Ganciclovir

CLINICAL USE

Antiviral agent :Treatment of life- or sight-threatening cytomegalovirus (CMV) in immunocompromised peopleCMV prophylaxis in immunosuppressed patients secondary to organ transplantation

DOSE IN NORMAL RENAL FUNCTION

Induction/treatment of active CMV disease: 5 mg/kg 12 hourly for 14–21 daysMaintenance for CMV retinitis: 6 mg/kg per day for 5 days per week or 5 mg/kg daily until recovery of adequate immunity

PHARMACOKINETICS

Molecular weight :255.2

%Protein binding :<2

%Excreted unchanged in urine : 84.6–94.6

Volume of distribution (L/kg) :0.54–0.87

half-life – normal/ESRD (hrs) :2.9/28.5

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50 : See ‘Other Information’

10 to 20 : See ‘Other Information’

<10 : See ‘Other Information’

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD :Dialysed. 1.25 mg/kg every day

HD :Dialysed. 1.25 mg/kg every day, given post dialysis on dialysis days

HDF/high flux :Dialysed. 1.25 mg/kg every day, given post dialysis on dialysis days

CAV/VVHD :Dialysed. 2.5 mg/kg per day

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugs

Antibacterials: increased risk of convulsions with imipenem-cilastatin

Antivirals: possibly increased didanosine concentration; avoid with lamivudine; profound myelosuppression with zidovudine – avoid if possibleIncreased risk of myelosuppression with other myelosuppressive drugsMycophenolate: concomitant treatment with ganciclovir and mycophenolate increase plasma levels of both drugs

ADMINISTRATION

Reconstition

Reconstitute 1 vial (500 mg) with 10 mL water for injection (50 mg/mL), then transfer dose to 100 mL sodium chloride 0.9%

Route

IV peripherally in fast-flowing vein or centrally – see below

Rate of Administration

Over 1 hour

Comments

May give 50% dose over 15 minutes after

HD : in washback (unlicensed)

OTHER INFORMATION

From SPC:Creatinine Clearance Dose (mL/min) (mg/kg/hours) >70 5 mg/kg 12 hourly 50 69 2.5 mg/kg 12 hourly 25 49 2.5 mg/kg 24 hourly 10 24 1.25 mg/kg 24 hourly

<10 : 1.25 mg/kg 24 hourly, given after haemodialysis on dialysis daysAlternative regimen used by some units:CreatinineClearance Dose(mL/min) (mg/kg/hours) >50 5 mg/kg 12 hourly 25 50 2.5 mg/kg 12 hourly 10 25 2.5 mg/kg 24 hourly

<10 : 1.25 mg/kg 24 hourlyMonitor patient for myelosuppression, particularly in patients receiving prophylactic co-trimoxazole therapyPre-dialysis therapeutic blood levels in range 5–12 mg/LNot to be infused in concentrations over 10 mg/mL peripherally

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