Ganciclovir Sodium

⛔ FDA Black Box Warning

WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with ganciclovir [see Warnings and Precautions (5.1) ] . Impairment of Fertility: Based on animal data and limited human data, Ganciclovir for Injection, USP may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions (5.3) ] . Fetal Toxicity: Based on animal data, Ganciclovir for Injection, USP has the potential to cause birth defects in humans [see Warnings and Precautions (5.4) ] . Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir for Injection, USP has the potential to cause cancers in humans [see Warnings and Precautions (5.5) ] . WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS See full prescribing information for complete boxed warning. Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with ganciclovir ( 5.1 ). Impairment of Fertility: Based on animal data and limited human data, Ganciclovir for Injection, USP may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females ( 5.3 ). Fetal Toxicity: Based on animal data, Ganciclovir for Injection, USP has the potential to cause birth defects in humans ( 5.4 ). Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir for Injection, USP has the potential to cause cancer in humans ( 5.5 ).

Contraindications

4 CONTRAINDICATIONS Ganciclovir for Injection, USP is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir or any component of the formulation. Hypersensitivity to ganciclovir or valganciclovir. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary In animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two times the exposure at the recommended human dose (RHD) [see Data ]. Although placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and in at least one case report in a pregnant woman, no adequate human data are available to establish whether ganciclovir for injection poses a risk to pregnancy outcomes. The background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Most maternal CMV infections are asymptomatic or they may be associated with a self-limited mononucleosis-like syndrome. However, in immunocompromised patients (i.e., transplant patients or patients with AIDS), CMV infections may be symptomatic and may result in significant maternal morbidity and mortality. The transmission of CMV to the fetus is a result of maternal viremia and transplacental infection. Perinatal infection can also occur from exposure of the neonate to CMV shedding in the genital tract. Approximately 10% of children with congenital CMV infection are symptomatic at birth. Mortality in symptomatic infants is about 10% and approximately 50 to 90% of symptomatic surviving newborns experience significant morbidity, including mental retardation, sensorineural hearing loss, microcephaly, seizures, and other medical problems. The risk of congenital CMV infection resulting from primary maternal CMV infection may be higher and of greater severity than that resulting from maternal reactivation of CMV infection. Data Animal Data Daily intravenous doses of ga