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 &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :255.2
  • %Protein binding &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :<2
  • %Excreted unchanged in urine &nbsp &nbsp : 84.6–94.6
  • Volume of distribution (L/kg) &nbsp &nbsp &nbsp :0.54–0.87
  • half-life – normal/ESRD (hrs)&nbsp &nbsp &nbsp :2.9/28.5

    DOSE IN RENAL IMPAIRMENT

    GFR (mL/MIN)

  • 20 to 50 &nbsp &nbsp : See ‘Other Information’
  • 10 to 20 &nbsp &nbsp : See ‘Other Information’
  • <10 &nbsp &nbsp &nbsp &nbsp &nbsp : See ‘Other Information’

    DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

  • CAPD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp:Dialysed. 1.25 mg/kg every day

  • HD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :Dialysed. 1.25 mg/kg every day, given post dialysis on dialysis days
  • HDF/high flux &nbsp :Dialysed. 1.25 mg/kg every day, given post dialysis on dialysis days
  • CAV/VVHD &nbsp &nbsp &nbsp: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 &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp : 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
  • 50 5 mg/kg 12 hourly 25 50 2.5 mg/kg 12 hourly 10 25 2.5 mg/kg 24 hourly
  • <10 &nbsp &nbsp &nbsp &nbsp &nbsp : 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