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Valganciclovir

Brand and Other Names: VALCYTE
Mechanism of Action:

Valganciclovir is an antiviral drug with activity against CMV [see Microbiology (12.4)].

Indications:

VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:

Adult Patients

  • Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
  • Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.

Pediatric Patients 

  • Prevention of CMV disease in kidney and heart transplant patients at high risk.
Route: Oral
Dose:
  • VALCYTE for oral solution and tablets should be taken with food. 
  • VALCYTE tablets should not be broken or crushed. 
  • Adult patients should use VALCYTE tablets, not VALCYTE for oral solution.
  • Adults with renal impairment: Adjust dose based on creatinine clearance. For adult patients receiving hemodialysis a dose recommendation cannot be given. 
Adverse Reactions:

Adult patients: Most common adverse reactions and laboratory abnormalities (reported in at least one indication by greater than or equal to 20% of patients) are diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting.

Pediatric patients: Most common adverse reactions and laboratory abnormalities (reported in greater than or equal to 20% of pediatric solid organ transplant recipients) are diarrhea, pyrexia, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.

Contraindication:

Hypersensitivity to valganciclovir or ganciclovir.

Warnings and Precautions:

Acute renal failure: Acute renal failure may occur in elderly patients (with or without reduced renal function), patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients or those taking nephrotoxic drugs, reduce dosage in patients with renal impairment, and monitor renal function. 

See package insert for full prescribing information.