Valganciclovir
VALCYTE
Pronunciation: val-gan-SYE-kloe-veer
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 in AIDS — induction | Adults | 900 mg BID with food × 21 days | 900 mg BID | 900 mg BID |
| CMV retinitis in AIDS — maintenance (or inactive retinitis) | Adults | 900 mg QD with food | 900 mg QD | 900 mg QD |
| Prevention of CMV disease — heart or kidney-pancreas transplant (high risk, D+/R-) | Adults | 900 mg QD, starting within 10 days of transplant | 900 mg QD until 100 days post-transplant | 900 mg QD |
| Prevention of CMV disease — kidney transplant (high risk, D+/R-) | Adults | 900 mg QD, starting within 10 days of transplant | 900 mg QD until 200 days post-transplant | 900 mg QD |
| Prevention of CMV disease — kidney transplant | Peds 4 months–16 y | Dose (mg) = 7 × BSA × CrCl (modified Schwartz) QD, starting within 10 days of transplant | QD until 200 days post-transplant | 900 mg QD (cap Schwartz CrCl at 150 mL/min/1.73m2) |
| Prevention of CMV disease — heart transplant | Peds 1 month–16 y | Dose (mg) = 7 × BSA × CrCl (modified Schwartz) QD, starting within 10 days of transplant | QD until 100 days post-transplant | 900 mg QD (cap Schwartz CrCl at 150 mL/min/1.73m2) |
Renal Adults (CrCl, mL/min) — induction / maintenance-prevention: ≥60: 900 mg BID / 900 mg QD; 40–59: 450 mg BID / 450 mg QD; 25–39: 450 mg QD / 450 mg every 2 days; 10–24: 450 mg every 2 days / 450 mg twice weekly; <10 on hemodialysis: not recommended (use ganciclovir). Peds: CrCl is built into the dosing equation.
Hepatic Undefined
Avoid if ANC <500 cells/µL, platelets <25,000/µL, or Hgb <8 g/dL; frequent CBC with differential and platelets.
Instructions
- Take with food.
- Do not break or crush tablets; avoid skin/mucosal contact with broken tablets, powder, or solution; handle/dispose as an antineoplastic.
- Adults use tablets, not oral solution. Peds: oral solution (50 mg/mL) preferred; round to nearest 25 mg; tablet acceptable if calculated dose within 10% of 450 mg.
- Oral solution: pharmacist reconstitutes; refrigerate, discard after 49 days.
Available strengths
- tab 450 mg
- sol 50 mg/mL
Cautions
- Hematologic toxicity
- Acute renal failure (elderly, nephrotoxic drugs, inadequate hydration)
- Impairment of fertility
- Fetal toxicity
- Mutagenesis and carcinogenesis
Adverse reactions
- Diarrhea
- Pyrexia
- Fatigue
- Nausea
- Tremor
- Neutropenia
- Anemia
- Leukopenia
- Thrombocytopenia
- Headache
- Insomnia
- Urinary tract infection
Pregnancy Expected reproductive toxicity like ganciclovir (teratogenic in rabbits at 2× human exposure); no human data; pregnancy test first, contraception ≥30 days after (females) and condoms ≥90 days after (males).
Lactation No human data (ganciclovir in rat milk); breastfeeding not recommended (serious infant AEs, HIV transmission).
Cost
| Strength | #/mo | generic $ | CostPlus | |
|---|---|---|---|---|
| 450 mg | tab | 60 BID | $114.90/mo | offered |
| 50 mg/mL | sol | per unit | $1.01/mL | not offered |
Generic entry2014
⚠ BOXED WARNINGS
- Hematologic toxicity
- Impairment of fertility
- Fetal toxicity
- Mutagenesis and carcinogenesis
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.