Ganciclovir

What it is and how it works

Mechanism of Action Ganciclovir is an antiviral drug with activity against CMV .

Indications

Ganciclovir for Injection, USP 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). prevention of CMV disease in adult transplant recipients at risk for CMV disease. Treatment of CMV Retinitis Ganciclovir for Injection, USP is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) . Prevention of CMV Disease in Transplant Recipients Ganciclovir for Injection, USP is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease . Treatment of CMV Retinitis Ganciclovir for Injection, USP is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) .

Dosage and administration (summary)

Ganciclovir for injection is administered only intravenously. Dosage in Adult Patients with Normal Renal Function Treatment of CMV retinitis 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 Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 7 to 14 days.

Contraindications

Ganciclovir for 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.

Warnings and precautions

Renal Impairment: Increased serum creatinine levels have been observed with the use of ganciclovir, particularly in elderly patients and transplant recipients receiving concomitant nephrotoxic drugs. Monitor renal function during therapy with ganciclovir, particularly in elderly patients and in patients taking other nephrotoxic drugs, and reduce dosage in patients with renal impairment. Hematologic Toxicity Granulocytopenia (neutropenia), anemia, thrombocytopenia and pancytopenia have been observed in patients treated with ganciclovir.

Pregnancy

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) .

Storage and supply

How Supplied Ganciclovir for Injection, USP is supplied in 10 mL sterile single-dose vials, each containing 543 mg ganciclovir sodium equivalent to 500 mg of ganciclovir as a white to off-white powder. The concentration of ganciclovir in the reconstituted solution is 50 mg/mL.

Source: Ganciclovir Sodium (Ganciclovir) — US FDA prescribing information, 2025-02-07, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.