Valganciclovir
VALCYTE
What it isOral ganciclovir prodrug inhibiting viral DNA polymerase; CMV treatment and transplant prophylaxis.
Why this oneIt gives IV-equivalent ganciclovir exposure orally, which converts inpatient therapy to outpatient.
What limits itMyelosuppression requires regular counts. Renally adjusted; teratogenic and carcinogenic, so handling precautions apply.
FDA-approved for
- CMV (2001)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| CMV retinitis — induction | Adults | 900 mg BID ×21 days | 900 mg BID | |
| CMV retinitis — maintenance | Adults | 900 mg QD | 900 mg QD | |
| Prevention of CMV disease | Heart or kidney-pancreas transplant | 900 mg QD (day ≤10 to 100 days post-transplant) | 900 mg QD | |
| Prevention of CMV disease | Kidney transplant | 900 mg QD (day ≤10 to 200 days post-transplant) | 900 mg QD | |
| Prevention of CMV disease — kidney transplant | Peds 4 mo–16 y | QD per BSA/CrCl algorithm (day ≤10 to 200 days post) | Per algorithm | |
| Prevention of CMV disease — heart transplant | Peds 1 mo–16 y | QD per BSA/CrCl algorithm (day ≤10 to 100 days post) | Per algorithm |
Renal Adjust dose based on creatinine clearance; no recommendation for adult hemodialysis patients.
Hepatic Undefined
Instructions
- Take with food
- Do not break or crush tablets
- Adults should use tablets, not the oral solution
Cautions
- Severe hematologic toxicity (avoid if ANC <500, platelets <25,000, or Hgb <8 g/dL); monitor CBC frequently
- Acute renal failure (elderly, nephrotoxic drugs, dehydration)
Adverse reactions
- Diarrhea
- Pyrexia
- Fatigue
- Nausea
- Tremor
- Neutropenia
- Anemia
- Leukopenia
- Thrombocytopenia
- Headache
- Insomnia
- Urinary tract infection
- Vomiting
Pregnancy Prodrug of ganciclovir; potential to cause birth defects (animal data); no human data.
Lactation Breastfeeding is not recommended.
⚠ BOXED WARNINGS
- Hematologic toxicity
- Impairment of fertility
- Fetal toxicity
- Mutagenesis and carcinogenesis
Cost, est. cash$10–$500/month
Generic entry2014
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.
Active metabolites
Mechanism of action: Valganciclovir ballicule
