Safety
Valcyte has a safety profile similar to that of oral ganciclovir.
- Selected adverse events from the pivotal trial were reported regardless of severity and drug relationship (up to 28 days after study treatment)
- The majority of adverse events were mild or moderate in intensity
Adverse Events Reported in ≥5% of Selected SOT Patients4
| Adverse Event | Valcyte n=24 |
Oral Ganciclovir n=126 |
| Diarrhea | 30% | 29% |
| Tremors | 28% | 25% |
| Graft rejection | 24% | 30% |
| Nausea | 23% | 23% |
| Headache | 22% | 27% |
| Insomnia | 20% | 16% |
| Hypertension | 18% | 15% |
| Vomiting | 16% | 14% |
| Leukopenia | 14% | 7% |
| Pyrexia | 13% | 14% |
Safety Information
WARNING: The clinical toxicity of Valcyte, which is metabolized to ganciclovir, includes granulocytopenia, anemia and thrombocytopenia. In animal studies, ganciclovir was carcinogenic, teratogenic and caused aspermatogenesis.
Valcyte tablets should not be administered if the absolute neutrophil count is less than 500 cells/µL, the platelet count is less than 25,000/µL, or the hemoglobin is less than 8 g/dL. Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow depression, and aplastic anemia have been observed in patients treated with Valcyte tablets (and ganciclovir). Other adverse events reported with a frequency of ≥5% included diarrhea, tremors, graft rejection, nausea, headache, insomnia, hypertension, vomiting and fever.
In liver transplant patients, there was a significantly higher incidence of tissue-invasive CMV disease in the Valcyte-treated group compared with the oral ganciclovir group (see CLINICAL TRIALS in the complete product information).
Reference:
4Valcyte® [product information]. Nutley, NJ: Roche Laboratories Inc.; January 2006.