What is Vitravene used for? Vitravene is used to treat a
virus called cytomegalovirus (CMV). CMV can affect one or both eyes in patients with
acquired immunodeficiency syndrome (AIDS) who cannot take other treatment(s) for CMV
retinitis or who did not respond to other treatments for CMV retinitis. The diagnosis
should be made after a comprehensive eye exam, including indirect ophthalmoscopy.Warning(s)
- Vitravene only works in the eye in which it is injected and does not treat CMV
elsewhere in the body. Because CMV may be in other parts of your body and not only in your
treated eye, your doctor will monitor you for CMV in the untreated eye or CMV elsewhere in
your body (e.g. pneumonitis, colitis).
- Vitravene is not recommended if you have been treated within the last 2-4 weeks
with cidofivir (VistideÒ ) because of the increased risk of
General Precautions with Vitravene:
- Vitravene is for eye(s) only.
- Vitravene is not a cure for CMV retinitis. CMV retinitis in some patients may get
worse during or following Vitravene treatment. You should have regular eye exams by your
- Inflammation of the eye (uveitis) occurs in approximately one out of four
patients being treated with Vitravene. This type of reaction is most common when starting
treatment with Vitravene. Your doctor may prescribe medication to treat the inflammation
and may interrupt Vitravene treatment until the inflammation stops.
- Increased pressure in the eye has been reported as another common side effect of
Vitravene injections. Your doctor should monitor the pressure in your eye(s) during each
visit and treat the increase in pressure if necessary.
- If you are receiving Vitravene, you should have regular follow-up eye exams.
What should I tell my doctor or health care provider?
- HIV-infected patients should continue taking their prescribed antiretroviral
medications, unless their doctor tells them otherwise.
Tell your health care provider if you are trying to become pregnant, are already
pregnant, or are breast-feeding.
What are some possible side effects of Vitravene? (This is NOT
a complete list of side effects reported with Vitravene. Your health care provider can
discuss with you a more complete list of side effects.)
The most common side effect is eye inflammation. This reaction is most common
when starting Vitravene and may be treated by your health care provider (See General
Other side effects that may relate to the eye(s) are:
Additional non-eye related side effects might include:
- Abnormal vision
- Swelling around the eye
- Blurred vision
- Bleeding in and around the eye
- Decreased visual sharpness, clearness,
- Reduced color vision
- Eye pain
- Objects in the field of vision (floaters)
- Increased eye pressure
- Sensitivity to light
- Retinal detachment
- Swelling of the retina
- Bleeding of the retina
- Color changes of the retina
- Stomach pain
- Low blood count
- Inflammation of the sinuses
- Liver or kidney problems
- Flu-like symptoms
- Chest pain
For more detailed information about Vitravene, ask your health care provider.
http://www.fda.gov/cder/foi/label/1998/20961lbl.pdf Vitravene Approved Label
Date Posted: 10/5/98