WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow aplasia and aplastic anemia have been reported in patients treated with valganciclovir [see Warnings and Precautions (5.1) ] . Impairment of Fertility: Based on animal data, valganciclovir may cause temporary or permanent inhibition of spermatogenesis [see Warnings and Precautions (5.2) ] . Fetal Toxicity: Based on animal data, valganciclovir has the potential to cause birth defects in humans [see Warnings and Precautions (5.3) ] . Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir has the potential to cause cancers in humans [see Warnings and Precautions (5.4) ] . WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS See full prescribing information for complete boxed warning . Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow aplasia and aplastic anemia have been reported in patients treated with valganciclovir ( 5.1 ). Impairment of Fertility: Based on animal data, valganciclovir may cause temporary or permanent inhibition of spermatogenesis ( 5.2 ). Fetal Toxicity: Based on animal data, valganciclovir has the potential to cause birth defects in humans ( 5.3 ). Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir has the potential to cause cancers in humans ( 5.4 ).
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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hematologic toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow depression, and aplastic anemia have occurred with the use of valganciclovir or ganciclovir. Avoid valganciclovir use if absolute neutrophil count is less than 500 cells/µL, platelet count is less than 25,000/µL, or hemoglobin is less than 8 g/dL. Use with caution in pre-existing cytopenias and when receiving myelosuppressive drugs or irradiation. Monitor with frequent testing of platelet and complete blood counts ( 5.1 ). Impairment of fertility: Based on animal studies, valganciclovir may cause temporary or permanent inhibition of spermatogenesis ( 5.2 ). Fetal toxicity: Based on animal studies, valganciclovir may cause fetal harm. Females of reproductive potential should use effective contraception during and following treatment and males should practice barrier contraception during and following treatment ( 5.3 ). Mutagenicity and carcinogenicity: Based on animal studies, valganciclovir is potentially mutagenic and carcinogenic ( 5.4 ). Acute renal failure: Acute renal failure may occur in elderly patients (with or without reduced renal function), patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients or those taking nephrotoxic drugs, reduce dosage in patients with renal impairment, and monitor renal function ( 2.5 , 5.5 , 8.5 , 8.6 , 12.3 ). 5.1 Hematologic Toxicity Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow aplasia, and aplastic anemia have been reported in patients treated with Valganciclovir or ganciclovir. Valganciclovir should be avoided if the absolute neutrophil count is less than 500 cells/µL, the platelet count is less than 25,000/µL, or the hemoglobin is less than 8 g/dL. Valganciclovir should also be used with caution in patients with pre-existing cytopenias, or who have received or who are receiving myelosuppressive drugs or irradiation. Cytopenia may occur at any time during treatment and may worsen with continued dosing. Cell counts usually begin to recover within 3 to 7 days after discontinuing drug. Due to the frequency of neutropenia, anemia, and thrombocytopenia in patients receiving valganciclovir [see Adverse Reactions (6.1) ] , complete blood counts with differential and platelet counts should be performed frequently, especially 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 valganciclovir, because of increased plasma concentrations of ganciclovir after valganciclovir administration [see Clinical Pharmacology (12.3) ] . 5.2 Impairment of Fertility Based on animal data with ganciclovir, valganciclovir 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 valganciclovir [see Use in Specific Populations (8.1 , 8.3) , Nonclinical Toxicology (13.1) ] . 5.3 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, valganciclovir has the potential to cause birth defects. Pregnancy should be avoided in female patients taking valganciclovir and in females with male partners taking valganciclovir. Females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment with valganciclovir. Similarly, males should be advised to practice barrier contraception during and for at least 90 days following treatment with valganciclovir [see Dosage and Administration (2.6) , Use in Specific Populations (8.1 , 8.3) , Nonclinical Toxicology (13.1) ]. 5.4 Mutagenesis and Carcinogenesis Animal data indicate that ganciclovir is mutagenic and carcinogenic. Valganciclovir should therefore be considered a potential carcinogen in humans [see Dosage and Administration (2.6) , Nonclinical Toxicology (13.1) ] . 5.5 Acute Renal Failure Acute renal failure may occur in: Elderly patients with or without reduced renal function. Caution should be exercised when administering valganciclovir to geriatric patients, and dosage reduction is recommended for those with impaired renal function [see Dosage and Administration (2.5), Use in Specific Populations (8.5 , 8.6) ] . Patients receiving potential nephrotoxic drugs. Caution should be exercised when administering valganciclovir to patients receiving potential nephrotoxic drugs. Patients without adequate hydration. Adequate hydration should be maintained for all patients.