Ganciclovir Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for CMV Retinitis

Induction therapy:
5 mg/kg IV at a constant rate over 1 hour, every 12 hours for 14 to 21 days.

Maintenance:
IV: 5 mg/kg IV at a constant rate over 1 hour once a day, 7 days/week or 6 mg/kg IV once a day, 5 days/week.
Oral: 1000 mg 3 times a day or 500 mg 6 times a day (every 3 hours while awake) with food.

Patients who experience progression of CMV retinitis while receiving maintenance treatment should receive reinduction treatment.

Because ganciclovir capsules are associated with risk of more rapid rate of CMV retinitis progression, they should be used as maintenance treatment only in those patients for whom this risk is balanced by the benefit associated with avoiding daily intravenous infusions. Oral ganciclovir should not be used for induction.

Usual Adult Dose for CMV Prophylaxis

Patients with advanced HIV: 1000 mg orally 3 times a day with food.

Transplant Recipients:
Initial: 5 mg/kg IV over 1 hour every 12 hours for 7 to 14 days
Maintenance:
IV: 5 mg/kg IV once a day, 7 days/week or 6 mg/kg IV once a day, 5 days/week.
Oral: 1000 mg orally 3 times a day with food.

Usual Pediatric Dose for CMV Retinitis

The safety and efficacy of ganciclovir in pediatric patients has not been established. The use of ganciclovir in the pediatric population warrants extreme caution due to the probability of carcinogenicity and reproductive toxicity. Administration to pediatric patients should be undertaken only after careful evaluation and only if the potential benefits outweigh the risks.

>3 months:
Induction therapy: 5 mg/kg IV every 12 hours for 14 to 21 days.
Maintenance: 5 mg/kg IV once daily for 7 days or 6 mg/kg IV once daily for 5 days.

Usual Pediatric Dose for CMV Prophylaxis

The safety and efficacy of ganciclovir in pediatric patients has not been established. The use of ganciclovir in the pediatric population warrants extreme caution due to the probability of carcinogenicity and reproductive toxicity. Administration to pediatric patients should be undertaken only after careful evaluation and only if the potential benefits outweigh the risks.

Transplant recipients:
>1 year to 18 years:
Induction therapy: 5 mg/kg IV every 12 hours for 7 to 14 days.
Maintenance:
IV: 5 mg/kg IV once daily 7 days a week, or 6 mg/kg IV once daily, 5 days a week.
Oral:
>= 6 months: 10 mg/kg every 8 hours with food, not to exceed adult dose.


HIV-infected patients:
>1 month to 12 years: 5 mg/kg IV once daily.
>12 years: Adult dose

Renal Dose Adjustments

CrCl < 10 mL/min:
Induction: 1.25 mg/kg IV 3 times a week.
Maintenance: 0.625 mg/kg IV 3 times a week or 500 mg 3 times a week.

CrCl 10 to 24 mL/min:
Induction: 1.25 mg/kg IV every 24 hours.
Maintenance: 0.625 mg/kg IV every 24 hours or 500 mg orally once a day.

CrCl 25 to 49 mL/min:
Induction: 2.5 mg/kg IV every 24 hours.
Maintenance: 1.25 mg/kg IV every 24 hours or 1000 mg once a day or 500 mg twice a day.

CrCl 50 to 69 mL/min:
Induction: 2.5 mg/kg IV every 12 hours.
Maintenance: 2.5 mg/kg IV every 24 hours or 1500 mg once a day or 500 mg 3 times a day.

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

The duration of treatment in transplant recipients is dependent upon the duration and degree of immunosuppression. In controlled clinical trials in bone marrow allograft recipients, treatment with ganciclovir IV was continued until day 100 to 120 post-transplantation. CMV disease occurred in several patients who discontinued treatment prematurely. In heart allograft recipients, the onset of newly diagnosed CMV disease occurred after treatment was stopped at day 28 post-transplant, suggesting that continued dosing may be necessary to prevent late occurrence of CMV disease in this patient population. In a controlled clinical trial of liver allograft recipients, treatment with ganciclovir capsules was continued through week 14 post-transplantation.

Duration of secondary prophylaxis in HIV-infected patients should continue until a CD4+ > 100 to 150 cells/microL has been maintained for at least 6 months and there is no evidence of active disease. Prophylaxis should be restarted when the CD4+ count drops below 100 to 150 cells/microL.

Precautions

The safety and efficacy of ganciclovir in pediatric patients has not been established. The use of ganciclovir in the pediatric population warrants extreme caution due to the probability of carcinogenicity and reproductive toxicity. Administration to pediatric patients should be undertaken only after careful evaluation and only if the potential benefits outweigh the risks.

Due to the frequency of granulocytopenia and thrombocytopenia in patients receiving ganciclovir, it is recommended that complete blood counts and platelet counts be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in cytopenia, or in whom neutrophil counts are less than 1000 cells/microL at the beginning of treatment. Patients should have serum creatinine or creatinine clearance values followed carefully to allow for dosage adjustments in renally impaired patients.

Dosage reductions should also be considered for those with neutropenia, anemia and/or thrombocytopenia. Ganciclovir should not be administered in patients with severe neutropenia (ANC less than 500/microL) or severe thrombocytopenia (platelets less than 25,000/microL).

Do not administer ganciclovir IV solution by rapid or bolus IV injection. The recommended infusion rate should not be exceeded. The toxicity of ganciclovir IV may be increased as a result of excessive plasma levels.

IM or subcutaneous injection of reconstituted ganciclovir IV solution may result in severe tissue irritation due to its high pH (11).

Dialysis

Dosing for patients undergoing hemodialysis should not exceed 1.25 mg/kg IV or 500 mg orally 3 times/week, following each hemodialysis session.

Other Comments

Ganciclovir capsules should be taken with food for optimal bioavailability.

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