II. Indications

  1. Cytomegalovirus Retinitis
  2. CMV Prophylaxis after Transplant
  3. Congenital CMV (off-label use)

III. Contraindications

  1. Absolute Neutrophil Count <500/mm3
  2. Hemoglobin <8 mg/dl
  3. Platelet Count <25,000/mm3

IV. Mechanism

  1. Active against the Herpesvirus family including Cytomegalovirus (CMV)
  2. Ganciclovir is a synthetic, Nucleoside analogue of 2'-deoxyguanosine
  3. Ganciclovir is metabolized to the active Ganciclovir-5-triphosphate (Ganciclovir-TP) by thymidine kinase
    1. Some CMV strains lack thymidine kinase, rendering them resistant to Ganciclovir
  4. Ganciclovir-TP inhibits viral DNA synthesis by being substituted into DNA in place of deoxyguanosine
    1. Competitively inhibits viral DNA Polymerases
    2. Prevents viral DNA elongation

V. Dosing: Adult

  1. Cytomegalovirus Retinitis
    1. Induction: 5 mg/kg IV over 1 hour every 12 hours for 14 to 21 days, then
    2. Maintenance: 6 mg/kg IV over 1 hour daily for 5 days per week OR 5 mg/kg IV daily
  2. CMV Prophylaxis after Transplant
    1. Induction: 5 mg/kg IV over 1 hour every 12 hours for 7 to 14 days, then
    2. Maintenance: 6 mg/kg IV over 1 hour daily for 5 days per week
  3. Renal Dosing
    1. eGFR 50 to 69 ml/min
      1. Induction: 2.5 mg/kg IV every 12 hours, then
      2. Maintenance: 2.5 mg/kg IV every 24 hours
    2. eGFR 25 to 49 ml/min
      1. Induction: 2.5 mg/kg IV every 24 hours, then
      2. Maintenance: 1.25 mg/kg IV every 24 hours
    3. eGFR 10 to 24 ml/min
      1. Induction: 1.25 mg/kg IV every 24 hours, then
      2. Maintenance: 0.625 mg/kg IV every 24 hours
    4. eGFR <10 ml/min or Hemodialysis
      1. Induction: 1.25 mg/kg IV three times weekly (after Hemodialysis)
      2. Maintenance: 0.625 mg/kg IV three times weekly (after Hemodialysis)

VI. Dosing: Child (Off-label)

  1. Not FDA approved for use in children
    1. Use Informed Consent regarding potential adverse effects including carcinogenicity
  2. Child (age >3 months old)
    1. See adult dosing above
  3. Symptomatic Congenital CMV
    1. Give 6 mg/kg IV every 12 hours for 6 weeks

VII. Adverse Effects

  1. Neutropenia
  2. Anema
  3. Thrombocytopenia
  4. Possibly carcinogenic
  5. Phlebitis (at infusion site)

VIII. Safety

  1. Avoid in Lactation
  2. Avoid in Pregnancy (Teratogenic)
    1. Men should use barrier Contraception (Condoms) for at least 3 months after Ganciclovir

IX. Drug Interactions

  1. Zidovudine
    1. Combination worsens Neutropenia
  2. Imipenem
    1. Risk of Seizures

XI. Pharmacokinetics

  1. Excreted unchanged in the urine

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Related Studies

Ontology: Ganciclovir (C0017066)

Definition (NCI_NCI-GLOSS) An antiviral agent used to prevent or treat cytomegalovirus infections that may occur when the body's immune system is suppressed. In gene therapy, ganciclovir is used with an altered herpes simplex virus-1 gene to kill advanced melanoma cells and brain tumor cells.
Definition (NCI) A synthetic guanine derivative with antiviral activity. As the active metabolite of ganciclovir, ganciclovir-5-triphosphate (ganciclovir-TP) appears to inhibit viral DNA synthesis by competitive inhibition of viral DNA polymerases and incorporation into viral DNA, resulting in eventual termination of viral DNA elongation.
Definition (MSH) An ACYCLOVIR analog that is a potent inhibitor of the Herpesvirus family including cytomegalovirus. Ganciclovir is used to treat complications from AIDS-associated cytomegalovirus infections.
Definition (CSP) 9-(1,3-dihydroxy-2-propoxy)methylguanine; acyclovir analog which inhibits DNA replication of CMV and therefore has efficacy against AIDS-related oculopathy.
Definition (CSP) family of acyclovir analogs with antiviral efficacy against herpes simplex and cytomegalovirus, a cause of AIDS-related blindness.
Definition (PDQ) A synthetic guanine derivative with antiviral activity. As the active metabolite of ganciclovir, ganciclovir-5-triphosphate (ganciclovir-TP) appears to inhibit viral DNA synthesis by competitive inhibition of viral DNA polymerases and incorporation into viral DNA, resulting in eventual termination of viral DNA elongation. Check for "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=40565&idtype=1" active clinical trials or "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=40565&idtype=1&closed=1" closed clinical trials using this agent. ("http://nciterms.nci.nih.gov:80/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C517" NCI Thesaurus)
Concepts Pharmacologic Substance (T121) , Nucleic Acid, Nucleoside, or Nucleotide (T114)
MSH D015774
SnomedCT 391660009, 372848001, 78025001, 76587005
LNC LP15741-9, MTHU004762
English Gancyclovir, 6H-Purin-6-one, 2-amino-1,9-dihydro-9-((2-hydroxy-1-(hydroxymethyl)ethoxy)methyl)-, 2'-Nor-2'-deoxyguanosine, 2-Amino-1,9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6H-purin-6-one, 9-[(1,3-Dihydroxy-2-propoxy)methyl]guanine, dihydroxypropoxymethylguanine, ganciclovir (medication), GANCICLOVIR, Ganciclovir [Chemical/Ingredient], ganciclovir, gancyclovir, GCV, Ganciclovir [eye], Ganciclovir [eye] (product), Nordeoxyguanosine, Ganciclovir product, Ganciclovir (product), Ganciclovir (substance), DHPG, 2'NDG, Ganciclovir
Swedish Ganciklovir
Czech ganciklovir
Finnish Gansikloviiri
Russian GANTSIKLOVIR, ГАНЦИКЛОВИР
Japanese ガンシクロビル, デノシン
Polish Gancyklowir
Spanish ganciclovir [uso oftálmico], ganciclovir [uso oftálmico] (producto), ganciclovir (producto), ganciclovir (sustancia), ganciclovir, nordesoxiguanosina, Ganciclovir
French BW 759, Ganciclovir, Gancyclovir
German Ganciclovir
Italian Ganciclovir
Portuguese Ganciclovir