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Valcyte
valganciclovir
Black Box Warnings .
Hematologic Toxicity
severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure, incl. aplastic anemia, reported
Fertility Impairment
may cause temporary or permanent spermatogenesis inhibition in males and fertility suppression in females based on animal data and limited human data
Fetal Toxicity
potential to cause birth defects based on animal data
Mutagenesis/Carcinogenesis
potential to cause cancers based on animal data
Adult Dosing .
Dosage forms: TAB: 450 mg; SOL: 50 mg per mL
CMV retinitis, AIDS-associated
- [induction tx]
- Dose: 900 mg PO bid x14-21 days; Info: give w/ food
- [maintenance tx]
- Dose: 900 mg PO qd; Info: give w/ food
CMV prophylaxis, heart transplant
- [900 mg PO qd until 100 days post-transplant]
- Start: w/ in 10 days of transplant; Info: give w/ food
CMV prophylaxis, kidney transplant
- [900 mg PO qd until 200 days post-transplant]
- Start: w/ in 10 days of transplant; Info: give w/ food
CMV prophylaxis, kidney-pancreas transplant
- [900 mg PO qd until 100 days post-transplant]
- Start: w/ in 10 days of transplant; Info: give w/ food
renal dosing
- [induction tx]
- CrCl 40-59: 450 mg bid; CrCl 25-39: 450 mg qd; CrCl 10-24: 450 mg q48h; CrCl <10: avoid use
- HD: 200 mg 3x/wk after dialysis; consider supplement if next maint. dose not due right after dialysis; PD: not defined
- [prophylaxis or maintenance tx]
- CrCl 40-59: 450 mg qd; CrCl 25-39: 450 mg q48h; CrCl 10-24: 450 mg 2x/wk; CrCl <10: avoid use
- HD: 100 mg 3x/wk after dialysis; consider supplement if next maint. dose not due right after dialysis; PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: TAB: 450 mg; SOL: 50 mg per mL
Special Note
- [dosing clarification]
- Info: see pkg insert for Mosteller BSA and modified Schwartz CrCl equations; use max CrCl 150 mL/min/1.73 m^2
CMV prophylaxis, heart transplant
- [1 mo-16 yo]
- Dose: total dose (mg) = [7 x BSA x CrCl] PO qd until 100 days post-transplant; Start: w/in 10 days of transplant; Max: 900 mg/day; Info: round calculated dose to nearest 10 mg increment; solution preferred, but may use tabs if calculated dose w/in 10% of avail. tab strength; give w/ food
CMV prophylaxis, kidney transplant
- [4 mo-16 yo]
- Dose: total dose (mg) = [7 x BSA x CrCl] PO qd until 200 days post-transplant; Start: w/in 10 days of transplant; Max: 900 mg/day; Info: round calculated dose to nearest 10 mg increment; solution preferred, but may use tabs if calculated dose w/in 10% of avail. tab strength; give w/ food
CMV retinitis, AIDS-associated (off-label)
- [induction tx, 13 yo and older]
- Dose: 900 mg PO bid x14-21 days; Info: give w/ food
- [maintenance tx, 13 yo and older]
- Dose: 900 mg PO qd; Info: give w/ food
renal dosing
- [prophylaxis]
- renal impairment: use usual peds dose equation
- HD/PD: not defined
- [induction tx]
- CrCl 40-59: 450 mg bid; CrCl 25-39: 450 mg qd; CrCl 10-24: 450 mg q48h; CrCl <10: avoid use
- HD: 200 mg 3x/wk after dialysis; consider supplement if next maint. dose not due right after dialysis; PD: not defined
- [maintenance tx]
- CrCl 40-59: 450 mg qd; CrCl 25-39: 450 mg q48h; CrCl 10-24: 450 mg 2x/wk; CrCl <10: avoid use
- HD: 100 mg 3x/wk after dialysis; consider supplement if next maint. dose not due right after dialysis; PD: not defined
hepatic dosing
- [not defined]