Cytovene (ganciclovir sodium)

Ganciclovir is commercially available as the base and as ganciclovir sodium; dosage is expressed in terms of ganciclovir.

In patients with impaired renal function, doses and/or frequency of administration of ganciclovir must be modified in response to the degree of impairment.

Dosage should be based on the patient's measured or estimated creatinine clearance. The patient's creatinine clearance (Ccr) can be estimated by using the following formulas:

When IV ganciclovir is used for the management of CMV retinitis in adults with renal impairment, the manufacturers recommend the following dosage for initial treatment (induction therapy) and maintenance therapy (secondary prophylaxis) based on creatinine clearance. (See Table 1.)

Table 1. Dosage of IV Ganciclovir for Management of CMV Retinitis in Adults with Renal Impairment

Creatinine Clearance Initial Treatment Maintenance Dosage (mL/minute) (Induction) Dosage 50-69 2.5 mg/kg every 12 hours 2.5 mg/kg every 24 hours 25-49 2.5 mg/kg every 24 hours 1.25 mg/kg every 24 hours 10-24 1.25 mg/kg every 24 0.625 mg/kg every 24 hours hours Less than 10 1.25 mg/kg 3 times 0.625 mg/kg 3 times weekly weekly

In adults undergoing hemodialysis, dosage of IV ganciclovir for initial treatment (induction therapy) of CMV retinitis should not exceed 1.25 mg/kg 3 times weekly and dosage for maintenance therapy should not exceed 0.625 mg/kg 3 times weekly. Because hemodialysis may reduce ganciclovir plasma concentrations by approximately 50% (see Pharmacokinetics: Elimination), dosing of the drug should be timed so that doses administered on the days of dialysis are given shortly after completion of dialysis.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

Drug interaction studies with ganciclovir were performed in patients with normal renal function. In patients with renal impairment, concomitant use of ganciclovir and other drugs eliminated by renal excretion may result in increased concentrations of ganciclovir and the concomitant drug and such patients should be closely monitored for toxicity associated with ganciclovir and the concomitant drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Animal data indicate that ganciclovir has the potential to cause fetal toxicity, including birth defects, in humans. Data regarding use of ganciclovir in pregnant women are inadequate to establish whether the drug poses a risk to pregnancy outcomes. Ganciclovir appears to cross the placenta based on ex vivo experiments with human placenta and at least one case report in a pregnant woman.

In animal studies, ganciclovir caused maternal and fetal toxicity and embryofetal mortality in pregnant mice and rabbits and teratogenic effects in rabbits at systemic exposures that were approximately 2 times those attained in humans at the recommended human dose. IV ganciclovir administered to pregnant mice (108 mg/kg daily) and rabbits (60 mg/kg daily) and administered to female mice (90 mg/kg) prior to mating, during gestation, and during lactation resulted in fetal resorptions in at least 85% of the mice and rabbits. Fetal growth retardation, embryolethality, and teratogenic effects (cleft palate, anophthalmia/microphthalmia, hydrocephaly, brachygnathia, aplastic organs (kidney, pancreas)) were reported in the rabbits. In pre/postnatal development studies in mice, maternal/fetal toxicity and embryolethality were observed and included hypoplasia of the testes and seminal vesicles in male offspring, as well as pathologic changes in the nonglandular region of the stomach.

Although most maternal CMV infections are asymptomatic or may be associated with a self-limited mononucleosis-like syndrome, CMV infections in pregnant immunocompromised patients (e.g., HIV-infected patients with AIDS, transplant recipients) may be symptomatic and result in substantial maternal morbidity and mortality. Perinatal transmission of CMV from an infected mother to her fetus can occur resulting in congenital CMV infection and disease. (See Congenital Cytomegalovirus Disease under Uses: Treatment of Cytomegalovirus Infection and Disease.)

Females of childbearing potential should undergo pregnancy testing before initiation of ganciclovir.

Females of childbearing potential should use effective contraception during and for at least 30 days after ganciclovir therapy and male patients should use effective barrier contraceptive methods during and for at least 90 days after ganciclovir therapy.

It is not known whether ganciclovir is distributed into human milk, affects the breast-fed infant, or affects milk production. The drug is distributed into milk in lactating rats; the milk-to-serum ratio at steady state is approximately 1.6 in rats.

Because of the potential for serious adverse reactions to ganciclovir in breast-fed infants, nursing women should be instructed not to breast-feed while they are receiving the drug. HIV-infected mothers should be instructed not to breast-feed their infants because of the risk of transmission of HIV.

No enhanced messaging available.