Valganciclovir

Side effects, and when to stop

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

• Hematologic Toxicity.
• Acute Renal Failure.
• Impairment of Fertility.
• Fetal Toxicity.
• Mutagenesis and Carcinogenesis.

The most common adverse reactions and laboratory abnormalities reported in at least one indication by greater than or equal to 20% of adult patients treated with valganciclovir hydrochloride tablets are diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting. The most common reported adverse reactions and laboratory abnormalities reported in greater than or equal to 20% of pediatric solid organ transplant recipients treated with valganciclovir hydrochloride for oral solution or tablets are diarrhea, pyrexia, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.

Who should not take it

Valganciclovir hydrochloride is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation.

Other medicines and interactions

In vivo drug-drug interaction studies were not conducted with valganciclovir. However, because valganciclovir is rapidly and extensively converted to ganciclovir, drug-drug interactions associated with ganciclovir will be expected for Valganciclovir. Drug-drug interaction studies with ganciclovir were conducted in patients with normal renal function. Following concomitant administration of valganciclovir and other renally excreted drugs, patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug. Therefore, these patients should be closely monitored for toxicity of ganciclovir and the coadministered drug.

Established and other potentially significant drug interactions conducted with ganciclovir are listed in Table 9. Table 9 Established and Other Potentially Significant Drug Interactions with Ganciclovir

1.1 Adult Patients

Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir hydrochloride is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV Disease: Valganciclovir hydrochloride 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-]).