VALCYTE

What it is

Valcyte is valganciclovir hydrochloride . Valcyte is available as film-coated tablets and as powder for oral solution . Each film coated tablet contains 496.3 mg valganciclovir HCl (corresponding to 450 mg valganciclovir) . The powder is reconstituted to form an oral solution, containing 55 mg valganciclovir HCl per mL (equivalent to 50 mg valganciclovir) . Valganciclovir is an L-valyl ester salt (prodrug) of ganciclovir which, after oral administration, is rapidly converted to ganciclovir by intestinal and hepatic esterases . Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, which inhibits replication of herpes viruses in vitro and in vivo .

Approved indications

— Treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS) . — Prophylaxis of CMV disease in adult and paediatric solid organ transplantation (SOT) patients who are at risk .

Dosing overview

For patients with active CMV retinitis, the recommended dosage is 900 mg twice daily for 21 days with food . Following induction treatment, or in patients with inactive CMV retinitis the recommended dose is 900 mg once daily with food . For kidney transplant patients, the recommended dose is 900 mg once daily with food, starting within 10 days post-transplantation and continuing until 200 days post-transplantation . For all other solid organ transplant patients, the recommended dose is 900 mg once daily with food, starting within 10 days post-transplantation and continuing until 100 days post-transplantation . In paediatric solid organ transplant patients, the recommended once daily dose of Valcyte is based on body surface area (BSA) and creatinine clearance (CrCl) derived from Schwartz formula (CrCLS), and is calculated using the equation: Paediatric Dose (mg) = 7 x BSA x CrCLS .

Key safety warnings

Clinical toxicities of Valcyte, which is metabolised to ganciclovir, include leucopenia and thrombocytopenia . Severe leucopenia, neutropenia, anaemia, thrombocytopenia, pancytopenia, bone marrow failure and aplastic anaemia have been observed in patients treated with Valcyte (and ganciclovir) . It is recommended that complete blood counts and platelet counts be monitored in all patients frequently during therapy; especially in patients with renal impairment in neonates and infants, in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leucopenia, or in whom neutrophil counts are less than 1000 cells/μL at the beginning of treatment . In animal studies ganciclovir was found to be mutagenic, clastogenic, aspermatogenic, teratogenic and carcinogenic and to impair fertility. Valcyte should therefore be considered a potential teratogen and carcinogen in humans with potential to cause birth defects and cancers . It is considered probable that in humans, valganciclovir at the recommended doses may cause temporary or permanent inhibition of spermatogenesis . In patients with impaired renal function, dosage adjustments based on creatinine clearance are required. Increased serum creatinine levels have been observed in trials evaluating Valcyte tablets. Patients should have serum creatinine or creatinine clearance values monitored carefully to allow for dosage adjustments in renally impaired patients .

Contraindications

Valcyte is contraindicated in patients with known hypersensitivity to valganciclovir, ganciclovir or to any of the excipients . Valcyte should not be administered if the absolute neutrophil count is less than 500 cells/μL, the platelet count is less than 25 000/μL, or the haemoglobin is less than 8 g/dL .

PBS listing

The powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL is listed on the PBS with 3 items, restriction type streamlined, and ex-manufacturer price of A$395.10 on the latest schedule of 2026-05-01 .

Regulatory history

Valcyte tablets 450 mg were first listed on the ARTG on 2002-06-17 . Valcyte powder for oral solution 50 mg/mL was first listed on the ARTG on 2010-03-24 . An AusPAR was approved on 2015-09-08 for extension of the use of Valcyte for prophylaxis against cytomegalovirus (CMV) disease in adult and paediatric solid organ transplantation patients who are at risk . The TGA evaluated data from two new paediatric studies (NV25409 and NP22523) which supported the use of valganciclovir in the paediatric solid organ transplantation population, with a dosing algorithm developed to achieve efficacious drug levels in children similar to those proven effective in adults .