Ganciclovir Sodium Interactions

Brand names: Ganciclovir

FDA Black Box Warning

WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS • 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 )]. WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS See full prescribing information for complete boxed warning . • Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with Ganciclovir for Injection. ( 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. ( 5.3 ) • Fetal Toxicity: Based on animal data, Ganciclovir for Injection has the potential to cause birth defects in humans. ( 5.4 ) • Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir for Injection has the potential to cause cancer in humans. ( 5.5 )

3 interactions on record

Established and Other Potentially Significant Drug Interactions with Ganciclovir 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. Imipenem-cilastatin: Seizures were reported in patients receiving ganciclovir and imipenem-cilastatin.

Source: FDA drug label - ganciclovir sodium

Patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug following concomitant administration of Ganciclovir Injection 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 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.

Source: FDA drug label - ganciclovir sodium

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 Injection should be considered only if the potential benefits are judged to outweigh the risks.

Source: FDA drug label - ganciclovir sodium