of CMV Retinitis in AIDS
The usual dose is 900 mg twice daily with food for 21 days
Use the dispenser provided and take two 450mg amounts (i.e. 2 dispensers filled to 450mg graduation) of the solution in the morning and two 450mg amounts in the evening.
The usual dose is 900 mg once daily with food.
Use the dispenser provided and take two 450mg amounts of solution (i.e. 2 dispensers filled to 450mg graduation) at the same time each day.
Prevention of CMV Disease in Transplantation
The usual dose is 900 mg once daily with food, starting within 10 days of your organ transplant until 100 days after the transplant.
If you have received a kidney transplant, the same daily dose is required until 200 days after the transplant.
Use the dispenser provided to take two 450mg amounts (i.e. 2 dispensers filled to 450mg graduation) of solution at the same time each day.
Your dose may have to be reduced or stopped if you have or develop low blood counts, have kidney disease, or if you are older than 65 years.
VALCYTE solution will be made up from the powder with water by the pharmacist just before you receive it.
You have to be careful when handling VALCYTE solution. You should avoid getting the solution on your skin or in your eyes. If you accidentally get the solution on your skin, wash the area thoroughly with soap and water. If you accidentally get the solution in your eyes, rinse your eyes thoroughly with water.
It is important that you use the dispenser provided in the pack to measure your dose of VALCYTE solution.
Two dispensers are provided in case one of them gets lost or damaged. Each dispenser is designed to measure up to a 500mg amount of solution in 25mg increments.
Always wash the dispenser thoroughly and allow it to dry after you have taken your dose.
Tell your doctor or pharmacist if you lose or damage both dispensers
They will advise you on how to continue to take your medicine.
Once the solution has been prepared, follow the instructions below to withdraw and take your medication.
1. Shake closed bottle well for about 5 seconds before each use.
2. Remove the child-resistant cap.
3. Before inserting the tip of the dispenser into bottle adapter, push the plunger completely down toward the tip of the dispenser. Insert tip firmly into opening of the bottle adapter.
4. Turn the entire unit (bottle and dispenser) upside down.
5. Pull the plunger out slowly until the desired amount of solution is withdrawn into the dispenser
6. Turn the entire unit right side up and remove the dispenser slowly from the bottle.
7. Dispense directly into mouth and swallow. Do not mix with any liquid prior to dispensing.
8. Close bottle with child-resistant cap after each use.
9. Immediately after administration disassemble the dispenser, rinse under running tap water and air dry prior to next use.
Do not use the solution after the expiry date which is 49 days from the day of preparation.
Take VALCYTE solution during or immediately after a meal.
If you take VALCYTE solution on an empty stomach, it may not work as well.
Take VALCYTE solution at about the same time each day.
Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take VALCYTE solution.
Continue taking VALCYTE solution until your doctor tells you to stop.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering your dose, ask your pharmacist for some hints.
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much VALCYTE. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.
Tell all doctors, dentists and pharmacists who are treating you that you are taking VALCYTE.
A barrier contraceptive should be used while taking VALCYTE and for 90 days after stopping treatment.
Tell your doctor if you become pregnant while taking VALCYTE.
See your doctor regularly so that your CMV disease, blood cell counts and any other potential side effects may be monitored carefully.
If blood cell counts are low then this may reduce your ability to fight infection, or for your blood to clot efficiently. If left undetected these effects on blood cells may contribute to death or serious illness.
If you have a CMV eye infection, you must also see your doctor regularly to monitor the condition of your retina (part of the eye).
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Be sure to keep all of your appointments with your doctor so that your progress can be checked.
Do not stop taking VALCYTE or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.
Do not give VALCYTE to anyone else even if they have the same condition as you.
Be careful when handling the VALCYTE solution. Do not get the solution on your skin or in your eyes.
If you accidentally get the solution on your skin, wash the area thoroughly with soap and water. If you accidentally get the solution in your eyes, rinse your eyes thoroughly with water.
Be careful driving or operating machinery until you know how VALCYTE affects you.
VALCYTE may cause drowsiness, dizziness, confusion or seizures (fits) in some people and therefore may affect alertness. Make sure you know how you react to VALCYTE before you drive a car or operate machinery or do anything else that could be dangerous if you are drowsy, dizzy or not alert.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking VALCYTE.
VALCYTE helps most people with CMV infections but it may have unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
These are more common side effects of VALCYTE and are usually short-lived.
Tell your doctor immediately if you notice any of the following:
These side effects may be serious. You may require medical attention.
Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if you notice any of the following:
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this list.
Keep VALCYTE solution in the original bottle.
Keep VALCYTE in the refrigerator (2-8°C). Do not freeze.
If you do not keep VALCYTE in the refrigerator, it may not work as well.
Keep VALCYTE where young children cannot reach it.
Do not use VALCYTE solution after its expiry date (49 days after it has been made up).
Your pharmacist will have written the expiry date on the bottle for you.
If your doctor tells you to stop taking VALCYTE, or the solution has passed its expiry date, ask your pharmacist what to do with any solution that is left over.
VALCYTE solution 50 mg/mL comes in a bottle with an adapter, and two oral dispensers.
The oral dispensers provided should not be used for measuring doses of any other medicines.
VALCYTE is also available as 450mg film-coated tablets.
VALCYTE solution is white to slightly yellow in colour.
Active ingredient - valganciclovir
Inactive ingredients -
VALCYTE solution also contains:
VALCYTE is distributed by:
Roche Products Pty Limited
ABN 70 000 132 865
4-10 Inman Road
Dee Why NSW 2099
Customer enquiries: 1800 233 950
Please check with your pharmacist for the latest Consumer Medicine Information.
Australian Registration Number AUST R 154382
This leaflet was prepared on 22 July 2011.