Hematologic Toxicity, Impairment of Fertility, Fetal Toxicity, Mutagenesis and Carcinogenesis

Hematologic Toxocity

• 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.

Fetal Toxicity

• 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.

Indications

• IV and oral products have specific indications (see package insert)

Oral Capsules

• 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.