Ganciclovir Sodium (2 brand names, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- CYTOVENE
- GANCICLOVIR SODIUM
Related Health Topics
Boxed Warning
• Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with Ganciclovir for Injection [see Warnings and Precautions (5.1)]. • Impairment of Fertility: Based on animal data and limited human data, Ganciclovir for Injection may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions (5.3)]. • Fetal Toxicity: Based on animal data, Ganciclovir for Injection has the potential to cause birth defects in humans [see Warnings and Precautions (5.4)]. • Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir for Injection has the potential to cause cancers in humans [see Warnings and Precautions (5.5)].
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.
Adverse Reactions
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: •Hematologic Toxicity [see Warnings and Precautions (5.1)] •Renal Impairment [see Warnings and Precautions (5.2)] •Impairment of Fertility [see Warnings and Precautions (5.3)] •Fetal Toxicity [see Warnings and Precautions (5.4)] •Mutagenesis and Carcinogenesis [see Warnings and Precautions (5.5)]
Drug Interactions
Drug-drug interaction studies were conducted in patients with normal renal function. Patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug following concomitant administration of Ganciclovir for Injection and drugs excreted by the same pathway as ganciclovir. Therefore, these patients should be closely monitored for toxicity of ganciclovir and the coadministered drug. Established and other potentially significant drug interactions conducted with ganciclovir are listed in Table 6 [see Clinical Pharmacology (12.3)]. Table 6. Established and Other Potentially Significant Drug Interactions with Ganciclovir for Injection Name of the Concomitant Drug Change in the Concentration of Ganciclovir or Concomitant Drug Clinical Comment Imipenem-cilastatin Unknown Coadministration with imipenem-cilastatin is not recommended because generalized seizures have been reported in patients who received ganciclovir and imipenem-cilastatin. Cyclosporine or amphotericin B Unknown Monitor renal function when Ganciclovir is coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine [see Warnings and Precautions (5.2)]. Mycophenolate mofetil (MMF) ↔ Ganciclovir (in patients with normal renal function)↔ MMF (in patients with normal renal function) Based on increased risk, patients should be monitored for hematological and renal toxicity. Other drugs associated with myelosuppression or nephrotoxicity (e.g., dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine and zidovudine) Unknown Because of potential for higher toxicity, coadministration with Ganciclovir should be considered only if the potential benefits are judged to outweigh the risks. Didanosine ↔ Ganciclovir↑ Didanosine Patients should be closely monitored for didanosine toxicity (e.g., pancreatitis). Probenecid ↑Ganciclovir Ganciclovir for Injection dose may n
Mechanism of Action
Ganciclovir is an antiviral drug with activity against CMV [see Microbiology (12.4)].
Overdosage
Reports of adverse reactions after overdoses with Ganciclovir, some with fatal outcomes, have been received from clinical trials and during postmarketing experience. One or more of the following adverse reactions has been reported with overdoses: Hematological toxicity: myelosuppression including pancytopenia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia, bone marrow failure Hepatotoxicity: hepatitis, liver function disorder Renal toxicity: worsening of hematuria in a patient with pre-existing renal impairment, acute kidney injury, elevated creatinine Gastrointestinal toxicity: abdominal pain, diarrhea, vomiting Neurotoxicity: seizure Since ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations in patients who have received an overdose of Ganciclovir [see Clinical Pharmacology (12.3)]. Adequate hydration should be maintained. The use of hematopoietic growth factors should be considered in patients with cytopenias [see Warnings and Precautions (5.1)].