University of Washington
Drug Information Sheet
|
Valganciclovir or Placebo |
Manufacturer: Roche
What is it?
Valganciclovir is an investigational drug that is being
studied to prevent the development of cytomegalovirus (CMV) in HIV-infected
people with detectable CMV in the bloodstream.
You will have an equal chance of receiving either valganciclovir or a
matching placebo once you are determined to be eligible to receive study
medication.
How does it work?
Valganciclovir
interferes with the life cycle of CMV to stop it from producing more
virus. Specifically, it ties up the DNA
polymerase enzyme so it cannot build the genetic material needed to make more
virus and infect more cells.
How do I take it?
·
Valganciclovir
and matching placebo are available as 450mg tablets.
·
The
dose will vary with a higher dose (2 tablets twice daily) at the start of the
study decreasing to 1 tablet daily in a stepwise manner. It
will be very important to read and follow the directions on the prescription
label—please call the pharmacy at 731-3454 if you have ANY questions!!.
·
Valganciclovir/placebo
should be taken after eating a meal.
It is extremely important that you take
valganciclovir exactly as directed. You
should set up a system that will help you remember to take your medicines so
that you do not miss any doses. If you
miss a dose, take it as soon as possible; however, if you skip a dose, do not
take two doses at once. Do not stop
taking the medication for any reason at any time unless you are directed to do
so by your study clinician. If you are unable to continue taking your
medication due to side effects, you should contact your study clinician
immediately.
Special Considerations
·
Valganciclovir
should be stored at controlled room temperature in a dry place, out of the
reach of children.
·
Please
bring your medication bottles (empty and partially used) to each study visit.
Interactions
Some
drugs taken together may have interactions that cause illness or impair the
effectiveness of the drugs. It is a good
idea to always check with your study clinician before taking any other
medications, prescription or otherwise, to be sure it will not interact with
valganciclovir.
·
If
you are taking didanosine (ddI or Videx®), you must take it at
least 2 hours before or after taking valganciclovir. Taking the medications together may increase
your risk of having side effects associated with didanosine.
·
Other
medications, such as zidovudine (AZT or Retrovir®) may have side effects that
are similar to valganciclovir. Taking
these medications together may increase your risk of experiencing these side
effects. (Please talk with your study clinician about these risks and refer to
possible side effects listed below.)
Not
everyone experiences side effects. When
they do occur, they may be mild, moderate or severe. Some side effects cannot be felt by the patient but can be found
through laboratory tests, so it is important to see your study clinician
regularly for checkups so that side effects can be detected early and treated.
Reported
side effects of valganciclovir include:
·
Low
white blood cell count (neutropenia, which may increase your risk of infection)
·
Low
platelet count (which may increase your risk of bleeding)
·
Low
red blood cell count (anemia, which may cause fatigue)
·
Nausea,
vomiting
·
Diarrhea,
gas
·
Loss
of appetite, stomach upset
·
Fatigue
·
Inflamed
pancreas
·
Fever
·
Rash
·
Elevated
liver function tests
Thus far, studies have shown that diarrhea, nausea, abdominal pain and gas are the most common of
these side effects.