GANCICLOVIR SODIUM

AbsorptionAt the end of a 1-hour intravenous infusion of 5 mg/kg ganciclovir, total AUC ranged between 22.1 ± 3.2 (n=16) and 26.8 ± 6.1 mcg∙hr/mL (n=16) and C max ranged between 8.27 ± 1.02 (n=16) and 9.0 ± 1.4 mcg/mL (n=16).

DistributionThe steady-state volume of distribution of ganciclovir after intravenous administration was 0.74 ± 0.15 L/kg (n=98). Ganciclovir diffuses across the placenta. Cerebrospinal fluid concentrations obtained 0.25 to 5.67 hours post-dose in 3 patients who received 2...

14.1 Treatment of CMV Retinitis In a retrospective, non-randomized, single-center analysis of 41 patients with AIDS and CMV retinitis diagnosed by ophthalmologic examination between August 1983 and April 1988, treatment with intravenous ganciclovir resulted in a delay in mean (median) time to first retinitis progression compared to untreated controls [105 (71) days from diagnosis vs. 35 (29) days from diagnosis]. Patients in this series received induction treatment of intravenous ganciclovir 5 mg/kg twice daily for 14 to 21 days followed by maintenance treatment with either 5 mg/kg once daily,...

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hematologic Toxicity [see Warnings and Precautions (5.1) ] Renal Impairment [see Warnings and Precautions (5.2) ] Impairment of Fertility [see Warnings and Precautions (5.3) ] Fetal Toxicity [see Warnings and Precautions (5.4) ] Mutagenesis and Carcinogenesis [see Warnings and Precautions (5.5) ] Most common adverse reactions and laboratory abnormalities reported in at least 20% of patients...

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 )

Renal Impairment: Increased serum creatinine levels have been observed with the use of ganciclovir, particularly in elderly patients and transplant recipients receiving concomitant nephrotoxic drugs. Monitor renal function during therapy with ganciclovir for injection, particularly in elderly patients and in patients taking other nephrotoxic drugs, and reduce dosage in patients with renal impairment. ( 5.2 ) 5.1 Hematologic Toxicity Granulocytopenia (neutropenia), anemia, thrombocytopenia and pa...

7 DRUG INTERACTIONS Drug-drug interaction studies were conducted in patients with normal renal function. Patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug following concomitant administration of ganciclovir for injection and drugs excreted by the same pathway as ganciclovir. Therefore, these patients should be closely monitored for t...