Precautions of Valcyte

1. Hematologic Toxicity

Due to the frequency of neutropenia, anemia, and thrombocytopenia in patients receiving Valcyte, complete blood counts with differential and platelet counts should be performed frequently, especially in infants, in patients with renal impairment, and in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leukopenia, or in whom neutrophil counts are less than 1000 cells/µL at the beginning of treatment. Increased monitoring for cytopenias may be warranted if therapy with oral ganciclovir is changed to Valcyte because of increased plasma concentrations of ganciclovir after Valcyte administration.

2. Acute Renal Failure

Acute renal failure may occur in:

• Elderly patients with or without reduced renal function. Caution should be exercised when administering Valcyte to geriatric patients, and dosage reduction is recommended for those with impaired renal function.

• Patients receiving potential nephrotoxic drugs. Caution should be exercised when administering Valcyte to patients receiving potential nephrotoxic drugs.

• Patients without adequate hydration. Adequate hydration should be maintained for all patients.

3. Impairment of Fertility

Based on animal data and limited human data, Valcyte at the recommended human doses may cause temporary or permanent inhibition of spermatogenesis in males, and may cause suppression of fertility in females. Advise patients that fertility may be impaired with use of Valcyte.

4. Fetal Toxicity

Ganciclovir may cause fetal toxicity when administered to pregnant women based on findings in animal studies. When given to pregnant rabbits at dosages resulting in 2 times the human exposure (based on AUC), ganciclovir caused malformations in multiple organs of the fetuses. Maternal and fetal toxicity were also observed in pregnant mice and rabbits. Therefore, Valcyte has the potential to cause birth defects. Pregnancy should be avoided in female patients taking Valcyte and in females with male partners taking Valcyte. Females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment with Valcyte because of the potential risk to the fetus. Similarly, males should be advised to use condoms during and for at least 90 days following treatment with Valcyte.