Ganciclovir Sodium (Monograph)

Brand name: Cytovene
Drug class: Nucleosides and Nucleotides

Medically reviewed by Drugs.com on Apr 10, 2024. Written by ASHP.

Warning

Hematologic toxicity (e.g., granulocytopenia, anemia, thrombocytopenia, pancytopenia) reported in patients receiving ganciclovir.¹
Based on animal data and limited human data, may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.¹
Based on animal studies, has the potential to cause birth defects in humans.¹
Based on animal studies, has the potential to cause cancers in humans.¹

Introduction

Antiviral; nucleoside analog of guanine; active against herpesviruses.¹ ² ¹⁴ ⁸⁵ ⁸⁶

Uses for Ganciclovir Sodium

Cytomegalovirus (CMV) Retinitis

Initial treatment (induction therapy) and maintenance therapy (secondary prophylaxis) of CMV retinitis in immunocompromised patients, including HIV-infected adults.¹ ² ⁴ ⁵ ¹¹ ¹⁴ ²¹ ²³ ²⁸ ⁸⁵ ⁸⁶ ⁹⁴ ¹⁰⁰ ¹⁰³ ¹⁰⁴ ¹⁰⁵ ¹¹⁷ ¹¹⁸ ¹²⁶ ¹²⁷ ¹³⁹ ¹⁵⁵ ¹⁶⁴ ¹⁸⁷ ²⁰⁷ ³¹¹ Also used for management of CMV retinitis in HIV-infected pediatric patients^{† [off-label]}.¹⁵⁵

Like other antivirals, ganciclovir is not a cure for CMV retinitis; stabilization or improvement of ocular manifestations may occur, but relapse and/or progression of CMV retinitis possible during or following ganciclovir therapy.¹ ⁴ ⁵ ⁸ ⁹ ¹¹ ¹³ ²¹ ²⁷ ²⁸ ⁶³ ⁶⁵ ⁹⁴ ¹⁰⁰ ¹²⁶ ¹²⁸ ¹³⁹ ¹⁶⁷

Retinitis is the most common clinical manifestation of CMV end-organ disease in HIV-infected patients;¹⁵⁵ ideally should be managed in consultation with an ophthalmologist familiar with diagnosis and treatment of retinal diseases.¹⁵⁵ ¹⁵⁶

Select antiviral regimen for initial treatment of CMV retinitis in HIV-infected individuals based on location and severity of CMV retinal lesions, severity of underlying immunosuppression, concomitant drug therapy, and patient’s ability to adhere to the treatment regimen.¹⁵⁵ ¹⁵⁶ Select antiviral regimen for maintenance therapy based on location of CMV retinal lesions, vision in contralateral eye, patient's immunologic and virologic status, and patient's response to antiretroviral therapy.¹⁵⁵ ¹⁵⁶

For management of immediate sight-threatening CMV retinal lesions (e.g., within 1.5 mm of the fovea) in HIV-infected adults and adolescents, CDC, NIH, and IDSA state that the preferred regimen is initial treatment (induction therapy) with intravitreal ganciclovir or intravitreal foscarnet (1–4 doses given over a period of 7–10 days) in conjunction with oral valganciclovir (twice daily for 14–21 days) followed by maintenance therapy (secondary prophylaxis) with oral valganciclovir (once daily).¹⁵⁵ One alternative regimen recommended by these experts for sight-threatening CMV retinitis in HIV-infected adults and adolescents is intravitreal ganciclovir^{† [off-label]} or intravitreal foscarnet (1–4 doses given over a period of 7–10 days) in conjunction with IV ganciclovir (twice daily for 14–21 days) followed by maintenance therapy (secondary prophylaxis) with oral valganciclovir (once daily).¹⁵⁵ Systemic antivirals (without an intravitreal antiviral) usually adequate for management of CMV retinitis in patients with only small peripheral lesions.¹⁵⁵

For management of CMV retinitis in HIV-infected pediatric patients^{† [off-label]}, CDC, NIH, IDSA, and others state that IV ganciclovir is drug of choice for initial treatment (induction therapy) and one of several options for maintenance therapy (secondary prophylaxis).¹⁵⁶ These experts state that oral valganciclovir may be considered in older children^{† [off-label]} and adolescents^{† [off-label]} transitioning from IV ganciclovir to oral valganciclovir to complete treatment and/or for maintenance therapy following improvement of retinitis.¹⁵⁶ Data are limited regarding use of intravitreal antivirals in children;¹⁵⁶ intravitreal injections are impractical in most children.¹⁵⁶

Because of risk of relapse, chronic maintenance therapy (secondary prophylaxis) of CMV retinitis usually continued until immune reconstitution occurs as a result of effective antiretroviral therapy.¹⁵⁵ ¹⁵⁶ CDC, NIH, and IDSA state that discontinuance of maintenance therapy of CMV retinitis can be considered in HIV-infected adults and adolescents if CMV lesions have been treated for ≥3–6 months and are inactive and there has been a sustained (i.e., 3–6 months) increase in CD4⁺ T-cell count to >100/mm³ in response to antiretroviral therapy.¹⁵⁵ Although safety of discontinuing maintenance therapy of CMV retinitis in HIV-infected pediatric patients not well studied, discontinuance of such therapy can be considered in those receiving antiretroviral therapy who have a sustained (i.e., >6 months) increase in CD4⁺ T-cell percentage to >15% (children <6 years of age) or increase in CD4⁺ T-cell count to >100/mm³ (children ≥6 years of age).¹⁵⁶

If maintenance therapy of CMV is discontinued, continue regular ophthalmologic monitoring (optimally every 3–6 months) for early detection of CMV relapse or immune reconstitution uveitis.¹⁵⁵ ¹⁵⁶ If CD4⁺ T-cell count decreases to <100/mm³ (adults, adolescents, children ≥6 years of age) or CD4⁺ T-cell percentage decreases to <15% (children <6 years of age), reinitiate CMV retinitis maintenance therapy.¹⁵⁵ ¹⁵⁶

Extraocular CMV Infections

Although safety and efficacy not established for management of extraocular CMV infections,¹ ² ¹⁴ has been used in immunocompromised patients for management of CMV GI disease^†,³ ⁴ ⁵ ⁶ ⁸ ¹¹ ¹⁶ ²⁰ ²¹ ²⁶ ⁶⁸ ⁶⁹ ⁷⁰ ⁸⁶ ⁹² ¹⁰² ¹⁰⁸ ¹¹⁰ ¹²² ¹³⁴ ¹⁴⁶ ¹⁵⁵ ¹⁶⁶ ¹⁹³ ¹⁹⁴ ²⁰⁷ pneumonitis^†,³ ⁴ ⁵ ⁸ ¹⁰ ¹¹ ¹⁵ ¹⁶ ¹⁷ ¹⁸ ¹⁹ ²⁰ ²¹ ³³ ⁴³ ⁶⁴ ⁷² ⁷³ ⁷⁴ ¹⁰⁶ ¹⁰⁷ ¹⁰⁸ ¹⁰⁹ ¹¹⁰ ¹¹¹ ¹²¹ ¹²² ¹³⁷ ¹⁴⁰ ¹⁴⁵ ¹⁴⁶ ¹⁴⁹ ¹⁵¹ ¹⁵⁴ ¹⁵⁵ ¹⁵⁹ ¹⁸⁰ ¹⁸⁸ ¹⁹³ ¹⁹⁸ ¹⁹⁹ ²⁰¹ ²⁰² ²⁰⁵ ²⁰⁷ ²¹⁹ ²²⁰ ²²⁵ encephalitis^†,⁴ ⁵ ⁸ ¹¹ ²¹ ⁸⁶ ¹¹⁰ ¹⁵⁵ ¹⁵⁶ ¹⁶⁵ ²⁰⁷ ²³¹ or other CMV infections^†.³ ⁴ ⁵ ⁸ ¹⁵ ¹⁹ ²⁰ ²¹ ⁶⁸ ¹⁰⁶ ¹⁰⁸ ¹¹⁰ ¹⁴⁰ ¹⁴⁶ ¹⁶⁶ ¹⁷¹ ²¹⁹

CDC, NIH, and IDSA state that IV ganciclovir usually is the preferred antiviral for initial management of CMV GI disease^† in HIV-infected adults and transition to oral valganciclovir may be considered when patient can tolerate and absorb oral drugs.¹⁵⁵

For management of well-documented CMV pneumonitis^† in HIV-infected adults, CDC, NIH, and IDSA state that either IV ganciclovir or IV foscarnet is a reasonable choice.¹⁵⁵

A combination regimen of IV ganciclovir and IV foscarnet has been used for management of CMV neurologic disease^† (e.g., CMV encephalitis or myelitis),⁸⁵ and is recommended by CDC, NIH, IDSA, and others for such infections in HIV-infected individuals.¹⁵⁵ ¹⁵⁶

Congenital CMV Disease

Although safety and efficacy not established,¹ ² ¹⁴ has been used for management of symptomatic congenital CMV disease^†.⁸⁵ ¹⁵⁶ ²⁹²

Transmission of CMV from infected mothers to their fetuses occurs as a result of maternal viremia and transplacental infection;¹ ² ¹⁴ perinatal infection also can occur from exposure to CMV shedding in mother's genital tract.¹ ² ¹⁴ Approximately 10% of neonates with congenital CMV infection are symptomatic at birth;¹ ² ¹⁴ mortality is about 10% and approximately 50–90% of symptomatic surviving neonates experience substantial morbidity (e.g., mental retardation, sensorineural hearing loss, microcephaly, seizures).¹ ² ¹⁴ Risk of congenital CMV infection resulting from primary maternal CMV infection may be higher and the disease more severe than that resulting from reactivation of maternal CMV infection.¹ ² ¹⁴

AAP and others recommend that oral valganciclovir be considered in neonates with moderate to severe symptomatic congenital CMV disease (with or without CNS involvement) when an antiviral indicated.⁸⁴ ⁸⁵ ²⁹² Regimen of IV ganciclovir either alone or followed by oral valganciclovir also has been used in neonates with symptomatic congenital CMV disease^†.⁸⁵

CDC, NIH, IDSA, and others state that IV ganciclovir can be considered for initial treatment of symptomatic congenital CMV disease with CNS involvement in HIV-exposed or HIV-infected infants^†.¹⁵⁶

Antivirals not usually recommended for neonates with asymptomatic congenital CMV infection or only mildly symptomatic infection without evidence of CNS involvement.⁸⁴ ²⁹²

Prevention of CMV Infection and Disease

Prophylaxis to prevent CMV infection and disease in solid organ transplant recipients, bone marrow transplant (BMT) recipients, and hematopoietic stem cell transplant (HSCT) recipients at high risk for the disease.¹ ² ¹⁴ ⁷⁴ ⁷⁶ ⁸¹ ⁸² ⁸⁵ ⁸⁶ ²⁷¹ ²⁸³ ²⁸⁴ ²⁸⁶ ²⁸⁷ ²⁸⁸ ³⁰⁴ ³⁰⁵ ³⁰⁶ ³⁰⁷ ³¹³ ³²⁴

Has been used for preemptive treatment of CMV infection and disease^† in transplant recipients.⁷⁴ ⁷⁶ ⁸¹ ⁸² ⁸⁵

Varicella-Zoster Virus (VZV) Infections

Although optimal regimens for management of progressive outer retinal necrosis caused by VZV^† not identified, CDC, NIH, and IDSA recommend that such infections in HIV-infected adults and adolescents be treated with at least one IV antiviral (acyclovir, ganciclovir, foscarnet, cidofovir) used in conjunction with at least one intravitreal antiviral (ganciclovir or foscarnet).¹⁵⁵ Some experts recommend IV ganciclovir and/or IV foscarnet used in conjunction with intravitreal ganciclovir^† and/or intravitreal foscarnet.¹⁵⁵ ¹⁵⁶ Prognosis for visual preservation in patients with progressive outer retinal necrosis caused by VZV is poor;¹⁵⁵ ¹⁵⁶ such infections should be managed in consultation with an ophthalmologist.¹⁵⁵

Ganciclovir Sodium Dosage and Administration

General

Test females of childbearing potential for pregnancy prior to initiation of ganciclovir.¹ ² ¹⁴ (See Pregnancy under Cautions.)
Assess renal function prior to and during ganciclovir therapy; adjust dosage as needed.¹ ² ¹⁴ (See Renal Effects Under Cautions.)
Frequently monitor CBCs with differential and platelet counts during ganciclovir therapy, especially in those who developed cytopenias during previous therapy with ganciclovir or other nucleoside analogs and in those with neutrophil counts <1000/mm³ prior to initiation of the drug.¹ ² ¹⁴ (See Hematologic Effects under Cautions.)
Ensure that patients are adequately hydrated.¹ ² ¹⁴
Do not exceed recommended ganciclovir dosage or recommended frequency and rate of administration.¹ ² ¹⁴

Administration

Administer by IV infusion.¹

Do not administer by rapid IV infusion or direct IV injection since potentially toxic plasma ganciclovir concentrations may result.¹

Do not administer by IM or sub-Q injection.¹

Has been administered by intravitreal injection^†;⁴ ⁵ ⁸ ²⁵ ⁶⁷ ⁸⁵ ¹¹⁷ ¹²⁹ ¹³⁵ ¹⁵⁵ ¹⁷⁰ ganciclovir preparation specifically for intravitreal administration not commercially available in US.

Has been administered orally;⁸⁵ ⁸⁶ ³²¹ ³²⁵ ³⁴⁷ oral preparations of ganciclovir no longer commercially available in US.

IV Infusion

For solution and drug compatibility information, see Compatibility under Stability.

Handle ganciclovir lyophilized powder and solutions of the drug cautiously because of the high pH of some preparations and because of the mutagenic and/or carcinogenic potential of the drug (see Mutagenicity and Carcinogenicity under Cautions).¹ ² Use of disposable gloves recommended.¹ ²

Since ganciclovir shares some of the properties of cytotoxic drugs, consider consulting specialized references for procedures for proper handling and disposal of cytotoxic drugs.¹ ² ¹⁴

To avoid phlebitis and pain at IV infusion site, select a vein with adequate blood flow to allow for rapid dilution and distribution of ganciclovir.¹ ² ¹⁴

Reconstitution and Dilution

For IV infusion, reconstitute single-dose vial containing 500 mg of ganciclovir by adding 10 mL of preservative-free sterile water for injection to provide a solution containing 50 mg/mL.¹ Do not use bacteriostatic water for injection containing parabens.¹ Gently swirl vial until drug is completely wetted and a clear reconstituted solution is obtained.¹ Withdraw appropriate dose of reconstituted solution from the vial and dilute in a compatible IV infusion solution (usually 100 mL).¹ Solutions containing ganciclovir concentrations >10 mg/mL not recommended for IV infusion.¹

Alternatively, if single-dose vials of solution containing 500 mg of ganciclovir (50 mg/mL) are used, shake vial containing the solution and withdraw appropriate dose and dilute in a compatible IV infusion solution (usually 100 mL).² Solutions containing ganciclovir concentrations >10 mg/mL not recommended for IV infusion.²

Alternatively, commercially available single-dose IV bags containing 500 mg of ganciclovir in 250 mL of 0.8% sodium chloride (2 mg/mL) can be used for IV infusion without further dilution.¹⁴ The solution in the bag should appear clear.¹⁴ If any crystals have formed in the solution, gently shake the bag to redissolve the crystals prior to use.¹⁴ Discard any unused portions of the premixed solution.¹⁴

Rate of Administration

Administer by IV infusion at a constant rate over 1 hour.¹ ² ¹⁴

Dosage

Available as ganciclovir and ganciclovir sodium;¹ ² dosage expressed in terms of ganciclovir.¹ ² ¹⁴

Pediatric Patients

CMV Retinitis in HIV-infected Pediatric Patients†

IV

Initial treatment (induction therapy) in children^†: CDC, NIH, IDSA, and others recommend 5 mg/kg every 12 hours for 14–21 days (may be increased to 7.5 mg/kg every 12 hours if needed).¹⁵⁶ ²⁹²

Maintenance therapy (secondary prophylaxis) in children^†: CDC, NIH, IDSA, and others recommend 5 mg/kg once daily for 5–7 days each week.¹⁵⁶ ²⁹²

Make decisions regarding discontinuance of CMV retinitis maintenance therapy in consultation with an ophthalmologist.¹⁵⁵ (See Cytomegalovirus [CMV] Retinitis under Uses.)

CNS or Disseminated CMV Infections in HIV-infected Pediatric Patients†

IV

Initial treatment (induction therapy) of CMV CNS infections in children^†: CDC, NIH, IDSA, and others recommend 5 mg/kg every 12 hours in conjunction with IV foscarnet.¹⁵⁶ Continue initial treatment until symptomatic improvement.¹⁵⁶

Initial treatment (induction therapy) of disseminated CMV infections in children^†: CDC, NIH, IDSA, and others recommend 5 mg/kg IV every 12 hours (may be increased to 7.5 mg/kg every 12 hours if needed).¹⁵⁶ Continue initial treatment for 14–21 days.¹⁵⁶

Maintenance therapy (secondary prophylaxis) of CNS or disseminated CMV infections in children^†: CDC, NIH, IDSA, and others recommend 5 mg/kg once daily for 5–7 days each week.¹⁵⁶

Congenital CMV Disease†

IV

Symptomatic congenital CMV disease^†: AAP and others recommend 6 mg/kg twice daily;⁸⁴ ²⁹² ³⁵⁰ transition to oral valganciclovir when infant is able to tolerate and absorb oral drugs.⁸⁴ ²⁹²

Initiate antiviral treatment within first month of life and continue for a total of 6 months.⁸⁴ ²⁹²

Prevention of CMV Infection and Disease in Pediatric Transplant Recipients†

IV

Prophylaxis of CMV in children^†: Some clinicians recommend 5 mg/kg every 12 hours for 5–7 days (or 7–14 days), followed by 5 mg/kg once daily 7 days each week or 6 mg/kg once daily 5 days each week.²⁹² ³⁵⁰ Continue for 100–120 days posttransplantation.²⁹² ³⁵⁰

Prophylaxis of CMV in children^†: Other clinicians recommend 5 mg/kg once daily continued for ≥3 months depending on immune status of the recipient and type of transplant.⁸¹

Preemptive treatment of CMV infection in high-risk pediatric patients^†: 5 mg/kg twice daily for 7–14 days followed by 5 mg/kg once daily recommended.²⁹²

VZV Infections†

IV

Progressive outer retinal necrosis caused by VZV in HIV-infected pediatric patients^†: CDC, NIH, IDSA, and others state 5 mg/kg every 12 hours (used with IV foscarnet) in conjunction with intravitreal ganciclovir^† (used with or without intravitreal foscarnet) can be considered.¹⁵⁶

Adults

CMV Retinitis

IV

Initial treatment (induction therapy): 5 mg/kg every 12 hours for 14–21 days.¹ ² ¹⁴ ¹⁵⁵ If patient has immediate sight-threatening CMV retinal lesions, CDC, NIH, and IDSA recommend that initial treatment also include an appropriate intravitreal antiviral.¹⁵⁵ (See Cytomegalovirus [CMV] Retinitis under Uses.)

Maintenance therapy (secondary prophylaxis): 5 mg/kg once daily 7 days each week¹ ² ¹⁴ ¹⁵⁵ or 6 mg/kg once daily 5 days each week.¹ ² ¹⁴

Make decisions regarding discontinuance of CMV retinitis maintenance therapy in consultation with an ophthalmologist.¹⁵⁵ (See Cytomegalovirus [CMV] Retinitis under Uses.)

CMV Esophagitis† or Colitis†

IV

CMV GI infections^†: 5 mg/kg every 12 hours for 14–21 days has been used for initial treatment (induction); alternatively, 2.5 mg/kg IV every 8 hours has been used.⁶ ⁸ ¹¹ ¹³ ¹⁵ ¹⁶ ²⁰ ³³ ⁶⁸ ⁷⁰ ⁹² ¹¹⁰ ¹⁴⁰ ¹⁴⁵ ¹⁴⁶ If maintenance therapy required, dosages comparable to those used for maintenance therapy of CMV retinitis have been used.⁶ ¹¹

CMV esophagitis^† or colitis^† in HIV-infected adults: CDC, NIH, and IDSA recommend 5 mg/kg every 12 hours for 21–42 days or until signs and symptoms have resolved.¹⁵⁵ Maintenance therapy (secondary prophylaxis) usually not necessary, but consider if relapse occurs.¹⁵⁵

CMV Pneumonitis†

IV

5 mg/kg IV every 12 hours for 14–21 days has been used for initial treatment (induction); alternatively, 2.5 mg/kg IV every 8 hours has been used.⁸ ¹¹ ¹³ ¹⁵ ¹⁶ ²⁰ ³³ ⁶⁸ ⁷⁰ ¹¹⁰ ¹⁴⁰ ¹⁴⁵ ¹⁴⁶ If maintenance therapy required, dosages comparable to those used for maintenance therapy of CMV retinitis have been used.¹¹

Well-documented CMV pneumonitis^† in HIV-infected adults: CDC, NIH, and IDSA recommend same dosage used for management of CMV retinitis in HIV-infected adults.¹⁵⁵ Optimal duration of treatment not established.¹⁵⁵

CMV Neurologic Disease†

IV

CMV neurologic disease^† in HIV-infected adults: CDC, NIH, and IDSA recommend same dosage used for management of CMV retinitis in HIV-infected adults.¹⁵⁵ Use in conjunction with IV foscarnet.¹⁵⁵ Optimal duration of treatment not established.¹⁵⁵

Prevention of CMV Infection and Disease in Transplant Recipients

IV

Prophylaxis of CMV: Manufacturers recommend 5 mg/kg every 12 hours for 7–14 days, followed by 5 mg/kg once daily 7 days each week or 6 mg/kg once daily 5 days each week.¹ ² ¹⁴ Continue until 100–120 days posttransplantation.¹ ² ¹⁴

Prophylaxis of CMV: Some experts recommend 5 mg/kg once daily.⁷⁶ ⁸¹ ⁸² Continue antiviral prophylaxis for 3 months in CMV-seropositive recipients of solid organs (kidney, pancreas, kidney/pancreas, liver, heart) and for 3–6 months in CMV-seronegative recipients of solid organs (kidney, pancreas, kidney/pancreas, liver, heart) from CMV-seropositive donors.⁸¹ ⁸²

Preemptive treatment of CMV infection in solid organ transplant recipients^†: 5 mg/kg twice daily recommended.⁸²

VZV Infections†

IV

Progressive outer retinal necrosis caused by VZV in HIV-infected adults^†: CDC, NIH, IDSA, and others state 5 mg/kg every 12 hours (used with or without IV foscarnet) in conjunction with intravitreal ganciclovir^† (used with or without intravitreal foscarnet) can be considered.¹⁵⁵

Special Populations

Renal Impairment

In patients with impaired renal function, doses and/or frequency of administration of ganciclovir must be modified in response to the degree of impairment.¹ ² ¹⁴

Base dosage on the patient’s measured or estimated Cl_cr.¹ ² ¹⁴

CMV Retinitis

IV

Adults with renal impairment: Manufacturers recommend the following dosage for initial treatment (induction therapy) and maintenance therapy (secondary prophylaxis) based on Cl_cr.¹ ² ¹⁴ (See Table 1.)

Table 1. Dosage of IV Ganciclovir for Management of CMV Retinitis in Adults with Renal Impairment1214
Cl_cr (mL/minute)	Initial Treatment (Induction) Dosage	Maintenance 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 hours	0.625 mg/kg every 24 hours
<10	1.25 mg/kg 3 times weekly	0.625 mg/kg 3 times weekly

Adults undergoing hemodialysis: Do not exceed initial treatment (induction therapy) dosage of 1.25 mg/kg 3 times weekly and do not exceed maintenance therapy dosage of 0.625 mg/kg 3 times weekly.¹ ² ¹⁴ Because hemodialysis may reduce ganciclovir plasma concentrations by approximately 50% (see Elimination under Pharmacokinetics),¹ ² ¹⁴ ⁶⁰ ¹²⁴ time doses on dialysis days to give them shortly after completion of dialysis.¹ ² ¹⁴

Geriatric Patients

Select dosage with caution because of age-related decreases in renal function.¹ ² ¹⁴ Assess renal function before and during ganciclovir therapy and adjust dosage as necessary.¹ ² ¹⁴ (See Renal Impairment under Dosage and Administration.)

Cautions for Ganciclovir Sodium

Contraindications

Clinically important hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation.¹ ² ¹⁴

Warnings/Precautions

Warnings

Hematologic Effects

Hematologic toxicity, including granulocytopenia (neutropenia), anemia, thrombocytopenia, and pancytopenia, reported in patients receiving ganciclovir.¹

Neutropenia (ANC <1000/mm³) frequently occurs and is most common dose-limiting adverse effect of ganciclovir.¹ ³ ⁴ ⁸ ¹¹ ²¹ ³³ ⁷⁵ ⁸⁵ ¹⁰⁹ ¹¹⁰ ¹²² ¹³³ ¹⁴⁹ ¹⁷² ²⁴⁸ ²⁶⁴ ²⁶⁵

Granulocytopenia (neutropenia) usually develops early in treatment (e.g., during the first or second week of induction therapy),¹ ³ ⁵ ²⁰ ²³ ⁷⁴ ⁸⁵ ¹²² but can occur at any time.¹ ⁵ ²⁰ ²³ ⁷⁴

In most cases, interruption of ganciclovir therapy¹ ³ ⁴ ⁸ ²³ ⁷⁴ ⁸⁵ ⁹² ¹²² ¹⁴⁹ ²⁴⁸ will result in increased neutrophil counts, usually evident within 3–7 days; however, prolonged or irreversible neutropenia has occurred.³ ⁴ ⁷⁴ ⁹² ¹²² ¹⁷⁴ Neutropenia has recurred following reinitiation of ganciclovir therapy,³ ³³ occasionally even with reduced dosage.³

Carefully monitor CBCs with differential and platelet counts in all patients, especially in those with renal impairment, baseline neutrophil counts <1000/mm³, or history of leukopenia during treatment with ganciclovir or other nucleoside analogs and in those receiving myelosuppressive drugs or radiation treatments.¹

Not recommended in patients with ANC <500/mm³, platelet count <25,000/mm³, or hemoglobin concentration <8 g/dL.¹ ² ¹⁴

Impairment of Fertility

Animal data from studies using ganciclovir and limited data from patients receiving valganciclovir (prodrug of ganciclovir) indicate ganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and may cause suppression of fertility in females.¹ ² ¹⁴

In a small clinical study in adult male renal transplant patients receiving CMV prophylaxis with valganciclovir for up to 200 days posttransplantation, mean sperm density in evaluable patients at end-of-treatment visit was decreased by 11 million/mL from baseline; among evaluable patients in an untreated control group, mean sperm density increased by 33 million/mL.¹ ² At final follow-up visit 6 months after the drug was discontinued, mean sperm density in evaluable patients in the valganciclovir group was comparable to that in evaluable patients in untreated control group (mean sperm density increased by 41 or 43 million/mL from baseline, respectively).¹ ²

Advise patients that ganciclovir may be associated with infertility.¹ ² ¹⁴

Teratogenicity

Animal data indicate that ganciclovir may cause fetal toxicity when administered to pregnant women.¹ ² ¹⁴

In studies in pregnant mice and rabbits, ganciclovir at dosages 2 times human exposure resulted in maternal toxicity and embryofetal toxicity (e.g., fetal resorptions, embryofetal mortality).¹ ² ¹⁴ In addition, teratogenic effects (cleft palate, anophthalmia/microphthalmia, hydrocephalus, brachygnathia, aplastic organs [kidney, pancreas]) reported in rabbits.¹ ² ¹⁴

Perform pregnancy testing before initiating ganciclovir in females of childbearing potential.¹ ² ¹⁴ Advise females of childbearing potential to use an effective method of contraception during and for ≥30 days after ganciclovir discontinued.¹ ² ¹⁴ Advise male patients to use a reliable method of barrier contraception during and for ≥90 days after ganciclovir discontinued.¹ ² ¹⁴ (See Pregnancy under Cautions.)

Mutagenicity and Carcinogenicity

Animal studies indicate that ganciclovir is mutagenic and carcinogenic.¹ ² ¹⁴

Consider ganciclovir a potential carcinogen in humans.¹

Other Warnings/Precautions

Renal Effects

Increased S_cr concentrations reported in geriatric patients and in transplant recipients receiving ganciclovir concomitantly with other nephrotoxic drugs (e.g., cyclosporine, amphotericin B).¹ ² ¹⁴

Patients should be adequately hydrated during ganciclovir therapy.¹ ² ¹⁴

Renal function monitoring is essential in all patients, especially in geriatric patients and transplant recipients receiving concomitant nephrotoxic drugs.¹ ² ¹⁴

Specific Populations

Pregnancy

Ganciclovir caused maternal and fetal toxicity, embryofetal mortality, and teratogenic effects in animal studies.¹ ² ¹⁴ (See Teratogenicity under Cautions.)

Data regarding use of ganciclovir in pregnant women inadequate to establish whether the drug poses a risk to pregnancy outcomes.¹ Placental transfer of ganciclovir observed in ex vivo experiments with human placenta and in at least one case report in a pregnant woman.¹

Perform pregnancy testing in females of childbearing potential prior to initiating ganciclovir.¹

Advise females of childbearing potential to use an effective method of contraception during and for ≥30 days after ganciclovir therapy.¹

Advise male patients to use a reliable method of barrier contraception during and for ≥90 days after ganciclovir therapy.¹

Lactation

Not known whether distributes into human milk, affects the breast-fed infant, or affects milk production.¹ ² ¹⁴ Distributed into milk in rats.¹ ² ¹⁴

Because of potential for serious adverse effects in the infant, women should not breast-feed infants while receiving ganciclovir.¹ ² ¹⁴

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission.¹ ² ¹⁴

Pediatric Use

Safety and efficacy not established in pediatric patients.¹ ² ¹⁴

In clinical trials in pediatric patients^†, granulocytopenia and thrombocytopenia were most commonly reported adverse effects.¹

Although pharmacokinetics reported in pediatric patients are similar to those reported in adults (see Pharmacokinetics), safety and efficacy of such ganciclovir exposures in pediatric patients not established.¹ ² ¹⁴

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹ ² ¹⁴

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.¹ ² ¹⁴

Assess renal function before and during therapy; make appropriate dosage adjustments as necessary.¹ ² ¹⁴ (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Safety and efficacy not evaluated.¹ ² ¹⁴

Renal Impairment

Use with caution in patients with impaired renal function.¹ ² ¹⁴

Dosage adjustment necessary in patients with renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Hematologic effects (leukopenia, neutropenia, thrombocytopenia, anemia), pyrexia, GI effects (diarrhea, nausea, decreased appetite, abdominal pain), catheter-associated effects (sepsis), hyperhidrosis, asthenia, headache, cough, dyspnea, increased creatinine concentrations.¹ ² ¹⁴

Drug Interactions

Drug interaction studies were performed in patients with normal renal function.¹ In patients with renal impairment, concomitant use of ganciclovir and other drugs eliminated by renal excretion may increase concentrations of ganciclovir and the concomitant drug; closely monitor for toxicity associated with ganciclovir and the concomitant drug.¹

Specific Drugs

Drug	Interaction	Comments
Amphotericin B	Possible increased S_cr¹	Monitor renal function¹
Antineoplastic agents (doxorubicin, hydroxyurea, vinblastine, vincristine)	Possible increased toxicity¹	Use concomitantly only if potential benefits outweigh risks¹
Co-trimoxazole	Possible increased toxicity¹	Use concomitantly only if potential benefits outweigh risks¹
Dapsone	Possible increased toxicity¹	Use concomitantly only if potential benefits outweigh risks¹
Didanosine	Increased peak plasma concentrations and AUC of didanosine; no effect on ganciclovir pharmacokinetics¹ Some in vitro evidence that ganciclovir antagonizes antiretroviral activity of didanosine⁸⁵ ²⁹⁴	If used concomitantly, monitor closely for didanosine toxicity¹ ³⁴⁷
Flucytosine	Possible increased toxicity¹	Use concomitantly only if potential benefits outweigh risks¹
Foscarnet	No apparent effect on pharmacokinetics of either drug³⁵² Physically incompatible³⁵² No in vitro evidence of antagonistic antiviral effects;²⁵³ in vitro evidence of additive or synergistic antiviral activity against CMV and herpes simplex virus type 2 (HSV-2)²⁷⁴ ²⁷⁵ ²⁷⁶ ²⁷⁷ ²⁷⁸	Do not admix³⁵²
Imipenem and cilastatin	Seizures reported with concomitant use¹ ³	Concomitant use not recommended¹
Immunosuppressive agents (azathioprine, corticosteroids, cyclosporine, mycophenolate mofetil, tacrolimus)	Immunosuppressive agents: Possible increased risk of myelosuppression or nephrotoxicity¹ ¹⁵ ¹⁹ ¹⁴⁰ ¹⁸⁸ ¹⁹³ ²⁰² ²¹⁹ ²⁶² Cyclosporine: Possible increased S_cr;¹ no effect on cyclosporine whole blood concentrations¹ Mycophenolate mofetil: No effect on pharmacokinetics of either drug;¹ possible increased toxicity¹ Tacrolimus: Possible increased toxicity¹	Immunosuppressive agents: Consider need for decreased dosage or temporary withdrawal of the immunosuppressive agent¹⁵ ¹⁹ ¹⁴⁰ ¹⁸⁸ ¹⁹³ ²⁰² ²¹⁹ ²⁶² Cyclosporine: Monitor renal function¹ Mycophenolate mofetil: Monitor for hematologic and renal toxicity¹ Tacrolimus: Use concomitantly only if potential benefits outweigh risks¹
Letermovir	No in vitro evidence of antagonistic anti-CMV effects³⁵¹
Pentamidine	Possible increased toxicity¹	Use concomitantly only if potential benefits outweigh risks¹
Probenecid	Possible increased ganciclovir concentrations¹	Monitor for ganciclovir-associated toxicity;¹ ganciclovir dosage may need to be reduced¹
Sulfamethoxazole	Possible increased toxicity¹	Use concomitantly only if potential benefits outweigh risks¹
Tenofovir	Tenofovir alafenamide or tenofovir disoproxil fumarate: Possible increased concentrations of ganciclovir and tenofovir²⁰⁰	Tenofovir alafenamide or tenofovir disoproxil fumarate: Monitor for tenofovir toxicities²⁰⁰
Trimethoprim	No effect on pharmacokinetics of either drug;¹ possible increased toxicity¹	Use concomitantly only if potential benefits outweigh risks¹
Zidovudine	Increased risk of hematologic toxicity¹ ²⁵ ⁸³ ²⁰⁰ ²⁹⁵ Some in vitro evidence that ganciclovir antagonizes antiretroviral activity of zidovudine⁸⁵ ²⁹⁴	Use concomitantly only if potential benefits outweigh risks¹ ¹⁸ ²⁵ ⁸³ ⁸⁷ ⁹⁶ ¹²⁶ ¹²⁹ ¹³³ ¹³⁵ ¹⁷⁰ ¹⁸⁷ ²⁹³ ²⁹⁵

Ganciclovir Sodium Pharmacokinetics

Absorption

Bioavailability

Following IV doses of 5 mg/kg every 12 hours given by IV infusion over 1 hour, peak plasma concentrations range between 8.3–9 mcg/mL.¹

No apparent accumulation in patients with normal renal function receiving IV dosages of 3–15 mg/kg daily in divided doses.³ ¹¹ ⁵⁹ ¹²⁴

Limited data indicate minimal systemic absorption following intravitreal injection^†.⁴ ²⁵ ⁶⁷

Distribution

Extent

Widely distributed following IV administration.⁸⁵ Autopsy findings in patients who had been receiving IV ganciclovir suggest the drug concentrates in kidneys, with substantially lower concentrations occurring in lung, liver, brain, and testes.⁵ ⁹ ⁶⁴

Appears to have good ocular distribution following IV administration;⁵ ⁸⁵ ⁹³ ¹⁰⁴ ¹¹⁷ distributed into aqueous and vitreous humor.³ ¹⁰⁴

Distributed into CSF following IV administration.¹ ³ ⁴ ⁵ ⁹ ²⁸ ⁵⁹ ⁶⁴ ⁶⁸

Crosses the placenta (based on ex vivo experiments and at least one case report in a pregnant woman).¹

Not known whether distributed into human milk;¹ distributed into milk in rats.¹ ³

Plasma Protein Binding

1–2%.¹

Elimination

Metabolism

With the exception of intracellular phosphorylation of the drug, ganciclovir does not appear to be metabolized appreciably in humans.¹ ⁴ ⁵ ¹¹ ²⁸ ⁵⁹ ⁶¹ ⁶⁴ ¹²⁴

Elimination Route

Following IV administration, approximately 90–99% of the dose is excreted unchanged in urine.¹ ³ ⁴ ⁵ ¹¹ ²⁸ ⁵⁹ ⁶¹ ⁶⁴ ¹²⁴ Renal excretion occurs via glomerular filtration and active tubular secretion.¹ ³ ⁵ ¹¹ ⁵⁹ ¹²⁴

Removed by hemodialysis;¹ ³ ⁵ ⁶⁰ ¹⁰⁸ ¹²⁴ ¹⁵¹ plasma concentrations reduced approximately 50% following 4-hour hemodialysis session.¹

Half-life

Adults with normal renal function: 3.5 hours.¹

Special Populations

Patients with impaired renal function: Plasma concentrations may be higher and elimination half-life prolonged.¹ ³ ⁵ ⁹ ¹¹ ²⁰ ⁵⁹ ⁶⁰ ⁶¹ ⁶⁴ ¹²⁴ In immunocompromised patients with renal impairment, mean plasma half-life was 4.4 hours in those with Cl_cr of 25–59 mL/minute and 10.7 hours in those with Cl_cr <25 mL/minute.¹ In adults with moderate to severe renal impairment (Cl_cr <50 mL/minute per 1.73 m²), terminal half-life ranged from 4.4–30 hours, depending on degree of impairment.¹ ³ ¹¹ ⁶⁰ ⁶¹ ⁶⁴ ¹²⁴

Geriatric patients: Pharmacokinetics not specifically evaluated, but renal clearance decreases with age and decreased ganciclovir total body clearance and prolonged half-life expected in adults ≥65 years of age.¹

Pediatric patients^†: Plasma half-life of 2.4 hours reported in a limited number of neonates 2–49 days of age^† and infants and children 9 months to 12 years of age^† receiving IV ganciclovir.¹

Stability

Storage

Parenteral

Powder for IV Infusion

Single-dose vials containing lyophilized powder: 25°C (may be exposed to 15–30°C).¹

Following reconstitution with preservative-free sterile water for injection, stable in vial for ≤12 hours at 25°C;¹ do not refrigerate or freeze.¹

Following further dilution in compatible IV infusion solution, store at 2–8°C for ≤24 hours;¹ do not freeze.¹

Concentrate for Injection, for IV Infusion

Single-dose vials containing 500 mg of ganciclovir (50 mg/mL): 25°C (may be exposed to 15–30°C).²

Following dilution in compatible IV infusion solution, store at 2–8°C and use within 24 hours.² Do not freeze.²

Injection for IV Infusion

Single-dose IV bags containing 500 mg of ganciclovir in 250 mL of 0.8% sodium chloride (2 mg/mL): 20–25°C (may be exposed to 15–30°C).¹⁴

Crystals may form in the premixed solution if exposed to temperatures lower than recommended;¹⁴ gently shake IV bag to redissolve crystals.¹⁴

Compatibility

Parenteral

Solution CompatibilityHID

Compatible
Dextrose 5% in water
Ringer's injection
Ringer's injection, lactated
Sodium chloride 0.9%

Drug Compatibility

Y-Site CompatibilityHID
Compatible
Allopurinol sodium
Anidulafungin
Caspofungin acetate
Defibrotide sodium
Docetaxel
Doxorubicin HCl liposome injection
Enalaprilat
Etoposide phosphate
Filgrastim
Fluconazole
Granisetron HCl
Letermovir
Linezolid
Melphalan HCl
Paclitaxel
Pemetrexed disodium
Propofol
Remifentanil HCl
Teniposide
Thiotepa
Incompatible
Aldesleukin
Amifostine
Amsacrine
Aztreonam
Fludarabine phosphate
Foscarnet sodium
Gemcitabine HCl
Ondansetron HCl
Piperacillin sodium–tazobactam sodium
Sargramostim
Tacrolimus
Vinorelbine tartrate
Variable
Cisatracurium besylate

Actions and Spectrum

Nucleoside antiviral.¹ ² ¹⁴ ⁸⁵ ⁸⁶
Prodrug with no antiviral activity until converted intracellularly to ganciclovir triphosphate.¹ ³⁶ ⁸⁵ ⁹⁸ ¹¹² ¹¹³ Initially converted to ganciclovir monophosphate via viral protein kinase pUL97;¹ ⁸⁵ further phosphorylated by cellular kinases to ganciclovir triphosphate.¹ ⁸⁵
Ganciclovir triphosphate is a viral DNA polymerase inhibitor;¹ ⁸⁵ exerts antiviral activity by interfering with viral DNA synthesis and viral replication by incorporating into viral DNA chains¹ ⁸ ⁹ ⁵⁷ ⁵⁸ ⁹⁹ ¹¹³ ¹³³ ²⁰⁶ ²⁰⁹ and competitively inhibiting viral DNA polymerase pUL54.¹ ¹⁹⁵
Active against various human herpesviruses,³ ²¹ ⁸⁵ ¹⁵² ²⁰⁹ ²²¹ ²³² including CMV,¹ ³ ¹¹ ¹² ³⁷ ⁸⁵ herpes simplex virus types 1 and 2 (HSV-1 and HSV-2),³ ¹¹ ¹² ⁴⁶ ⁷⁸ ⁷⁹ ⁸⁰ ⁸¹ ⁹⁷ ¹⁶¹ ¹⁶³ ²⁰⁹ ²²² and VZV.³ ¹¹ ¹² ³⁷ ⁹⁷ ²²¹ Although clinical importance unclear, has some in vitro activity against Epstein-Barr virus (EBV)³ ¹¹ ¹² ⁸⁵ ⁸⁹ ⁹⁷ ¹⁶⁹ ²²² and human herpesvirus type 6⁸⁵ ²³² and type 8.⁸⁵ Not active against HIV.⁸⁵
CMV resistant to ganciclovir have been selected in vitro in the presence of increasing concentrations of the drug.¹ ⁸⁵ Ganciclovir-resistant CMV have been reported in ganciclovir-naive patients¹ and may emerge after prolonged treatment or prophylaxis with the drug.¹ ⁸⁵ Consider possibility of ganciclovir-resistant CMV in patients who show poor clinical response or relapse or experience persistent viral shedding during ganciclovir therapy.¹ ⁸⁵
Resistance to ganciclovir usually results from amino acid substitutions in the viral protein kinase pUL97 and/or viral DNA polymerase pUL54.¹ ⁸⁵
Cross-resistance between ganciclovir and foscarnet and/or cidofovir reported.¹ ⁸⁵

Advice to Patients

Inform patients that ganciclovir may cause hematologic toxicity, including granulocytopenia (neutropenia), thrombocytopenia, and anemia, and that frequent blood tests are required to closely monitor blood cell counts.¹ ² ¹⁴
Advise patients that ganciclovir has been associated with decreased renal function and that S_cr and Cl_cr should be monitored during treatment with the drug and dosage adjustments made if needed.¹ ² ¹⁴
Advise patients that ganciclovir may cause seizures, dizziness, and/or confusion, which may affect cognitive abilities (e.g., ability to drive or operate machinery).¹ ² ¹⁴
When ganciclovir used for management of CMV retinitis, advise patients that the drug is not a cure for CMV retinitis; progression may occur during or after ganciclovir treatment.¹ ² ¹⁴ Regular ophthalmologic examinations necessary; some patients may require more frequent follow-up.¹ ² ¹⁴
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹
Advise patients that ganciclovir is considered a potential carcinogen in humans.¹ ² ¹⁴
Advise patients that ganciclovir may cause temporary or permanent infertility in humans.¹ ² ¹⁴
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ ² ¹⁴ Advise women to avoid pregnancy and to not breast-feed infants.¹ ² ¹⁴
Advise females of childbearing potential to use effective contraception during and for ≥30 days after ganciclovir therapy.¹ ² ¹⁴ Advise male patients to use barrier contraception during and for ≥90 days after ganciclovir therapy.¹ ² ¹⁴
Importance of advising patients of other important precautionary information.¹ ² ¹⁴ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ganciclovir
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IV infusion only	2 mg/mL (500 mg) in 0.8% Sodium Chloride*	Ganciclovir Injection

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ganciclovir Sodium
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Concentrate, for injection, for IV infusion only	50 mg (of ganciclovir) per mL (500 mg)	Ganciclovir Injection
	For injection, for IV infusion only	500 mg (of ganciclovir)*	Cytovene-IV	Roche
			Ganciclovir Sodium for Injection

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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Pill RX636 RX636 is Ganciclovir 250 mg — Ganciclovir 250 mg (RX636 RX636)