1. Prevention of cytomegalovirus (CMV) disease in transplant recipients adult.
2. Treatment of CMV retinitis in immunocompromised adult (including patients with AIDS).

Antiviral Agent
Ganciclovir is phosphorylated by viral and cellular kinases into ganciclovir triphosphate which competitively inhibits the binding of deoxyguanosine triphosphate to DNA polymerase resulting in inhibition of viral DNA synthesis.

1.Distribution(Adults): Vd: 0.74 ± 0.15 L/kg; widely to all tissues including CSF and ocular tissue.
2.Protein binding: 1% to 2%.
3.Half-life elimination(Adults): Mean: IV: 3.5 ± 0.9 hours; Oral: 4.8 ± 0.9 hours; CrCl <25 mL/minute: 10.7 ± 5.7 hours.
4.Excretion: Urine (80% to 99% as unchanged drug).

Hypersensitivity to ganciclovir, valganciclovir, acyclovir, or any component of the formulation

Infant risk cannot be ruled out.

1.Dermatologic: Hyperhidrosis (12%)
2.Gastrointestinal: Abdominal pain ((20%), decreased appetite (14%), diarrhea (44%), nausea ((20%), vomiting (13%)
3.Hematologic & oncologic: Anemia (25%), decrease in absolute neutrophil count (<500/mcL: 25%; 500 to 749/mcL: 14%; 750 to 1,000/mcL: 26%), leukopenia (41%)
4.Infection: Infection (13%), sepsis (15%)
5.Nervous system: Asthenia ((20%), headache ((20%)
6.Respiratory: Cough ((20%), dyspnea ((20%)
7.Miscellaneous: Fever (48%)

Cytomegalovirus, prophylaxis in transplant recipients:
1.Allogeneic hematopoietic cell transplant recipients: IV: 5 mg/kg/dose every 12 hours for 5 to 7 days, then 5 mg/kg/dose every 24 hours until day 100 post-transplant.
2.Solid organ transplant recipients: IV: 5 mg/kg/dose every 24 hours; duration of prophylaxis is dependent on type of transplant, as well as donor and recipient cytomegalovirus (CMV) serostatus.
Cytomegalovirus, treatment:
1. IV: 5 mg/kg/dose every 12 hours; duration varies based on site and severity of infection, type of immunocompromise, and clinical response.
Cytomegalovirus retinitis, treatment:
1.IV: 5 mg/kg/dose every 12 hours for 14 to 21 days; for patients with HIV and high-risk solid organ transplant recipients, follow with chronic maintenance therapy.

Limited data available

CrCl (mL/minute)	Induction (usual dose 5 mg/kg/dose Q12H)	Maintenance (usual dose 5 mg/kg/dose Q24H)
≥70 mL/min	No dosage adjustment necessary	No dosage adjustment necessary
50-70 mL/min	2.5 mg/kg/dose Q12H	2.5 mg/kg/dose Q24H
25-50 mL/min	2.5 mg/kg/dose Q24H	1.25 mg/kg/dose Q24H
10-25 mL/min	1.25 mg/kg/dose Q24H	0.625 mg/kg/dose Q24H
<10 mL/min	1.25 mg/kg/dose Q48H-Q72H	0.625 mg/kg/dose Q48H-Q72H

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).