Ganciclovir

Ganciclovir is an antiviral drug with activity against CMV [see Microbiology (12.4) ] .

• Ganciclovir Injection Ganciclovir Injection is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the: treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). ( 1.1 ) prevention of CMV disease in adult transplant recipients at risk for CMV disease.

• Ganciclovir Injection Ganciclovir Injection is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation. Hypersensitivity to ganciclovir or valganciclovir.contraindicated

2. DOSAGE AND ADMINISTRATION Ganciclovir Injection is administered only intravenously. 2.1 Dosage in Adult Patients with Normal Renal Function Treatment of CMV retinitis ( 2.3 ) Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days. Maintenance: 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week. Prevention of CMV disease in transplant recipients ( 2.4 ) Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 7 to 14 days. Maintenance: 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily, 7 days per week, or 6 mg/kg once daily, 5 days per week until 100 to 120 days post-transplantation. Adults with renal impairment: Adjust dosage based on creatinine clearance. ( 2.5 ) 2.1 Important Dosing and Administration Information To avoid phlebitis/pain at the infusion site, Ganciclovir Injection must only be administered by intravenous infusion over 1 hour, preferably via plastic cannula, into a vein with adequate blood flow to permit rapid dilution and distribution. only be administered by intravenous infusion over 1 hour, preferably via plastic cannula, into a vein with adequate blood flow to permit rapid dilution and distribution. Do not administer Ganciclovir Injection by rapid or bolus intravenous injection which may increase toxicity as a result of excessive plasma levels. The recommended dosage and infusion rate for Ganciclovir Injection should not be exceeded.

Renal Impairment: Increased serum creatinine levels have been observed with the use of Ganciclovir Injection, particularly in elderly patients and transplant recipients receiving concomitant nephrotoxic drugs. Monitor renal function during therapy with Ganciclovir Injection, particularly in elderly patients and in patients taking other nephrotoxic drugs, and reduce dosage in patients with renal impairment. ( 5.2 )) 5.1 Hematologic Toxicity Granulocytopenia (neutropenia), anemia, thrombocytopenia and pancytopenia have been observed in patients treated with Ganciclovir Injection. The frequency and severity of these events vary widely in different patient populations . Ganciclovir Injection is not recommended if the absolute neutrophil count is less than 500 cells/mcL, hemoglobin is less than 8 g/dL, or the platelet count is less than 25,000 cells/mcL. Ganciclovir Injection should also be used with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation. Granulocytopenia (neutropenia) usually occurs during the first or second week of treatment but may occur at any time during treatment. Cell counts usually begin to recover within 3 to 7 days after discontinuing drug. Colony-stimulating factors have been shown to increase neutrophil and white blood cell counts in patients receiving Ganciclovir Injection Granulocytopenia (neutropenia), anemia, thrombocytopenia and pancytopenia have been observed in patients treated with Ganciclovir Injection.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hematologic Toxicity [see Warnings and Precautions (5.1) ] Renal Impairment [see Warnings and Precautions (5.2) ] Impairment of Fertility [see Warnings and Precautions (5.3) ] Fetal Toxicity [see Warnings and Precautions (5.4) ] Mutagenesis and Carcinogenesis [see Warnings and Precautions (5.5) ] Most common adverse reactions and laboratory abnormalities reported in at least 20% of patients were: pyrexia, diarrhea, leukopenia, nausea, anemia, asthenia, headache, cough, decreased appetite, dyspnea, abdominal pain, sepsis, hyperhidrosis, and blood creatinine increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharmascience Inc. at 1-888-550-6060 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience in Adult Patients Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. The most common adverse reactions and laboratory abnormalities reported in at least 20% of patients were pyrexia, diarrhea, leukopenia, nausea, anemia, asthenia, headache, cough, decreased appetite, dyspnea, abdominal pain, sepsis, hyperhidrosis, and blood creatinine increased. Selected adverse reactions that occurred during clinical trials of Ganciclovir Injection are summarized below, according to the participating study patient population.

Lactation: Breastfeeding is not recommended with use of Ganciclovir Injection. (8.2) 8.1 Pregnancy Risk Summary In animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two times the exposure at the recommended human dose (RHD) [see Data] . Although placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and in at least one case report in a pregnant woman, no adequate human data are available to establish whether Ganciclovir Injection poses a risk to pregnancy outcomes. The background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo-fetal risk Most maternal CMV infections are asymptomatic or they may be associated with a self-limited mononucleosis-like syndrome. However, in immunocompromised patients (i.e., transplant patients or patients with AIDS), CMV infections may be symptomatic and may result in significant maternal morbidity and mortality.

Metabolism

Absorption At the end of a 1-hour intravenous infusion of 5 mg/kg ganciclovir, total AUC ranged between 22.1 ± 3.2 (n=16) and 26.8 ± 6.1 mcg∙hr/mL (n=16) and C max ranged between 8.27 ± 1.02 (n=16) and 9.0 ± 1.4 mcg/mL (n=16). Distribution The steady-state volume of distribution of ganciclovir after intravenous administration was 0.74 ± 0.15 L/kg (n=98).

Reports of adverse reactions after overdoses with Ganciclovir Injection Reports of adverse reactions after overdoses with Ganciclovir Injection , some with fatal outcomes, have been received from clinical trials and during postmarketing experience. One or more of the following adverse reactions has been reported with overdoses: myelosuppression including pancytopenia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia, bone marrow failure Hematological toxicity: myelosuppression including pancytopenia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia, bone marrow failure hepatitis, liver function disorder Hepatotoxicity: hepatitis, liver function disorder worsening of hematuria in a patient with pre-existing renal impairment, acute kidney injury, elevated creatinine Renal toxicity: worsening of hematuria in a patient with pre-existing renal impairment, acute kidney injury, elevated creatinine abdominal pain, diarrhea, vomiting Gastrointestinal toxicity: abdominal pain, diarrhea, vomiting seizure Neurotoxicity: seizure Since ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations in patients who have received an overdose of Ganciclovir …

• Jul 16, 2003ANDAANDA076222Hikma
• Sep 15, 2009NDANDA022211Bausch And Lomb
• Jun 21, 2010ANDAANDA090658Fresenius Kabi Usa
• Dec 6, 2016ANDAANDA204950Ph Health
• Dec 8, 2017ANDAANDA207645Pharmascience Inc
• Nov 8, 2018ANDAANDA204204Slate Run Pharma

1. 1Off Label Use1,74316%
2. 2Drug Ineffective1,52614%
3. 3Cytomegalovirus Infection1,25612%
4. 4Drug Resistance7206.7%
5. 5Pyrexia6165.7%
6. 6Neutropenia5805.4%
7. 7Product Use In Unapproved Indication5795.4%
8. 8Pancytopenia5415.0%
9. 9Diarrhoea4604.3%
10. 10Cytomegalovirus Viraemia4324.0%
11. 11Pneumonia4324.0%
12. 12Sepsis4213.9%
13. 13Respiratory Failure4083.8%
14. 14Multiple Organ Dysfunction Syndrome4073.8%
15. 15Cytomegalovirus Infection Reactivation3833.6%

Recent PubMed references pinned to Ganciclovir as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Valganciclovir therapeutic drug monitoring-guided dosing for cytomegalovirus prophylaxis in lung transplant patients.
  Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2026 · Katada Y, Umemura K, Nakagawa S, et al.
  PMID 42102918DOI 10.1016/j.jiac.2026.102986
• Novel oral chidamide and valganciclovir regimen for EBV-PTLD post-hematopoietic stem cell transplantation: A case report.
  Medicine · 2026 · Wu Y, Zhong Z, Mei H, et al.
  PMID 42071869DOI 10.1097/MD.0000000000048412
• Four-year neurodevelopmental outcomes in infants with symptomatic congenital cytomegalovirus disease treated with oral valganciclovir: A prospective follow-up study in Japan.
  Brain & development · 2026 · Kakei Y, Morioka I, Imai T, et al.
  PMID 42044599DOI 10.1016/j.braindev.2026.104539
• [Efficacy of Ganciclovir Combined With Recombinant Human Interferon α-1b for Viral Encephalitis in Children].
  Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2026 · Han B, Zhao L, Han X, et al.
  PMID 42021910DOI 10.12182/20260360507
• Anti-cytomegalovirus medications among very low birth weight infants in the United States from 2016 to 2023.
  Journal of perinatology : official journal of the California Perinatal Association · 2026 · Proaño A, Green M, Zevallos Barboza A, et al.
  PMID 42009896DOI 10.1038/s41372-026-02658-1
• Sustainable RP-HPLC Method Development Using AQbD Approach for Simultaneous Estimation of Valganciclovir Hydrochloride and Piperine-Loaded Lipid Nanoparticles.
  Biomedical chromatography : BMC · 2026 · Mahalkari A, Mastiholimath V, Muppayyanamath A, et al.
  PMID 41980886DOI 10.1002/bmc.70443
• Simultaneous LC-MS/MS method for the quantification of 5-flucytosine, ganciclovir, and valganciclovir to support combined prodrug-activated gene therapy.
  Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2026 · Lee YH, Kim JW, Kim HJ, et al.
  PMID 41967452DOI 10.1016/j.jchromb.2026.125062
• Ganciclovir for severe neonatal varicella pneumonia when acyclovir is unavailable: a case report.
  Virology journal · 2026 · Shen Y, Qu S
  PMID 41952168DOI 10.1186/s12985-026-03142-0

The 10 most recently updated of 230 ClinicalTrials.gov registrations naming Ganciclovir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients
  Recruiting · Phase 3 · Interventional · 90 enrolled · University of Wisconsin, Madison
  NCT06407232updated 2026-06-11
• Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)
  Recruiting · Phase 2 · Interventional · 140 enrolled · National Cancer Institute (NCI)
  NCT01419561updated 2026-06-08
• Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
  Active not recruiting · Phase 2 · Interventional · 75 enrolled · National Cancer Institute (NCI)
  NCT00092222updated 2026-06-05
• CMV Immunity Monitoring in Lung Transplant Recipients
  Recruiting · Phase 2 · Interventional · 50 enrolled · NYU Langone Health
  NCT05708755updated 2026-05-29
• Study Evaluating the Efficacy and Safety of Artesunate
  Recruiting · Phase 2 · Interventional · 90 enrolled · Amivas Inc.
  NCT06853184updated 2026-05-19
• Secondary Prophylaxis After CMV Disease in Kidney Transplant Patients Targeted by γδ T Cells Immunomonitoring.
  Completed · Phase 2 · Interventional · 38 enrolled · University Hospital, Bordeaux
  NCT03339661updated 2026-05-12
• Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients
  Completed · Phase 4 · Interventional · 70 enrolled · Medical University of South Carolina
  NCT06034925updated 2026-04-30
• Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
  Recruiting · Observational · 1,600 enrolled · Duke University
  NCT03511118updated 2026-04-24
• ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION
  Completed · Phase 1 · Phase 2 · Interventional · 20 enrolled · Laureate Institute for Brain Research, Inc.
  NCT04724447updated 2026-04-21
• Letermovir for CMV Prevention After Lung Transplantation
  Completed · Phase 2 · Interventional · 15 enrolled · Fernanda P Silveira, MD, MS
  NCT05041426updated 2026-04-09

Frequently asked questions

How does Ganciclovir work?

Ganciclovir is an antiviral drug with activity against CMV [see Microbiology (12.4) ] .

What is Ganciclovir used for?

According to FDA labeling, Ganciclovir carries indications including: Ganciclovir Injection Ganciclovir Injection is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the: treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). ( 1.1 ) prevention of CMV disease in adult transplant recipients at risk for CMV disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ganciclovir?

Ganciclovir is classified as Antivirals, Nucleosides and nucleotides excl. reverse transcriptase inhibitors, Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor, Nucleoside Analog Antiviral, DNA Polymerase Inhibitors, Nucleic Acid Synthesis Inhibitors, Decreased DNA Replication, Decreased Protein Synthesis.

What are the brand names for Ganciclovir?

Ganciclovir is marketed under brand names including Zirgan.

What are the contraindications for Ganciclovir?

Ganciclovir labeling lists contraindications including: Ganciclovir Injection Ganciclovir Injection is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation. Hypersensitivity to ganciclovir or valganciclovir.. Always consult the full prescribing information and a clinician.