Information for Patients: 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 instructed to take CYTOVENE capsules
with food to maximize bioavailability.
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-IV or CYTOVENE. Similarly, men
should be advised to practice barrier contraception during
and for at least 90 days following treatment with CYTOVENE-IV
or CYTOVENE.
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
(Retrovir®*). 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 (Videx®#). 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-IV
or CYTOVENE. Some patients will require more frequent
follow-up.
Transplant Recipients: Transplant recipients should be
counseled regarding the high frequency of impaired renal
function in transplant recipients who received CYTOVENE-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-IV
solution compared with those who received placebo in the
same trials may indicate that CYTOVENE-IV played a significant
role.
Laboratory Testing: Due to the frequency
of neutropenia, anemia and thrombocytopenia in patients
receiving CYTOVENE-IV and CYTOVENE (see ADVERSE EVENTS),
it is recommended that complete blood counts and platelet
counts be performed frequently, especially in patients
in whom ganciclovir or other nucleoside analogues have
previously resulted in leukopenia, or in whom neutrophil
counts are less than 1000 cells/µL at the beginning
of treatment. Increased serum creatinine levels have been
observed in trials evaluating both CYTOVENE-IV and CYTOVENE.
Patients should have serum creatinine or creatinine clearance
values monitored carefully to allow for dosage adjustments
in renally impaired patients (see DOSAGE AND ADMINISTRATION).
See also WARNINGS and PRECAUTIONS
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