Safety
Valcyte has a safety profile similar to that of oral ganciclovir.
Safety profiles of Valcyte and IV ganciclovir during the 4-week randomized phase of the pivotal study were comparable, with the obvious exception of catheter-related infections
Percentage of Selected Adverse Events Occurring During the Randomized Phase4
| Adverse Event | Valcyte n=79 |
IV Ganciclovir n=79 |
| Diarrhea | 16% | 10% |
| Neutropenia | 11% | 13% |
| Nausea | 8% | 14% |
| Headache | 9% | 5% |
| Anemia | 8% | 8% |
| Catheter-related infection | 3% | 11% |
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. Didanosine blood levels can be significantly increased when didanosine is taken with Valcyte. Cytopenias may be exacerbated by zidovudine. Other side effects occuring with a frequency of ≥5% may include diarrhea, fever, nausea, neutropenia, headache, vomiting, insomnia, abdominal pain, retinal detachment, peripheral neuropathy and parestheisa
Reference:
4 Valcyte® [product information]. Nutley, NJ: Roche Laboratories Inc.; January 2006.