GANCICLOVIR SODIUM

Antiviral medicine active against cytomegalovirus (CMV)

Dosage Forms

Powder for Injection

500 mg

Uses

  • Life-threatening or sight-threatening cytomegalovirus (CMV) infection
  • Congenital cytomegalovirus infection of the CNS
  • Prevention of CMV disease during immunosuppressive therapy

Dose and Duration

Treatment of CMV infection
Adult and child: by IV infusion over 1 hour, induce with 5 mg/kg every 12 hours for 14–21 days. In patients at risk of relapse CMV retinitis, give a maintenance dose of 6 mg/kg once daily on 5 days per week or 5 mg/kg once daily until adequate recovery of immunity
Prevention of CMV
Adult and child: induce with 5 mg/kg by IV infusion every 12 hours for 7–14 days and maintenance dose as above in treatment
Congenital cytomegalovirus infection of the CNS
Neonate: by IV infusion, 6 mg/kg every 12 hours for 6 weeks
In renal impairment:
Creatinine clearance Induction dose
≥ 70 ml/min 5 mg/kg every 12 hours
50–69 ml/min 2.5 mg/kg every 12 hours
25–49 ml/min 2.5 mg/kg/day
10–24 ml/min 1.25 mg/kg/day
< 10 ml/min 1.25 mg/kg/day after haemodialysis

Contraindications

  • Hypersensitivity to vanganciclovir, ganciclovir, acyclovir or valaciclovir
  • Low haemoglobin, neutrophil or platelet counts

Side Effects

  • Gastrointestinal disturbances
  • Hepatic dysfunction, renal impairment
  • Dyspnoea, chest pain, cough
  • Headache, insomnia, convulsions, dizziness, depression, anxiety, confusion, abnormal thinking, fatigue
  • Peripheral neuropathy
  • Weight loss, anorexia
  • Infection, pyrexia, night sweats
  • Anaemia, leucopoenia, thrombocytopenia, pancytopenia
  • Myalgia, arthralgia
  • Macular oedema, retinal detachment, vitreous floaters, eye pain, ear pain
  • Dermatitis, pruritus
  • Injection-site reactions

Interactions

  • Imipenem with cilastatin (increased risk of convulsions)
  • Zidovudine (profound myelosuppression when used concomitantly; avoid concomitant use)

Pregnancy

  • Do not use

Breast-feeding

  • Do not use

⚠️ Caution

  • In pregnancy, ganciclovir is potentially teratogenic and carcinogenic risk
  • Ensure effective contraception for men and women during treatment and for at least 3 months after treatment
  • Risk of ganciclovir resistance is higher in patients with a higher viral load or dose on long duration treatment
  • Do full blood count monitoring; correct or suspend treatment in case of severe decline in blood counts
  • Use with caution in history of cytopenia and in patients receiving radiotherapy
  • Ganciclovir is a vesicant and thus should be infused into a vein with adequate flow preferably using plastic cannula
  • Use with caution in children due to possible risk of long-term carcinogenic or reproductive toxicity