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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 on Jul 9, 2018

Warning

  • Clinical toxicity of oral and IV ganciclovir includes granulocytopenia, anemia, and thrombocytopenia.1

  • In animal studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis.1

  • The only FDA-approved indications for IV ganciclovir are treatment of CMV retinitis in immunocompromised patients and prevention of CMV disease in transplant recipients at risk.1

  • The only FDA-approved indications for oral ganciclovir are prevention of CMV disease in patients with advanced HIV infection, maintenance treatment of CMV retinitis in immunocompromised patients, and prevention of CMV disease in solid organ transplant recipients.1

  • Because oral ganciclovir is associated with a risk of more rapid progression of CMV retinitis, it should be used as maintenance treatment only in those for whom this risk is balanced by the benefits associated with avoiding daily IV infusions.1

Introduction

Antiviral; purine nucleoside analog of guanine.1 2 3 8 9 10 11 12

Uses for Cytovene

Cytomegalovirus (CMV) Infections

Treatment of CMV retinitis in immunocompromised patients, including HIV-infected patients.1 5 11 21 28 100 103 104 105 117 118 126 127 139 164 174 175 187 207 225 243 268 ganciclovir is not curative; stabilization or improvement of ocular manifestations may occur, but progression of retinitis is possible during or following treatment.1 4 5 8 9 11 13 21 27 28 63 65 77 94 100 120 126 128 139 167 168

Drugs of choice for initial induction and maintenance therapy of CMV retinitis are IV ganciclovir, IV foscarnet, IV cidofovir, oral valganciclovir, or intravitreal fomivirsen.268 319 322 331 A regimen of both ganciclovir and foscarnet is used for treatment of CMV retinitis in patients who have relapsed following monotherapy with either drug.268 319 322 331

Primary prevention (primary prophylaxis) of CMV disease in HIV-infected patients at risk for the disease, including adults, adolescents, and children who are positive for CMV antibody and have CD4+ T-cell counts <50/mm3.317 320 321 322 USPHS/IDSA recommends oral ganciclovir as the drug of choice for primary CMV prophylaxis in these patients.317

Long-term suppressive or maintenance therapy (secondary prophylaxis) of recurrent CMV disease in HIV-infected adults, adolescents, or children.317 USPHS/IDSA recommends IV ganciclovir or IV foscarnet as drugs of choice for such prophylaxis.317

Prevention of CMV disease in solid organ transplant recipients and bone marrow transplant (BMT) recipients at risk for the disease.1 268 271 283 284 286 287 304 305 307 313 324

Has been used in immunocompromised patients for parenteral treatment of extraocular CMV infections, including GI infections,3 4 5 6 8 11 16 20 21 26 68 69 70 76 77 92 102 108 110 122 134 146 166 193 194 207 pneumonitis,3 4 5 8 10 11 15 16 17 18 19 20 21 33 43 64 72 73 74 106 107 108 109 110 111 121 122 137 140 145 146 147 149 151 154 159 180 188 193 198 199 200 201 202 207 219 220 225 nervous system,4 5 8 11 21 110 165 207 231 hepatobiliary,4 5 8 20 21 68 106 108 146 166 219 or cardiac110 171 220 CMV infections.3 5 8 15 19 108 140 Safety and efficacy have not been established for extraocular CMV infections;1 2 use in these infections should be limited to severe and/or potentially life-threatening infections when potential benefits outweigh risks.3 6 15 16 72 106 107 110 134 146 219 262

Safety and efficacy not established for treatment of congenital or neonatal CMV disease or for treatment of CMV infections in immunocompetent patients.1

Cytovene Dosage and Administration

General

  • Frequent monitoring of neutrophil and platelet counts is necessary during ganciclovir induction and maintenance therapy.1 2 20 191

  • Dosage adjustment and/or interruption of ganciclovir therapy may be necessary if hematologic abnormalities occur.1 2

  • Ganciclovir should be withheld if the ANC declines to <500/mm3 or the platelet count declines to <25,000/mm3 and should not be resumed until there is evidence of bone marrow recovery.1 2

Administration

Administer orally or by slow IV infusion.1 2

Do not administer by rapid IV infusion or direct IV injection since potentially toxic plasma ganciclovir concentrations may result.1 2 In addition, do not administer by IM or sub-Q injection.1 2

Can be administered via a commercially available intravitreal implant for treatment of CMV retinitis.323 340 Although ganciclovir has been administered by intravitreal injection for the treatment of ocular infections,4 5 8 67 84 117 129 135 170 209 safety and efficacy of intravitreal injection of solutions made from the powder for IV infusion have not been established.4 5 8 67 170

Oral Administration

Administer orally with food.1

Oral ganciclovir should be used only for prevention of CMV disease in HIV-infected patients or transplant recipients at risk for the disease or for maintenance treatment of CMV retinitis in patients in whom the disease is stable following initial IV induction therapy.1

IV Infusion

For solution and drug compatibility information see Compatibility under Stability.

Handle the powder and reconstituted and diluted solutions cautiously because of the high pH of the solutions and because of the mutagenic and/or carcinogenic potential of the drug.1 2 Use protective equipment (e.g., latex gloves, protective eyewear).1 2

Since ganciclovir shares some of the properties of cytotoxic drugs, consider consulting specialized references for procedures for proper handling and disposal of antineoplastics, although there is no general agreement that all of the procedures recommended in such guidelines are necessary or appropriate.1 2

Because of the high pH of ganciclovir solutions, a vein with adequate blood flow should be used to allow for rapid dilution and distribution of the drug, which may minimize risk of phlebitis.1 2

Reconstitution and Dilution

For intermittent IV infusion, reconstitute 500-mg vial by adding 10 mL of sterile water for injection to provide a solution containing 50 mg/mL.1 2 Bacteriostatic water for injection containing parabens should not be used.1 2 Shake vial well to ensure complete dissolution of the drug.1 2

The appropriate dose of reconstituted solution should then be withdrawn from the vial and diluted in 50–250 (usually 100) mL of a compatible IV infusion solution.1 2 8 For use in fluid-restricted patients, the appropriate dose of reconstituted solution may be diluted to a concentration ≤10 mg/mL; use of more concentrated solutions is not recommended.1 2 8 191

Rate of Administration

Administer by slow IV infusion over 1 hour, either via a large peripheral or central vein,4 190 at a constant rate of administration.1 2

For highly concentrated solutions (e.g., 5–10 mg/mL), a controlled-infusion device (e.g., pump) is recommended.8 262

Dosage

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

Because the risk of toxicity may be increased with higher doses and/or more rapid infusion,1 2 recommended doses, frequencies of administration, and rate of IV infusion should not be exceeded.1 2

Pediatric Patients

Cytomegalovirus (CMV) Infections
Treatment of CMV Retinitis
Oral

Maintenance therapy in children >3 months of age: after an initial IV induction regimen, 1 g 3 times daily.1 191 Alternatively, 500 mg 6 times daily (every 3 hours while awake).1 191

IV

Initial induction therapy in children >3 months of age: 5 mg/kg every 12 hours for 14–21 days.1 191

Maintenance treatment in children >3 months of age: 5 mg/kg once daily.1 2 5 20 191 216 268 Alternatively, 6 mg/kg once daily 5 days weekly.1 2 71 106 191 262 268

Primary Prevention (Primary Prophylaxis) of CMV in HIV-infected Children and Adolescents
Oral

Infants and children: 30 mg/kg 3 times daily.317

Adolescents: 1 g 3 times daily.317

Prevention of Recurrence (Secondary Prophylaxis) of CMV in HIV-infected Children and Adolescents
Oral

1 g 3 times daily.317 Initiate secondary prophylaxis after initial induction treatment.317

IV

Infants and children: 5 mg/kg daily.317

Adolescents: 5–6 mg/kg once daily 5–7 days each week.317

Consideration can be given to discontinuing secondary CMV prophylaxis in adolescents with sustained (e.g., for ≥6 months) increase in CD4+ T-cell counts to >100–150/mm3 in response to potent antiretroviral therapy.317 This decision should be made in consultation with an ophthalmologist and factors such as the magnitude and duration of CD4+ T-cell increase, anatomic location of the retinal lesion, vision in the contralateral eye, and feasibility of regular ophthalmic monitoring should be considered.317 Relapse of CMV retinitis could occur following discontinuance of secondary prophylaxis, especially in those whose CD4+ T-cell count decreases to <50/mm3; relapse has been reported rarely in those with CD4+ T-cell counts >100/mm3.317

Reinitiate secondary CMV prophylaxis if CD4+ T-cell count decreases to <100–150/mm3.317

Adults

Cytomegalovirus (CMV) Infections
Treatment of CMV Retinitis
Oral

Maintenance therapy after an initial IV induction regimen: 1 g 3 times daily.1 Alternatively, 500 mg 6 times daily (every 3 hours while awake).1

IV

Initial induction therapy: 5 mg/kg every 12 hours for 14–21 days.1 191

Maintenance therapy: 5 mg/kg once daily.1 2 5 20 191 216 268 Alternatively, 6 mg/kg once daily 5 days weekly.1 2 71 106 191 262 268

Primary Prevention (Primary Prophylaxis) of CMV in HIV-infected Adults
Oral

1 g 3 times daily.1 317

Prevention of Recurrence (Secondary Prophylaxis) of CMV in HIV-infected Adults
Oral

1 g 3 times daily.317 Initiate secondary prophylaxis after initial induction treatment.317

IV

5–6 mg/kg once daily 5–7 days each week.317

Consideration can be given to discontinuing secondary CMV prophylaxis in adults with sustained (e.g., for ≥6 months) increase in CD4+ T-cell counts to >100–150/mm3 in response to potent antiretroviral therapy.317 This decision should be made in consultation with an ophthalmologist and factors such as the magnitude and duration of CD4+ T-cell increase, anatomic location of the retinal lesion, vision in the contralateral eye, and feasibility of regular ophthalmic monitoring should be considered.317 Relapse of CMV retinitis could occur following discontinuance of secondary prophylaxis, especially in those whose CD4+ T-cell count decreases to <50/mm3; relapse has been reported rarely in those with CD4+ T-cell counts >100/mm3.317

Reinitiate secondary CMV prophylaxis if CD4+ T-cell count decreases to <100–150/mm3.317

Prevention of CMV Disease in Transplant Recipients
Oral

1 g 3 times daily.1

IV

Initially, 5 mg/kg every 12 hours for 7–14 days, then 5 mg/kg once daily 7 days per week or 6 mg/kg once daily 5 days per week.1

Duration of ganciclovir maintenance in organ transplant recipients depends on several factors including the duration and degree of immunosuppression.1 283 302 303 Bone marrow allograft recipients have received IV ganciclovir for up to 100–120 days following transplantation.1 271 284 In cardiac allograft recipients, ganciclovir should be continued for >28 days in patients to prevent late development of CMV disease.1 283 Liver transplant recipients have received oral ganciclovir for up to 98 days following transplantation.1 325

Special Populations

Renal Impairment

In patients with impaired renal function, doses and/or frequency of administration of oral or IV ganciclovir must be modified in response to the degree of impairment.1 2 5 6 9 11 28 33 191 346 Dosage should be based on the patient’s measured or estimated Clcr.1 2

IV Dosage for Adults with Renal Impairment1

Clcr (mL/min)

Induction Dosage

Maintenance Dosage

50–69

2.5 mg/kg every 12 h

2.5 mg/kg every 24 h

25–49

2.5 mg/kg every 24 h

1.25 mg/kg every 24 h

10–24

1.25 mg/kg every 24 h

0.625 mg/kg every 24

<10

1.25 mg/kg 3 times weekly, following hemodialysis

0.625 mg/kg 3 times weekly, following hemodialysis

Oral Dosage for Adults with Renal Impairment1

Clcr (mL/min)

Dosage

50–69

1.5 g once daily or 500 mg 3 times daily

25–49

1 g once daily or 500 mg 2 times daily

10–24

500 mg once daily

<10

500 mg 3 times weekly, following hemodialysis

Geriatric Patients

Select dosage with caution because of age-related decreases in renal function.1 2 (See Renal Impairment under Dosage and Administration.)

Cautions for Cytovene

Contraindications

  • Known hypersensitivity to ganciclovir or acyclovir.1 2

Warnings/Precautions

Warnings

Hematologic Effects

Hematologic toxicity, principally neutropenia (ANC <1000/mm3) and/or thrombocytopenia (platelet count <50,000/mm3) frequently occurs.1 2 3 4 8 11 21 33 75 109 110 122 133 149 172 215 248 264 265 Anemia also reported.1

Neutropenia usually develops early in treatment (e.g., during the first or second week of induction therapy),1 2 3 5 20 23 74 122 but can occur at any time.1 2 5 20 23 74

In most cases, interruption of ganciclovir therapy1 2 3 4 8 23 74 92 122 149 190 248 or a decrease in dosage2 4 6 8 140 149 190 248 will result in increased neutrophil counts, usually evident within 3–7 days; however, prolonged or irreversible neutropenia has occurred.1 2 3 4 74 92 122 174 Bacterial or fungal sepsis and subsequent death have been reported occasionally in patients with ganciclovir-induced neutropenia.1 2 3 4 74 122 174 In addition, neutropenia has recurred following reinitiation of ganciclovir therapy,1 2 3 33 occasionally even at reduced dosage.3

CBCs should be monitored frequently.1 2 20 191 279 Neutrophil and platelet counts should be performed several times weekly (every other day or 2 or 3 times weekly) during IV induction therapy and at least weekly thereafter during maintenance therapy.1 2 279 More frequent monitoring is recommended for patients who have previously experienced leukopenia with ganciclovir or another nucleoside analog or in whom neutrophil counts are <1000/mm3 prior to initiating therapy with the drug.1 2 Manufacturer suggests that daily monitoring of neutrophil counts be considered in such patients;2 others suggest that less frequent monitoring (e.g., twice weekly) may be sufficient during maintenance therapy.262 Manufacturer also recommended that neutrophil and platelet counts be monitored daily in patients undergoing hemodialysis.1 2

If neutropenia and/or thrombocytopenia occur, dosage adjustment and/or interruption of ganciclovir therapy may be necessary.1 2 3 4 5 6 8 100 102 104 105 106 122 140 149 164 189 190 191 248

Do not use if ANC is <500/mm3 or if platelet count is <25,000/mm3.1

Use with caution in patients with preexisting cytopenias or a history of cytopenic reactions to other drugs, chemicals, or radiation therapy.1 2

Mutagenic, Carcinogenic, and Teratogenic Potential

Ganciclovir has mutagenic and teratogenic potential that should be considered when weighing the benefits and risks of therapy.1

Women of childbearing potential should use effective contraception during treatment.1 In addition, men should practice barrier contraception during and for ≥90 days after treatment.1

Potential carcinogen in humans.1

Effects on Fertility

Animal studies indicate ganciclovir causes inhibition of spermatogenesis and subsequent infertility; effects were reversible at lower doses and irreversible at higher doses.1 Suppression of fertility in female animals also noted.1

Human data not available; possibility that ganciclovir at recommended doses may cause temporary or permanent inhibition of spermatogenesis.1

General Precautions

Local Reactions

Initially reconstituted ganciclovir solutions have a high pH (pH 11).1 Despite further dilution in IV fluids, phlebitis and/or pain may occur at site of IV infusion.1

To avoid local irritation, care must be taken to infuse only into veins with adequate blood flow to permit rapid dilution and distribution of the drug.1

Sodium Content

Ganciclovir sodium contains approximately 4 mEq of sodium per gram of ganciclovir.1 2 191

Specific Populations

Pregnancy

Category C.1 (See Mutagenic, Carcinogenic, and Teratogenic Potential under Cautions.)

Lactation

Distributed into milk in animals;1 3 not known whether distributed into milk in humans.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy of oral or IV ganciclovir not established in children.1

Only limited experience with IV ganciclovir in children younger than 12 years of age.1 2 157 217 Safety and efficacy in treatment of congenital or neonatal CMV infections, including retinitis, not established.1 2

Because of the drug’s potential for long-term carcinogenic and adverse reproductive effects, manufacturer warns that oral or IV ganciclovir should be used in children with extreme caution and only when potential benefits outweigh possible risks.1 2

Geriatric Use

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

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

Renal Impairment

Use with caution in patients with impaired renal function.1

Dosage adjustments necessary based on degree of renal impairment.1

Common Adverse Effects

Hematologic effects (neutropenia, thrombocytopenia, anemia);1 2 5 75 131 172 174 nervous system effects (headache, confusion);1 2 3 8 injection site reactions (inflammation, phlebitis, pain.1 2 21 122 133 215

Interactions for Cytovene

Nephrotoxic Drugs

Possible increased risk of adverse effects; use concomitantly with caution and closely monitor renal function.1

Specific Drugs

Drug

Interaction

Comments

Amphotericin B

Possible additive toxicity, including nephrotoxicity1

Use concomitantly only if potential benefits outweigh risks.1

Consider risk of nephrotoxicity in renal transplant patients.1

Antineoplastic agents (adriamycin, vinblastine, vincristine)

Possible additive toxicity1

Use concomitantly only if potential benefits outweigh risks1

Co-trimoxazole

Possible additive toxicity1

Use concomitantly only if potential benefits outweigh risks1

Dapsone

Possible additive toxicity1

Use concomitantly only if potential benefits outweigh risks1

Didanosine

Increased AUC of didanosine; no effect on ganciclovir pharmacokinetics1 347 b

Appropriate dosages for concomitant use with respect to safety and efficacy not established.b

If used concomitantly, monitor closely for didanosine toxicity.347

Flucytosine

Possible additive toxicity1

Use concomitantly only if potential benefits outweigh risks1

Foscarnet

In vitro evidence of additive or synergistic antiviral activity against CMV and HSV-2274 275 276 277 278

Imipenem

Seizures reported with concomitant use1 2 3 258

Use concomitantly only when potential benefits outweigh possible risks1 2 258

Immunosuppressive agents (azathioprine, corticosteroids, cyclosporine)

Possible increased risk of bone marrow suppression or increased risk of nephrotoxicity. No effect on cyclosporine clearance.15 19 140 188 193 202 219 262

Consider need for decreased dosage or temporary withdrawal of the immunosuppressive agent15 19 140 188 193 202 219 262

Interferons

In vitro evidence of synergistic antiviral effects against CMV, HSV-1 or -2, and varicella-zoster virus with interferons alfa and beta and, to a lesser extent, interferon gamma180 181 182 183 184 221

Pentamidine

Possible additive toxicity1

Use concomitantly only if potential benefits outweigh risks1

Probenecid

Possible increase in AUC and decrease in renal clearance of ganciclovir 1

Zidovudine

Possible pharmacokinetic interaction.1

Increased risk of hematologic toxicity.1 2 83 84 295

Concomitant use not recommended1 18 83 84 87 96 126 129 133 135 170 187 191 293 295

Cytovene Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from GI tract;3 4 8 26 58 235 peak plasma concentrations attained within 1 hour after a dose.58

Absolute bioavailability of oral ganciclovir is only 5 or 6–9% under fasting or nonfasting conditions, respectively.1

Distribution

Extent

Distribution into human body tissues and fluids has not been fully elucidated.5 9 64 262 Autopsy findings in patients who received IV ganciclovir suggest that the drug concentrates in the kidney, with substantially lower concentrations occurring in lung, liver, brain, and testes.5 9 64

Appears to have good ocular distribution following IV administration;2 5 93 104 117 distributed into aqueous and vitreous humor.3 104

Distributed into CSF following IV administration.1 2 3 4 5 9 28 59 64 68

Crosses the placenta in animals.3 Distributed into milk in animals;1 3 not known whether distributed into milk in humans.1

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 2 4 5 11 28 59 61 64 124

Elimination Route

Following oral administration, 86% of the dose is recovered in feces and 5% is recovered in urine.1

Following IV administration, approximately 90–99% of the dose is excreted unchanged in urine.1 2 3 4 5 11 28 59 61 64 124 Renal excretion appears to occur principally via glomerular filtration,1 2 3 5 11 59 124 although limited renal tubular secretion also may occur.1 2 5 59

Removed by hemodialysis.1 2 3 5 60 108 124 151

Half-life

In adults with normal renal function: half-life in the initial distribution phase averages 0.23–0.76 hours and half-life in the terminal elimination phase averages 2.53–3.6 hours.1 2 3 4 5 8 9 11 59 61 64 124 132 205 Half-life following oral administration is 4.8 hours.1

Special Populations

Plasma concentrations may be higher and elimination half-life prolonged in patients with impaired renal function.1 2 3 5 9 11 20 59 60 61 64 124 In adults with moderate to severe renal impairment (Clcr <50 mL/minute per 1.73 m2), terminal half-life ranges from 4.4–30 hours, depending on degree of impairment.1 2 3 11 60 61 64 124

Stability

Storage

Oral

Capsules

5–25°C.1

Parenteral

Powder for IV Infusion

Room temperature <40°C.1

Following reconstitution with sterile water for injection, solutions containing 50 mg /mL are stable for 12 hours at 15–30°C and should not be refrigerated1 2 since a precipitate may form.263

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

Amphotericin B cholesteryl sulfate complex

Anidulafungin

Caspofungin acetate

Docetaxel

Doxorubicin HCl liposome injection

Enalaprilat

Etoposide phosphate

Filgrastim

Fluconazole

Granisetron HCl

Linezolid

Melphalan HCl

Paclitaxel

Pemetrexed disodium

Propofol

Remifentanil HCl

Teniposide

Thiotepa

Incompatible

Aldesleukin

Amifostine

Aztreonam

Fludarabine phosphate

Foscarnet sodium

Gemcitabine HCl

Ondansetron HCl

Piperacillin sodium–tazobactam sodium

Sargramostim

Tacrolimus

Vinorelbine tartrate

Variable

Cisatracurium besylate

Actions and Spectrum

  • Purine nucleoside analog structurally and pharmacologically related to acyclovir.1 2 3 5 23 52 54 112

  • Inactive until converted intracellularly to ganciclovir triphosphate.1 2 3 36 98 112 113

  • Ganciclovir triphosphate inhibits viral DNA synthesis and viral replication by incorporating into viral DNA chains1 2 8 9 57 58 99 113 133 206 209 and competitively inhibiting viral DNA polymerase.2 195

  • Active in vitro and in vivo against various Herpesviridae,1 2 3 21 152 209 221 232 including human cytomegalovirus (CMV), herpes simplex virus types 1 and 2 (HSV-1 and HSV-2),1 2 3 11 12 37 46 78 79 80 81 89 97 161 163 209 222 human herpesvirus type 6232 (the presumed causative agent of roseola),233 Epstein-Barr virus (EBV),1 2 3 11 12 37 89 97 161 169 209 222 and varicella-zoster virus (VZV).1 2 3 11 12 37 89 97 161 209 221

  • More active than acyclovir against CMV,4 8 16 22 57 112 210 but has activity similar to that of acyclovir against susceptible HSV.4 8 9 40 42 54 55 89 97 186

  • Some CMV with in vitro resistance to ganciclovir may be susceptible to foscarnet,290 291 but some strains may be resistant to both drugs.292

Advice to Patients

  • Advise patients being treated for CMV retinitis that ganciclovir is not a cure; they may continue to experience progression and/or recurrence, especially during periods of continued immunosuppression.1 2 Regular ophthalmologic examinations (minimum every 4–6 weeks) are necessary; some patients may require more frequent follow-up.1

  • Advise transplant recipients regarding the high frequency of impaired renal function reported in transplant recipients who receive ganciclovir, especially those receiving concomitant therapy with a nephrotoxic drug (e.g., cyclosporine, amphotericin B).1 2

  • All patients should be informed that the major toxicities of ganciclovir are granulocytopenia (neutropenia), thrombocytopenia, and anemia and of the need for frequent blood tests to closely monitor blood cell counts.1 2

  • Advise patients that ganciclovir causes tumors in animal and that the drug is considered a potential carcinogen in humans.1 2

  • Advise male patients that ganciclovir has caused decreased sperm production in animals and may cause infertility in humans.1 2 191 In addition, because of the mutagenic potential of ganciclovir, advise male patients to employ barrier contraceptive methods during and for ≥90 days after therapy with the drug.1 191 262

  • Advise female patients that ganciclovir causes birth defects in animals and should not be used during pregnancy.1 Because of the mutagenic potential of ganciclovir, advise female patients of childbearing potential to use effective contraception during treatment with the drug.1 2 191

  • Importance of taking capsules with food to maximize bioavailability.1

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (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

Oral

Capsules

250 mg*

Cytovene

Roche

Ganciclovir Capsules

500 mg*

Cytovene

Roche

Ganciclovir Capsules

Ganciclovir Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for iv infusion only

500 mg (of ganciclovir)

Cytovene-iv

Roche

AHFS DI Essentials. © Copyright 2018, Selected Revisions July 9, 2013. 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. Roche. Cytovene-IV (ganciclovir sodium for injection) and Cytovene (ganciclovir capsules) prescribing information. Nutley, NJ; 2000 Sep.

2. Syntex Laboratories, Inc. Cytovene (ganciclovir sodium) product monograph. Palo Alto, CA; 1989 Jul.

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. Glatt AE, Chirgwin K, Landesman SH. Treatment of infections associated with human immunodeficiency virus. N Engl J Med. 1988; 318:1439-48. http://www.ncbi.nlm.nih.gov/pubmed/3285211?dopt=AbstractPlus

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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