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Ganciclovir (Systemic)

Pronunciation

Pronunciation

(gan SYE kloe veer)

Index Terms

  • DHPG Sodium
  • Ganciclovir Sodium
  • GCV Sodium
  • Nordeoxyguanosine

Dosage Forms

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)

Brand Names: U.S.

  • Cytovene

Pharmacologic Category

  • Antiviral Agent

Pharmacology

Ganciclovir is phosphorylated to a substrate which competitively inhibits the binding of deoxyguanosine triphosphate to DNA polymerase resulting in inhibition of viral DNA synthesis

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

Excretion

Urine (80% to 99% as unchanged drug)

Half-Life Elimination

Prolonged with renal impairment

Neonates 2-49 days of age: 2.4 hours

Children 9 months to 12 years: 2.4 ± 0.7 hours

Adults: Mean: 2.5-3.6 hours (range: 1.7-5.8 hours)

Protein Binding

1% to 2%

Special Populations: Renal Function Impairment

CrCl 50 to 79 mL/min

Cl is about 128 mL/min; half-life is about 4.6 h.

CrCl 25 to 49 mL/min

Cl is approximately 57 mL/min; half-life is approximately 4.4 h.

CrCl less than 25 mL/min

Cl is approximately 30 mL/min; half-life is approximately 10.7 h.

Hemodialysis

Reduces ganciclovir by about 50% after IV administration.

Use: Labeled Indications

Treatment of CMV retinitis in immunocompromised individuals, including patients with acquired immunodeficiency syndrome; prophylaxis of CMV infection in transplant patients

Use: Unlabeled

CMV retinitis: May be given in combination with foscarnet in patients who relapse after monotherapy with either drug

Contraindications

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

Dosing: Adult

CMV retinitis:

Manufacturer's labeling:

Induction therapy: IV (slow infusion): 5 mg/kg/dose every 12 hours for 14 to 21 days followed by maintenance therapy

Maintenance therapy: IV (slow infusion): 5 mg/kg/day as a single daily dose for 7 days/week or 6 mg/kg/day for 5 days/week

Alternate dosing (HHS [OI adult 2015]):

Peripheral lesions (alternative to preferred therapy): IV: Induction: 5 mg/kg/dose every 12 hours for 14 to 21 days followed by chronic maintenance (secondary prophylaxis)

Immediate sight-threatening lesions (adjacent to the optic nerve or fovea): Intravitreal injection (off-label route): Induction therapy: 2 mg of an extemporaneously prepared solution administered as intravitreal injections for 1 to 4 doses over a period of 7 to 10 days; administer with a concomitant systemically administered agent (oral valganciclovir preferred).

CMV disease, chronic maintenance (secondary prophylaxis) in HIV-infected patients (off-label use; alternative to preferred therapy): IV: 5 mg/kg/dose 5 to 7 times weekly; continue until sustained CD4 count >100 cells/mm3 in response to ART for 3 to 6 months; discontinue only after consultation with an ophthalmologist) (HHS [OI adult 2015]).

CMV disease, prophylaxis (secondary) in transplant patients: IV (slow infusion): 5 mg/kg/dose every 12 hours for 7 to 14 days, duration of maintenance therapy is dependent on clinical condition and degree of immunosuppression

CMV esophagitis or colitis in HIV-infected patients (off-label use): IV: 5 mg/kg/dose every 12 hours, then change to oral valganciclovir therapy once oral therapy is tolerated; total duration of therapy: 21 to 42 days or until symptom resolution (HHS [OI adult 2015])

CMV neurological disease in HIV-infected patients (off-label use): IV: 5 mg/kg/dose every 12 hours plus foscarnet until symptoms improve (HHS [OI adult 2015])

Varicella-zoster: Acute retinal necrosis (ARN) in HIV-infected patients (off-label use): Intravitreal injection (off-label route): 2 mg of an extemporaneously prepared solution administered as an intravitreal injection twice weekly for 1 to 2 doses in combination with IV acyclovir for 10 to 14 days, followed by valacyclovir for 6 weeks (HHS [OI adult 2015])

Varicella-zoster: Progressive outer retinal necrosis in HIV-infected patients (off-label use): IV: 5 mg/kg/dose every 12 hours (with or without IV foscarnet) plus intravitreal ganciclovir and/or intravitreal foscarnet (HHS [OI adult 2015])

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

CMV retinitis:

Children: IV (slow infusion): Manufacturer's labeling:

Induction therapy: 5 mg/kg/dose every 12 hours for 14 to 21 days followed by maintenance therapy

Maintenance therapy: 5 mg/kg/day as a single daily dose for 7 days/week or 6 mg/kg/day for 5 days/week

Adolescents: Refer to adult dosing.

CMV disease, chronic maintenance (secondary prophylaxis) in HIV-exposed/-infected patients (off-label use):

Infants and Children: IV: 5 mg/kg/dose daily (CDC 2009)

Adolescents (alternative to preferred therapy): Refer to adult dosing.

CMV disease, prophylaxis (secondary) in transplant patients: Children: IV (slow infusion): Refer to adult dosing.

CMV esophagitis or colitis in HIV-infected patients (off-label use): Adolescents: Refer to adult dosing.

CMV neurological disease in HIV-exposed/-infected patients (off-label use): Infants, Children, and Adolescents: IV: Refer to adult dosing.

Varicella-zoster: Acute retinal necrosis (ARN) in HIV-infected patients (off-label use): Adolescents: Refer to adult dosing.

Varicella-zoster: Progressive outer retinal necrosis in HIV-exposed/-infected patients (off-label use):

Infants and Children: IV: 5 mg/kg/dose every 12 hours plus systemic foscarnet and intravitreal ganciclovir or intravitreal foscarnet (CDC 2009)

Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

IV (Induction):

CrCl 50 to 69 mL/minute: Administer 2.5 mg/kg/dose every 12 hours.

CrCl 25 to 49 mL/minute: Administer 2.5 mg/kg/dose every 24 hours.

CrCl 10 to 24 mL/minute: Administer 1.25 mg/kg/dose every 24 hours.

CrCl <10 mL/minute: Administer 1.25 mg/kg/dose 3 times/week following hemodialysis.

IV (Maintenance):

CrCl 50 to 69 mL/minute: Administer 2.5 mg/kg/dose every 24 hours.

CrCl 25 to 49 mL/minute: Administer 1.25 mg/kg/dose every 24 hours.

CrCl 10 to 24 mL/minute: Administer 0.625 mg/kg/dose every 24 hours

CrCl <10 mL/minute: Administer 0.625 mg/kg/dose 3 times/week following hemodialysis.

Intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days): Dialyzable (50%): CMV Infection: IV: Induction: 1.25 mg/kg every 48 to 72 hours; Maintenance: 0.625 mg/kg every 48 to 72 hours. Note: Dosing dependent on the assumption of 3 times/week, complete IHD sessions.

Peritoneal dialysis (PD): Dose as for CrCl <10 mL/minute.

Continuous renal replacement therapy (CRRT) (Heintz 2009; Trotman 2005): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug concentrations in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 to 2 L/hour and minimal residual renal function) and should not supersede clinical judgment: CMV Infection:

CVVH: IV: Induction: 2.5 mg/kg every 24 hours; Maintenance: 1.25 mg/kg every 24 hours

CVVHD/CVVHDF: IV: Induction: 2.5 mg/kg every 12 hours; Maintenance: 2.5 mg/kg every 24 hours

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling.

Reconstitution

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Reconstitute 500 mg vial with 10 mL unpreserved sterile water not bacteriostatic water because parabens may cause precipitation. Typically, dilute in 100 mL D5W or NS to a concentration ≤10 mg/mL for infusion.

Administration

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

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Dietary Considerations

Some products may contain sodium.

Compatibility

Stable in D5W, LR, NS; incompatible with paraben preserved bacteriostatic water for injection (may cause precipitation).

Y-site administration: Incompatible with amifostine, amsacrine, aztreonam, cefepime, cytarabine, doxorubicin, fludarabine, foscarnet, gemcitabine, ondansetron, piperacillin/tazobactam, vinorelbine.

Storage

Store intact vials at temperatures below 40°C (104°F). Reconstituted solution is stable for 12 hours at room temperature, however, conflicting data indicates that reconstituted solution is stable for 60 days under refrigeration (4°C). Stability of parenteral admixture in D5W or NS at room temperature (25°C) and at refrigeration temperature (4°C) for 35 days has been reported. However, the manufacturer recommends use within 24 hours of preparation.

Drug Interactions

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. Consider therapy modification

Mycophenolate: May increase the serum concentration of Ganciclovir-Valganciclovir. Ganciclovir-Valganciclovir may increase the serum concentration of Mycophenolate. Monitor therapy

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

Reverse Transcriptase Inhibitors (Nucleoside): Ganciclovir-Valganciclovir may enhance the adverse/toxic effect of Reverse Transcriptase Inhibitors (Nucleoside). Hematologic toxicity with zidovudine is of particular concern. Ganciclovir-Valganciclovir may increase the serum concentration of Reverse Transcriptase Inhibitors (Nucleoside). Management: Monitor patients receiving any of these combination closely for toxicity of the reverse transcriptase inhibitor. Avoid zidovudine. Intravitreal implants would not be affected. Exceptions: Stavudine. Consider therapy modification

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

Adverse Reactions

>10%:

Dermatologic: Diaphoresis (12%)

Gastrointestinal: Diarrhea (44%), anorexia (14%), vomiting (13%)

Hematologic & oncologic: Thrombocytopenia (57%), leukopenia (41%), anemia (16% to 26%), neutropenia (ANC <500/mm3: 12% to 14%)

Infection: Sepsis (15%)

Ophthalmic: Retinal detachment (11%; relationship to ganciclovir not established)

Renal: Increased serum creatinine (2% to 14%)

Miscellaneous: Fever (48%)

1% to 10%:

Central nervous system: Chills (10%), neuropathy (9%)

Dermatologic: Pruritus (5%)

<1% (Limited to important or life-threatening): Alopecia, brain disease, bronchospasm, cardiac arrhythmia, cataract, cholestasis, coma, dyspnea, edema, eosinophilia, exfoliative dermatitis, extrapyramidal reaction, hemorrhage, hepatic failure, hepatitis, hypersensitivity reaction (including anaphylaxis), pancreatitis, pancytopenia, psychosis, pulmonary fibrosis, renal failure, rhabdomyolysis, seizure, SIADH (syndrome of inappropriate antidiuretic hormone secretion), Stevens-Johnson syndrome, torsades de pointes, urticaria, vision loss

ALERT: U.S. Boxed Warning

Blood dyscrasias:

The clinical toxicity of ganciclovir IV includes granulocytopenia, anemia and thrombocytopenia. In animal studies ganciclovir was carcinogenic, teratogenic and caused aspermatogenesis.

Appropriate use:

Ganciclovir IV is indicated for use only in the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients and for the prevention of CMV disease in transplant patients at risk for CMV disease

Carcinogenic/teratogenic:

In animal studies ganciclovir was carcinogenic, teratogenic and caused aspermatogenesis

Warnings/Precautions

Concerns related to adverse effects:

• Blood dyscrasias: [US Boxed Warning]: Granulocytopenia (neutropenia), anemia, and thrombocytopenia may occur. Dosage adjustment or interruption of therapy may be necessary in patients with neutropenia and/or thrombocytopenia.

• Carcinogenic/teratogenic: [US Boxed Warning]: Animal studies have demonstrated carcinogenic and teratogenic effects, and inhibition of spermatogenesis; contraceptive precautions for female and male patients need to be followed during and for at least 90 days after therapy with the drug.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment or interruption of therapy may be necessary.

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Other warnings/precautions:

• Administration: Take care to administer only into veins with good blood flow.

• Appropriate use: [US Boxed Warning]: Indicated only for treatment of CMV retinitis in the immunocompromised patient and CMV prevention in transplant patients at risk.

Monitoring Parameters

CBC with differential and platelet count, serum creatinine

Pregnancy Risk Factor

C

Pregnancy Considerations

[U.S. Boxed Warning]: Animal studies have demonstrated carcinogenic and teratogenic effects, and inhibition of spermatogenesis. Female patients should use effective contraception during therapy; male patients should use a barrier contraceptive during and for at least 90 days after therapy.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dizziness, fatigue, lack of appetite, nausea, vomiting, or diarrhea. Have patient report immediately to prescriber signs of infection, bruising, bleeding, loss of strength and energy, sweating a lot, illogical thinking, urinary retention, change in amount of urine passed, change in balance, hallucinations, depression; black, tarry, or bloody stools; burning or numbness feeling; seizures; severe abdominal pain; vision changes; vomiting blood; or injection site irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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