ganciclovir sodium: clinical use

Prescribing considerations

• Confirm the licensed indication and involve an appropriate CMV, infection, transplant, oncology or paediatric specialist.
• Review baseline renal function, full blood count, platelets, pregnancy potential and interacting medicines.
• Renal impairment substantially increases exposure and haematological toxicity.
• Exercise particular caution in children because of potential reproductive and long-term carcinogenic toxicity.
• Use appropriate hazardous-medicine precautions during preparation and disposal.

Contraindications and cautions

• Hypersensitivity to ganciclovir, valganciclovir or a formulation excipient.
• Breastfeeding.
• Do not initiate when blood counts are below the product-specific SmPC thresholds.

Monitoring

• Full blood count with differential and platelets; increase surveillance in renal impairment, neonates, infants or patients with prior cytopenia.
• Serum creatinine or estimated creatinine clearance.
• Clinical and virological response; consider resistance when response remains poor or viral shedding persists.
• Infusion site and neurological, renal and haematological toxicity.

Clinical pharmacology

Ganciclovir is preferentially phosphorylated in CMV-infected cells, then inhibits viral DNA polymerase and DNA elongation. It undergoes little metabolism and is predominantly excreted unchanged by the kidneys; clearance closely follows renal function.

Formulation and product differences

• Both selected products are single-use powders requiring reconstitution and further dilution for intravenous infusion.
• Prepared solutions are alkaline and must not be administered intramuscularly or subcutaneously.

Solution for infusion

Route: Intravenous

Strengths: 500 mg