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Cytovene

Generic Name: Ganciclovir Sodium
Class: Nucleosides and Nucleotides
VA Class: AM800
Chemical Name: 2-Amino-1,9-dihydro-9-[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6H-purin-6-one sodium salt
CAS Number: 84245-13-6

Medically reviewed by Drugs.com. Last updated on Aug 12, 2019.

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 Cytovene

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.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 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, 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 and adolescents 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

Cytovene 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 Clcr.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 Clcr.1 2 14 (See Table 1.)

Table 1. Dosage of IV Ganciclovir for Management of CMV Retinitis in Adults with Renal Impairment1214

Clcr (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 Cytovene

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 Scr 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

Interactions for Cytovene

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 Scr1

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 Scr;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

Cytovene 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 Clcr of 25–59 mL/minute and 10.7 hours in those with Clcr <25 mL/minute.1 In adults with moderate to severe renal impairment (Clcr <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

For information on systemic interactions resulting from concomitant use, see Interactions.

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 Scr and Clcr 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

AHFS DI Essentials™. © Copyright 2020, Selected Revisions August 12, 2019. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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

References

1. Genentech. Cytovene-IV (ganciclovir sodium for injection) prescribing information. Nutley, NJ; 2018 Aug.

2. Pharmascience Inc. Ganciclovir sodium injection, solution prescribing information. Candiac Canada; 2018 Nov.

3. Syntex Research. Investigator’s monograph: ganciclovir. 5th ed. Palo Alto, CA: 1987 Dec. (Syntex Document No. RS-21592)

4. Jacobson MA, Mills J. Serious cytomegalovirus disease in the acquired immunodeficiency syndrome (AIDS). Ann Intern Med. 1988; 108:585-94. http://www.ncbi.nlm.nih.gov/pubmed/2831765?dopt=AbstractPlus

5. Fletcher CV, Balfour HH Jr. Evaluation of ganciclovir for cytomegalovirus disease. DICP. 1989; 23:5-12. http://www.ncbi.nlm.nih.gov/pubmed/2541566?dopt=AbstractPlus

6. Chachoua A, Dieterich D, Krasinski K et al. 9-(1,3-Dihydroxy-2-propoxymethyl)guanine (ganciclovir) in the treatment of cytomegalovirus gastrointestinal disease with the acquired immunodeficiency syndrome. Ann Intern Med. 1987; 107:133-7. http://www.ncbi.nlm.nih.gov/pubmed/3037960?dopt=AbstractPlus

7. Visor GC, Lin LH, Jackson SE et al. Stability of ganciclovir sodium (DHPG sodium) in 5% dextrose or 0.9% sodium chloride injections. Am J Hosp Pharm. 1986; 43:2810-2. http://www.ncbi.nlm.nih.gov/pubmed/3492139?dopt=AbstractPlus

8. Drew WL. Cytomegalovirus infection in patients with AIDS. J Infect Dis. 1988; 158:449-56. http://www.ncbi.nlm.nih.gov/pubmed/2841381?dopt=AbstractPlus

9. Weintraub M, Standish R. Ganciclovir: an antiviral agent for AIDS and other immunocompromised patients. Hosp Formul. 1987; 22:1011-6.

10. Weller IVD. ABC of AIDS: treatment of infections and antiviral agents. BMJ. 1987; 295:200-3. http://www.ncbi.nlm.nih.gov/pubmed/3115376?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1247044&blobtype=pdf

11. Laskin OL, Cederberg DM, Mills J et al. Ganciclovir for the treatment and suppression of serious infections caused by cytomegalovirus. Am J Med. 1987; 83:201-7. http://www.ncbi.nlm.nih.gov/pubmed/3039841?dopt=AbstractPlus

12. Tuazon CU, Labriola AM. Management of infectious and immunological complications of acquired immunodeficiency syndrome (AIDS)—current and future prospects. Drugs. 1987; 33:66-84. http://www.ncbi.nlm.nih.gov/pubmed/3545766?dopt=AbstractPlus

13. Bach MC, Bagwell SP, Knapp NP et al. 9-(1, 3-Dihydroxy-2-propoxymethyl)guanine for cytomegalovirus infections in patients with the acquired immunodeficiency syndrome. Ann Intern Med. 1985; 103:381-2. http://www.ncbi.nlm.nih.gov/pubmed/2992335?dopt=AbstractPlus

14. Exela Pharma Sciences, LLC. Ganciclovir injection solution prescribing information. Lenoir, NC; 2017 Sep.

15. Nicholson ML, Flower AJE, Simpson A et al. Ganciclovir for severe cytomegalovirus infection in transplant recipients. Lancet. 1988; 2:1501-2. http://www.ncbi.nlm.nih.gov/pubmed/2904627?dopt=AbstractPlus

16. Rostoker G, Ben Maadi A, Buisson C et al. Ganciclovir for severe cytomegalovirus infection in transplant recipients. Lancet. 1988; 2:1137-8. http://www.ncbi.nlm.nih.gov/pubmed/2903346?dopt=AbstractPlus

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18. Tindall B, Swanson C, Whyte BM et al. Fourth international conference on the acquired immunodeficiency syndrome. Med J Aust. 1989; 150: 87-92.

19. Hiesse C, Farquet C, Dussaix E et al. Ganciclovir for cytomegalovirus infection in renal transplant recipients. Lancet. 1989; 1:216-7.

20. Erice A, Jordan MC, Chace BA et al. Ganciclovir treatment of cytomegalovirus disease in transplant recipients and other immunocompromised hosts. JAMA. 1987; 257:3082-7. http://www.ncbi.nlm.nih.gov/pubmed/3035246?dopt=AbstractPlus

21. Collaborative DHPG Treatment Study Group. Treatment of serious cytomegalovirus infections with 9-(1,3-dihydroxy-2-propoxymethyl)guanine in patients with AIDS and other immunodeficiencies. N Engl J Med. 1986; 314:801-5. http://www.ncbi.nlm.nih.gov/pubmed/3005861?dopt=AbstractPlus

22. Meyers JD. Management of cytomegalovirus infection. Am J Med. 1988; 85(Suppl 2A):102-6. http://www.ncbi.nlm.nih.gov/pubmed/2841853?dopt=AbstractPlus

23. Masur H, Lane HC, Palestine A et al. Effect of 9-(1,3-dihydroxy-2-propoxymethyl) guanine on serious cytomegalovirus disease in eight immunosuppressed homosexual men. Ann Intern Med. 1986; 104:41-4. http://www.ncbi.nlm.nih.gov/pubmed/3000248?dopt=AbstractPlus

24. Dorsky DI, Crumpacker CS. Drugs five years later: acyclovir. Ann Intern Med. 1987; 107:859-74. http://www.ncbi.nlm.nih.gov/pubmed/3318610?dopt=AbstractPlus

25. Henry K, Cantrill H, Kish MA. Intravitreous ganciclovir for patients receiving zidovudine. JAMA. 1987; 257:3066. http://www.ncbi.nlm.nih.gov/pubmed/3035245?dopt=AbstractPlus

26. Mau S, Salamone FR, Muller RJ et al. Trimetrexate, ganciclovir, foscarnet, fluconazole—investigational drugs used in the management of AIDS. Hosp Pharm. 1989; 24:209-14.

27. Jordan MC. Ganciclovir for treatment of cytomegalovirus disease. DICP. 1989; 23:85-6. http://www.ncbi.nlm.nih.gov/pubmed/2541567?dopt=AbstractPlus

28. Laskin OL, Stahl-Bayliss CM, Kalman CM et al. Use of ganciclovir to treat serious cytomegalovirus infections in patients with AIDS. J Infect Dis. 1987; 155:323-7. http://www.ncbi.nlm.nih.gov/pubmed/3027195?dopt=AbstractPlus

29. Wood MJ, Geddes AM. Antiviral therapy. Lancet. 1987; 2:1189-93. http://www.ncbi.nlm.nih.gov/pubmed/2890817?dopt=AbstractPlus

30. Nahata MC. Clinical use of antiviral drugs. Drug Intell Clin Pharm. 1987; 21:399-405. http://www.ncbi.nlm.nih.gov/pubmed/3556126?dopt=AbstractPlus

31. Devita VT, Broder S, Fauci AS et al. Developmental therapeutics and the acquired immunodeficiency syndrome. Ann Intern Med. 1987; 106:568-81. http://www.ncbi.nlm.nih.gov/pubmed/2435201?dopt=AbstractPlus

32. Deeter RG, Khanderia U. Recent advances in antiviral therapy. Clin Pharm. 1986; 5:961-76. http://www.ncbi.nlm.nih.gov/pubmed/3542344?dopt=AbstractPlus

33. Keay S, Bissett J, Merigan TC. Ganciclovir treatment of cytomegalovirus infections in iatrogenically immunocompromised patients. J Infect Dis. 1987; 156:1016-21. http://www.ncbi.nlm.nih.gov/pubmed/2824621?dopt=AbstractPlus

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35. Tyms AS, Davis JM, Jeffries DJ et al. BWB759U and an analogue of acyclovir, inhibits human cytomegalovirus in vitro. Lancet. 1984; 2:924-5. http://www.ncbi.nlm.nih.gov/pubmed/6148640?dopt=AbstractPlus

36. St. Clair MH, Miller WH, Miller RL et al. Inhibition of cellular α DNA polymerase and herpes simplex virus-induced DNA polymerases by the triphosphate of BW759U. Antimicrob Agents Chemother. 1984; 25:191-4. http://www.ncbi.nlm.nih.gov/pubmed/6324666?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=185472&blobtype=pdf

37. Mar EC, Cheng YC, Huang ES. Effect of 9-(1, 3-dihydroxy-2-propoxymethyl) guanine on human cytomegalovirus replication in vitro. Antimicrob Agents Chemother. 1983; 24:518-21. http://www.ncbi.nlm.nih.gov/pubmed/6316844?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=185366&blobtype=pdf

38. Goring DR, DuBow MS. A cytotoxic effect associated with 9-(1,3-dihydroxy-2-propoxymethyl) guanine is observed during the selection for drug resistant human cells containing a single herpesvirus thymidine kinase gene. Biochem Biophys Res Commun. 1985; 133:195-201. http://www.ncbi.nlm.nih.gov/pubmed/3878145?dopt=AbstractPlus

39. Smee DF. Interaction of 9-(1,3-dihydroxy-2 -propoxymethyl) guanine with cytosol and mitochondrial deoxyguanosine kinases: possible role in anti-cytomegalovirus activity. Mol Cell Biochem. 1985; 69:75-81. http://www.ncbi.nlm.nih.gov/pubmed/3001505?dopt=AbstractPlus

40. Smee DF, Martin JC, Verheyden JPH et al. Anti-herpesvirus activity of the acyclic nucleoside 9-(1,3-dihydroxy-2-propoxymethyl) guanine. Antimicrob Agents Chemother. 1983; 23:676-82. http://www.ncbi.nlm.nih.gov/pubmed/6307132?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=184786&blobtype=pdf

41. Biron KK, Stanat SC, Sorrell JB et al. Metabolic activation of the nucleoside analog 9-[2-hydroxy-1-(hydroxymethyl)ethoxymethyl]guanine in human diploid fibroblasts infected with human cytomegalovirus. Proc Natl Acad Sci USA. 1985; 82:2473-7. http://www.ncbi.nlm.nih.gov/pubmed/2986118?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=397581&blobtype=pdf

42. Field AK, Davies ME, DeWitt C et al. 9-[2-Hydroxy-1-(hydroxymethyl)ethoxymethyl]guanine: a selective inhibitor of herpes group virus replication. Proc Natl Acad Sci USA. 1983; 80:4139-43. http://www.ncbi.nlm.nih.gov/pubmed/6306664?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=394216&blobtype=pdf

43. Cheng YC, Huang ES, Lin JC et al. Unique spectrum of activity of 9-[(1,3-dihydroxy-2 -propoxy)methyl]guanine against herpesviruses in vitro and its mode of action against herpes simplex virus type 1. Proc Natl Acad Sci, USA. 1983; 80: 2767-70.

44. Oberg B, Johansson NG. The relative merits and drawbacks of new nucleoside analogues with clinical potential. J Antimicrob Chemother. 1984; 14(Suppl A):5-26. http://www.ncbi.nlm.nih.gov/pubmed/6436227?dopt=AbstractPlus

45. Cheng YC, Grill SP, Dutschman GE et al. Metabolism of 9-(1,3-dihydroxy-2-propoxymethyl) guanine and a new anti-herpes virus compound, in herpes simplex virus infected cells. J Biol Chem. 1983; 258:12460-4. http://www.ncbi.nlm.nih.gov/pubmed/6313660?dopt=AbstractPlus

46. Smith KO, Galloway KS, Kennell WL et al. A new nucleoside analog, 9-[2-hydroxy-1 -(hydroxymethyl)ethoxy]methyl]guanine, highly active in vitro against herpes simplex virus types 1 and 2. Antimicrob Agents Chemother. 1982; 22:55-61. http://www.ncbi.nlm.nih.gov/pubmed/6289741?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=183674&blobtype=pdf

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49. Freitas VR, Smee DF, Chernow M et al. Activity of 9-(1,3-dihydroxy-2-propoxymethyl)guanine compared with that of acyclovir against human and monkey, and rodent cytomegaloviruses. Antimicrob Agents Chemother. 1985; 28:240-5. http://www.ncbi.nlm.nih.gov/pubmed/3010840?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=180226&blobtype=pdf

50. Plotkin SA, Drew WL, Felsenstein D et al. Sensitivity of clinical isolates of human cytomegalovirus to 9-(1,3-dihydroxy-2 -propoxymethyl)guanine. J Infect Dis. 1985; 152: 833-4. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=3154749&blobtype=pdf

51. Cheng YC, Grill SP, Dutschman GE et al. Effects of 9-(1,3-dihydroxy-2-propoxymethyl)guanine, a new antiherpesvirus compound, on synthesis of macromolecules in herpes simplex virus-infected cells. Antimicrob Agents Chemother. 1984; 26:283-8. http://www.ncbi.nlm.nih.gov/pubmed/6095751?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=176152&blobtype=pdf

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54. Germershausen J, Bostedor R, Field AK et al. A comparison of the antiviral agents 2′-nor-2 ′-deoxyguanosine and acyclovir: uptake and phosphorylation in tissue culture and kinetics of in vitro inhibition of viral and cellular DNA polymerases by their respective triphosphates. Biochem Biophys Res Commun. 1983; 116:360-7. http://www.ncbi.nlm.nih.gov/pubmed/6316950?dopt=AbstractPlus

55. Collins P, Oliver NM. Comparison of the in vitro and in vivo antiherpes virus activities of the acyclic nucleosides and acyclovir (Zovirax), 9-[(2-hydroxy-1-hydroxymethyl-ethoxy)methyl]guanine (BWB759U). Antiviral Res. 1985; 5:145-56. http://www.ncbi.nlm.nih.gov/pubmed/2992369?dopt=AbstractPlus

56. Smee DF, Boehme R, Chernow M et al. Intracellular metabolism and enzymatic phosphorylation of 9-(1,3-dihydroxy-2-propoxymethyl)guanine and acyclovir in herpes simplex virus-infected and uninfected cells. Biochem Pharmacol. 1985; 34: 1049-56. http://www.ncbi.nlm.nih.gov/pubmed/3872662?dopt=AbstractPlus

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61. Weller S, Liao SHT, Cederberg DM et al. The pharmacokinetics of ganciclovir in patients with cytomegalovirus (CMV) infections. J Pharm Sci. 1987; 76:S120.

62. O’Donnell JJ, Jacobson MA, Mills J. Development of cytomegalovirus (CMV) retinitis in a patient with AIDS during ganciclovir therapy for CMV colitis. New Engl J Med. 1987; 316:1607-8. http://www.ncbi.nlm.nih.gov/pubmed/3035374?dopt=AbstractPlus

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64. Shepp DH, Dandliker PS, de Miranda P et al. Activity of 9-[2-hydroxy-1- (hydroxymethyl)ethoxymethyl]guanine in the treatment of cytomegalovirus pneumonia. Ann Intern Med. 1985; 103:368-73. http://www.ncbi.nlm.nih.gov/pubmed/2992333?dopt=AbstractPlus

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67. Henry K, Cantrill H, Fletcher C et al. Use of intravitreal ganciclovir (dihydroxy propoxymethyl guanine) for cytomegalovirus retinitis in a patient with AIDS. Am J Ophthalmol. 1987; 103:17-23. http://www.ncbi.nlm.nih.gov/pubmed/3026186?dopt=AbstractPlus

68. Stein DS, Verano AS, Levandowski RA. Successful treatment with ganciclovir of disseminated cytomegalovirus infection after liver transplantation. Am J Gastroenterol. 1988; 83:684-6. http://www.ncbi.nlm.nih.gov/pubmed/2837082?dopt=AbstractPlus

69. Kotler DP, Tierney AR, Altilio D et al. Body mass repletion during ganciclovir treatment of cytomegalovirus infections in patients with acquired immunodeficiency syndrome. Arch Intern Med. 1989; 149:901-5. http://www.ncbi.nlm.nih.gov/pubmed/2539791?dopt=AbstractPlus

70. Jacobson MA, Cello JP, Sande MA. Cholestasis and disseminated cytomegalovirus disease in patients with the acquired immunodeficiency syndrome. Am J Med. 1988; 84:218-24. http://www.ncbi.nlm.nih.gov/pubmed/2841850?dopt=AbstractPlus

71. Jabs DA, Enger C, Bartlett JG. Cytomegalovirus retinitis and acquired immunodeficiency syndrome. Arch Ophthalmol. 1989; 107:75-80. http://www.ncbi.nlm.nih.gov/pubmed/2535932?dopt=AbstractPlus

72. Hecht DW, Snydman DR, Crumpacker CS et al. Ganciclovir for treatment of renal transplant-associated primary cytomegalovirus pneumonia. J Infect Dis. 1988; 157:187-90. http://www.ncbi.nlm.nih.gov/pubmed/2826608?dopt=AbstractPlus

73. Reed EC, Bowden RA, Dandliker PS et al. Treatment of cytomegalovirus pneumonia with ganciclovir and intravenous cytomegalovirus immunoglobulin in patients with bone marrow transplants. Ann Intern Med. 1988; 109:783-8. http://www.ncbi.nlm.nih.gov/pubmed/2847610?dopt=AbstractPlus

74. Ljungman P, Hakki M, Boeckh M. Cytomegalovirus in hematopoietic stem cell transplant recipients. Hematol Oncol Clin North Am. 2011; 25:151-69. http://www.ncbi.nlm.nih.gov/pubmed/21236396?dopt=AbstractPlus

75. Hermans PE, Cockerill FR III. Antiviral agents. Mayo Clin Proc. 1987; 62:1108-15. http://www.ncbi.nlm.nih.gov/pubmed/3500376?dopt=AbstractPlus

76. Meesing A, Razonable RR. Pharmacologic and immunologic management of cytomegalovirus infection after solid organ and hematopoietic stem cell transplantation. Expert Rev Clin Pharmacol. 2018; 11:773-788. http://www.ncbi.nlm.nih.gov/pubmed/30009675?dopt=AbstractPlus

78. Klein RJ, Friedman-Kien AE. Effect of 9-(1, 3-dihydroxy-2-propoxymethyl)guanine on the acute local phase of herpes simplex virus-induced skin infections in mice and the establishment of latency. Antimicrob Agents Chemother. 1985; 27:763-8. http://www.ncbi.nlm.nih.gov/pubmed/3874596?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=180149&blobtype=pdf

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