We explain everything you need to know about taking the antiviral valganciclovir for CMV infection.

What is Valcyte 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 does Valcyte work?

  • Valcyte tablets and oral solution contain the active ingredient valganciclovir. (Valganciclovir is also available without a brand name, ie as the generic medicine.)
  • 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.
  • How do I take Valcyte?

    • Valcyte tablets and oral solution should preferably be taken with or just after food or a meal.
    • Valcyte tablets should be swallowed whole with a drink and not 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.
    • 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 – don't take a double dose to make up for a missed dose.

    What should I know before taking Valcyte?

    • 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.
    • Valcyte can cause birth defects if it is taken during pregnancy, or if men taking it father a child. Women taking this medicine must use effective contraception to avoid getting pregnant during treatment, and for at least one month following 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.
    • Valcyte has the potential to cause cancers and to reduce fertility in men and women. It will only be used when the benefits of using it outweigh any possible risks. You should discuss this with your doctor.

    Who might need a lower Valcyte dose or extra monitoring?

    • Elderly people.
    • People with kidney or liver problems.
    • 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.

    Who shouldn't take Valcyte?

    • People who are allergic to ganciclovir, valganciclovir, aciclovir or valaciclovir.
    • People having haemodialysis for kidney failure.
    • People who are allergic to any of its ingredients.

    Can I take Valcyte while pregnant or breastfeeding?

    • Valcyte 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 Valcyte should use an effective method of contraception to avoid getting pregnant during treatment, and for at least one month following treatment. Men taking Valcyte should use barrier contraceptives, such as condoms, to avoid fathering a child both during, and for at least three months following treatment with this medicine.
    • Valganciclovir may pass into breast milk and could cause unwanted effects in a nursing infant. If you need treatment with Valcyte you must not breastfeed. Ask your doctor for further advice.

    What are the possible side effects of Valcyte?

    Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects known to be associated with valganciclovir. Just because a side effect is stated here doesn't mean that all people taking Valcyte will experience that or any side effect.

    Very common 

    • Decreased numbers of white blood cells or red blood cells in the blood (neutropenia or anaemia – see warning above).
    • Shortness of breath.
    • Diarrhoea.

    Common 

    • 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 above).
    • Loss of appetite.
    • Depression or anxiety.
    • Confusion or abnormal thinking.
    • Headache.
    • Difficulty sleeping (insomnia).
    • Alteration in taste.
    • Disorder of the peripheral nerves causing weakness , numbness or tingling sensations (peripheral neuropathy).
    • Dizziness.
    • 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.
    • Cough.
    • 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.
    • Itching.

    Uncommon 

    • Psychosis, hallucinations or agitation.
    • Tremor.
    • Deafness.
    • Irregular heartbeat (arrhythmias).
    • Low blood pressure.
    • Inflammation of the pancreas (pancreatitis).
    • Dry skin.
    • Hair loss.
    • Kidney failure.

    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:

    • didanosine
    • zidovudine.

    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
    • co-trimoxazole
    • dapsone
    • flucytosine
    • hydroxyurea
    • mycophenolate
    • nucleoside analogues for HIV
    • pentamidine
    • tacrolimus
    • trimethoprim
    • zalcitabine
    • zidovudine.

    References:

    http://www.netdoctor.co.uk/medicines/infections/a8515/valcyte-valganciclovir/

    http://www.valcyte.com/patient

    https://www.medicines.org.uk/emc/medicine/9315

    http://www.medicines.ie/medicine/14582/SPC/VALCYTE+50+mg+ml+powder+for+oral+solution/

    https://www.drugs.com/mtm/valcyte.html

    http://www.medbroadcast.com/drug/getdrug/valcyte

    https://en.wikipedia.org/wiki/Valganciclovir

     

    Health Reference: COPD