Valganciclovir hydrochloride (Valcyte®)
For full prescribing information for Valcyte®, click here.
Updated Boxed Warning
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS
Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with VALCYTE.
Impairment of Fertility: Based on animal data, VALCYTE may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.
Public Information from the FDA and Medscape
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Cite this: FDA Safety Labeling Changes: April-June 2017 - Medscape - Aug 31, 2017.