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Ganciclovir (systemic): Drug information

Ganciclovir (systemic): Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Ganciclovir (systemic): Patient drug information" and "Ganciclovir (systemic): Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Hematologic toxicity:

Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported with ganciclovir.

Impairment of fertility:

Based on animal data and limited human data, ganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.

Fetal toxicity:

Based on animal data, ganciclovir has the potential to cause birth defects in humans.

Mutagenesis and carcinogenesis:

Based on animal data, ganciclovir has the potential to cause cancer in humans.

Brand Names: US
  • Cytovene [DSC]
Brand Names: Canada
  • Cytovene
Pharmacologic Category
  • Antiviral Agent
Dosing: Adult

Note: Ganciclovir is not recommended in patients with an ANC <500 cells/mm3, hemoglobin <8 g/dL, or platelet count <25,000 cells/mm3; colony stimulating factors have been shown to increase neutrophil and white blood cell counts in patients receiving ganciclovir.

Cytomegalovirus, preemptive therapy in hematopoietic cell transplant recipients

Cytomegalovirus, preemptive therapy in hematopoietic cell transplant recipients (off-label use):

<100 days post-transplant: IV: 5 mg/kg/dose every 12 hours for 7 days (autologous transplant) or 7 to 14 days (allogenic transplant), then 5 mg/kg/dose every 24 hours for 1 to 2 weeks or until the indicator test is negative (minimum total induction and maintenance treatment is 2 weeks when 14 days of twice daily is used and 3 weeks when a 7-day induction course is used) (Ref).

>100 days post-transplant: IV: 5 mg/kg/dose every 12 hours for 7 to 14 days, then 5 mg/kg/dose every 24 hours for 1 to 2 weeks or until the indicator test is negative (Ref).

Cytomegalovirus, prophylaxis in transplant recipients

Cytomegalovirus, prophylaxis in transplant recipients:

Allogeneic hematopoietic cell transplant recipients: IV: 5 mg/kg/dose every 12 hours for 5 to 7 days, then 5 mg/kg/dose every 24 hours until day 100 post-transplant (Ref).

Solid organ transplant recipients: IV: 5 mg/kg/dose every 24 hours; duration of prophylaxis is dependent on type of transplant, as well as donor and recipient cytomegalovirus (CMV) serostatus (Ref).

Cytomegalovirus, treatment, other tissue-invasive disease

Cytomegalovirus, treatment, other tissue-invasive disease (eg, colitis, esophagitis, pneumonitis, neurological disease) (off-label use): IV: 5 mg/kg/dose every 12 hours; duration varies based on site and severity of infection, type of immunocompromise, and clinical response (Ref). For neurological disease, use in combination with foscarnet until symptoms improve (Ref).

Cytomegalovirus, treatment, resistant virus

Cytomegalovirus, treatment, resistant virus (off-label use):

UL97 mutation for <5x ganciclovir EC50: IV: 10 mg/kg/dose every 12 hours (Ref).

Ganciclovir-resistant strains: IV: 5 mg/kg/dose every 24 hours in combination with daily foscarnet and monthly CMV hyperimmunoglobulin (Ref).

Cytomegalovirus retinitis, treatment

Cytomegalovirus retinitis, treatment:

Initial therapy for immediate sight-threatening lesions (adjacent to the optic nerve or fovea):

Intravitreal injection (off-label route): 2 mg in 0.05 mL of an extemporaneously prepared solution administered as an intravitreal injection once weekly until lesion inactivity is achieved; administer in combination with a systemic antiviral (Ref).

IV: 5 mg/kg/dose every 12 hours for 14 to 21 days; for patients with HIV and high-risk solid organ transplant recipients, follow with chronic maintenance therapy (secondary prophylaxis) (Ref).

Chronic maintenance therapy (secondary prophylaxis) (alternative agent): IV: 5 mg/kg/dose once daily (7 days/week) or 6 mg/kg/dose once daily (5 days/week). For patients with HIV, continue ≥3 to 6 months until sustained CD4 count >100 cells/mm3 in response to antiretroviral therapy; discontinue only after consultation with an ophthalmologist (Ref).

Varicella zoster virus

Varicella zoster virus (off-label use):

Acute retinal necrosis (adjunctive agent): Intravitreal injection (off-label route): 2 mg in 0.05 mL of an extemporaneously prepared solution administered as an intravitreal injection twice weekly until there is evidence of clinical response; administer in combination with systemic antiviral therapy (Ref).

Progressive outer retinal necrosis:

Intravitreal injection (off-label route): 2 mg in 0.05 mL of an extemporaneously prepared solution administered as an intravitreal injection twice weekly (Ref).

IV: 5 mg/kg/dose every 12 hours plus intravitreal ganciclovir and/or intravitreal foscarnet (Ref).

Duration: Not well defined; based on clinical, virologic, and immunologic responses in consultation with an ophthalmologist (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: IV:

Ganciclovir Dose Adjustments for Altered Kidney Functiona,b,c

CrCl (mL/minute)

Induction

If the usual recommended dose is 5 mg/kg/dose every 12 hours

Maintenance

If the usual recommended dose is 5 mg/kg/dose every 24 hours

a Manufacturer's labeling

b Calculated using the Cockcroft-Gault equation

c Optimal ganciclovir pharmacokinetic/pharmacodynamic targets and dose adjustments in kidney dysfunction are not well established. A pharmacokinetic study with Monte Carlo simulations in critically ill patients with kidney impairment suggests using higher than manufacturer-recommended ganciclovir doses to attain minimum ganciclovir target trough concentrations of >1.5 mg/L (the median 50% inhibitory concentration in ganciclovir-sensitive cytomegalovirus isolates) in patients with CKD-EPI estimated GFR <50 mL/minute/1.73 m2 (Krens 2020). However, the risks and benefits of utilizing higher doses have not been evaluated; individualized therapy along with therapeutic drug monitoring are likely needed in these patients (Ho 2021).

≥70 mL/minute

No dosage adjustment necessary

No dosage adjustment necessary

50 to <70 mL/minute

2.5 mg/kg/dose every 12 hours

2.5 mg/kg/dose every 24 hours

25 to <50 mL/minute

2.5 mg/kg/dose every 24 hours

1.25 mg/kg/dose every 24 hours

10 to <25 mL/minute

1.25 mg/kg/dose every 24 hours

0.625 mg/kg/dose every 24 hours

<10 mL/minute

1.25 mg/kg/dose 3 times weekly (every 48 to 72 hours)

0.625 mg/kg/dose 3 times weekly (every 48 to 72 hours)

Hemodialysis, intermittent (thrice weekly): Dialyzable (50% to 60% using low-flux filters (Ref)):

Note: Recommended dose adjustments are based on a usual induction dose of 5 mg/kg/dose every 12 hours and a maintenance dose of 5 mg/kg/dose every 24 hours.

IV:

Induction: 1.25 mg/kg/dose 3 times weekly (after hemodialysis on dialysis days) (Ref).

Maintenance: 0.625 mg/kg/dose 3 times weekly (after hemodialysis on dialysis days) (Ref).

Peritoneal dialysis:

Note: Recommended dose adjustments are based on an induction dose of 5 mg/kg/dose every 12 hours and a maintenance dose of 5 mg/kg/dose every 24 hours.

IV:

Induction: 1.25 mg/kg/dose 3 times weekly (Ref).

Maintenance: 0.625 mg/kg/dose 3 times weekly (Ref).

CRRT: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection) and consideration of initial loading doses. Close monitoring of response and adverse reactions (eg, hematologic toxicity) due to drug accumulation is important.

Note: Recommended dose adjustments assume minimal kidney function and are based on a usual induction dose of 5 mg/kg/dose every 12 hours and a maintenance dose of 5 mg/kg/dose every 24 hours.

IV:

Induction: 2.5 mg/kg/dose every 24 hours (Ref).

Maintenance: 1.25 mg/kg/dose every 24 hours (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection) and consideration of initial loading doses. Close monitoring of response and adverse reactions (eg, hematologic toxicity) due to drug accumulation is important.

Note: Recommended dose adjustments assume minimal kidney function and are based on a usual induction dose of 5 mg/kg/dose every 12 hours and a maintenance dose of 5 mg/kg/dose every 24 hours.

IV:

Induction: 2.5 mg/kg/dose every 24 hours (when scheduled dose falls on a PIRRT day, administer after PIRRT) (Ref).

Maintenance: 1.25 mg/kg/dose every 24 hours (when scheduled dose falls on a PIRRT day, administer after PIRRT) (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Obesity: Adult

The recommendations for dosing in patients with obesity are based upon the best available evidence and clinical expertise. Senior Editorial Team: Jeffrey F. Barletta, PharmD, FCCM; Manjunath P. Pai, PharmD, FCP; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC.

Class 1, 2, and 3 Obesity (BMI ≥30 kg/m2):

IV: Use ideal body weight for weight-based dosing to avoid overdosing and subsequent toxicity (eg, hematological toxicity) (Ref). Consider the use of therapeutic drug monitoring (if available) to minimize drug toxicity (Ref).

Rationale for recommendations: There are no ganciclovir pharmacokinetic or dosing studies in patients with obesity. Available data from patients without obesity, which include wide patient weight ranges, do not statistically support weight to be an important descriptor for IV ganciclovir pharmacokinetics (Ref). This lack of pharmacokinetic data coupled with a profound hematological toxicity profile suggest a conservative approach to use ideal body weight for dose calculations in patients with obesity (Ref). Ganciclovir is primarily excreted unchanged in urine and careful attention to estimated kidney function is also essential in patients with obesity (Ref).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Ganciclovir (systemic): Pediatric drug information")

Note: Routes of administration may vary (including IV and intravitreal); use caution.

Congenital cytomegalovirus infection, symptomatic; treatment

Congenital cytomegalovirus (CMV) infection, symptomatic; treatment (continuation from neonatal period): Limited data available: Infants: IV: 6 mg/kg/dose every 12 hours; transition to oral valganciclovir (when able) to complete total treatment duration of 6 months (Ref).

Cytomegalovirus disease, treatment; immunocompromised host

Cytomegalovirus disease, treatment; immunocompromised host:

Non-HIV-exposed/-infected: Infants, Children, and Adolescents: Limited data available:

Induction therapy (initial treatment): IV: 5 mg/kg/dose every 12 hours for ≥2 to 3 weeks and until resolution of viremia and symptoms. Dose may be increased to 7.5 mg/kg/dose twice daily if response inadequate (Ref).

Chronic maintenance therapy (secondary prophylaxis), if indicated: IV: 5 mg/kg/dose as a single daily dose 5 to 7 days/week; duration dependent on degree of immunosuppression (Ref). Note: Not routinely recommended in solid organ transplant (Ref).

HIV-exposed/-infected (Ref): Infants and Children: Limited data available:

Induction therapy (initial treatment): IV: 5 mg/kg/dose every 12 hours for 14 to 21 days followed by chronic maintenance therapy; may be increased to 7.5 mg/kg/dose twice daily if response inadequate.

Chronic maintenance therapy (secondary prophylaxis): IV: 5 mg/kg/dose as a single daily dose 5 to 7 days per week; continue maintenance therapy (with ganciclovir, valganciclovir, or foscarnet as appropriate) until patient has been receiving antiretroviral therapy for ≥6 months and achieves age-specific CD4 cell count targets for at least 6 months (age <6 years: CD4 percentage ≥15%; age ≥6 years: >100 cells/mm3).

Cytomegalovirus disease, preemptive therapy; transplant recipients

Cytomegalovirus disease, preemptive therapy; transplant recipients: Limited data available: Note: Requires serial blood monitoring for CMV; therapy is initiated when a CMV positivity threshold is reached (Ref).

Hematopoietic cell transplant recipients: Infants, Children, and Adolescents:

<100 days posttransplant: IV: 5 mg/kg/dose every 12 hours for 7 days (autologous transplant) or 7 to 14 days (allogenic transplant), then 5 mg/kg/dose every 24 hours until the indicator test is negative (minimum total induction and maintenance treatment is 2 weeks when 14 days of twice-daily dosing is used and 3 weeks when a 7-day induction course is used) (Ref).

>100 days posttransplant: IV: 5 mg/kg/dose every 12 hours for 7 to 14 days, then 5 mg/kg/dose every 24 hours for 1 to 2 weeks or until the indicator test is negative (Ref).

Solid organ transplant recipients: Infants, Children, and Adolescents: IV: 5 mg/kg/dose every 12 hours; individualize duration based on CMV blood concentrations; some institutions decrease frequency to every 24 hours after 2 weeks (Ref). Note: Preemptive therapy strategy not recommended for lung transplant recipients (Ref).

Cytomegalovirus disease, prophylaxis; transplant recipients

Cytomegalovirus disease, prophylaxis; transplant recipients: Note: For patients considered at risk for CMV disease based on donor and recipient CMV serostatus:

Hematopoietic cell transplant recipients (allogeneic) Infants, Children, and Adolescents: Limited data available: IV: 5 mg/kg/dose every 12 hours for 5 to 7 days starting at neutrophil engraftment, then 5 mg/kg/dose every 24 hours until day 100 posttransplant (Ref).

Solid organ transplant recipients: Infants, Children, and Adolescents: Limited data available: IV: 5 mg/kg/dose every 24 hours; initiate therapy within 10 days after transplant. Oral valganciclovir typically preferred when appropriate. Total duration of prophylaxis varies depending on organ(s) transplanted, donor and recipient CMV serostatus, and immunosuppressive regimen; typically continued for 3 to 6 months; may be continued for up to 12 months in certain cases (Ref).

Cytomegalovirus infection, CNS; treatment

Cytomegalovirus infection, CNS; treatment: Limited data available: HIV-exposed/-infected:

Infants and Children (Ref):

Induction therapy (initial treatment): IV: 5 mg/kg/dose every 12 hours in combination with foscarnet until symptoms improve; follow with chronic maintenance therapy (secondary prophylaxis).

Chronic maintenance therapy (secondary prophylaxis): IV: 5 mg/kg/dose once daily; continue maintenance therapy (with ganciclovir, valganciclovir, or foscarnet as appropriate) until patient has been receiving antiretroviral therapy for ≥6 months and achieves CD4 cell count targets for at least 6 months (age <6 years: CD4 percentage ≥15%; age ≥6 years: >100 cells/mm3).

Adolescents: 5 mg/kg/dose every 12 hours in combination with foscarnet until symptoms improve; optimal duration not defined (Ref).

Cytomegalovirus retinitis

Cytomegalovirus retinitis (immunocompromised patients [including patients with HIV]):

IV:

Infants and Children (Ref): Limited data available:

Induction therapy (initial treatment): IV: 5 mg/kg/dose every 12 hours for 14 to 21 days followed by chronic maintenance therapy (secondary prophylaxis); may be increased to 7.5 mg/kg/dose twice daily if response inadequate.

Chronic maintenance therapy (secondary prophylaxis): IV: 5 mg/kg/dose as a single daily dose 5 to 7 days per week; for patients with HIV, continue maintenance therapy until patient has been receiving antiretroviral therapy for ≥6 months and achieves CD4 cell count targets for at least 6 months (age <6 years: CD4 percentage ≥15%; age ≥6 years: >100 cells/mm3); discontinue only after consultation with an ophthalmologist.

Adolescents (Ref): Limited data available:

Induction therapy (initial treatment): IV: 5 mg/kg/dose every 12 hours for 14 to 21 days, in combination with intravitreal therapy for immediately sight-threatening lesions, followed by chronic maintenance therapy (secondary prophylaxis).

Chronic maintenance therapy (secondary prophylaxis): IV: 5 mg/kg/dose once daily; for patients with HIV, continue for ≥3 to 6 months until sustained CD4 count >100 cells/mm3 in response to antiretroviral therapy; discontinue only after consultant with an ophthalmologist.

Intravitreal: Induction therapy (immediately sight-threatening lesions): Children ≥9 years and Adolescents: Limited data available: 2 mg of an extemporaneously prepared solution administered as an intravitreal injection weekly until lesions are inactive; administer with a concomitant systemically administered agent (Ref).

Varicella-zoster, acute retinal necrosis in patients with HIV

Varicella-zoster, acute retinal necrosis in patients with HIV: Limited data available: Intravitreal: Adolescents: 2 mg of an extemporaneously prepared solution administered as an intravitreal injection twice weekly for 1 to 2 doses in combination with appropriate IV therapy (Ref).

Varicella-zoster, progressive outer retinal necrosis in patients with HIV

Varicella-zoster, progressive outer retinal necrosis in patients with HIV: Limited data available:

IV: Infants, Children, and Adolescents: IV: 5 mg/kg/dose every 12 hours as part of an appropriate combination regimen (Ref).

Intravitreal: Infants, Children, and Adolescents: 2 mg of an extemporaneously prepared solution administered as an intravitreal injection twice weekly; administer in combination with IV therapy (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Infants, Children, and Adolescents: There are no pediatric-specific recommendations; based on experience in adult patients, dosage adjustment necessary.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

>10%:

Dermatologic: Hyperhidrosis (12%)

Gastrointestinal: Abdominal pain (≥20%), decreased appetite (14%), diarrhea (44%), nausea (≥20%), vomiting (13%)

Hematologic & oncologic: Anemia (25%), decrease in absolute neutrophil count (<500/mcL: 25%; 500 to 749/mcL: 14%; 750 to 1,000/mcL: 26%), leukopenia (41%)

Infection: Infection (13%), sepsis (15%)

Nervous system: Asthenia (≥20%), headache (≥20%)

Ophthalmic: Retinal detachment (11%)

Renal: Increased serum creatinine (1.5 to <2.5 mg/dL: 14%; ≥2.5 mg/dL: 2%)

Respiratory: Cough (≥20%), dyspnea (≥20%)

Miscellaneous: Fever (48%)

1% to 10%:

Dermatologic: Pruritus (5%)

Hematologic & oncologic: Thrombocytopenia (6%)

Nervous system: Chills (10%), peripheral neuropathy (9%)

Frequency not defined:

Cardiovascular: Cardiac arrhythmia, chest pain, edema, hypertension, hypotension, phlebitis, vasodilation

Dermatologic: Alopecia, cellulitis, dermatitis, skin rash, urticaria, xeroderma

Endocrine & metabolic: Weight loss

Gastrointestinal: Abdominal distention, constipation, dysgeusia, dyspepsia, dysphagia, eructation, flatulence, gastrointestinal perforation, oral candidiasis, oral mucosa ulcer, pancreatitis, xerostomia

Genitourinary: Hematuria, urinary frequency, urinary tract infection

Hematologic & oncologic: Bone marrow failure, pancytopenia

Hepatic: Abnormal hepatic function tests, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase

Hypersensitivity: Hypersensitivity reaction

Infection: Candidiasis, influenza

Local: Inflammation at injection site

Nervous system: Abnormal dreams, agitation, anxiety, changes in thinking, confusion, depression, dizziness, drowsiness, fatigue, hypoesthesia, insomnia, malaise, myasthenia, pain, paresthesia, psychosis, seizure, tremor

Neuromuscular & skeletal: Arthralgia, back pain, lower limb cramp, muscle spasm, myalgia

Ophthalmic: Conjunctivitis, eye disease (vitreous disorder), eye pain, macular edema, visual impairment

Otic: Deafness, otalgia, tinnitus

Renal: Altered kidney function, decreased creatinine clearance, kidney failure

Respiratory: Upper respiratory tract infection

Miscellaneous: Multi-organ failure

Postmarketing:

Cardiovascular: Cardiac conduction disorder, heart failure, peripheral ischemia, torsades de pointes, vasculitis, ventricular tachycardia

Dermatologic: Exfoliative dermatitis, Stevens-Johnson syndrome

Endocrine & metabolic: Acidosis, hypercalcemia, hyponatremia, increased serum triglycerides, SIADH

Gastrointestinal: Cholelithiasis, cholestasis, ulcerative bowel lesion

Genitourinary: Infertility, testicular hypotrophy

Hematologic & oncologic: Agranulocytosis, hemolytic anemia, hemolytic-uremic syndrome

Hepatic: Hepatic failure, hepatitis

Hypersensitivity: Anaphylaxis, drug reaction with eosinophilia and systemic symptoms (Kitayama 2023)

Nervous system: Amnesia, anosmia, aphasia, ataxia (Möhlmann 2016), bradyphrenia (Möhlmann 2016), cerebrovascular accident, cranial nerve palsy (third), dysesthesia, encephalopathy (Möhlmann 2016), extrapyramidal reaction, facial nerve paralysis, hallucination, intracranial hypertension, irritability

Neuromuscular & skeletal: Arthritis, myelopathy, rhabdomyolysis

Ophthalmic: Cataract, dry eye syndrome

Renal: Renal tubular disease

Respiratory: Bronchospasm, pulmonary fibrosis

Contraindications

Hypersensitivity to ganciclovir, valganciclovir, acyclovir, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hematologic toxicity: Neutropenia usually occurs during the first 1 to 2 weeks of treatment but may occur at any time; cell counts usually begin to recover within 3 to 7 days of treatment discontinuation. Use with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation.

• Renal toxicity: Increased serum creatinine levels have been reported in elderly patients and transplant recipients receiving concomitant nephrotoxic medications (eg, cyclosporine, amphotericin B).

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment recommended.

Special populations:

• Older adult: Increased serum creatinine levels have been reported; use with caution and closely monitor serum creatinine.

Other warnings/precautions:

• Administration: Ensure patients are adequately hydrated. Avoid rapid infusion. Phlebitis and/or pain may occur at injection site despite adequate dilution; infuse solution into veins with adequate blood flow.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous [preservative free]:

Generic: 500 mg/250 mL (250 mL); 500 mg/10 mL (10 mL)

Solution Reconstituted, Intravenous [preservative free]:

Cytovene: 500 mg (1 ea [DSC])

Generic: 500 mg (1 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Ganciclovir Intravenous)

500 mg/250 mL (per mL): $0.24

Solution (Ganciclovir Sodium Intravenous)

500 mg/10 mL (per mL): $7.20

Solution (reconstituted) (Ganciclovir Sodium Intravenous)

500 mg (per each): $82.08 - $116.72

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Cytovene: 500 mg (1 ea)

Generic: 500 mg (1 ea)

Administration: Adult

IV: For IV infusion; should not be administered by IM, SUBQ, or rapid or bolus IV injection. Administer by slow IV infusion over at least 1 hour. Too rapid infusion can cause increased toxicity due to excessive plasma levels. Flush line well with NS before and after administration.

Intravitreal (off-label route): Administer in appropriate sterile setting by health care professional experienced in administration of intravitreal ophthalmic injections. The dose is 2 mg in a volume ranging from 0.04 to 0.1 mL (Ref).

Administration: Pediatric

Follow same precautions utilized with antineoplastic agents when preparing and administering ganciclovir.

Parenteral:

IV: Administer by slow IV infusion over at least 1 hour; infusing too rapidly can cause increased toxicity due to excessive plasma levels. Flush line well with NS before and after administration. Do not administer IM or SUBQ; may cause severe tissue irritation due to high pH.

Intravitreal: Administer in appropriate sterile setting by health care professional experienced in administration of intravitreal ophthalmic injections.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 2]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Use: Labeled Indications

Cytomegalovirus, prophylaxis in transplant recipients: Prevention of cytomegalovirus (CMV) disease in adult transplant recipients at risk for CMV disease.

Cytomegalovirus, treatment, retinitis: Treatment (induction and maintenance [secondary prophylaxis]) of CMV retinitis in adults who are immunocompromised, including patients with HIV.

Use: Off-Label: Adult

Cytomegalovirus, preemptive therapy in hematopoietic cell transplant recipients; Cytomegalovirus, treatment, other tissue-invasive disease; Cytomegalovirus, treatment, resistant virus; Varicella zoster virus

Medication Safety Issues
Sound-alike/look-alike issues:

Cytovene may be confused with Cytosar, Cytosar-U

Ganciclovir may be confused with acyclovir

Metabolism/Transport Effects

Substrate of OAT1/3

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Amphotericin B: Ganciclovir-Valganciclovir may enhance the nephrotoxic effect of Amphotericin B. Risk C: Monitor therapy

Cladribine: Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. Risk X: Avoid combination

CycloSPORINE (Systemic): Ganciclovir-Valganciclovir may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Risk C: Monitor therapy

Didanosine: Ganciclovir-Valganciclovir may increase the serum concentration of Didanosine. Risk C: Monitor therapy

Fexinidazole: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Management: Avoid use of fexinidazole with OAT1/3 substrates when possible. If combined, monitor for increased OAT1/3 substrate toxicities. Risk D: Consider therapy modification

Imipenem: Ganciclovir-Valganciclovir may enhance the adverse/toxic effect of Imipenem. Specifically, the risk of seizures may be increased. Management: Avoid concomitant use of these agents unless the prospective benefits of therapy outweigh the risks. Risk D: Consider therapy modification

Leflunomide: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Maribavir: May diminish the therapeutic effect of Ganciclovir-Valganciclovir. Risk X: Avoid combination

Mycophenolate: May enhance the adverse/toxic effect of Ganciclovir-Valganciclovir. Specifically, the risk for leukopenia or neutropenia may be increased with this combination. Mycophenolate may increase the serum concentration of Ganciclovir-Valganciclovir. Risk C: Monitor therapy

Nitisinone: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Pretomanid: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Ganciclovir-Valganciclovir. Risk C: Monitor therapy

Tacrolimus (Systemic): Ganciclovir (Systemic) may enhance the nephrotoxic effect of Tacrolimus (Systemic). Risk C: Monitor therapy

Taurursodiol: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk X: Avoid combination

Tenofovir Products: May increase the serum concentration of Ganciclovir-Valganciclovir. Ganciclovir-Valganciclovir may increase the serum concentration of Tenofovir Products. Risk C: Monitor therapy

Teriflunomide: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Vaborbactam: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Vadadustat: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Zidovudine: Ganciclovir-Valganciclovir may enhance the adverse/toxic effect of Zidovudine. Specifically, hematologic toxicity may be enhanced. Risk C: Monitor therapy

Reproductive Considerations

Patients who may become pregnant should undergo pregnancy testing prior to initiation and use effective contraception during and for at least 30 days after the last dose of ganciclovir.

Male patients should use a barrier contraceptive during and for at least 90 days after ganciclovir therapy. Based on data from valganciclovir studies in renal transplant recipients, ganciclovir may cause temporary or permanent inhibition of spermatogenesis.

Pregnancy Considerations

Ganciclovir crosses the placenta.

Based on animal data, ganciclovir has the potential to cause birth defects in humans.

Outcome information following use of ganciclovir for cytomegalovirus (CMV) infection during pregnancy following a kidney or liver transplant (Miller 1995; Pescovitz 1999; Puliyanda 2005) or in pregnant patients with HIV (Bergin 2014; Brandy 2002) is limited.

Maternal CMV infection can be asymptomatic and self-limited or symptomatic. CMV infection in immunocompromised patients is associated with significant maternal morbidity and mortality. Congenital CMV infection may also occur; hearing loss, intellectual disability, microcephaly, seizures, and other medical problems have been observed in infants with congenital CMV infection.

Until additional data are available, use of ganciclovir for the treatment of congenital CMV outside of a clinical trial is not currently recommended (SMFM 2016).

The indications for treating maternal CMV retinitis during pregnancy are the same as in patients who are not pregnant with HIV. In general, intravitreous injections for local therapy are preferred for retinal disease to limit systemic exposure during the first trimester when possible. Systemic antiviral therapy should be started after the first trimester. Ganciclovir is not the preferred systemic therapy during pregnancy. Close fetal monitoring is recommended (HHS [OI adult 2022]).

Breastfeeding Considerations

It is not known if ganciclovir is present in breast milk.

Due to the potential for serious adverse reactions in the breastfeeding infant, breastfeeding is not recommended by the manufacturer. The Health and Human Services perinatal HIV guidelines do not recommend breastfeeding for patients in the United States with HIV infection when safer infant feeding options are available (HHS [perinatal] 2021).

Cytomegalovirus can also be transferred via breast milk; the risk of adverse outcomes if infection occurs is more likely in infants born <32 weeks' gestation and <1,500 g (Osterholm 2020).

Dietary Considerations

Some products may contain sodium.

Monitoring Parameters

CBC with differential at baseline and twice weekly (especially in patients with kidney impairment, history of drug-induced leukopenia, or neutrophil counts <1,000 cells/mm3 at initiation), serum creatinine at baseline and once weekly (Tice 2004); pregnancy test prior to initiation in patients who may become pregnant; frequent ophthalmological exams in patients with CMV retinitis.

Mechanism of Action

Ganciclovir is phosphorylated by viral and cellular kinases into ganciclovir triphosphate which competitively inhibits the binding of deoxyguanosine triphosphate to DNA polymerase resulting in inhibition of viral DNA synthesis.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: Children 9 months to 12 years: 0.64 ± 0.22 L/kg; Adults: 0.74 ± 0.15 L/kg; widely to all tissues including CSF and ocular tissue

Protein binding: 1% to 2%

Half-life elimination:

Neonates 2 to 49 days of age: 2.4 hours

Children 9 months to 12 years: 2.4 ± 0.7 hours

Adults: Mean: IV: 3.5 ± 0.9 hours; Oral: 4.8 ± 0.9 hours; CrCl <25 mL/minute: 10.7 ± 5.7 hours

Excretion: Urine (80% to 99% as unchanged drug)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Clearance is decreased and half-life is prolonged.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Ganciclovir richet;
  • (AU) Australia: Ganciclovir;
  • (BR) Brazil: Cymevir | Itagan;
  • (CN) China: Ai lin wei | Di du | Le fan;
  • (DE) Germany: Vitrasert;
  • (HR) Croatia: Cymevene;
  • (HU) Hungary: Cymevene;
  • (NO) Norway: Cymevene;
  • (NZ) New Zealand: Ganciclovir;
  • (PK) Pakistan: Cymevene;
  • (PR) Puerto Rico: Cytovene | Ganciclovir;
  • (QA) Qatar: Cymevene | Cymevene IV;
  • (ZA) South Africa: Cymevene
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