Ganciclovir

Aka: Ganciclovir, Cytovene

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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

X. Monitoring

  1. Complete Blood Count
  2. Renal Function

XI. Pharmacokinetics

  1. Excreted unchanged in the urine

XII. Resources

  1. Ganciclovir Injection Solution (DailyMed)
    1. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=26361de8-39b5-4266-90f6-2b307940135d

XIII. References

  1. Hamilton (2020) Tarascon Pocket Pharmacopoeia
  2. (2013) Med Lett Drugs Ther 11(127): 19-30 [PubMed]
  3. (1989) Med Lett Drugs Ther 31(799): 79-80 [PubMed]

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