Hematologic Toxicity, Impairment of Fertility, Fetal Toxicity, Mutagenesis and Carcinogenesis
- Granulocytopenia, anemia and thrombocytopenia, and pancytopenia have been reported in patients treated with ganciclovir.
Impairment of Fertility
- Based on animal data and limited human data, ganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.
- Based on animal data, ganciclovir has the potential to cause birth defects in humans.
Mutagenesis and Carcinogenesis
- Based on animal data, gancyclovir has the potential to cause cancers in humans.
- IV and oral products have specific indications (see package insert)
- Associated with risk of rapid rate of CMV retinitis progression and should be used as maintenance therapy only in patients who benefit from avoiding daily intravenous infusions.
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