Valganciclovir.txt

CLINICAL USE

Induction and maintenance treatment of CMV retinitis in AIDS patients Treatment (unlicensed indication) and prophylaxis of CMV disease in transplant patients

DOSE IN NORMAL RENAL FUNCTION

Induction/treatment: 900 mg twice daily for 21 days Maintenance/prophylaxis: 900 mg daily

PHARMACOKINETICS

Molecular weight &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp : 390.8 (as hydrochloride)

%Protein binding &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp : <2 (as ganciclovir)

%Excreted unchanged in urine &nbsp &nbsp : 84.6–94.6 (as ganciclovir)

Volume of distribution (L/kg) &nbsp &nbsp &nbsp : 0.519–0.841

half-life – normal/ESRD (hrs)&nbsp &nbsp &nbsp : 4.1/67.5

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

40–59 Induction/Treatment: 450 mg twice daily Maintenance/Prophylaxis: 450 mg daily 25–39 Induction/Treatment: 450 mg daily Maintenance/Prophylaxis: 450 mg every 48 hours 10–24 Induction/Treatment: 450 mg every 48 hours Maintenance/Prophylaxis: 450 mg twice weekly

<10 &nbsp &nbsp &nbsp &nbsp &nbsp : Treatment: 450 mg 2–3 times a week Prophylaxis: 450 mg 1–2 times a week See ‘Other Information’

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp: Dialysed. See ‘Other Information’

HD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp : Dialysed. See ‘Other Information’

HDF/high flux &nbsp : Dialysed. See ‘Other Information’

CAV/VVHD &nbsp &nbsp &nbsp: Likely dialysability. Dose as in GFR=10–24 mL/min

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugs

Antibacterials: increased risk of convulsions with imipenem-cilastatin

Antivirals: possibly increased didanosine concentration; profound myelosuppression with zidovudine – avoid if possible Mycophenolate: possibly increased concentrations of both mycophenolic acid and ganciclovir Increased risk of myelosuppression with other myelosuppressive drugs

ADMINISTRATION

Reconstition

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Route

Oral

Rate of Administration

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Comments

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OTHER INFORMATION

900 mg valganciclovir twice daily is therapeutically equivalent to 5 mg/kg intravenous ganciclovir twice daily Valganciclovir is a prodrug of ganciclovir Take with food if possible Manufacturer advises to avoid in severe renal impairment due to increased risk of bone marrow suppression Doses of 450 mg once or twice a week have been used to treat CMV disease in patients with GFR <10 mL/min on dialysis Approximately 50% of ganciclovir is removed by haemodialysis .

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