Classifications: antiviral agent; Therapeutic: antiviral
Pregnancy Category: C
450 mg tablets
Rapidly converted to ganciclovir by intestinal and hepatic enzymes. In cells infected with cytomegalovirus (CMV), ganciclovir
is phosphorylated to ganciclovir triphosphate, which inhibits viral DNA synthesis.
Antiviral drug active against cytomegalovirus (CMV). Prevents replication of viral CMV DNA.
Treatment of CMV retinitis; prevention of CMV disease in high-risk kidney, kidney-pancreas, and heart transplant patients
(not effective in liver transplants).
Hypersensitivity to valganciclovir, ganciclovir, or acyclovir. Not recommended for persons on hemodialysis; renal failure;
dental work; antimicrobial resistance; neutropenia, thrombocytopenia; pregnancy (category C), females of childbearing age;
Impaired kidney function; older adults; dental disease; anemia; leukopenia; bone marrow depression; concomitant use of myelosuppressive
drugs; irradiation. Safety and efficacy in children are not established.
Route & Dosage
Adult: PO 900 mg once daily with food, starting within 10 d of transplantation until 100 d posttransplantation
Cytomegalovirus Retinitis Induction
Adult: PO 900 mg b.i.d. with food x 21 d
Cytomegalovirus Retinitis Maintenance
Adult: PO 900 mg q.d. with food
Clcr 4059 mL/min: 450 mg b.i.d. (induction) or q.d. (maintenance); 2539 mL/min: 450 mg q.d. (induction) or q2d (maintenance);
1024 mL/min: 450 mg q2d (induction) or twice weekly (maintenance)
- Exercise caution in handling tablets. Do not crush or break tablets. Avoid direct contact of crushed or broken tablets with
skin or mucous membranes.
- Give with food.
- Do not give to patients on hemodialysis.
- Store at 25°30° C (77°86° F).
Adverse Effects (≥1%)Body as a Whole: Fever,
local and systemic infections, hypersensitivity reactions. CNS: Headache, insomnia,
, convulsions, psychosis, confusion, hallucinations, agitation. GI: Diarrhea, nausea, vomiting, abdominal pain. Hematologic: Neutropenia, anemia, thrombocytopenia, pancytopenia
, bone marrow suppression, aplastic anemia. Special Senses: Retinal detachment.
InteractionsDrug: antineoplastic agents
, amphotericin B, didanosine, trimethoprim-sulfa-methoxazole (TMP-SMZ), dapsone, pentamidine, probenecid, zidovudine
may increase bone marrow
suppression and other toxic effects of valganciclovir; may increase risk of nephrotoxicity from
cyclosporine; antiretroviral agents
may decrease valganciclovir levels; valganciclovir may increase levels and toxicity
of antiretroviral agents
; may increase risk of seizures due to imipenem-cilastatin.
Well absorbed from GI tract, 60% reaches systemic circulation as ganciclovir
38 d. Peak:
13 h. Duration: Clinical
relapse can occur 14 d to 3.5 mo after stopping therapy; positive blood and urine cultures recur 1260 d after
Distributes throughout body including CSF, eye, lungs, liver, and kidneys; crosses placenta in animals; not known if distributed
into breast milk. Metabolism:
Metabolized in intestinal wall to ganciclovir
is not metabolized. Elimination:
9499% of dose is excreted unchanged in urine. Half-Life:
Assessment & Drug Effects
- Withhold drug and notify physician for any of the following: Absolute neutrophil count <500 cells/mm3, platelet count <25,000/mm3, hemoglobin <8 g/dL, declining creatinine clearance.
- Monitor for S&S of bronchospasm in asthma patients; notify physician immediately.
- Lab tests: Baseline and frequent serum creatinine or creatinine clearance, CBC with differential, platelet count, Hct & Hgb.
Patient & Family Education
- Schedule ophthalmologic follow-up examinations at least every 46 wk while being treated with valganciclovir.
- Keep all scheduled appointments for laboratory tests.
- Do not drive or engage in potentially hazardous activities until response to drug is known.
- Report any of the following immediately: unexpected bleeding, infection.
- Use effective methods of contraception (barrier and other types) during and for at least 90 d following treatment.
- Discontinue drug and notify physician immediately in the event of pregnancy.