How does it work?
Valcyte tablets and oral solution contain the active ingredient valganciclovir. Valganciclovir is known as a pro-drug. Once inside the body it is broken down into the active ingredient ganciclovir, which is an antiviral medicine. It is used to treat infection with a virus called cytomegalovirus (CMV).
CMV is a member of the herpes group of viruses. In healthy people this common virus normally produces symptoms milder than the common cold. However, in people whose immune systems are compromised, such as people with AIDS, or people who have had an organ transplant and are taking powerful medicines that suppress the immune system, it can cause serious infection because the immune system cannot fight it. (This is referred to as opportunistic infection.)
In immunocompromised people, infection with CMV can lead to complications such as a condition called CMV retinitis. In CMV retinitis the virus causes severe inflammatory changes in the retina of the eye, which can lead to blindness.
Ganciclovir works by blocking the action of an enzyme called DNA polymerase that is found in the CMV virus. This enzyme is required by the virus for it to copy genetic material (from RNA to DNA), a process that is necessary for the virus to multiply and survive. Ganciclovir is also incorporated into the DNA of the virus. By blocking the action of DNA polymerase and disrupting viral DNA, ganciclovir prevents CMV from multiplying. This controls the infection and helps the immune system to deal with it.
What is it used for?
- Treating cytomegalovirus infection affecting the eyes (CMV retinitis) in people with AIDS.
- Preventing cytomegalovirus (CMV) infection in people who have had an organ transplant from a CMV positive donor.
How do I take it?
- Valcyte tablets and oral solution should preferably be taken with food.
- The tablets should be swallowed whole with a drink and not broken or crushed - see warning below.
- The dose prescribed and how often to take the medicine depends on what it is being used for. It is important to follow the instructions given by your doctor. These will also be printed on the dispensing label that your pharmacist has put on the packet of medicine.
- You should take the medicine at regular intervals and always complete the course prescribed, even if you think the infection has cleared up.
- If you forget to take a dose take it as soon as you remember, unless it is nearly time to take your next dose. In this case skip the missed dose and continue as usual dont take a double dose to make up for a missed dose.
- This medicine may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
- This medicine can sometimes cause a decrease in the normal amounts of blood cells in the blood. You will need to have regular blood tests to check your blood cells during your treatment. You should consult your doctor immediately if you experience any of the following symptoms, as they may indicate a problem with your blood cells: unexplained bruising or bleeding, purple spots, sore throat, mouth ulcers, high temperature (fever), feeling tired or general illness.
- People with impaired kidney function should have their kidney function monitored while taking this medicine.
- This medicine has the potential to cause cancers and birth defects. It may also inhibit sperm production in men, which may be temporary or permanent, and may suppress fertility in women. For this reason, this medicine should only be used when the benefits of treatment outweigh any possible risks. You should discuss this with your doctor.
- This medicine can cause birth defects if it is taken during pregnancy, or if men taking it father a child. For this reason, women taking this medicine should use effective contraception to avoid getting pregnant during treatment. Men taking this medicine should use barrier contraceptives, such as condoms, to prevent fathering a child both during, and for at least three months following treatment with this medicine.
- Valcyte tablets should not be broken or crushed. Due to their potential side effects any broken tablets should be handled with care - avoid direct contact with skin, eyes or mucous membranes such as the lining of the mouth or nose. If such contact occurs, wash thoroughly with soap and water, rinse eyes thoroughly with sterile water, or plain water if sterile water is unavailable.
- People who are switching to this medicine from ganciclovir capsules should be aware that the dose of ganciclovir provided by valganciclovir tablets and ganciclovir capsules is not equivalent, and the medicines cannot be switched on a one-to-one basis. If you are switching from ganciclovir capsules to this medicine follow the dosing instructions you have been given carefully. If you are unsure about your dose seek further advice from your doctor or pharmacist.
Use with caution in
- Elderly people.
- People with decreased kidney function.
- People with decreased liver function.
- People with low levels of white blood cells, platelets, red blood cells or haemoglobin in their blood (neutropenia, leucopenia, thrombocytopenia or anaemia).
- People receiving radiotherapy treatment.
- People with a history of blood disorders caused by a medication.
Not to be used in
- People who are allergic to ganciclovir, valganciclovir, aciclovir or valaciclovir.
- People having haemodialysis for kidney failure.
- This medicine is not recommended for use in children and adolescents.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine may be harmful to a developing baby. It should not be used during pregnancy unless the benefits to the mother outweigh the potential risks to the baby. Seek medical advice from your doctor.
- Women taking this medicine should use an effective method of contraception to avoid getting pregnant during treatment. Men taking this medicine should use barrier contraceptives, such as condoms, to prevent fathering a child both during, and for at least three months following treatment with this medicine.
- This medicine may pass into breast milk. As this could cause unwanted effects in a nursing infant, women needing treatment with this medicine must not breastfeed. Ask your doctor for further advice.
- Take this medication with or after food.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Very common (affect more than 1 in 10 people)
- Decreased numbers of white blood cells or red blood cells in the blood (neutropenia or anaemia see warning section above).
- Shortness of breath.
Common (affect between 1 in 10 and 1 in 100 people)
- Fever or shivering.
- Feeling weak or tired.
- Chest pain.
- Weight loss.
- Yeast infection of the mouth (oral thrush).
- Blood infections.
- Decreased numbers of platelets (clotting cells) in the blood (thrombocytopenia see warning section above).
- Loss of appetite.
- Depression or anxiety.
- Confusion or abnormal thinking.
- Difficulty sleeping (insomnia).
- Alteration in taste.
- Disorder of the peripheral nerves causing weakness , numbness or tingling sensations (peripheral neuropathy).
- Seizures (convulsions).
- Eye disorders such as floaters,swelling of the area at the back of the eye responsible for seeing fine detail (macular oedema), retinal detachment or eye pain.
- Ear pain.
- Disturbances of the gut such as constipation, nausea, vomiting, indigestion, flatulence or abdominal pain.
- Abnormal liver or kidney function.
- Pain in the muscles and joints.
- Night sweats.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Psychosis, hallucinations or agitation.
- Irregular heartbeat (arrhythmias).
- Low blood pressure.
- Inflammation of the pancreas (pancreatitis).
- Dry skin.
- Hair loss.
- Kidney failure.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
You should tell your doctor or pharmacist what medicines you are using, particularly those listed below, before you start treatment with this medicine. This includes those bought without a prescription and herbal medicines. Likewise, check with your doctor or pharmacist before starting any new medicines while you are taking this medicine, to make sure that the combination is safe.
If this medicine is taken with imipenem/cilastatin there may be an increased risk of seizures. This combination of medicines should be avoided unless your doctor considers the benefits outweigh any risks.
Probenecid slows the removal of ganciclovir from the body and so may increase the blood level of ganciclovir.
This medicine may increase the blood levels of the following medicines and as a result may increase the risk of side effects with these medicines:
There may be an increased risk of side effects if this medicine is taken with any of the following medicines, which can have similar and hence additive side effects:
- amphotericin B
- chemotherapy medicines
- nucleoside analogues for HIV
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain valganciclovir as the active ingredient.