Adult: Induction treatment: 900 mg bid for 21 days. Maintenance treatment: 900 mg once daily. Induction treatment may be repeated if retinitis worsens. Duration of maintenance treatment should be individualised depending on the patient’s safety (refer to country-specific guidelines).
Oral Prophylaxis of cytomegalovirus infection in organ transplantation
Adult: For solid organ transplant recipients (other than kidney): 900 mg once daily starting within 10 days and continuing until 100 days post-transplantation. For kidney transplant recipients: 900 mg once daily starting within 10 days and may be continued until 200 days post-transplantation. Child: Dosage and treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
Should be taken with food. Take during or immediately after meals.
Reconstitution
Oral solution: Reconstitute with 91 mL of purified water; add approx half the volume of water in the bottle, recap then shake the bottle for about 1 minute, add the remainder of the water to the bottle and shake the bottle well for another minute thereafter.
Contraindications
Hypersensitivity to valganciclovir or ganciclovir. Haemodialysis patients (CrCl <10 mL/min). Lactation.
Special Precautions
Patient with known hypersensitivity to aciclovir, penciclovir or their prodrugs (e.g. valaciclovir, famciclovir); pre-existing haematological cytopenia or history of drug-related haematological cytopenia. Not indicated for patients if their absolute neutrophil count is <500 cells/mm3, platelet count is <25,000 cells/mm3, or haemoglobin is <8 g/dL. Not intended for use in liver transplant recipients (recommendation may vary among countries, refer to country-specific guidelines). Renal impairment. Elderly. Pregnancy.
Adverse Reactions
Significant: Hypersensitivity reactions; haematologic toxicity (e.g. severe leucopenia, neutropenia, anaemia, pancytopenia, bone marrow failure, aplastic anaemia); acute renal failure, temporary or permanent spermatogenesis inhibition, fertility suppression, birth defects, cancer. Ear and labyrinth disorders: Ear pain. Eye disorders: Eye pain, visual impairment, vitreous floaters, retinal detachment (HIV patients treated for cytomegaloviral retinitis), conjunctivitis, macular oedema. Gastrointestinal disorders: Nausea, abdominal pain, dyspepsia, flatulence, mouth ulceration, dysgeusia, dysphagia, upper abdominal pain, constipation, vomiting, diarrhoea, abdominal distention, pancreatitis. General disorders and administration site conditions: Pain, fatigue, chills, pyrexia, malaise, asthenia. Hepatobiliary disorders: Hepatic function abnormal. Infections and infestations:Candida infections (including oral candidiasis), sepsis, influenza. Investigations: Increased serum phosphatase, AST, ALT, serum creatinine; decreased creatinine renal clearance. Metabolism and nutrition disorders: Decreased appetite, decreased weight. Musculoskeletal and connective tissue disorders: Back pain, muscle spasm, arthralgia, myalgia. Nervous system disorders: Headache, dizziness, insomnia, neuropathy peripheral, paraesthesia, hypoaesthesia, seizure. Psychiatric disorders: Confusional state, anxiety, depression. Renal and urinary disorders: UTI, renal impairment. Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea, URTI. Skin and subcutaneous tissue disorders: Rash, pruritus, dermatitis, cellulitis, night sweats, alopecia. Vascular disorders: Hypotension. Potentially Fatal: Bleeding associated with thrombocytopenia.
Patient Counseling Information
This drug may cause dizziness, sedation, confusion, and seizure; if affected, do not drive or operate machinery. Women of childbearing potential must use effective contraceptive methods during and at least 30 days after treatment. Men with female partners of childbearing potential should use barrier methods of contraception during and for 90 days after treatment.
Monitoring Parameters
Confirm pregnancy status prior to treatment. Monitor CBC and platelet count (baseline and periodically during treatment; more frequently during treatment in infants, patients with renal impairment, history of drug-induced leucopenia, neutrophil counts <1,000 cells/mm3 at treatment initiation); serum creatinine (baseline and periodically during treatment).
Overdosage
Symptoms: Abdominal pain, diarrhoea, vomiting, generalised tremor, seizure, myelosuppression (e.g. leucopenia, neutropenia, granulocytopenia, pancytopenia, bone marrow failure), hepatitis, liver function disorder, elevated creatinine, worsening of haematuria in patient with pre-existing renal impairment, acute kidney injury. Management: Symptomatic and supportive treatment. Adequate hydration and haemodialysis may be useful in reducing serum concentrations of valganciclovir. May consider the use of haematopoietic growth factors.
Drug Interactions
Increased risk of haematological adverse effects with zidovudine. Increased serum concentration of didanosine. Increased plasma concentration with probenecid. Increased risk of seizures with imipenem-cilastatin. Enhanced toxic effects with myelosuppressive drugs or agents affecting renal function (e.g. nucleosides [e.g. didanosine, stavudine, zidovudine], nucleotide analogues [e.g. adefovir, tenofovir], immunosuppressants [e.g. ciclosporin, mycophenolate mofetil, tacrolimus], antineoplastic agents [e.g. doxorubicin, hydroxyurea, vinblastine, vincristine], and anti-infective agents [e.g. amphotericin B, dapsone, flucytosine, pentamidine, trimethoprim/sulfonamides]).
Food Interaction
High-fat meals increase the plasma concentration of valganciclovir.
Action
Description: Mechanism of Action: Valganciclovir, an antiviral drug, is a prodrug of ganciclovir. Ganciclovir competitively inhibits the binding of deoxyguanosine-triphosphate to DNA polymerase, thereby preventing viral DNA synthesis. Pharmacokinetics: Absorption: Well absorbed from the gastrointestinal tract. Food (high-fat meal) increases absorption. Bioavailability: Approx 60%. Time to peak plasma concentration: 1-3 hours (ganciclovir). Distribution: Widely distributed to all tissue including CSF and ocular tissue. Plasma protein binding: 1-2% (ganciclovir). Metabolism: Rapidly and extensively metabolised in the intestinal wall and liver via hydrolysis by intestinal mucosal cells and hepatocytes into ganciclovir. Excretion: Via urine (80-90%, mainly as ganciclovir). Elimination half-life: 4.08 hours (ganciclovir).
Chemical Structure
Valganciclovir Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 135413535, Valganciclovir. https://pubchem.ncbi.nlm.nih.gov/compound/Valganciclovir. Accessed Nov. 23, 2023.
Storage
Store between 15-30°C. Reconstituted oral solution: Store between 2-8°C for ≤49 days. Do not freeze. Follow applicable procedures for receiving, handling, administration, and disposal.
J05AB14 - valganciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
References
Anon. Valganciclovir Hydrochloride. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 01/09/2023.Anon. Valganciclovir. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/09/2023.Buckingham R (ed). Valganciclovir Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/09/2023.Joint Formulary Committee. Valganciclovir. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/09/2023.Valcyte 450 mg Film-coated Tablets (Neon Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/09/2023.Valcyte 50 mg/mL Powder for Oral Solution (Roche Products Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/09/2023.Valcyte Tablet, Film Coated, Valcyte Hydrochloride Powder, for Solution (H2-Pharma, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/09/2023.Valcyte Tablets 450 mg (DKSH Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/09/2023.Valganciclovir Hydrochloride for Oral Powder, for Solution (Actavis Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/09/2023.Valganciclovir Hydrochloride Tablet (Dr. Reddy’s Laboratories Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/09/2023.Viatris Ltd. Valganciclovir Viatris 450 mg Film-coated Tablet data sheet 16 May 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 01/09/2023.
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