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Valganciclovir oral

Updated 2 Feb 2023 | Cytomegalovirus (CMV)


Oral formulations of valganciclovir.

Drugs List

  • VALCYTE 450mg tablets
  • VALCYTE 50mg/ml powder for oral solution
  • valganciclovir 450mg tablets
  • valganciclovir 50mg/ml powder for oral solution sugar-free
  • Therapeutic Indications


    Prevention of cytomegalovirus infection in solid organ transplant patients
    Treatment of cytomegalovirus (CMV) retinitis in patients with AIDS

    Induction and maintenance treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

    Prevention of CMV disease in CMV-negative patients who have received a solid organ transplant from a CMV-positive donor.



    Strict adherence to dosage recommendation is essential to avoid overdose.

    Induction treatment of CMV retinitis:
    In patients with active CMV retinitis, the recommended dose is 900mg valganciclovir twice a day for 21 days.
    Prolonged induction treatment may increase the risk of bone marrow toxicity.

    Maintenance treatment of CMV retinitis:
    Following induction treatment, or in patients with inactive CMV retinitis, the recommended dose is 900mg valganciclovir once daily.
    Patients whose retinitis worsens may repeat induction treatment, however, consideration should be given to the possibility of viral drug resistance.

    Prevention of CMV disease in solid organ transplantation
    In transplant recipients the recommended dose is 900mg valganciclovir once a day. Treatment should start within ten days of transplantation and continue until 100 days post-transplantation.

    For patients who have received a kidney transplant, prophylaxis may continue up to 200 days post-transplantation.


    Treatment of CMV retinitis

    Prevention of CMV disease in solid organ transplantation
    Children older than 16 years old
    In transplant recipients the recommended dose is 900mg valganciclovir once a day. Treatment should start within ten days of transplantation and continue until 100 days post-transplantation.

    For patients who have received a kidney transplant, prophylaxis may continue up to 200 days post-transplantation.

    Birth to 16 years old
    Paediatric dose (mg) = 7 x body surface area (BSA) metres square, derived from Mosteller BSA formula x creatinine clearance, derived from the Schwartz formula (CrCLS)

    In transplant recipients the recommended once daily mg dose should start within ten days of transplantation and continue until 100 days post-transplantation.

    For patients who have received a kidney transplant, prophylaxis may continue up to 200 days post-transplantation.

    All calculated doses should be rounded to the nearest 25mg increment for the actual deliverable dose. If calculated dose exceeds 900mg, maximum dose of 900mg is to be administered. The oral solution formulation is preferred in order to administer the calculated doses however the solid oral formulation may be used if the calculated doses are within 10% of the available solid oral doses and the patient is able to swallow this formulation. For example, if the calculated dose is between 405mg and 495mg, one 450mg tablet may be taken.

    Monitor serum creatinine levels regularly and consider changes in height and weight and adapt dose appropriately.

    Mosteller formula
    BSA metres square = square root of height (cm) x weight (kg) divided by 3600

    Schwartz formula
    Schwartz creatinine clearance (ml/minute/1.73 metres square) = k (based of Jaffe method of measuring serum creatinine) x height (cm) divided by serum creatinine (mg/dl)

    where k = 0.45 for patients aged below 2 years, 0.55 for boys aged 2 to 12 and girls aged 2 to 16, and 0.7 for boys aged 13 to 16 years. Lowering of the k value may be necessary for appropriate sub-populations e.g. in paediatric patients with low birth weight.

    Patients with Renal Impairment

    Serum creatinine levels or creatinine clearance should be monitored carefully and dosage adjusted according to the creatinine clearance, as shown below:

    Creatinine clearance 60 ml/minute or greater
    No dosage adjustment necessary - see 'Dosage - Adults'

    Creatinine clearance 40 to 59 ml/minute
    Induction dose: 450mg twice daily
    Maintenance/prevention dose: 450mg once daily

    Creatinine clearance 25 to 39 ml/minute
    Induction dose: 450mg once daily
    Maintenance/prevention dose: 225mg once daily or 450mg (1 tablet) every other day

    Creatinine clearance 10 to 24 ml/minute
    Induction dose: 225mg once daily or 450mg (1 tablet) every other day
    Maintenance/prevention dose: 125mg once daily or 450mg (1 tablet) twice weekly

    Creatinine clearance less than 10ml/minute (using the oral solution only)
    Induction dose: 200mg three times a week after dialysis
    Maintenance/prevention dose: 100mg three times a week after dialysis

    Additional Dosage Information

    Valganciclovir is rapidly and extensively metabolised to ganciclovir after oral dosing. Oral valganciclovir 900mg twice daily is therapeutically equivalent to intravenous ganciclovir 5mg/kg twice daily.


    Absolute neutrophil count below 0.5 x 10 to the power of 9 / L
    Haemoglobin concentration below 8g / dL
    Platelet count below 25 x 10 to the power of 9 / L

    Precautions and Warnings

    Children under 18 years
    Concurrent radiotherapy
    Females of childbearing potential
    History of cytopenic reaction
    Glucose-galactose malabsorption syndrome
    Lactose intolerance
    Renal impairment - creatinine clearance below 60ml/minute

    Reduce dose in patients with creatinine clearance below 60ml/min
    Advise ability to drive/operate machinery may be affected by side effects
    May contain sodium benzoate: may increase risk of jaundice in neonates
    Some formulations contain lactose
    Avoid contact of powder with skin and mucous membranes
    Avoid contact of prepared solution with skin and mucous membranes
    Monitor full blood count regularly
    Monitor height and weight in children
    Monitor serum creatinine
    Consider treatment with blood growth factors if severe cytopenias develop
    Consider dose interruption if patient develops severe cytopenias
    Adjust dose if switching patient from ganciclovir (not bioequivalent)
    Not licensed for all indications in all age groups
    May cause impaired fertility
    Female: Contraception required during and for 1 month after treatment
    Male: Use barrier contraception during and for 3 months after treatment

    In animal studies, ganciclovir was found to be mutagenic, teratogenic, aspermatogenic and carcinogenic, and a suppressor of female fertility. Valganciclovir should be considered a potential teratogen and carcinogen in humans with the potential to cause birth defects and cancers. It is also considered likely that valganciclovir causes temporary or permanent inhibition of spermatogenesis. Before valganciclovir treatment is commenced patients should be advised of the potential risks to the foetus.

    If prophylaxis is extended beyond 100 days the possible risk of developing leucopenia and neutropenia should be taken into consideration.

    It is recommended that complete blood counts and platelet counts be monitored during therapy. Increased haematological monitoring may be warranted in patients with renal impairment. In patients developing severe leucopenia, neutropenia, anaemia, thrombocytopenia and/or pancytopenia it is recommended that treatment with haematopoietic growth factors and/or dose interruption be considered.

    The bioavailability of ganciclovir after a single dose of 900mg valganciclovir is approximately 60%, compared with approximately 6% after administration of 1000mg oral ganciclovir (as capsules). Excessive exposure to ganciclovir may be associated with life-threatening adverse reactions. Dose recommendations should be closely followed when instituting therapy, when switching from induction to maintenance treatment, and in patients who may switch from oral ganciclovir to valganciclovir as valganciclovir cannot be substituted for ganciclovir capsules on a milligram-to-milligram basis.

    Lung and intestinal transplant patients were not included in the clinical study using valganciclovir for the prevention of CMV disease in transplantation so experience in these patients is limited.

    Pregnancy and Lactation


    Valganciclovir is contraindicated during pregnancy.

    The manufacturer does not recommend using valganciclovir during pregnancy. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.


    Valganciclovir is contraindicated during breastfeeding.

    Use of valganciclovir when breastfeeding is contraindicated by the manufacturer. It is unknown if valganciclovir is excreted in breast milk, however the possibility of it causing serious adverse reactions in the nursing infant cannot be discounted. Therefore, breastfeeding must be discontinued.

    Side Effects

    Abdominal distension
    Abdominal pain
    Abnormal thinking
    Allogeneic transplant rejection
    Anaphylactic reaction
    Aplastic anaemia
    Back pain
    Bone marrow depression
    Candidiasis (mouth or throat)
    Chest pain
    Decrease in creatinine clearance
    Decreased appetite
    Dry skin
    Ear pain
    Eye pain
    Hepatic impairment
    Hypersensitivity reactions
    Increase in alkaline phosphatase
    Increase in serum ALT/AST
    Macular oedema
    Mouth ulcers
    Muscle spasm
    Night sweats
    Peripheral neuropathy
    Psychotic disorder
    Renal failure
    Renal impairment
    Retinal detachment
    Serum creatinine increased
    Visual disturbances
    Vitreous disorder
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: November 2019

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T. and Rowe, H, Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Valcyte 450 mg film-coated tablets. Roche Products Limited. Revised May 2018.

    Summary of Product Characteristics: Valcyte 50 mg/ml powder for oral solution. Roche Products Limited. Revised December 2020.

    Summary of Product Characteristics: Valganciclovir 450 mg film-coated tablets. TEVA UK Limited. Revised April 2016.

    NICE Evidence Services Available at: Last accessed: 23 November 2022

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