Hematologic Toxicity; Impairment of Fertility; Fetal Toxocity; Mutagenesis & Carcinogenesis
Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow aplasia and aplastic anemia have been reported in patients treated with valganciclovir hydrochloride for oral solution.
Impairment of Fertility: Based on animal and limited humandata, valganciclovir hydrochloride for oral solution may cause temporary or permanent inhibition of spermatogenesis and suppression of fertility in females.
Fetal Toxicity: Based on animal data, valganciclovir hydrochloride for oral solution has the potential to cause birth defects in humans.
Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir hydrochloride for oral solution has the potential to cause cancers in humans.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Frequent complete blood counts and platelet counts performed, especially in patients with previous hematological reactions with this drug or other nucleoside analogues.
Patient Counseling Information