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Ganciclovir (systemic): Drug information

Ganciclovir (systemic): Drug information
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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: Canada
  • Cytovene
Pharmacologic Category
  • Antiviral Agent
Dosing: Adult

Dosage guidance: Safety: 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, mild to moderate disease, treatment

Cytomegalovirus, mild to moderate disease, treatment (off-label use):

Note: Reserve use for patients who are immunocompromised with nonsevere symptoms without tissue-invasive disease and questionable GI absorption or concern for rapidly progressive infection (Ref).

IV: 5 mg/kg every 12 hours at least until cytomegalovirus viral load is undetectable for 1 or 2 consecutive weeks and symptoms are resolved (minimum treatment course: 2 weeks) (Ref). May obtain CMV viral load after treatment to monitor for relapse (Ref).

Cytomegalovirus, nonretinitis tissue-invasive disease, treatment

Cytomegalovirus, nonretinitis tissue-invasive disease (eg, colitis, esophagitis, pneumonitis, neurological disease), treatment (off-label use): IV: 5 mg/kg every 12 hours; duration is at least 2 to 3 weeks and often longer depending on site and severity of infection, type of immunocompromise, and clinical and virologic response (Ref). For neurological disease, consider use in combination with foscarnet until symptoms improve (Ref).

Cytomegalovirus, resistant virus, treatment

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

Note: Some experts reserve for low-level (UL97 mutation for <2 × ganciclovir EC50) ganciclovir resistance (Ref).

IV: 10 mg/kg every 12 hours. Duration depends on clinical and virologic response; if no improvement, switch to a different agent (Ref).

Cytomegalovirus retinitis, treatment

Cytomegalovirus retinitis, treatment:

Induction therapy: Note: For immediate sight-threatening lesions (adjacent to the optic nerve or fovea), use intravitreal therapy in combination with systemic therapy (Ref).

Intravitreal (off-label route): 2 to 2.5 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 (alternative systemic agent): 5 mg/kg every 12 hours for 14 to 21 days followed by maintenance therapy (Ref). Note: Reserve for patients unable to tolerate oral therapy (Ref).

Chronic maintenance therapy (secondary prophylaxis) (alternative agent): IV: 5 mg/kg once daily (7 days/week) or 6 mg/kg once daily (5 days/week). For patients with HIV, continue ≥3 to 6 months until CD4 count steadily >100 cells/mm3 on antiretroviral therapy and all lesions are inactive; for transplant recipients, duration varies depending on response and immunosuppression, discontinue only after consultation with an ophthalmologist (Ref).

Cytomegalovirus, transplant recipients, preemptive therapy

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

Note: The choice between prophylaxis and preemptive therapy to prevent cytomegalovirus (CMV) disease in transplant recipients depends on transplant type, recipient/donor CMV serostatus, other CMV-risk factors, and transplant center. Most experts reserve preemptive therapy for hematopoietic cell transplant recipients and low-risk solid organ transplant recipients. The viral threshold for initiation varies by institution (Ref).

IV: 5 mg/kg twice daily until viral load undetectable (Ref); for hematopoietic cell transplant recipients, may switch to 5 mg/kg once daily after at least 1 to 2 weeks of induction therapy and substantial viral load reduction, then continue until undetectable (Ref).

Cytomegalovirus, transplant recipients, prophylaxis

Cytomegalovirus, transplant recipients, prophylaxis (alternative agent):

Note: The choice between prophylaxis and preemptive therapy to prevent cytomegalovirus (CMV) disease in transplant recipients depends on transplant type, recipient/donor CMV serostatus, other CMV-risk factors, and transplant center (Ref).

Allogeneic hematopoietic cell transplant recipients: Note: If prophylaxis is used for hematopoietic cell transplant recipients, experts recommend other agents (Ref). IV: 5 mg/kg every 12 hours for ~7 days, then 5 mg/kg every 24 hours until day ~100 post-transplant (Ref) or 5 mg/kg every 24 hours from day −8 to day −2 followed by high dose valacyclovir post-transplant (Ref).

Solid organ transplant recipients: Note: Experts recommend other agents (Ref), although in some circumstances, ganciclovir is used in the immediate post-transplant period before transitioning to an oral agent (Ref). IV: 5 mg/kg every 24 hours; duration of prophylaxis is dependent on type of transplant, as well as donor and recipient cytomegalovirus (CMV) serostatus (Ref).

Varicella zoster virus

Varicella zoster virus (off-label use):

Acute retinal necrosis (adjunctive agent): Intravitreal (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 (off-label route): 2 mg in 0.05 mL of an extemporaneously prepared solution administered as an intravitreal injection twice weekly in combination with systemic antiviral therapy (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: Liver 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: Liver 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.

Solution, Intravenous [preservative free]:

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

Solution Reconstituted, Intravenous [preservative free]:

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): $52.80 - $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 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. Note: If using premixed bag, gently shake bag prior to administration to redissolve any crystals that may have formed; solution must be clear of crystals at time of use.

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

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 1]).

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 2023; NIOSH 2024; 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, transplant recipients, prophylaxis: Prevention of cytomegalovirus (CMV) disease in adult transplant recipients at risk for CMV disease.

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

Use: Off-Label: Adult

Cytomegalovirus, mild to moderate disease, treatment; Cytomegalovirus, nonretinitis tissue-invasive disease (eg, colitis, esophagitis, pneumonitis, neurological disease), treatment; Cytomegalovirus, resistant virus, treatment; Cytomegalovirus, transplant recipients, preemptive therapy; 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 MATE1/2-K, 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 increase nephrotoxic effects of Amphotericin B. Risk C: Monitor

Cladribine: Agents that Undergo Intracellular Phosphorylation may decrease therapeutic effects of Cladribine. Risk X: Avoid

CycloSPORINE (Systemic): Ganciclovir-Valganciclovir may increase nephrotoxic effects of CycloSPORINE (Systemic). Risk C: Monitor

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

Fexinidazole: May increase 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 increase adverse/toxic effects 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 serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor

Maribavir: May decrease therapeutic effects of Ganciclovir-Valganciclovir. Risk X: Avoid

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

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

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

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

Tacrolimus (Systemic): Ganciclovir (Systemic) may increase nephrotoxic effects of Tacrolimus (Systemic). Risk C: Monitor

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

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

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

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

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

Zidovudine: Ganciclovir-Valganciclovir may increase adverse/toxic effects of Zidovudine. Specifically, hematologic toxicity may be enhanced. Risk C: Monitor

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 data 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) are 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] 2024).

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.

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;
  • (HK) Hong Kong: Ganciclovir;
  • (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
  1. Acosta EP, Brundage RC, King JR, et al. Ganciclovir population pharmacokinetics in neonates following intravenous administration of ganciclovir and oral administration of a liquid valganciclovir formulation. Clin Pharmacol Ther. 2007;81(6):867-872. doi:10.1038/sj.clpt.6100150 [PubMed 17392728]
  2. American Academy of Pediatrics (AAP). In: Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH, eds. Red Book: 2021 Report of the Committee on Infectious Diseases. 32nd ed. American Academy of Pediatrics; 2021.
  3. Amir J, Wolf DG, Levy I. Treatment of Symptomatic Congenital Cytomegalovirus Infection With Intravenous Ganciclovir Followed by Long-Term Oral Valganciclovir. Eur J Pediatr. 2010;169(9):1061-1067. [PubMed 20232081]
  4. Aronoff GR, Bennett WM, Berns JS, et al. Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children, 5th ed. Philadelphia, PA: American College of Physicians; 2007.
  5. Asberg A, Humar A, Rollag H, et al; VICTOR Study Group. Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant. 2007;7(9):2106-2113. doi:10.1111/j.1600-6143.2007.01910.x [PubMed 17640310]
  6. Bergin S, Ferguson W, Corcoran S, et al. Symptomatic primary cytomegalovirus infection in a HIV-positive pregnant woman. Int J STD AIDS. 2014;25(14):1041-1043. doi:10.1177/0956462414528314 [PubMed 24648317]
  7. Bradley JS, Nelson JD, Barnett ED, et al, eds. Nelson's Pediatric Microbial Therapy. 27th ed. American Academy of Pediatrics; 2021.
  8. Brandy RC, Schleiss MR, Witte DP, Siddiqi TA, Fame PT. Placental transfer of ganciclovir in a woman with acquired immunodeficiency syndrome and cytomegalovirus disease. Pediatr Infect Dis J. 2002;21(8):796-797. doi:10.1097/00006454-200208000-00023 [PubMed 12233717]
  9. Caldés A, Colom H, Armendariz Y, et al. Population pharmacokinetics of ganciclovir after intravenous ganciclovir and oral valganciclovir administration in solid organ transplant patients infected with cytomegalovirus. Antimicrob Agents Chemother. 2009;53(11):4816-4824. doi:10.1128/AAC.00085-09 [PubMed 19738014]
  10. Cheng YC, Kang EY, Hwang YS, Hsiao CH. Treatment of cytomegalovirus anterior segment infection with intravitreal injection of ganciclovir in adjunction with or without oral valganciclovir: a long-term results. Sci Rep. 2021;11(1):3105. doi:10.1038/s41598-021-82637-y [PubMed 33542372]
  11. Choopong P, Vivittaworn K, Konlakij D, Thoongsuwan S, Pituksung A, Tesavibul N. Treatment outcomes of reduced-dose intravitreal ganciclovir for cytomegalovirus retinitis. BMC Infect Dis. 2016;16:164. doi:10.1186/s12879-016-1490-6 [PubMed 27090644]
  12. Dong Q, Leroux S, Shi HY, et al. Pilot study of model-based dosage individualization of ganciclovir in neonates and young infants with congenital cytomegalovirus infection. Antimicrob Agents Chemother. 2018;62(5):e00075-18. doi: 10.1128/AAC.00075-18 [PubMed 29507070]
  13. Doss KM, Kling CE, Heldman MR, et al. Real-world effectiveness of preemptive therapy (PET) for cytomegalovirus (CMV) disease prevention in CMV high-risk donor seropositive/recipient seronegative (D+R-) liver transplant recipients (LTxR). Transpl Infect Dis. 2023;25(2):e14015. doi:10.1111/tid.14015 [PubMed 36734631]
  14. Expert opinion. Senior Obesity Editorial Team: Jeffrey F. Barletta, PharmD, FCCM; Manjunath P. Pai, PharmD, FCP; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC.
  15. Expert opinion. Senior Renal Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
  16. Fletcher C, Sawchuk R, Chinnock B, et al. Human Pharmacokinetics of the Antiviral Drug DHPG. Clin Pharmacol Ther. 1986;40(3):281-286. [PubMed 3017630]
  17. Ganciclovir premixed solution [prescribing information]. Lenoir, NC: Exela Pharma Sciences; September 2017.
  18. Ganciclovir sodium 500 mg/2 mL vial [prescribing information]. Schaumburg, IL: Sagent Pharmaceuticals; August 2019.
  19. Ganciclovir sodium lyophilized powder [prescribing information]. Berkeley Heights, NJ: Hikma Pharmaceuticals USA Inc; February 2021.
  20. Gando S, Kameue T, Nanzaki S, et al. Pharmacokinetics and Clearance of Ganciclovir During Continuous Hemodiafiltration. Crit Care Med. 1998;26(1):184-187. [PubMed 9428565]
  21. Goodrich JM, Bowden RA, Fisher L, et al. Ganciclovir Prophylaxis to Prevent Cytomegalovirus Disease After Allogeneic Marrow Transplant. Ann Intern Med. 1993;118(3):173-178. [PubMed 8380242]
  22. Gore DM, Gore SK, Visser L. Progressive outer retinal necrosis: outcomes in the intravitreal era. Arch Ophthalmol. 2012;130(6):700-706. doi:10.1001/archophthalmol.2011.2622 [PubMed 22801826]
  23. Gudnason T, Belani KK, Balfour HH Jr. Ganciclovir Treatment of Cytomegalovirus Disease in Immunocompromised Children. Pediatr Infect Dis J. 1989;8(7):436-440. [PubMed 2547191]
  24. Hakki M, Aitken SL, Danziger-Isakov L, et al. American Society for Transplantation and Cellular Therapy Series: #3-prevention of cytomegalovirus infection and disease after hematopoietic cell transplantation. Transplant Cell Ther. 2021;27(9):707-719. doi:10.1016/j.jtct.2021.05.001 [PubMed 34452721]
  25. Heintz BH, Matzke GR, Dager WE. Antimicrobial Dosing Concepts and Recommendations for Critically Ill Adult Patients Receiving Continuous Renal Replacement Therapy or Intermittent Hemodialysis. Pharmacotherapy. 2009;29(5):562-577. [PubMed 19397464]
  26. Ho SA, Slavin M, Roberts JA, Yong M. Optimization of ganciclovir use in allogeneic hematopoietic cell transplant recipients - the role of therapeutic drug monitoring. Expert Rev Anti Infect Ther. 2021;19(6):707-718. doi:10.1080/14787210.2021.1851193 [PubMed 33201745]
  27. Hodson L, Ovesen J, Couch J, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Managing hazardous drug exposures: information for healthcare settings, 2023. https://doi.org/10.26616/NIOSHPUB2023130. Updated April 2023. Accessed December 27, 2024.
  28. Horvatits T, Kitzberger R, Drolz A, et al. Pharmacokinetics of ganciclovir during continuous venovenous hemodiafiltration in critically ill patients. Antimicrob Agents Chemother. 2014;58(1):94-101. doi:10.1128/AAC.00892-13 [PubMed 24145543]
  29. Jacobson MA. Treatment of AIDS-related cytomegalovirus retinitis. Connor RF, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 6, 2024.
  30. Khoury JA, Storch GA, Bohl DL, et al. Prophylactic versus preemptive oral valganciclovir for the management of cytomegalovirus infection in adult renal transplant recipients. Am J Transplant. 2006;6(9):2134-2143. doi:10.1111/j.1600-6143.2006.01413.x [PubMed 16780548]
  31. Kimberlin DW, Jester PM, Sánchez PJ, et al. Valganciclovir for symptomatic congenital cytomegalovirus disease. N Engl J Med. 2015;372(10):933-943. doi:10.1056/NEJMoa1404599 [PubMed 25738669]
  32. Kitayama S, Makino T, Fujita K, et al. Ganciclovir-induced drug reaction with eosinophilia and systemic symptoms. Skin Health Dis. 2023;3(5):e269. doi:10.1002/ski2.269 [PubMed 37799364]
  33. Kotton CN, Kumar D, Caliendo AM, et al. The Third International Consensus Guidelines on the management of cytomegalovirus in solid-organ transplantation. Transplantation. 2018;102(6):900-931. doi:10.1097/TP.0000000000002191 [PubMed 29596116]
  34. Krens SD, Hodiamont CJ, Juffermans NP, Mathôt RAA, van Hest RM. Population pharmacokinetics of ganciclovir in critically ill patients. Ther Drug Monit. 2020;42(2):295-301. doi:10.1097/FTD.0000000000000689 [PubMed 31425489]
  35. Lake KD, Fletcher CV, Love KR, et al. Ganciclovir pharmacokinetics during renal impairment. Antimicrob Agents Chemother. 1988;32(12):1899-1900. doi:10.1128/AAC.32.12.1899 [PubMed 2854457]
  36. Lalezary M, Recchia FM, Kim SJ. Treatment of congenital cytomegalovirus retinitis with intravitreous ganciclovir. Arch Ophthalmol. 2012;130(4):525-527. doi:10.1001/archophthalmol.2011.1615 [PubMed 22491927]
  37. Li L, Li X, Xia Y, et al. Recommendation of antimicrobial dosing optimization during continuous renal replacement therapy. Front Pharmacol. 2020;11:786. doi:10.3389/fphar.2020.00786 [PubMed 32547394]
  38. Marsico C, Aban I, Kuo H, et al. Blood viral load in symptomatic congenital cytomegalovirus infection. J Infect Dis. 2019;219(9):1398-1406. doi:10.1093/infdis/jiy695 [PubMed 30535363]
  39. Matthews T, Boehme R. Antiviral Activity and Mechanism of Action of Ganciclovir. Rev Infect Dis. 1988;10(suppl 3):490-494.
  40. McGloughlin S, Roberts JA, O'Donoghue S, Martin J, Briscoe S, Lipman J. Ganciclovir pharmacokinetics and suggested dosing in continuous venovenous haemodiafiltration. Int J Antimicrob Agents. 2011;37(1):90-92. doi:10.1016/j.ijantimicag.2010.10.003 [PubMed 21075610]
  41. Merigan TC, Renlund DG, Keay S, et al. A Controlled Trial of Ganciclovir to Prevent Cytomegalovirus Disease After Heart Transplantation. N Engl J Med. 1992;326(18):1182-1186. [PubMed 1313549]
  42. Milano F, Pergam SA, Xie H, et al. Intensive strategy to prevent CMV disease in seropositive umbilical cord blood transplant recipients. Blood. 2011;118(20):5689-5696. doi:10.1182/blood-2011-06-361618 [PubMed 21937692]
  43. Miller BW, Howard TK, Goss JA, Mostello DJ, Holcomb WL Jr, Brennan DC. Renal transplantation one week after conception. Transplantation. 1995;60(11):1353-1354. [PubMed 8525535]
  44. Möhlmann MC, Stiksma J, Kramer MH. Ganciclovir-induced ataxia and encephalopathy. Neth J Med. 2016;74(10):449-450. [PubMed 27966439]
  45. Morlet N, Young S, Naidoo D, Fong T, Coroneo MT. High dose intravitreal ganciclovir for CMV retinitis: a shelf life and cost comparison study. Br J Ophthalmol. 1995;79(8):753-755. doi:10.1136/bjo.79.8.753 [PubMed 7547787]
  46. Mylonakis E, Kallas WM, Fishman JA. Combination antiviral therapy for ganciclovir-resistant cytomegalovirus infection in solid-organ transplant recipients. Clin Infect Dis 2002;34(10):1337-1341. [PubMed 11981729]
  47. Nicastro E, Giovannozzi S, Stroppa P, et al. Effectiveness of preemptive therapy for cytomegalovirus disease in pediatric liver transplantation. Transplantation. 2017;101(4):804-810. doi:10.1097/TP.0000000000001531 [PubMed 27755504]
  48. Nunez-Nunez M, Bellapart J, O'Donoghue S, et al. Variable ganciclovir concentrations in a critically ill patient receiving continuous renal replacement therapy and plasma exchange? Int J Antimicrob Agents. 2014;43(6):572-573. doi:10.1016/j.ijantimicag.2014.03.001 [PubMed 24853257]
  49. Osterholm EA, Schleiss MR. Impact of breast milk-acquired cytomegalovirus infection in premature infants: pathogenesis, prevention, and clinical consequences? Rev Med Virol. 2020;30(6):1-11. doi:10.1002/rmv.2117 [PubMed 32662174]
  50. Ovesen JL, Sammons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
  51. Padullés A, Colom H, Bestard O, et al. Contribution of population pharmacokinetics to dose optimization of ganciclovir-valganciclovir in solid-organ transplant patients. Antimicrob Agents Chemother. 2016;60(4):1992-2002. doi:10.1128/AAC.02130-15 [PubMed 26824942]
  52. Pescovitz MD. Absence of teratogenicity of oral ganciclovir used during early pregnancy in a liver transplant recipient. Transplantation. 1999;67(5):758-759. doi:10.1097/00007890-199903150-00021 [PubMed 10096536]
  53. Puliyanda DP, Silverman NS, Lehman D, et al. Successful use of oral ganciclovir for the treatment of intrauterine cytomegalovirus infection in a renal allograft recipient. Transpl Infect Dis. 2005;7(2):71-74. doi:10.1111/j.1399-3062.2005.00089.x. [PubMed 16150094]
  54. Razonable RR, Humar A. Cytomegalovirus in solid organ transplant recipients-Guidelines of the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13512. doi:10.1111/ctr.13512 [PubMed 30817026]
  55. Refer to manufacturer's labeling.
  56. Saitoh A, Sakamoto S, Fukuda A, et al. A universal preemptive therapy for cytomegalovirus infections in children after live-donor liver transplantation. Transplantation. 2011;92(8):930-935. doi:10.1097/TP.0b013e31822d873d [PubMed 21941226]
  57. Schleiss MR. Antiviral Therapy of Congenital Cytomegalovirus Infection. Semin Pediatr Infect Dis. 2005;16(1):50-59. [PubMed 15685150]
  58. Selby PR, Shakib S, Peake SL, et al. A systematic review of the clinical pharmacokinetics, pharmacodynamics and toxicodynamics of ganciclovir/valganciclovir in allogeneic haematopoietic stem cell transplant patients. Clin Pharmacokinet. 2021;60(6):727-739. doi:10.1007/s40262-020-00982-z [PubMed 33515202]
  59. Singh R, Singh R, Trehan A, Jain R, Bhalekar S. Cytomegalovirus retinitis in an ALL child on exclusive chemotherapy treated successfully with intravitreal ganciclovir alone. J Pediatr Hematol Oncol. 2013;35(3):e118-e119. doi: 10.1097/MPH.0b013e31827078ad [PubMed 23042013]
  60. Society for Maternal-Fetal Medicine (SMFM), Hughes BL, Gyamfi-Bannerman C. Diagnosis and antenatal management of congenital cytomegalovirus infection. Am J Obstet Gynecol. 2016;214(6):B5-B11. doi:10.1016/j.ajog.2016.02.042 [PubMed 26902990]
  61. Sommadossi JP, Bevan R, Ling T, et al. Clinical Pharmacokinetics of Ganciclovir in Patients With Normal and Impaired Renal Function. Rev Infect Dis. 1988;10(suppl 3):507-514.
  62. Stockmann C, Roberts JK, Knackstedt ED, Spigarelli MG, Sherwin CM. Clinical pharmacokinetics and pharmacodynamics of ganciclovir and valganciclovir in children with cytomegalovirus infection. Expert Opin Drug Metab Toxicol. 2015;11(2):205-219. doi:10.1517/17425255.2015.988139 [PubMed 25428442]
  63. Stockmann C, Sherwin CM, Knackstedt ED, Hersh AL, Pavia AT, Spigarelli MG. Therapeutic drug monitoring of ganciclovir treatment for cytomegalovirus infections among immunocompromised children. J Pediatric Infect Dis Soc. 2016;5(2):231-232. doi:10.1093/jpids/piw008 [PubMed 26962197]
  64. Suresh S, Lee BE, Robinson JL, Akinwumi MS, Preiksaitis JK. A risk-stratified approach to cytomegalovirus prevention in pediatric solid organ transplant recipients. Pediatr Transplant. 2016;20(7):970-980. doi:10.1111/petr.12786 [PubMed 27565955]
  65. Swan SK, Munar MY, Wigger MA, Bennett WM. Pharmacokinetics of ganciclovir in a patient undergoing hemodialysis. Am J Kidney Dis. 1991;17(1):69-72. doi:10.1016/s0272-6386(12)80253-8 [PubMed 1846060]
  66. Tice AD, Rehm SJ, Dalovisio JR, et al. Practice guidelines for outpatient parenteral antimicrobial therapy Clin Infect Dis. 2004;38(12):1651–1672. [PubMed 15227610]
  67. Tomblyn M, Chiller T, Einsele H, et al. Guidelines for preventing infectious complications among hematopoietic cell transplantation recipients: a global perspective. Biol Blood Marrow Transplant 2009;15(10):1143-1238. [PubMed 19747629]
  68. Trotman RL, Williamson JC, Shoemaker DM, et al. Antibiotic Dosing in Critically Ill Adult Patients Receiving Continuous Renal Replacement Therapy. Clin Infect Dis. 2005;41(8):1159-1166. [PubMed 16163635]
  69. Tunkel AR, Glaser CA, Bloch KC, et al. The Management of Encephalitis: Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin Infect Dis. 2008;47(3):303-327. [PubMed 18582201]
  70. United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01
  71. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf. Updated July 22, 2021. Accessed August 9, 2021.
  72. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf. Updated August 15, 2024. Accessed September 3, 2024.
  73. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for the prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children. https://clinicalinfo.hiv.gov/en/guidelines/pediatric-opportunistic-infection/whats-new. Updated March 19, 2021. Accessed May 25, 2021.
  74. Vethamuthu J, Feber J, Chretien A, Lampe D, Filler G. Unexpectedly high inter- and intrapatient variability of ganciclovir levels in children. Pediatr Transplant. 2007;11(3):301-305. doi:10.1111/j.1399-3046.2006.00669.x [PubMed 17430487]
  75. Witzke O, Nitschke M, Bartels M, et al. Valganciclovir prophylaxis versus preemptive therapy in cytomegalovirus-positive renal allograft recipients: long-term results after 7 years of a randomized clinical trial. Transplantation. 2018;102(5):876-882. doi:10.1097/TP.0000000000002024 [PubMed 29166336]
  76. Young S, Morlet N, Besen G, et al. High-dose (2000-microgram) intravitreous ganciclovir in the treatment of cytomegalovirus retinitis. Ophthalmology. 1998;105(8):1404-1410. doi:10.1016/s0161-6420(98)98020-4 [PubMed 9709750]
  77. Zamora M. Prevention of cytomegalovirus infection in lung transplant recipients. Connor RF, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 6, 2024a.
  78. Zamora M. Clinical manifestations, diagnosis, and treatment of cytomegalovirus infection in lung transplant recipients. Connor RF, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 3, 2024b.
  79. Zhang B, Fila M, Fakhoury M, et al. Pharmacokinetics and dosage individualization of ganciclovir and valganciclovir in an infant with nephrotic syndrome associated with cytomegalovirus infection. J Antimicrob Chemother. 2014;69(4):1150-1151. doi:10.1093/jac/dkt472 [PubMed 24252753]
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