Ganciclovir Injection is a nucleoside analogue 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.

Anti-viral drugs

Ganciclovir's antiviral activity inhibits virus replication. This inhibitory action is highly selective as the drug must be converted to the active form by a virus-encoded cellular enzyme, thymidine kinase (TK). TK catalyzes phosphorylation of ganciclovir to the monophosphate, which is then subsequently converted into the diphosphate by cellular guanylate kinase and into the triphosphate by a number of cellular enzymes. In vitro, ganciclovir triphosphate stops replication of herpes viral DNA. When used as a substrate for viral DNA polymerase, ganciclovir triphosphate competitively inhibits dATP leading to the formation of 'faulty' DNA. This is where ganciclovir triphosphate is incorporated into the DNA strand replacing many of the adenosine bases. This results in the prevention of DNA synthesis, as phosphodiester bridges can longer to be built, destabilizing the strand. Ganciclovir inhibits viral DNA polymerases more effectively than it does cellular polymerase, and chain elongation resumes when ganciclovir is removed.

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. 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 until 100 to 120 days post-transplantation.

Didanosine: Patients should be closely monitored for didanosine toxicity. Zidovudine: Potential to cause neutropenia and anemia. Monitor with frequent tests of white blood cell counts with differential and hemoglobin levels. Probenecid: Ganciclovir dose may need to be reduced. Monitor for evidence of ganciclovir toxicity. Imipenem-cilastatin: Generalized seizures have been reported in patients with concomitant use of ganciclovir and imipenem-cilastatin. Cyclosporine or amphotericin B: Monitor renal function. Drugs such as dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim or sulfamethoxazole combinations or other nucleoside analogues should be considered for concomitant use with ganciclovir only if the potential benefits are judged to outweigh the risks

Hypersensitivity to ganciclovir, valganciclovir or acyclovir.

Most common adverse reactions and laboratory abnormalities reported in at least 20% of patients were fever, diarrhea, leukopenia, anemia, catheter-related events (including catheter infection and catheter sepsis), and elevated creatinine levels.

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). No data are available regarding the presence of ganciclovir in human milk, the effects on the breastfed infant, or the effects on milk production.

Hematologic toxicity: Granulocytopenia (neutropenia), anemia, thrombocytopenia, and pancytopenia have been reported with use of ganciclovir. Avoid the use of Ganciclovir Injection if absolute neutrophil count is less than 500 cells/µL, hemoglobin is less than 8 g/dL, or platelet count is less than 25,000 cells/µL. Use with caution in patients with pre-existing cytopenias or in patients receiving myelosuppressive drugs or irradiation. Monitor with frequent complete blood and platelet counts.Impairment of renal function: Increased serum creatinine levels have been observed with the use of ganciclovir, particularly in elderly patients and transplant patients receiving concomitant nephrotoxic drugs. Monitor renal function during therapy with Ganciclovir Injection, particularly in elderly patients and in patients taking other nephrotoxic drugs, and reduce dosage in patients with renal impairmentImpairment of fertility: Based on animal studies, Ganciclovir Injection may cause temporary or permanent female and male infertility.Fetal toxicity: Based on findings in animal studies, Ganciclovir Injection may cause fetal toxicity. Females of reproductive potential should use effective contraception during treatment and for at least 30 days following treatment with Ganciclovir Injection. Males should practice barrier contraception during treatment and for at least 90 days following treatment with Ganciclovir Injection.

Store at 20°C to 25°C