You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
VALCYTE (valganciclovir hydrochloride) is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).
VALCYTE is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).
VALCYTE is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk.
Adult patients should use VALCYTE tablets, not VALCYTE for oral solution.
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS
VALCYTE is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction to valganciclovir, ganciclovir, or any component of the formulation.
WARNINGS AND PRECAUTIONS
Adult Patients: The most common adverse events and laboratory abnormalities reported in at least one indication by >20% of patients are diarrhea, pyrexia, nausea, tremor, neutropenia, anemia, graft rejection, thrombocytopenia, and vomiting.
Pediatric Patients: The most common adverse events and laboratory abnormalities reported in >20% of pediatric solid organ transplant recipients are diarrhea, pyrexia, hypertension, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.
Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please see the full Prescribing Information, including Boxed WARNING, for additional Important Safety Information at www.valcyte.com.