"The European Medicines Agency (EMA) has updated information on the risk for body fat changes and lactic acidosis associated with antiretroviral medications for HIV infection.
HIV medicines will no longer require a warning regarding fa"...
All patients should be informed that the major toxicities of ganciclovir are granulocytopenia (neutropenia), anemia and thrombocytopenia and that dose modifications may be required, including discontinuation. The importance of close monitoring of blood counts while on therapy should be emphasized. Patients should be informed that ganciclovir has been associated with elevations in serum creatinine.
Patients should be advised that ganciclovir has caused decreased sperm production in animals and may cause infertility in humans. Women of childbearing potential should be advised that ganciclovir causes birth defects in animals and should not be used during pregnancy. Women of childbearing potential should be advised to use effective contraception during treatment with CYTOVENE (ganciclovir) -IV. Similarly, men should be advised to practice barrier contraception during and for at least 90 days following treatment with CYTOVENE-IV.
Patients should be advised that ganciclovir causes tumors in animals. Although there is no information from human studies, ganciclovir should be considered a potential carcinogen.
All HIV+ Patients
These patients may be receiving zidovudine. Patients should be counseled that treatment with both ganciclovir and zidovudine simultaneously may not be tolerated by some patients and may result in severe granulocytopenia (neutropenia). Patients with AIDS may be receiving didanosine. Patients should be counseled that concomitant treatment with both ganciclovir and didanosine can cause didanosine serum concentrations to be significantly increased.
HIV+ Patients With CMV Retinitis
Ganciclovir is not a cure for CMV retinitis, and immunocompromised patients may continue to experience progression of retinitis during or following treatment. Patients should be advised to have ophthalmologic follow-up examinations at a minimum of every 4 to 6 weeks while being treated with CYTOVENE (ganciclovir) -IV. Some patients will require more frequent follow-up.
Transplant recipients should be counseled regarding the high frequency of impaired renal function in transplant recipients who received CYTOVENE (ganciclovir) -IV solution in controlled clinical trials, particularly in patients receiving concomitant administration of nephrotoxic agents such as cyclosporine and amphotericin B. Although the specific mechanism of this toxicity, which in most cases was reversible, has not been determined, the higher rate of renal impairment in patients receiving CYTOVENE (ganciclovir) -IV solution compared with those who received placebo in the same trials may indicate that CYTOVENE (ganciclovir) -IV played a significant role.
Last reviewed on RxList: 4/2/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Cytovene Information
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