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Heart Function Service: Heart Transplant Protocols

               Protocol for Administration of Valganciclovir (Valcyte®)


               Description: Valganciclovir is a prodrug of ganciclovir and is rapidly converted to ganciclovir by
               intestinal and hepatic esterases after oral administration.  Ganciclovir is a synthetic analogue of
               2’-deoxyguanosine and inhibits replication of cytomegalovirus.

               Indication: approved for the prevention of CMV disease in kidney, heart, and kidney-pancreas
               transplant patients and not indicated for use in either adult or pediatric liver transplant
               patients.  It has been used off-label for CMV/EBV treatment and prevention in solid organ
               transplant patients, including liver patients.

               Dose:
               Children < 13 yo:
               Treatment dose:  15 mg/kg po BID (max 900mg/dose)
               Prophylactic dose: 15 mg/kg po QDAY (max 900mg/dose) for 9 months

               Children ≥ 13 yo:
               Treatment dose: 900mg po BID
               Prophylactic dose: 900mg po QDAY for 9 months

               Renal adjustment:
               Valganciclovir treatment dose
                    GFR (ml/min)               ≥ 13 yo                          <13yo

                         >60                  900 mg BID                 15 mg/kg/dose BID

                       >40-59                 450 mg BID                 7.5 mg/kg/dose BID
                        25-39                 450 mg QD                  7.5 mg/kg/dose QD
                        10-24                450 mg QOD                 7.5 mg/kg/dose QOD


               Valganciclovir prophylaxis dose
                    GFR (ml/min)               ≥ 13 yo                          <13yo

                         >60                  900 mg QD                  15 mg/kg/dose QD
                       >40-59                 450 mg QD                  7.5 mg/kg/dose QD

                        25-39                450 mg QOD                 7.5 mg/kg/dose QOD
                        10-24            450 mg twice weekly        7.5 mg/kg/dose twice weekly

               Administration:
               Swallow tablets whole; tablets should not be broken or crushed.

               Handling:
               Valcyte is teratogenic, mutagenic and carcinogenic.  Avoid direct contact with broken or
               crushed tablets, the powder for oral solution, and the constituted oral solution with skin or







               Updated November 9, 2017                                                                    82
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