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Ganciclovir (Systemic)

Medically reviewed by Drugs.com. Last updated on Oct 8, 2020.

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. [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)

Brand Names: U.S.

  • Cytovene [DSC]

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

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

Protein Binding

1% to 2%

Special Populations: Renal Function Impairment

Clearance is decreased and half-life is prolonged.

Use: Labeled Indications

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

Cytomegalovirus retinitis (immunocompromised patients): Treatment of CMV retinitis in immunocompromised adult patients, including patients with AIDS.

Off Label Uses

Cytomegalovirus disease, preemptive therapy (hematopoietic cell transplant recipients)

Based on the American Society for Blood and Marrow Transplantation Guidelines for Preventing Infectious Complications among Hematopoietic Cell Transplantation Recipients, ganciclovir is an effective and recommended agent in the preemptive management of cytomegalovirus (CMV) in bone marrow transplant recipients.

Cytomegalovirus disease, treatment (solid organ transplant recipients)

Based on The Transplantation Society International CMV Consensus Group Guidelines, ganciclovir is an effective and recommended agent in the treatment of CMV disease in solid organ transplant recipient.

Cytomegalovirus esophagitis or colitis treatment in patients with HIV

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV, ganciclovir is an effective and recommended agent for the treatment of esophagitis or colitis due to CMV disease in patients with HIV.

Cytomegalovirus neurological disease in patients with HIV

Based on the US Department of HHS Guidelines for Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV, ganciclovir is an effective and recommended agent for the treatment of neurological disease due to CMV disease in patients with HIV.

Cytomegalovirus retinitis, secondary prevention in patients with HIV

Based on the US Department of HHS Guidelines for Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV, ganciclovir is an effective and recommended agent for the secondary prophylaxis of CMV retinitis in patients with HIV.

Varicella-zoster: Acute retinal necrosis in patients with HIV

Based on the US Department of HHS Guidelines for Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV, intravitreal ganciclovir in combination with intravenous acyclovir is an effective and recommended agent in the management of varicella-zoster virus acute retinal necrosis in patients with HIV.

Varicella-zoster: Progressive outer retinal necrosis in patients with HIV

Based on the US Department of HHS Guidelines for Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV, ganciclovir is an effective and recommended agent in the management of this condition in patients with HIV.

Contraindications

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

Dosing: Adult

Cytomegalovirus retinitis (immunocompromised patients):

Immediate sight-threatening lesions (adjacent to the optic nerve or fovea):

Intravitreal injection (off label): 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) (HHS [OI adult 2020]).

IV (alternative agent): 5 mg/kg/dose every 12 hours for 14 to 21 days followed by chronic maintenance therapy (secondary prophylaxis) (HHS [OI adult 2020]).

Chronic maintenance therapy (alternative agent): IV: 5 mg/kg/dose once daily (7 days/week) or 6 mg/kg/dose once daily (5 days/week) for 3 to 6 months until sustained CD4 count >100 cells/mm3 in response to antiretroviral therapy; discontinue only after consultation with an ophthalmologist (HHS [OI adult 2020]; manufacturer’s labeling).

Cytomegalovirus disease prophylaxis in transplant patients: IV:

Hematopoietic cell transplant recipients (allogeneic): 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 (ASBMT [Tomblyn 2009]).

Solid organ transplant recipients: 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 (AST-IDCOP [Razonable 2019]; Kotton 2013).

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

<100 days post-transplant: 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) (ASBMT [Tomblyn 2009]).

>100 days post-transplant: 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 (ASBMT [Tomblyn 2009]).

Cytomegalovirus disease, treatment (solid organ transplant recipients) (off-label use): IV: 5 mg/kg/dose every 12 hours until resolution of symptoms and 1 or 2 consecutive undetectable CMV viral load samples are obtained (minimum treatment course: 2 weeks) (AST-IDCOP [Razonable 2019]; Kotton 2013).

UL97 mutation for <5x ganciclovir EC50: 10 mg/kg/dose every 12 hours (AST-IDCOP [Razonable 2019]; Kotton 2013).

Ganciclovir-resistant strains: 5 mg/kg/dose every 24 hours in combination with daily foscarnet and monthly CMV hyperimmunoglobulin (Mylonakis 2002).

Cytomegalovirus esophagitis or colitis in patients with HIV (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 2020]).

Cytomegalovirus neurological disease in patients with HIV (off-label use): IV: 5 mg/kg/dose every 12 hours plus foscarnet until symptoms improve (HHS [OI adult 2020]).

Varicella-zoster:

Acute retinal necrosis in patients with HIV (off-label use): Intravitreal injection (off label): 2 mg in 0.05 mL 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 2020]).

Progressive outer retinal necrosis in patients with HIV (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 2020]).

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

CMV infection: Limited data available: IV:

Congenital CMV (symptomatic; CNS-disease); treatment (independent of HIV status): Infants: 6 mg/kg/dose every 12 hours for 6 weeks; if neonate diagnosed as HIV-positive a longer duration of therapy may be considered (CDC, 2009; Redbook, 2009)

CNS infection, treatment (HIV-exposed/-positive): Infants and Children: 5 mg/kg/dose every 12 hours plus foscarnet; continue until symptoms improve, followed by chronic suppression (CDC, 2009)

Disseminated disease and retinitis, treatment:

Induction therapy: Infants ≥3 months and Children: 5 mg/kg/dose every 12 hours for 14-21 days; may be increased to 7.5 mg/kg/dose every 12 hours (CDC, 2009)

Maintenance therapy: Infants ≥ 3 months and Children: 5 mg/kg/dose as a single daily dose for 5-7 days/week (CDC, 2009)

Secondary prevention in HIV-exposed/-infected patients: Infants and Children: 5 mg/kg/dose once daily (CDC, 2009)

Prevention in transplant recipients: Children: Initial: 5 mg/kg/dose every 12 hours for 1-2 weeks, followed by 5 mg/kg/dose once daily 7 days/week or 6 mg/kg/dose once daily 5 days/week for 100 days

Prevention in lung/heart-lung transplant patients (CMV-positive donor with CMV-positive recipient): Children: 6 mg/kg/dose once daily for 28 days

Other CMV infections: Children: Initial: 5 mg/kg/dose every 12 hours for 14-21 days; maintenance therapy: 5 mg/kg/dose once daily for 7 days/week or 6 mg/kg/dose once daily for 5 days/week

Varicella zoster; progressive outer retinal necrosis: Limited data available: IV: Infants, Children, and Adolescents: 5 mg/kg/dose every 12 hours plus systemic foscarnet and intravitreal ganciclovir or foscarnet (CDC, 2009; Kaplan, 2009)

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

Reconstitution

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

Administration

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.

Dietary Considerations

Some products may contain sodium.

Storage

Store intact vials and premixed solution bags at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Reconstituted solution in the vial is stable at room temperature for 12 hours; do not refrigerate or freeze. Diluted solutions for infusion should be refrigerated and used within 24 hours of preparation; do not freeze.

Drug Interactions

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

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

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

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

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

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

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

Adverse Reactions

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

>10%:

Dermatologic: Hyperhidrosis (12%)

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

Hematologic & oncologic: Thrombocytopenia (6%; ≤50,000/mcL: 8% to 57%; <25,000/mcL: 3% to 32%), leukopenia (41%), neutropenia (ANC <500/mcL: 4% to 25%; 500 to 1,000/mcL: 14% to 29%), anemia (25%; hemoglobin <6.5 g/dL: 5%)

Infection: Sepsis (15%), infection (13%)

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

Renal: Increased serum creatinine (2% to 50%; ≥2.5 mg/dL: 2% to 20%)

Miscellaneous: Fever (48%)

1% to 10%:

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

Dermatologic: Pruritus (5%)

Infection: Catheter sepsis (8%)

Local: Catheter infection (9%), catheter-site reaction (5%)

Frequency not defined:

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

Central nervous system: Abnormal dreams, abnormality in thinking, agitation, anxiety, confusion, depression, dizziness, drowsiness, fatigue, headache, hypoesthesia, insomnia, malaise, myasthenia, pain, paresthesia, psychosis, seizure

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

Endocrine & metabolic: Weight loss

Gastrointestinal: Abdominal distention, abdominal pain, aphthous stomatitis, constipation, dysgeusia, dyspepsia, dysphagia, eructation, flatulence, gastrointestinal perforation, nausea, oral candidiasis, oral mucosa ulcer, pancreatitis, xerostomia

Genitourinary: Hematuria, urinary frequency, urinary tract infection

Hematologic & oncologic: Bone marrow failure

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

Infection: Candidiasis, influenza

Local: Inflammation at injection site

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

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

Otic: Deafness, otalgia, tinnitus

Renal: Decreased creatinine clearance, renal failure syndrome, renal function abnormality

Respiratory: Cough, dyspnea, upper respiratory tract infection

Miscellaneous: Multiorgan failure

<1%, postmarketing, and/or case reports: Acidosis, agranulocytosis, amnesia, anaphylaxis, anosmia, aphasia, arthritis, bronchospasm, cardiac conduction disturbance, cataract, cerebrovascular accident, cholelithiasis, cholestasis, cranial nerve palsy (third), dysesthesia, dysphasia, encephalopathy, exfoliative dermatitis, extrapyramidal reaction, facial nerve paralysis, granulocytopenia, hallucination, hemolytic anemia, hemolytic-uremic syndrome, hepatic failure, hepatitis, hypercalcemia, hypersensitivity reaction, hyponatremia, increased serum triglycerides, infertility, intracranial hypertension, irritability, myelopathy, oculomotor nerve paralysis, pancytopenia, peripheral ischemia, pulmonary fibrosis, renal tubular disease, rhabdomyolysis, SIADH, Stevens-Johnson syndrome, testicular hypotrophy, torsades de pointes, ulcerative bowel lesion, vasculitis, ventricular tachycardia, xerophthalmia

ALERT: U.S. 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.

Warnings/Precautions

Concerns related to adverse effects:

• Carcinogenic/teratogenic: [US Boxed Warning]: 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. Based on animal data, ganciclovir has the potential to cause birth defects and cancers in humans.

• Hematologic toxicity: [US Boxed Warning]: Granulocytopenia (neutropenia), anemia, thrombocytopenia, and pancytopenia may occur. 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. Colony-stimulating factors have been shown to increase neutrophil and white blood cell counts in patients receiving ganciclovir. Use with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation. Frequently monitor complete blood count with differential and platelet counts, especially in patients with renal impairment and in patients who have previously experienced drug-induced leukopenia or who have neutrophil counts <1,000 cells/mm3 at the beginning of treatment. Ganciclovir is not recommended in patients with an absolute neutrophil count (ANC) <500 cells/mm3, hemoglobin <8 g/dL, or platelet count <25,000 cells/mm3.

• Renal toxicity: Increased serum creatinine levels have been reported in elderly patients and transplant patients receiving concomitant nephrotoxic medications (eg, cyclosporine, amphotericin B). Monitor renal function during therapy, especially in elderly patients and those receiving concomitant nephrotoxic agents.

Disease-related concerns:

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

Special populations:

• Elderly: 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.

Monitoring Parameters

CBC with differential and platelet count at baseline and twice weekly, serum creatinine at baseline and once weekly (Tice 2004); pregnancy test prior to initiation in females of reproductive potential; frequent ophthalmological exams in patients with CMV retinitis.

Reproductive Considerations

[US Boxed Warning]: 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.

Female patients should undergo pregnancy testing prior to initiation and use effective contraception during and for at least 30 days after therapy. Male patients should use a barrier contraceptive during and for at least 90 days after therapy.

Pregnancy Considerations

Ganciclovir crosses the placenta. [US Boxed Warning]: Based on animal data, ganciclovir has the potential to cause birth defects in humans.

Adverse events following congenital cytomegalovirus (CMV) infection may also occur. Hearing loss, mental retardation, microcephaly, seizures, and other medical problems have been observed in infants with congenital CMV infection.

The indications for treating maternal CMV retinitis during pregnancy are the same as in nonpregnant HIV infected women. In general, intravitreous injections for local therapy are preferred for retinal disease to limit systemic exposure during the first trimester when possible. Ganciclovir is not the preferred systemic therapy in pregnant women. Close fetal monitoring is recommended (HHS [OI adult 2019]).

Patient Education

What is this drug used for?

• It is used to treat a viral infection of the eyes in people with immune system problems.

• It is used to prevent cytomegalovirus (CMV) disease after organ transplant.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Fatigue

• Loss of strength and energy

• Lack of appetite

• Nausea

• Vomiting

• Abdominal pain

• Passing gas

• Constipation

• Nightmares

• Dry mouth

• Trouble sleeping

• Hair loss

• Dry skin

• Change in taste

• Back pain

• Muscle pain

• Joint pain

• Muscle spasm

• Leg cramps

• Weight loss

• Diarrhea

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• Bleeding like vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding

• Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain

• Pancreatitis like severe abdominal pain, severe back pain, severe nausea, or vomiting

• Severe headache

• Severe dizziness

• Passing out

• Vision changes

• Sweating a lot

• Confusion

• Anxiety

• Swelling

• Eye pain

• Shortness of breath

• Noise or ringing in the ears

• Abnormal heartbeat

• Behavioral changes

• Hearing loss

• Depression

• Tremors

• Burning or numbness feeling

• Seizures

• Abdominal swelling

• Chest pain

• Injection site pain or irritation

• Severe eye irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.